PWS Steris Sterilizer Maintenance 12.19.2025.docx

Performance Work Statement (PWS) Steris Full-Service Maintenance Contract

1.0 Title

Steris Equipment Service and Full Service Maintenance

2.0 Scope

The contractor shall provide the Biomedical Engineering and Research Departments with full-service maintenance, corrective maintenance, and OEM-aligned Full Service Maintenance for all Steris equipment listed in Attachment A. Service shall comply with all OEM specifications, VA policies, VISN 19 requirements, NFPA, OSHA, TJC, and infection prevention standards. Para 6.1 and 6.2 are for the Biomedical Engineering Department and Para 6.3 and 6.4 are for the Research Department.

3.0 Background

Steris equipment supports Sterile Processing Service operations and is critical to reprocessing reusable medical equipment (RME). Maintaining proper functionality is essential to patient safety.

4.0 Equipment List

Refer to Attachment A for Equipment List.

5.0 Period of Performance

Base Year: 03/01/2026 – 02/28/2027 Option Year 1: 03/01/2027 – 02/29/2028 Option Year 2: 03/01/2028 – 02/28/2029 Option Year 3: 03/01/2029 – 02/28/2030 Option Year 4: 03/01/2030 – 02/28/2031

6.0 Requirements

6.1 Unscheduled Full Service Maintenance for Biomedical Engineering

6.1.1 The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

6.1.2 Only the Biomedical Engineer, Point of Contact, or Contracting Office Representative designated by the Contracting Officer (CO) has the authority to approve/request an unscheduled maintenance service call to the contractor.

6.1.3 The contractor's Field Service Engineer (FSE) shall respond on site within four (4) hours after receipt of request for service. The contractor shall provide parts, if required to effect repair, within 24 hours of diagnosing the problem.

6.2 Scheduled Full Service Maintenance for Biomedical Engineering

6.2.1 The Contractor shall perform Full Service Maintenance Service to ensure that the equipment listed performs in accordance with the original manufacturer’s specifications. Annual PM Service must be completed by December 31st of each year. An outline of the Preventative Maintenance (PM) schedule and procedures shall be provided to the Biomedical Engineer.

The contractor shall provide a written description of the Full Service Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

a. Cleaning of equipment.

b. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer's specifications.

c. Calibrating and lubricating the equipment.

d. Performing remedial, non-emergent maintenance.

e. Testing and replacing faulty and worn parts and/or parts likely to fail or become faulty or worn.

f. Inspection and replacement of worn or frayed electrical wiring and cables.

g. Returning the equipment to the operating condition and mode

h. Providing documentation of services performed.

6.2.2 All service/repairs shall be performed during normal hours of coverage unless requested or approved by the Biomedical Engineer. The only exception is hardware/software update/upgrade installations which shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the Biomedical Engineer). The contractor shall provide software/hardware updates at no charge.

6.2.3 All exceptions to the PM schedule shall be arranged and approved in advance with the Point of Contact, or Biomedical Engineer. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained

(as applicable). This documentation shall be provided to the Point of Contact at the completion of the PM.

6.2.4 Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

6.3 Unscheduled Maintenance for Research

6.3.1 The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, to include all intervening service calls performed between scheduled services and calibrations. All required parts shall be furnished by the contractor to the VA at no cost. The contractor shall repair the equipment to functional level equivalent to the original manufacturer’s specifications.

6.4 Scheduled Maintenance for Research

6.4.1 The Contractor shall perform PM Service to ensure that the equipment listed performs in accordance with the original manufacturer’s specifications. Annual PM Service must be completed by December 31st of each year. An outline of the PM schedule and procedures shall be provided to the Research Department.

The contractor shall provide a written description of the Full Service Maintenance Inspections. This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

6.4.4 Work performed outside the normal hours of coverage, at the request of FSE, shall be considered service during normal hours of coverage and shall be exempt from an extra labor hour charge.

6.5 Contractor Test Equipment

The contractor shall ensure all contractor supplied test equipment is properly calibrated, and certified. If requested by the COR or POC, the contract shall be able to supply any certificates tied to the quality of the test equipment. Test equipment calibration shall be traceable to a national standard.

6.6 Hours of Coverage

Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding the federal holidays listed as follows:

Federal Holidays:

Any other day specifically declared a National Holiday by the President of the United States.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

6.7 Documentation (ESR)

6.7.1 The documentation shall include detailed descriptions of the scheduled and unscheduled Full Service maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the specifications Each ESR must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor and contract number

b. Name of FSE who performed services

c. Contractor service ESR number/log number

d. Date, time (starting and ending), equipment downtime and hours on-site for service call.

e. VA purchase order number(s) covering the call if outside normal working hours.

f. Description of problems reported by the POC/user (if applicable).

g. Identification of equipment to be serviced:

· Inventory ID number,

· Manufacturer's name, device name, model number & serial number,

· Any other manufacturer's identification numbers.

h. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including:

· Labor and Travel,

· Parts (with part numbers),

· Materials and Circuit Location of problem/corrective action.

· Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

i. Signatures:

· FSE performing services described.

· Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or CO before service is completed

6.7.2 The Contractor shall log in with Biomedical Engineering or the Research Department prior to performing any services. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall log out with Biomedical Engineering or the Research Department and submit the ESR(s) to the Biomedical Engineer or the Research Department Point of Contact. All ESRs shall be submitted to the equipment user for an “acceptance signature” and then to the POC for an “authorization signature”. If the POC is unavailable, a signed, authorized copy of the ESR shall be sent to the contractor after the work can be reviewed (if requested or noted on the ESR).

6.8 Compliance Requirements

Includes OSHA & PPE, Flu & COVID requirements, VA 6500.6 security, OEM training qualifications, facility rules, and no unauthorized service calls.

7.0 Additional Charges

There will be no additional charge for time spent at the site (during or after the normal coverage areas) awaiting the arrival of additional FSE and/or delivery of parts.

8.0 Reporting Required Services Beyond Service Scope

The contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COR or POC, in writing, of the existence or development of any defects in, or repairs required, to the scheduled equipment which, the contractor does not consider his/her responsibility due to “abuse” or “damage” to the equipment. The contractor shall furnish the Government with a written estimate of the cost to make the necessary repairs.

9.0 Acceptance of Condition of Equipment

The contractor accepts responsibility for the equipment covered under this equipment in an “as is” condition. Inspection of the equipment by the contractor shall be done prior to coverage, if required by the contractor.

10.0 Competency and Certification of Personnel Servicing Equipment

10.5 Each respondent must have an established business, with an office and full time staff. The staff shall include a fully qualified FSE and fully qualified alternate FSE.

10.6 “Fully Qualified” is based on successful completion of factory training and experience in the field. For training, the FSE shall have successfully completed a formalized training program for the equipment identified in the schedule. For field experience, the FSE(s) shall have a minimum of two years of experience (with the exception of equipment on the market less than two years) with respect to scheduled and unscheduled Full Service maintenance, on the covered equipment.

10.7 The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by fully qualified competent FSEs. The contractor shall provide copies of all factory certificates for FSEs showing types of equipment and dates of training for all equipment identified to be covered. When deemed appropriate, the COR or Contracting Office Representative reserve the right to prohibit contractor personnel from working on VAMC equipment.

11.0 Service Manuals/Tools/Equipment

The contractor shall provide tools, (test) equipment, service manuals or service diagnostic software. 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) necessary to meet the performance requirements and repair of the medical equipment. A reference list of applicable service manuals and their respective locations shall be provided to the Biomedical Engineer or the Research Department upon request.

12.0 Records Management Obligations

The contractor shall furnish all spare and replacement parts needed to service the equipment. The price of all parts used to perform all scheduled and unscheduled Full Service maintenance shall be included in the coverage. The Government will not pay for any parts provided (during either scheduled or unscheduled Full Service maintenance), by the contractor during the period of the medical equipment being covered. Only new standard parts (manufactured by the maker of the equipment, or equal) shall be furnished to maintain the equipment.

13.0 Records Management Obligations

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Department of Veterans Affairs records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their Department of Veterans Affairs contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Department of Veterans Affairs and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Department of Veterans Affairs or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Department of Veterans Affairs. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Department of Veterans Affairs control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Department of Veterans Affairs guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The Department of Veterans Affairs owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Department of Veterans Affairs shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Department of Veterans Affairs-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

14.0 Quality Control:

Please note that the contractor’s performance will be evaluated by the COR in accordance with a Quality Assurance Surveillance Plan (QASP) developed by the VA. This plan includes performance metrics and methods of surveillance such as random inspections, customer feedback, service reporting, and direct observation. While the QASP itself is not included, contractors must be aware that adherence to the performance requirements is essential and will be closely monitored throughout the term of the contract.

Expectations:

- Preventive Maintenance completion: Contractor must ensure that the Preventative maintenance is 100% on schedule, with a 2% monthly deduction for noncompliance.

- Corrective Maintenance response: Contractor must respond within 2-hours by phone and be on site within 1 business day onsite for Corrective Maintenance, with a 2% monthly deduction for delays.

- Uptime: Contractor must ensure that the system is up a minimum of 95% of the time, with a 2% monthly deduction for delays.

- ESR submission: Contractor must submit all required documentation within 24 hours, with a 2% monthly deduction for delays.

- Parts: Contractor must only use OEM parts, achieving 100% compliance, with a 2% monthly deduction for violations.

Performance Standards (AQL) AQL thresholds:

- PM completion: 100%

- Response times: 95%

- Uptime: 95%

- Documentation accuracy: 95%