SOW.docx

STATEMENT OF WORK (SOW)

1. GENERAL INFORMATION

1. Title of Project: Dialysis Water Testing Samples. The agency requires testing of water for Endotoxins, Colony Count and AAMI Contaminants. The work will be performed in an off-site Laboratory. The facility’s staff will collect water samples using aseptic technique.

2. Scope of Work: The Contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. The Contractor will provide C.W. Bill Young VA Healthcare System (VAHCS) with a variety of testing on an as needed basis. Services must include providing all testing materials, appropriate shipping materials for test submission and an option for prepaid shipping labels to expedite the shipping process.

3. Background: The Bay Pines VAHCS requires water testing that conforms to ANSI/AAMI 23500:2014 standards for the reverse osmosis and dialysis machines in the dialysis department. If new standards are released during contract period vendor will be notified when the facility will switch over to new standards.

4. Performance Period: The Contractor shall begin to provide the services requested under this SOW immediately following the award of the contract, unless otherwise directed by the Contracting Officer (CO). The period of performance for the base year of the Indefinite Delivery, Indefinite Quantity (IDIQ) will be 1/13/2025 through 1/12/2026; at which time, up to four (4) option years may be exercised at the sole discretion of the Government.

5. Type of Contract: This is an IDIQ contract that will consist of a base year and four (4) option years.

B. CONTRACT AWARD MEETING

The Contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting or has advised the Contractor that a kick off meeting is waived.

C. GENERAL REQUIREMENTS

1. Upon award of the contract the Contractor shall provide C.W. Bill Young VAHCS with sufficient materials for one month of testing as determined between the head of the department and the Contractor and continue to restock as needed.

The laboratory will provide all sample collection supplies to include:

· Shipping box

· Freezer pack

· Requisition

· Test tubes and bottles

· Shipment of supplies to clients

· Restock kits and re-send to client after use

2. The Contractor will be properly insured and licensed and will be responsible for certification of their facilities through the required regulatory bodies. Contractor must have ISO/IEC 17025:2017 Accreditation.

3. In the event that the testing facility is unable to meet the requirements of this contract, the Contractor will identify an alternate testing facility and will make all arrangements required to coordinate work through that facility until the Contractor’s site is operational again.

4. Contractor will be capable of supporting the following requirements:

4.1 48 Hour Colony Count Testing:

· Specimen is to be cultured on culture media using the spread plate method.

· Specimen volume is to be measured with a sterile pipette.

· The agency requires that the samples be processed within 24 hours of collection.

· Culture is to be incubated for 2 day (48hr) as per ANSI/AAMI 23500:2014 TSA (Trypticase Soy agar) or standards method agar and plate count agar incubated at 35 degrees centigrade for 48 hours.

· Results must be reported as total viable colony count of colony forming units per ml of fluid (CFU/ml).

· Contractor must provide those results via phone, fax or email for C.W. Bill Young VAHCS to identify any actionable results.

· Contractor must notify the designated person(s) immediately upon receiving results that exceed the alert level as defined in the most recent standards. Bay Pines VAHCS will provide a phone number to contact in case of such an event.

· Alert and Critical levels are based on ANSI/AAMI 23500:2014 standards or more recent standards if changed during the contract period and vendor will be notified.

4.2 Endotoxin (LAL):

· Sample tubes will be provided by the Contractor.

· Provided tubes must be sterile and pyrogen free.

· The agency requires that the samples be processed within 24 hours of collection.

· Endotoxin tests must be FDA Approved using the Kinetic Limulus Amoebocyte Lysate (LAL) method.

· Test results must be reported in endotoxin units per ml (EU/ml).

· Contractor must provide results via phone, fax & email for Bay Pines VAHCS to identify any actionable results.

· Contractor must notify the designated person(s) immediately upon receiving results that exceed the alert level as defined in the most recent standards. Bay Pines VAHCS will provide a phone number to contact in case of such an event.

· Alert and Critical levels are based on ANSI/AAMI 23500:2014 standards or more recent standards if changed during the contract period and vendor will be notified.

4.3 AAMI Panel:

· The test method should be sensitive enough to detect the maximum allowable contaminant levels in water described in tables 1 and 2 reproduced from ISO 13959:2014 from ANSI/AAMI 23500: 2014 standards.

· Panel will include, at minimum, tests for the following

4.4 Federal Express Labels:

Contractor shall provide Federal Express Labels including label for Friday collection.

4.4 Courier Shipment:

Contractor will coordinate courier shipments for emergent testing needs for Saturday or Sunday collection. This is not a regularly scheduled function but should be available on an as needed basis. Additionally, emergent testing must be available on Saturdays and Sundays.

1. SCHEDULE FOR DELIVERABLES

1. The Contractor shall deliver equipment requested to the stated location within 24 hours of notification of need. This notification will come from Bay Pines VAHCS in the form of a phone call and email to contact information provided by the Contractor.

2. In the event that the Contractor is notified of an emergent need, and additional testing kits are required, those kits will be sent within 24 hours.

3. If for any reason any deliverable cannot be delivered within the scheduled time frame, the Contractor is required to explain why in writing to the CO. This notice to the CO shall cite the reasons for the delay, and how the delay will be avoided in the future. The CO will then review the facts and issue a response, in accordance with applicable regulations.

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

F. REPORTING REQUIREMENTS

The contractor will submit invoices on a monthly basis to the identified Contracting Officers Representative (COR) for review and submission to the Austin Finance Center for payment.

G. GOVERNMENT RESPONSIBILITIES

Government will provide the Contractor with properly collected specimens as determined by the type of test required.