Attachment 1_SOW_QC_Reagents.pdf
PDF 166 KB Posted
- Solicitation number
- Solicitation_75H70726Q00104
About this file
This is a Statement of Work (SOW) for quality control material supply services to Zuni PHS Indian Hospital Laboratory located in Zuni, New Mexico.
The contractor shall supply and manage laboratory quality control (QC) materials to ensure accuracy and validity of clinical patient test results in compliance with CLIA, CAP, and FDA regulations. The contractor must be the manufacturer or authorized distributor/reseller of proposed QC materials and provide documentation of authorization upon request. Key performance requirements include: ensuring timely delivery of required QC materials on a request or standing-order basis; providing 24/7 technical and educational support via email and telephone; delivering lot specifications, accuracy information, and communicating identified issues promptly; providing QC charting for monitoring each lot of analytes; maintaining sufficient product stability for laboratory use; and providing data management support to improve laboratory analytical performance. The contractor must also have the ability to add or remove QC materials as required by the Government within the scope of the resulting order. The contract includes a base period of twelve months from the award date, with four optional twelve-month renewal periods. The specific QC material/item list requirements are referenced as attached to the solicitation document.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Attachment 5_Pricing Schedule.docx | DOCX document | |
| Attachment 2_QC materials list.pdf | ||
| Attachment 4_Performance Questionnaire Sol 75H70726Q00104.docx | DOCX document | |
| Sol_75H70726Q00104.pdf |
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Text version
Zuni PHS Indian Hospital
Project Name: Quality Control Material
STATEMENT OF WORK
Introduction and Background:
The regulatory agencies - Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists
(CAP) and the Federal Drug Administration (FDA) mandate strict adherence to quality control to ensure accurate results. Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results. Quality control is a measure of precision, or how well the measurement system reproduces the same result over time and under varying operating conditions. Laboratory quality control material is usually run at the beginning of each shift, after an instrument is serviced, when reagent lots are changed, after equipment calibration, and whenever patient results seem inappropriate. Quality control material should approximate the same matrix as patient specimens, taking into account properties such as viscosity, turbidity, composition, and color. It should be simple to use, with minimal vial-to-vial variability, because variability could be misinterpreted as systematic error in the method or instrument. It should be stable for long periods of time, and available in large enough quantities for a single batch to last at least one year. Liquid controls are more convenient than lyophilized (freeze-dried) controls because they do not have to be reconstituted, minimizing pipetting error.
Objectives:
Quality control will be used for Laboratory Quality Control reagents to ensure the accuracy and validity of clinical patient test results.
Scope of Work:
SOW for this request will include:
• Ensure availability of the required QC materials identified in the attached Quality Control
Material/Item List.
The Contractor shall be the manufacturer or an authorized distributor/reseller of the proposed
QC materials and, upon Government request, provide documentation demonstrating such authorization.
• Ensure products and reagents are delivered timely when requested or on a standing-order basis, as applicable.
• Provide continued data management support to help improve laboratory analytical performance.
• Provide lot specifications and accuracy information and communicate identified issues in a timely manner.
• Provide the ability to add or remove QC materials, as required by the Government and within the scope of the resulting order.
• Provide continued technical and educational support by email and/or telephone 24 hours a day, 7 days a week.
• Provide QC charting for monitoring each lot of analytes.
• Provide QC lots with sufficient stability for laboratory use.
Deliver to:
Zuni Indian Hospital Laboratory
21 B Avenue
Zuni, NM 87327
Period of Performance:
Base Period: Twelve (12) months from the date established in the solicitation or resulting award.
Option Period 1: Twelve (12) months, if exercised.
Option Period 2: Twelve (12) months, if exercised.
Option Period 3: Twelve (12) months, if exercised.
Option Period 4: Twelve (12) months, if exercised.
Quality Control Material/Item List: The required QC material/item list is attached to the solicitation.
File details come from the government source that posted it. Updated .