J065--steris service B+4(671-23-1-196-0003)(VA-23-0006166)

STATEMENT OF WORK

The contractor shall provide services to troubleshoot, repair, perform preventive maintenance (PM), calibration, and replace defective parts. The service maintenance agreement shall cover one (1) base year and 4 option years with a start date of 15 November 2022 through 14 November 2023. The contractor shall provide other support services described herein for each Steris Corporation/AMSCO Vision Multi-Chamber Steam, ETO, Plasma Sterilizer Systems, and any other equipment outlined in the SOW. This equipment is located within the at South Texas Health Care Systems facilities. The equipment that needs to be serviced is listed below with their respective serial numbers.

Model Serial Number

Reliance Crest 11,15,20 W Ultrasonic Cleaner 0209C0471

Medium Century 26x26 Steam Custom 030671606

Medium Century 26x26 Steam Custom 030711623

V PRO maX OOME 030761705

V PRO maX OOME 030991611

Century 26x37.5 Steam Sterilizer DD 031000709

Century 16/20 Ster Elec SD 031010812

Century 26x37.5 Steam Sterilizer SD 031011206

Century 26x37.5 Steam Sterilizer DD 032410708

Century 26x37.5 Steam Sterilizer SD 032530702

AMSCO 400 16/20 STERIS Generator Sterilizer SD 032682008

AMSCO 400 16/20 STERIS Generator Sterilizer SD 032762016

Century 26x37.5 Steam Sterilizer SD 033430910

Century 16/20 Ster Elec SD 033440902

Century 16/20 Ster Elec SD 033490903

Innowave PCF Sonic Irrigator 05200077419

Innowave PCF Sonic Irrigator 05200077420

Caviwave Pro Console CRP17 WRD 0613ST2240003

Logiquip Fixed Height Processing Sink 082317206

Caviwave Pro Cleaner CRP17 W 1218TC0057

Caviwave Pro Cleaner CRP17 W 1218TC0058

Caviwave Pro Cleaner CRP17 W 1218TC0059

Chrom CES CH05 08 Carbon Steel 75 KW 33483

Reliance/Hamo Genfore Automated Washer Electric 3605510012

Reliance/Hamo Vision Single Chamber Washer 3614917027

Reliance 1321 Vision Cart Washer Steam From 3616615xxx 3624216010

Reliance Vision Multi Chamber Washer 3632914002

Reliance Vision Multi Chamber Washer 3633514038

Reliance 1327 Vision Cart Washer Electric From 3616615xxx 3604921001A

AMSCO 7052HP 7053HP Washer 11/1/22 3619521008

AMSCO 7052HP 7053HP Washer 11/1/22 3616821004

AMSCO 600 Electric SD 11/1/22 31602113

Innowave PCF Sonic Irrigator 12/1/22 7213180101

Innowave PCF Sonic Irrigator 12/1/22 7213180102

V PRO maX 2 LOW TEMPERATURE STERILIZATION SYSTEM 12/1/22 32182107

AMSCO Drying Cabinet with Purge Option 11/1/22 3991

InnoWave ECO 6/1/23 12214617214

AMSCO 50 Reprocessing Sink 52107272S

MSCO 50 Reprocessing Sink 52107211S

Acu sInQ Enzymatic Dosing System 8290676

Acu sInQ Enzymatic Dosing System 8190494

Acu sInQ Enzymatic Dosing System 8221910

Acu sInQ Enzymatic Dosing System 7002130

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:

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 (COR).

The holidays observed by the Federal Government are New Year s Day, Martin Luther King Day, Memorial Day, 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.

The Contractor s Field Service Engineers must report to the COR 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:

The Contractor shall provide all required test equipment, qualified competent personnel, and Original Equipment Manufacturer (OEM) parts to 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 COR). 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.

The Contractor shall notify the COR 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).

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

Parts:

The Contractor shall furnish all parts as necessary to maintain the equipment, 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. All parts necessary for the maintenance or repair of this equipment shall be furnished as part of this contract. Any refurbished parts the Contractor may propose to use are subject to the same inspection and QC procedures as all other materials used in the manufacture of products and shall be warranted to the same extent as all other components.

Documentation/Reports:

The Contractor shall submit a legible field service report within 3 working days, which shall include detailed descriptions of the preventive maintenance inspection and/or emergency repair services performed, including replaced parts and estimated prices required for the service call.

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:

The Contractor s staff -- or the staff of any sub-contractor used by the Contractor -- 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.

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 providing preventive maintenance and emergency repair services on the same make and model of equipment covered under this contract. Proof of experience shall be submitted along with quotes.

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 COR 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 Contracting Officer may determine to be reasonably necessary to protect the lives and health of occupants of the building. The 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 and hold the Contractor in default.

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. 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.

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.

Security Statement:

Reference the Interconnection Security Agreement already in place between the contractor and the U.S. Department of Veterans Affairs.

VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS

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

a. Documentation requirements:

1) If fully vaccinated, shall show proof of vaccination

i. 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

2) 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.

3) 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.

4) 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.

2. 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 following website: COVID-19 Screening Tool. Regularly check the website for updates.

a. Contractor employees who work away from VA locations, but who will have direct patient 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, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

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

(End of VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors)