N3594919RCA4010_Statement_of_Work_Version_30_July_2019.docx

Statement of Work Sterilization Services- Comprehensive

1. Scope: The contractor shall 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 deliver back to Naval Hospital Twentynine Palms for the government-owned surgical instrument sets at Naval Hospital Twentynine Palms (NHTP). See Appendix A for Product Description and quantities. All sets will require functional testing during assembly. All sets will be processed according to AAMI standards and/or manufacture instructions for use.

Contractor shall perform the services in accordance with Navy bureau of Medicine, Joint Commission, and Association for Advancement of medical Instrumentation (AAMI) regulations and guidelines, and in accordance with the US, States, and Local laws and regulations.

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

2.1. Contracting Officer (KO): A warranted representative of the federal government who has the express authority to enter into, administer, and/or terminate contracts and make related determinations and findings. The KO is the only person authorized to approve changes to any terms, conditions, or requirements of the contract.

2.3. Technical Representative (TR): A Government employee appointed by the KO and responsible for the inspection, evaluation, and acceptance of products and services provided in accordance with the terms and conditions of the contract.

3. Location:

3.1. Place of Performance shall be:

4. General Performance Requirements:

4.1.1. The Contractor shall provide comprehensive sterile processing services in accordance with Navy Bureau of Medicine, Joint Commission, and Association for the Advancement of Medical Instrumentation (AAMI) regulations and guidelines. Contractor will comply with US, State, and Local laws and regulations in regards to the materials covered.

4.1.2. Ensure that only fully-qualified technicians who have gone through proper certification 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, contractor shall provide written assurance of the competency their personnel as well as a list of credentials for approved personnel. The KO and/or TR may authenticate the training requirements and request training certificates or credentials from the Contractor at any time.

4.1.3. Test equipment: Test equipment calibration shall be traceable to national Institutes of Standards and technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by TR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on NHTP equipment.

4.2. Pick-up and Delivery

4.2.1 Except for the very first pick-up and very last drop-off, the pick-up/drop-off will be a combined process. The pick-up and drop-off schedule will be coordinated between the customer and the vendor once the contract has been awarded. See Appendix B for sample of delivery schedule.

4.2.2 The vendor shall pick-up the dirty instruments/trays, the vendor will clean, decontaminate, check, test instruments, reassemble, package and sterilize at their facility.

4.2.3 Upon return to NHTP, the vendor shall 1) drop-off clean sterilized trays and 2) Pick-up dirty instruments/trays to be cleaned.

4.2.4. Contractor shall furnish a written or electronic Service Report (SR) to the Duty Staff at NHTP Sterile Processing Department. All SR’s shall be submitted upon delivery of sets or instruments to NHTP. The contractor or their representative shall complete the SR to include, at a minimum, the following information:

5. Summary of work performed and problems encountered (including damaged, mission items and incomplete sets)

6. Compliance report; to include but not limited to:

6.a. Chemical and biological testing 6.b. Water quality testing 6.c. Lot/Load numbers 6.d. Copies of washer/disinfector and sterilizer receipts

4.2.5. 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.

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

4.2.7. Transportation of instrumentation sets: Transportation of instrument sets will be within AAMI recommended guidelines; at a minimum. All contractor provided containment devices carrying instrument sets shall be loaded and off loaded by contractor personnel.

4.3. Response Time and Labor:

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

4.3.2. Turnaround time. The vendor shall drop-off sterilized instruments/trays back to NHTP upon their next run (which ever two days of the week is selected by the customer and vendor). Turnaround time will not exceed 48 hours. Pick-up and drop-off hours will be between 0800 and 1500.

4.3.3. 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 KO.

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

6. Shipment: Contractor shall pickup, process, and deliver the materials twice a week, with the exception of the very first pick-up and very last drop-off, the pick-up/drop-off. All items being returned to NHTP MUST be transported and delivered in a manner preserving sterility. All shipping expenses/costs are provided for in this contract and included in the contract price. Pick-up and drop-off hours will be between 0800 and 1500.

7. Liability:

7.1. The contractor shall not be liable for any loss, damage, or delay due to any cause beyond their reasonable control, including but not limited to fire, explosion, theft, flood, riot, civil commotion, war, malicious acts of mischief, or other circumstances outside of human control.

7.2. Insurance: Contractor shall be required to have liability insurance to cover any actions on the part of the Contractor or their sub-contractors which result in injury or death to patients, staff, visitors, or other contractors. Coverage shall be of at least $500,000.00. Liability insurance shall meet the requirements set forth in FAR 28.307-2.

8. Security and safety requirements:

8.1. The contractor is required to maintain the necessary clearances to perform this contract. All cost for completing the requirements for access are the responsibility of the contractor.

8.2. Identification, Parking and Smoking regulations at NHTP: Field service personnel shall wear visible photo identification at all times while on the premises of NHTP. It is the responsibility of the field service personnel to park in the appropriate designated parking areas. Smoking is prohibited inside any building at NHTP 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. Violations of regulations may result in citation answerable in the United States (Federal) District Court. Violation of any policy which results in lost time for Contractor or his sub-contractors is the sole responsibility of the contractor, and shall not be charged to the government. Contractor employees shall demonstrate appropriate behavior and dress at all times.

8.3. Contractor check-in/check-out: contractor is required to report to Sterile Processing Division at Naval Hospital Twentynine Palms, 1145 Sturgis Rd, Twentynine Palms, CA 92278. Sterile Processing is located on the first floor and is best accessed via the supply loading dock. Check-in/check-out will be between 0800 and 1500.

8.4. Government right of Refusal: NHTP reserves the right to reject any of the contractor’s personnel and refuse them permission to enter the premises or work on NHTP equipment. This right may be exercised at any time. The reasons for rejections may include: lack of training and experience, but may also include but not be limited to: behavior, attire, and security concerns.

9. Compliance with applicable laws: Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of their business. The contractor’s personnel shall comply with the DoD Information Assurance Policies applicable. Contractors are required to maintain a Drug free workplace, as well as to require any sub-contractor to do the same. Contract shall require wage determinations and comply with applicable Federal and State worker’s compensation and occupational disease statutes.

10. Modifications to contract: Only the KO has the authority to obligate the government, and then only in writing. No modification or instruction from any party shall be construed to authorize the contractor to take any action for which they expect compensation without written authorization from the KO.

11. Invoicing: 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.

Appendix A. Product Description The quantity of each instrument/tray will vary per pick-up.

Appendix B. Example Schedule of Pick-up and Drop-off/Delivery. Actual pick-up and drop-off schedule will be coordinated between the customer and vendor at a later date.

Week #1. Tuesday: Pick-up dirty instruments/trays. Thursday: Drop-off clean instruments and collect dirty instruments.

Week #2 through 7: Tuesday: Drop-off clean instruments and collect dirty instruments. Thursday: Drop-off clean instruments and collect dirty instruments.

Week #8: Tuesday: Drop-off clean instruments and collect dirty instruments. Thursday: Drop-off clean instruments.

-End of Statement of Work-