Statement of Work - SAM.pdf
PDF 80 KB Posted
- Attached to
- Shield Test Kits
- Solicitation number
- IHS1522255
About this file
This Statement of Work describes the Elko Service Unit's requirement for non-personal professional laboratory services to provide Shield™ colorectal cancer screening tests at the Southern Bands Health Center in Elko, Nevada. The contractor shall provide Shield™ blood tests, all necessary collection kits, and deliver test results (positive or negative) to ordering physicians within approximately two weeks. The contractor must also provide training materials and support to healthcare providers and phlebotomists at the facility regarding proper use of the Shield™ screening test. Services are required on an as-needed basis, with an estimated volume of 20 blood vials per month. The contract covers a 12-month base period with four optional one-year renewal periods contingent on satisfactory performance and government needs.
The contract is structured on a unit-price basis, with the unit price representing full payment for all services provided. The contractor is prohibited from billing or attempting to collect from Indian Health Services (IHS) patients or alternative resources. The contractor must comply with IHS guidelines and procedures, and failure to meet established standards may result in contract cancellation. Performance will be evaluated based on standards contained within the Statement of Work. The period of performance begins 12 months from the date of contract award, as mutually agreed between the Contracting Officer and Contractor.
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Text version
STATEMENT OF WORK
Shield™ Colon Cancer SCREENING
It is the intent of the Elko Service Unit (ESU) to acquire non-personal professional laboratory services for colorectal screening for the Southern Bands Health Center located in, Elko, NV.
Contractor is requested to provide non-personal professional laboratory services for a 12- month base period and four (4) one (1) year option periods. The intent of this contract is to establish a method whereby ESU can get colorectal screenings for patients. These services shall be for an “on needed basis” when a colorectal blood sample is given to the contractor estimating 20 blood vials per month for 12 months.
BACKGROUND: Colorectal Cancer (CRC) is a significant public health concern. The Shield™ blood test, a non-invasive screening option, has been approved by the FDA and is offered to individuals aged 45 and older. This contract aims to provide this screening test to defined patient population with the Southern Bands Health Center to increased screening rates and improve early detection.
CLINICAL JUSTIFICATION: Research suggests that a high degree of patients are resistant to traditional colon cancer screening due to the invasive nature of colonoscopies and the collection challenges associated with Fecal Occult Blood tests (FOBT). FOBTs require patients to handle stool samples, which is a source of resistance and discomfort. Patients often face logistical barriers and anxiety, leading to low adherence rates for these methods. The FOBT, specifically the guaiac-based version (gFOBT), is subject to dietary and medication restrictions that can lead to inaccurate results, including false positives from dietary peroxidases or false negatives from Vitamin C. While a colonoscopy is considered the "gold standard" for its ability to both screen for and remove precancerous polyps, it requires extensive bowel preparation, sedation, and recovery time. For patients who are unwilling or unable to undergo a colonoscopy, the Shield blood test offers a non-invasive and easy-to-complete alternative.
The Shield™ test, as a simple blood draw, circumvents these issues and provides a more convenient and patient-friendly alternative that is expected to increase screening compliance.
The clinical consensus supports that a more accessible screening test that increases participation is beneficial. The ECLIPSE clinical study validated Shield™ as a high-sensitivity blood test for colon cancer screening, with an 83% sensitivity for colon cancer and 90% specificity.
SCOPE: The contractor shall provide Shield™ blood tests and all necessary collection kits to the Southern Bands Health Center and deliver test results (positive or negative) to the ordering physician within a specified timeframe (e.g., appropriately two weeks). The contractor will provide training materials and support to participating healthcare providers and phlebotomists at the Southern Bands Health Center on the proper use of the Shield™ screening test.
LOCATION: All blood draw services with the screening kits shall be performed at the following location;
Southern Bands Health Center
515 Shoshone Circle
Elko, NV 89801
1. PRICING SCHEDULE:
The unit price paid to the Contractor shall be considered as payment in full for services provided under this award. In no way, unless directed by the IHS, shall any provider attempt to bill or collect from any IHS patient, or from any alternate resource for which the patient may be eligible, any monies for services provided under this award.
2. STATEMENT OF WORK RESPONSIBILITIES:
The contractor shall be expected to assist and provide services and duties as may be requested for the normal operational requirements for the department and personnel. The contractor shall provide work that is consistent with the guidelines and procedures of the IHS. Failure of the contractor to meet these standards can result in cancellation of this contract. The contractor’s performance and abilities shall be evaluated based upon performance standards that are contained in this statement of work.
3. PERIOD OF PERFORMANCE
As mutually agreed between the Contracting Officer and the Contractor, 12 months from the date of contract award. The contract may be renewed for up to four additional one-year option periods, contingent on satisfactory performance and government needs.
END OF STATEMENT OF WORK
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