Attachment I - PWS Sterilizer Maintenance (Beaufort).pdf

DHA PWS Template Under SAT August 2022 Rev. 1

Department of Defense Defense Health Agency

Performance Work Statement

Sterrad 100NX Repair and Maintenance Services

06 October 2026

Naval Medical Readiness and Training Command Beaufort, SC

August 2022 Rev. 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide maintenance and repair service for two

(2) Sterrad 100NX (ST100NX) sterilizers.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform maintenance and repair services for two (2) ST100NX sterilizers as defined in this Performance Work Statement (PWS).

1.1.2 Background: Naval Hospital Beaufort has a requirement for maintenance and repair service on two (2) ST100NX sterilizers. The previous contract was held by Advanced Sterilization Products services (ASP) for a full maintenance contract from April 07, 2021, to October 06, 2026.

1.1.3 Scope: The contractor shall provide maintenance services which include on-site corrective repairs, normal working hour coverage (8:00AM to 4:30PM Monday through Friday excluding recognized Federal holidays; emergency services and routine preventative maintenance services to Government-owned equipment. Maintenance will include all systems, subsystem components, and assemblies (i.e. the contractor is responsible for total maintenance of the entire system). All maintenance provisions will apply to hardware, firmware, and software, as appropriate, unless otherwise stated by the Government.

1.1.4 Period of Performance (PoP): The Period of Performance has a Base Period, including four optional periods and one (1) six-month extension.

Base Year: 06 October 2026 to 05 October 2027 Option Year 1: 06 October 2027 to 05 October 2028 Option Year 2: 06 October 2028 to 05 October 2029 Option Year 3: 06 October 2029 to 05 October 2030 Option Year 4: 06 October 2030 to 05 October 2031 6-Month Extension: 06 October 2031 to 05 April 2032

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at Naval Hospital Beaufort Bldg. 1, 1 Pinckney Blvd. Beaufort, SC 29902

1.2.2 Recognized Federal holidays: The contractor shall not be required to perform services on all Federally recognized holidays.

1.2.3 Hours of operation: The contractor is responsible for conducting business between the hours of 8:00 A.M. to 4:30 P.M., Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an

August 2022 Rev. 1 adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.2.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours. In the event that emergency service outside the normal working hours is required by the Government, Vendor will bill the Government at published commercial rates negotiated and approved by a Government Contracting Officer prior to Vendor services are rendered.

1.3 Contractor Identification

1.3.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES: The Government will be responsible for maintaining the proper environment, including utilities and site requirements necessary for the system to function properly as specified by Vendor, the OEM. The Government will operate the ASP system(s) in accordance with the instruction manual(s) provided by ASP, the OEM. The Government will certify that the equipment to be maintained under this PWS and resulting contract will be in good operating condition on the effective date of contract award. For the purpose of this PWS and resulting contract, “good operating condition” means the conditions necessary for the equipment to function as intended by ASP and the OEM without corrective maintenance.

2.1.1 Vendor Pre-Maintenance Inspections: The Vendor representative(s) at each Government site will request a pre-maintenance inspection prior to the onset of the contract. All apparent discrepancies will be identified upon submittal of Vendor’s quote, and any claims will be submitted to the Government within 30 days of contract award. If the Government does not afford Vendor an inspection prior to the Vendor quoting for services, Vendor will conduct the pre-maintenance inspection within 10 days of contract award and any adjustments to Vendor’s original quote and will be submitted within 30 days of contract award. Vendor will identify all non-apparent/ hidden discrepancies no later than the first scheduled preventative maintenance.

Vendor will submit any claims resulting from hidden defects to the Government within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during pre-maintenance inspections will be repaired by Vendor under a separate purchase order. The cost of repairs will not exceed Vendor’s normal retail rate for required repairs. Vendor will leave the equipment in good operating condition at the expiration of this contract. During the final week of the awarded service contract, the Government will make final inspection of the equipment. Any correction of mutually agreed deficiencies noted during this inspection will be resolved prior to contract end.

August 2022 Rev. 1

2.1.2 Vendor Furnished Property and Material: The Vendor will provide all service literature, reference publications, laptop computers and diagnostic software to be used by Vendor service technicians and as required for the completion of the services in accordance with the PWS and resulting contract.

2.1.3 Replacement Parts: The contractor will have ready access to unique and/or high mortality replacement parts. All parts Vendor supplies will be compatible with the existing system(s). In the event that replacements parts are required to be shipped, shipping will be performed in the fastest reasonable means possible (e.g., next day air) at no additional cost to the Government.

The Vendor, at our expense, for only preventative maintenance and corrective maintenance within scope of this PWS, will replace all worn or defective parts necessary to restore the equipment to 100% operational OEM condition. The Vendor is not responsible for consumable items.

Vendor installed replacement parts will become the property of the Government and the replaced malfunctioning parts will become Vendor property. Vendor will properly dispose of replaced items at no additional cost to the Government, including all “environmental” fees where required. Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts will be Vendor’s responsibility.

All replacement parts will be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies will be allowed, provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. Vendor will specifically annotate on the final Field Service Report the use and identification of rebuilt parts and the period of warranty. Replacement parts will maintain the integrity of system / equipment certification to include compliance with any UL, AMA, JACHO, Manufactures Certifications or any other certifications, as they apply.

Vendor will include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates will be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by Vendor. Vendor will provide installation within 30 days of release, regardless of Preventative Maintenance Schedules.

