SOW STERIS-updated.docx

Statement of Work Scope of Work:

Contractor shall provide services to conduct chamber cleanings six times a year for the sterilizers located within the STVHCS. The chamber cleanings shall be conducted on seven Amsco 400 Series units. Contractor shall provide all materials, labor, tools, lodging, etc, applicable to accomplish this job. Equipment shall be calibrated to OEM standards after cleanings. This equipment is located within the at South Texas Health Care Systems facilities. The sterilizers are listed below with locations:

Audie Main Hospital: Amsco 400 Series 60H (QTY:3) 7400 Merton Minter Amsco 400 Series 20S (QTY:2) San Antonio, Texas 78229 DataPoint: Amsco 400 Series 20S (QTY:2) 8410 Datapoint Dr San Antonio, Texas 78229 Performance Period: The period of performance of this contract shall consist of one 12-month base period, May 1, 2025, to April 30, 2026. At the discretion of the Contracting Officer, the Government may exercise up to Four 12-month option periods.

Option Year 1: May 1, 2026, to April 30, 2027 Option Year 2: May 1, 2027, to April 30, 2028 Option Year 3: May 1, 2028, to April 30, 2029 Option Year 4: May 1, 2029, to April 30, 2030 Conformance Standards:

All services provided under this contract must be performed in conformance with the Code of Federal Regulations Part 21, National Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), and Original Equipment Manufacturer standards and specifications.

Hours of Work:

1. Hours of work for PM and emergency repairs shall be during normal business hours, Monday through Friday, 7:30 am through 4:30 pm. This excludes federal holidays or as otherwise arranged with the Contracting Officer Representative .

1. The holidays observed by the Federal Government are New Year’s Day, Martin Luther King Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day and President’s Day. Also, any other day declared by the President of the United States to be a national holiday.

1. The Contractor’s Field Service Engineers must report to the POC to apply for a Contractor’s Badge. If a contractor’s badge is not obtained, they must sign in at the Security Police Desk to obtain a one-day badge. Field Service Engineers must sign in at Biomedical Engineering Services and inform Biomedical Engineering personnel of their presence before work begins. Upon completion of work, the Field Service Engineer must report to Biomedical Engineering personnel and debrief them on the work accomplished. If they received a one-day badge from the Security Police they must report back to the Security Police Desk to return the badge and sign out.

Description of Services Provided by the Contractor:

a. The Contractor shall provide all required test equipment, qualified competent personnel, and Original Equipment Manufacturer (OEM) parts to install, repair and return this system to an operable condition in accordance with Steris Corporation/AMSCO’s specifications and Federal Drug Administration’s 21 Code of Federal Regulations (21 CFR). The Contractor shall use the OEM established procedures and checklists, (or Contractor-supplied equivalent satisfactory to the Government POC). A Field Service Report shall be supplied to the COR at the completion of installation and calibration to include a detailed check list of procedures performed.

b. The Contractor shall notify the POC of the existence or development of any defects in, or repairs to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse).

c. System check-ups: The contractor shall perform inspections of the system at any time at the request of the POC during the warranty period.

Parts:

The Contractor shall furnish all parts as necessary to conduct chamber cleanings on the Steris Sterilizers, covered by this contract, in accordance with the Conformance Standards Section. The Contractor stipulates by submitting his offer that he has ready access to new standard parts (manufactured, supplied by the manufacturer, or equal thereto). All parts supplied shall be of current manufacture and have full compatibility with existing equipment. Documentation of intended parts source(s) shall be provided to the Contracting Officer upon request.

NOTE: Any additional charges to be claimed must have been approved by the Contracting Officer before service was performed and a valid purchase order must be obtained prior to initiation of the service repair if outside scope/hours of coverage.

Competency of Personnel Servicing Equipment:

1. The Contractor’s staff shall include a “fully qualified” Field Service Representative assigned to this area and a “fully qualified” Field Service Representative who shall serve as the backup.

1. “Fully qualified” is based upon training and on experience in the field. For training, the Field Service Representatives must have successfully completed a formalized training program for the equipment covered under this contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience

1. Personnel with any laptops, thumb drives or CD/DVD’s intended to be plugged in to the equipment are required to allow these devices to be scanned by Biomedical Engineering personnel for malware before they are plugged in to the systems. After repairs are completed, these systems must be brought to Biomedical Engineering personnel to be scanned for possible patient personnel health history.

Test Equipment:

Upon request of the Government POC or the Contracting Officer, the Contractor shall provide a copy of the current Calibration Certification of all test equipment which is to be used by the Contractor to perform service under this contract. Calibration of equipment shall be traceable and in conformance with test equipment Original Equipment Manufacturer standards.

Safety Requirements:

In the performance of this contract, the Contractor shall take such safety precautions as the Government POC may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Government POC and/or Contracting Officer shall notify the Contractor of any safety issues and the action necessary to correct these issues. Such notice, when served on the Contractor or his representative at the work site, shall be deemed sufficient for the corrective actions to be taken. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or part of the work.

Information Systems Officer, Information Protection:

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services in the application of complex adaptive system theory to health care organizations. The certification and accreditation requirements do not apply to this procurement nor is a security accreditation package required.

Privacy Officer:

The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Manager:

RECORDS MANAGEMENT:

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. 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 by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. 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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.