DRAFT SCALP COOLING SYSTEM SOW.docx
DOCX document 17 KB Posted
- Attached to
- Scalp Cooling Systems - Oncology Federal contract opportunity
- Solicitation number
- 36C10X24Q0109
About this file
This statement of work outlines requirements for scalp cooling systems to be provided to Veterans Affairs medical centers nationwide. The Department of Veterans Affairs seeks to acquire an automatic, machine-based scalp cooling system that is FDA approved and portable for use in VA infusion clinics. The scalp cooling systems must provide disposable caps for patients and allow for self-administration. Considerations for patient safety include disposability, modifiability for various clinical and non-clinical settings, portability without posing trip hazards, and prevention of overcooling effects or shock risk. The period of performance is one base year plus two optional one-year extensions. Deliverables include direct provision and logistics to VA medical centers, supplies, installation instructions, warranty coverage, and customer service available within three days to address any issues.
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| File | Type | Posted |
|---|---|---|
| RFI 36C10X24Q0109 - Scalp Cooling Systems.doc | DOC document |
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Statement of Work Department of Veterans Affairs Veterans Health Administration National Oncology and Precision Medicine Program Scalp Cooling Systems
1.0 Introduction:
The Veterans Health Administration (VHA) National Oncology and Precision Medicine Program is comprised of state-of-the-art services and tools for diagnosing and treating Veterans with cancer. VA's National Precision Oncology Program (NPOP) was launched in 2016 as part of the White House's Cancer Moonshot Initiative to eliminate cancer. Using precision oncology enables VA physicians to better select cancer treatment strategies for each individual Veteran. Oncologists at VA use molecular testing - which analyzes a patient's genomic profile - to more accurately determine a Veteran's cancer prognosis and the best course of treatment.
One of the most distressing aspects of a cancer diagnosis is the fear of hair loss. Based on a study conducted among “women with non-metastatic breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling (SC) experienced 50% less hair loss after the fourth chemotherapy cycle compared with those who received no SC.” This scalp cooling initiative will provide patients nation-wide with a safe and effective solution for chemotherapy induced alopecia (CIA).
2.0 Scope of Work:
These requirements are intended to acquire a commercial product provided to the VA on a as needed basis as scalp cooling systems are requested at VA facilities. The Department of Veterans Affairs (VA) will identify a vendor that can provide an automatic machine-based system for scalp cooling that is patient care appropriate and Federal Drug Administration (FDA) authorized, for placement in VA infusion clinics, with the necessary maintenance to support all eligible Veterans using clinics nationwide at the VA.
The scalp cooling systems must provide the following capabilities:
| 2.1 | Equipment Requirements |
| a. | All materials are to be new and unused |
| b. | Provide an automatic machine-based scalp cooling system for patients undergoing chemotherapy nationwide in an indefinite delivery and indefinite quantity (IDIQ). |
| c. | Provide disposable cap for patients: The cap is to be placed on the patient prior to chemotherapy and does not have to be changed or removed until the treatment is completed. |
| d. | Provide a portable device which may be moved easily by a single individual provider or patient and easily fits within confined spaces, safely. |
| e. | Provide a device which may be self-administered to allow maximum utilization by patients and providers and includes patient training. |
| 2.2 | Patient Safety Considerations |
| a. | Devices should be disposable and easy to use. |
| b. | Modifiable to utilize by the patient individually and in numerous clinical and non-clinical settings. |
| c. | Portable and not a trip hazard. |
| d. | Provides consideration to the overcooling effect of the scalp device, which can cause increased pain during scalp cooling sessions. |
| e. | Tested to ensure no-shock risk to patient. |
| 3.0 | Period of Performance: |
The period of performance consists of a 12-month base period and two possible one-year option periods.
| 4.0 | Deliverables |
| 4.1 | Provided directly to VA Medical Centers for receipt and logistics. Stations to be determined by the Program Office. |
| 4.2 | Supplies per Sections 2.1 and 2.2. |
| 4.3 | Deliveries shall be made between the hours of 8:00 am and 4:00 pm (local time) during normal workdays. |
| 4.4 | Instructions for installation, setup, testing and successful utilization shall be provided by Contractor within 30 days of delivery. |
| 4.5 | Warranty Coverage |
| 4.6 | Customer service capable of responding to issues within 3 business days. |
Any software updates will be made available by the vendor and installed in accordance with Veterans Affairs Information Technology policies.
| 4.7 | Changes to the delivery and installation after formal acceptance will be agreed upon jointly by the Contractor and the Government; with the Government providing the Contractor written documentation of the changes. |
| 4.8 | FOB Destination |
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