2.2 Vendor Report Requirements: During normal duty hours, Vendor Field Service Engineer (FSE) personnel will check-in with the Biomedical Engineering Division upon arrival at the Government site and again prior to departure. (Biomedical Engineering is located in Bldg. 1 South Side Basement Floor; phone: 843-228-5546.) Vendor FSEs will personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, Vendor FSE’s will notify the Command Duty Officers Quarter Deck Desk (Bldg. 1, East Side 1st Floor; phone: 843-228-5200) and the systems operator designated by BME.

August 2022 Rev. 1

Vendor will provide to BME a full-service report within two (2) days after completion of all service performed. The Vendor Service Report will include, but not be limited to: contract number, equipment description (model, serial number, equipment control number), Vendor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. Vendor will affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag will contain: Vendor’s name, the technician performing inspection and date of inspection legibly printed.

2.2.1 Preventive Maintenance Services: The contractor will perform preventive maintenance twice per year in accordance with ASP, the OEM, recommendations. All test equipment used in the performance of this PWS and resulting contract will be calibrated (if required / as required by manufacture of test equipment) and will be in compliance with Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Original Equipment Manufacturer (OEM), Defense Health Agency (DHA) standards, and Federal Drug Administration (FDA) standards as required.

2.2.2 Corrective Maintenance: The Government BME will request corrective maintenance to Vendor’s technical POC. The Vendor will assign a unique Log/Reference Number to each Government request for corrective maintenance. Vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a Vendor FSE. Telephone consultation will: 1) provide instructions in determining operator error; 2) to determine the most likely cause of the problem; 3) to determine if resolution of the problem requires the dispatch of an FSE; and 4) to identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

Vendor’s normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. Vendor Service Tech will respond via telephone within four (4) hours after receipt of trouble call and make a best effort to provide on-site service no later than the close of business (4:30 pm) on the next business day. Vendor will make a best effort to have all equipment operational within 72 hours of initial on-site response.

2.2.3 Vendor Pricing Inclusions: The contractor’s pricing will be inclusive of all costs including parts, labor, travel, and shipping, unless otherwise indicated. Any/all exclusions are listed as follows: No Exclusions. Vendor FSE’s will have their own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation/repair of all equipment included in this contract.

2.2.4 Removal of Government Property: Whenever the contractor determines the repair of equipment cannot be performed at the Government site, Vendor will notify BME, who will make arrangements for Vendor to remove the item to Vendor’s designated site. Vendors may be required to sign a government form accepting responsibility for the Government equipment. In these cases, Vendor will provide a detailed description of removed items. For associated items / accessories, Vendor will provide a detailed description and quantities of items to be removed.

August 2022 Rev. 1

Description will include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components. All charges resulting from Vendor -determined requirement to transport Government owned property, covered by the contract resulting from this PWS, to and from an alternate repair location will be Vendor’s responsibility.

2.3 Equipment Modification and Upgrades: The contractor will only incorporate OEM specified modifications, alterations and upgrades. BME approval will be obtained prior to Vendor’s installation of any modification, alteration, or upgrades. The Government will not alter the system without prior notification to Vendor. Vendor, at no additional cost, will provide software updates to the Government. Installation of updates will be mutually determined by Vendor and the Government. All supplied software will be warranted current and free of defects such as viruses.

2.3.1 Service beyond the Scope of this PWS and Resulting Contract: The contractor will immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which Vendor considers they are not responsible for under the terms of this contract.

At the same time of the notification, the contractor will furnish BME with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this PWS will not be covered under this contract but will be to be ordered under a separate purchase order.

3.0 Qualifications/Considerations

3.1 Special Qualifications/Considerations: ASP Equipment listed in this contract will be maintained to meet all ASP’s, as the original equipment manufacturer (OEM) specifications.

ASP as the OEM is sole authorized maintenance provider of ASP equipment. As such, ASP trained Field Service Engineers are the only qualified / authorized personnel for the maintenance and repair of all ASP equipment listed within this contract. No sub-contractors will be used to fulfill the requirements of this contract. Vendor Field Service Engineers (FSE) qualification includes certification by ASP, the OEM, as being trained /qualified to perform required repairs.

Vendor will have ready access to parts inventory of OEM replacement parts. Vendor will provide trained, experienced, English-speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance. Vendor will provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A Vendor systems operator will be made available to answer technical questions regarding system operations and applications. The Vendor Point of Contact (POC). Service calls can be placed 24 hours a day, 7 days per week by the Government calling a Vendor supplied toll-free response center. Vendor qualified service reps will make a “best effort” to call back within 4-hours during normal business hours (8am – 5pm CST / Monday – Friday excluding Federal Holidays) to schedule and Vendor service visit.

4.0 Points of Contact

August 2022 Rev. 1

4.1 Points of Contact:

Biomed Division Phone: 843-228-5546 Email: dha.beaufort.Beaufort-NH.list.biomed-trouble-tickets@health.mil

HTM Manager Amos Hodnett Jr.

Phone: 843-228-5552 Email: amos.hodnett.mil@health.mil

BMETs Vincent Nesbitt: 843-228-5560 vincent.a.nesbitt.civ@health.mil mailto:dha.beaufort.Beaufort-NH.list.biomed-trouble-tickets@health.mil mailto:amos.hodnett.mil@health.mil mailto:vincent.a.nesbitt.civ@health.mil