Indianapolis SPS SOW.docx

36C25024Q0532 0002

Attachment 2: Statement of Work

STATEMENT OF WORK (SOW)

SOW Title: Sterile Processing Service (SPS) Water and Steam Testing Background: The medical center is required to complete testing on all water and steam systems utilize in the reprocessing of reusable medical devices. Water impurities can have adverse effects on medical devices and patient outcomes. The requirements of Association for the Advancement of Medical Instrumentation (AAMI) ST108: Water for the Processing of Medical Devices are intended to mitigate the risks associated with water identified to be in improper quality.

Scope: The Richard L Roudebush VA Medical Center, Indianapolis requires water quality testing to meet the criteria of AAMI ST108 for reprocessing of reusable medical equipment. This is located at the Richard L Roudebush VA Medical Center, located at 1481 W. 10th Street, Indianapolis, IN 46202 and Vet House located at 2669 Cold Springs Rd., Indianapolis, IN 46222. Services shall be in accordance with the terms, conditions, provisions and schedule of the contract.

Specific Tasks For Testing-Deliverable Product:

1. Contractor shall provide all labor, materials, equipment, transportation, lodging and supervision necessary to collect appropriate samples and deliver to a lab meeting requirement for processing of AAMI ST108.

2. Contractor shall provide training to SPS and Engineering personnel on AAMI ST108 requirements and responsibilities within one (1) week of contract award.

3. Contractor shall provide same tester each time to avoid the need of an escort. Escort shall be provided for first month of testing.

4. Tester shall be proficient in AAMI ST108 testing methods and procedures and documentation of training shall be provided.

5. Lab shall be within one hour driving distance of VAMC to allow for emergency sample drop-off if needed by facility personnel.

6. Contractor shall provide a handheld resistivity meter as well as pH hardness color metric dipsticks to the Richard L Roudebush VAMC. Contractor shall calibrate the resistivity meter monthly during their testing visit and provide a calibration certification with this visit as part of the report. Contractor shall provide a detailed site-specific operation manual and training to the Richard L Roudebush VAMC SPS personnel and Engineering staff as well as training on use, results analysis, and mitigation of the tests performed.

Table 1 AAMI ST108 Utility Water Testing

Table 2 AAMI ST108 Critical Water Testing

Table 3 AAMI ST108 Steam Testing

Performance: The Government shall document performance. Any report shall become a part of the supporting documentation for any contractual action.

Security Requirements: Contractor shall not have access to VA Sensitive Information, patient records, or data.

General Requirements

1. All on site work shall be coordinated with Leroney Bond, Administrative Officer, SPS, 317-955-9845 A-B109, Leroney.Bond@va.gov, or Sean Rosenfeld 317-988-2515, sean.rosenfeld@va.gov, at least seven (7) days prior to performance of services.

2. For testing services performed during normal work hours, 7:30 a.m. to 4:00 p.m. at the Richard L Roudebush VA Medical Center and Vet House, contractor’s tester shall report to Sterile Processing Services Administrative Officer, Building 1, RM A-B109, 317-955-9845.

3. The contractor shall respond to routine communications within 48 hours.

4. The contractor shall provide emergency response, including a site visit if requested, within 4 hours of the request, 24 hours a day, and 365 days per year.

5. Situations requiring more frequent analysis and/or special testing other than the specified requirements may arise. Contractor shall not perform any extra cost work without written authorization from the contracting officer.

6. Any deficiencies or problems noted with VA test results or with the water treatment system test results are to be reported immediately to the COR. If problems are identified, the contractor shall recommend corrective actions immediately.

Deliverables

1. The contractor shall provide complete written reports within 5 business days after each analysis and inspection.

a. The reports shall include all test results, the date of the test, testing parameters, recommendations, and a review with the COR.

b. Each report shall highlight the results with a green for pass and red for fail, indicating whether the results pass or fail the parameters specified in AAMI ST108.

c. For any products utilized in the testing process, the following shall be documented on the report: name, ingredients, control range, test procedures, physical state (liquid, powder, etc.), container size, method of delivery, compatibility with present materials being used, catalog data, Material Safety Data Sheets (MSDS) sheets.

2. The reports shall be sent to the COR, Sean Rosenfeld (sean.rosenfeld@va.gov).

Contracting Officer Representative (COR)

Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI): The Richard L Roudebush VA Medical Center shall not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the contractor to bring the appropriate equipment; and/or supplies necessary to complete the work as required per this contract.

Other Pertinent Information or Special Considerations: All work shall be performed by personnel qualified to work on the specific equipment. All work performed shall be compliant with AAMI ST108 guidelines and shall be designed to assure that the Richard L Roudebush VA Medical Center is providing the best possible water to process reusable medical equipment.

Place of Performance: The Richard L Roudebush Department of Veterans Affairs Medical Center located at 1481 W. 10th Street, Indianapolis, IN 46202 and Vet House located at 2669 Cold Springs Rd., Indianapolis, IN 46222. AAMI ST108 testing shall take place in Sterile Processing department, Reverse Osmosis mechanical room, and GI Decontamination processing.