PWS-Sterilization Services rev 20250204.pdf

STATEMENT OF WORK

Sterile Processing Services For

Used Medical & Dental Instruments

1. Introduction/Background

The purpose of this Contract is to provide all services, labor, parts, materials, and equipment necessary for the proper receipt and handling, transport to the sterile processing facility, performance of sterile processing, proper wrapping and protection, quality assurance check performed to ensure sterilization, and sterile delivery back to U.S.

Naval Medical Readiness Training Unit (USNMRTU) Sasebo and its in-house Clinics for the government-owned instrument sets at USNMRTU Sasebo. All sets will require functional testing during assembly. All sets will be processed according to AAMI standards and/or manufacturer’s instructions for use (IFU).

2. Scope of Work

The vendor shall perform the services in accordance with Navy Bureau of Medicine, Joint Commission, and Association for Advancement of Medical Instrumentation (AAMI) regulations and guidelines. Services to be performed include proper transportation to the sterile processing facility of used medical & dental instruments, performance sterile processing of surgical instruments. The vendor will perform quality assurance check performed to ensure sterilization, and sterile delivery back to NMRTU Sasebo. All sets will also require functional testing completed during assembly.

2.1 Definitions: As used throughout this work statement, the following terms shall have the meaning set forth below:

2.2. General Performance Requirements:

2.3. The Vendor shall provide comprehensive sterile processing services and equipment in accordance with American Association for Medical Instrumentation (AAMI) ST79 regulations and guidelines.

2.4. Ensure that only fully-qualified technicians who have gone through proper trainings and education be employed in the performance of any and all work performed under this contract. Personnel shall have sufficient experience to demonstrate proficiency in performance of the services. Upon request, vendor shall provide written assurance of the competency of their personnel as well as a list of Japan’s U.S. equivalent trainings needed to perform such task. The KO may authenticate the training requirements and request training certificates or credentials from the Vendor at any time.

2.5. End-User Requirements: In order to maintain its quality sterilization standards, USNMRTU Sasebo will provide the vendor the following items:

Item Number Description Quantity

2.5.1 3M, Class 5 (type 5) steam indicators 1 Bag

2.5.2 3M, Class 1 steam tapes 1 Tape

2.5.3 Light Blue Muslin wrap (36 X 36 size) 1 Bag

2.5.4 Light Blue Muslin wrap (24 X 24 size) 1 Bag

2.5.5 Peal Pack (3.5X 8 in) 1 Box

2.5.6 Peal Pack (5 X 10.5 in) 1 Box

2.5.7 Peal Pack (7.5 X 13 in) 1 Box

2.5.8 Peal Pack (10 X15.5 in) 1 Box

2.5.9 Tip protector (2 X 5in; 6.5 X 8in; 5.5 X 9.6in) 1 Box each

Considering a Total of 15,000 pieces

2.6. Vendor shall furnish a written or electronic Service Report (SR) to the USNMRTU Sterile Processing Division personnel. All SR's shall be submitted upon delivery of sets or instruments to USNMRTU. The vendor or their representative shall complete the SR to include, at a minimum, the following information:

1. Vendor Name

2. Point-of-contact’s printed name, telephone number, and signature

3. Date and Time of Delivery (departed Vendor facility)

4. List of items serviced and returned

5. Summary of Work Performed and Problems Encountered (including damaged items, missing items, and incomplete sets).

6. Compliance Report; to include chemical and biological testing.

2.7. Preventive maintenance shall be performed on sets/instruments in a manner which will minimize corrective maintenance, and will include but is not limited to: calibration, adjustment, lubrication, safety, or functionality issues, testing required to maintain a safe environment of care, electrical safety testing, and output testing.

2.8. Furnish and utilize approved disinfectants, cleaners, and lubricants in accordance with OEM guidelines (instructions for use) or AAMI guidelines for instrumentation.

2.9. Transportation of Instrument Sets: Transportation of instrument sets will be within AAMI recommended guidelines, at a minimum. All vendor-provided containment devices carrying instrument sets shall be loaded and off-loaded by vendor personnel.

2.10. Response Time and Labor:

2.11. Vendor shall use commercially reasonable efforts to respond by telephone within one (1) hour of contact from USNMRTU, regarding any issue pertaining to the services. Under no circumstances shall the Vendor assume an inquiry, via telephone or any other means, is an authorization to provide services not specifically covered by the terms of the contract.

2.12. All compensation for labor is provided for in this contract and included in the contract price. Any work that would require additional charges must be approved, in writing, in advance by the contracting officer.

2.13. Travel and Related Expenses: Vendor shall be responsible for its service related trip expenses, including round trip travel, mileage, and overnight living expenses.

2.14. Shipment: Vendor shall pick-up, process, and deliver the materials in set times agreed to on the quotes. The department can make allowances for extended timeframes on some sets upon request due to the complexity of those sets. In such cases, written authorization from the Sterilization Process Department must be acquired prior to delay.

All items being returned to USNMRTU Sasebo MUST be transported and delivered in manner preserving sterility.

All shipping expenses/costs are provided for in this contract and included in the contract price.

3. Period of Performance

See SAM Notice

4. Security and Safety Requirements:

The Vendor is required to submit/complete Commander Fleet Activities, Sasebo (CFAS Base Security) access requirements for access to Naval Base Sasebo. Vendor shall obtain the necessary clearances to perform this contract. All costs for completing the requirements for access are the responsibility of the vendor.

Identification, Parking, and Smoking Regulations at USNMRTU Sasebo: service personnel have photo identification at all times while on the premises of USNMRTU Sasebo. It is the responsibility of the service personnel to park in the appropriate designated parking areas. Information on parking is available from USNMRTU Sasebo quarterdeck. Smoking is prohibited inside any buildings of USNMRTU Sasebo and is restricted to designated smoking locations only. Possession of weapons, alcohol, or pharmaceuticals that are not over the counter and not prescribed to the individual/family is prohibited on the premises. Enclosed containers, including tool kits, are subject to search.

Contractor Check-In/Check-Out: Contractor is required to report to Sterile Processing Division (SPD) in clinic building loading dock, Second Floor, at USNMRTU Sasebo upon pick-up and delivery of materials.

5. Place of Performance:

Medical and dental instruments and equipment will be processed at Contractor’s facilities located in Shimonoseki, Yamaguchi Japan. Upon completion of requested service(s), items will be delivered to USNMRTU Sasebo, Japan between 0900 to 1600 Monday through Friday, excluding Japanese holidays, Saturday and Sundays.

6. Maintenance Costs:

Costs of full maintenance services include labor, service, travel time, mileage, and all other related expenses necessary to carry out requested SPD services. All invoicing shall be done in accordance with this statement of work and in accordance with contract. Failure to do so may delay or interfere with payment for services rendered.