Nitrile and Vinyl Glove Testing
ID: 75A50324R00016Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFOFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSEASPR ADMINISTRATION FOR STRATEGIC PREPAREDNESS AND RESPONSEWashington, DC, 20201, USA

NAICS

Testing Laboratories and Services (541380)

PSC

MEDICAL- LABORATORY TESTING (Q301)

Original Source

https://sam.gov/opp/a73d6c0bc73e4bb9be4fdec89cc20c9c/view
Timeline
    Description

    The Department of Health and Human Services (HHS) is seeking proposals for laboratory testing services of disposable nitrile and vinyl examination gloves as part of solicitation 75A50324R00016. The primary objective is to conduct biocompatibility testing and statistical sampling to ensure that the gloves meet the necessary ASTM and ISO safety standards, which are critical for protecting healthcare providers and patients from infection risks. This procurement is vital for maintaining the Strategic National Stockpile (SNS) and ensuring the availability of effective personal protective equipment during emergencies. Proposals are due by October 21, 2024, and interested contractors should contact Lawrence McCoy at Lawrence.Mccoy@hhs.gov for further information.

    Point(s) of Contact
    Lawrence McCoy
    Lawrence.Mccoy@hhs.gov
    Files
    Title
    Posted
    75A50324R00016 Amendment 0001 Testing.pdf
    The amended solicitation 75A50324R00016 outlines the requirements for the Strategic National Stockpile (SNS) of the U.S. Department of Health and Human Services, which seeks laboratory testing services for disposable nitrile and vinyl examination gloves. The proposal deadline is set for October 21, 2024. The contract will focus on conducting biocompatibility testing, statistical sampling, and providing comprehensive reports to ensure the gloves meet necessary safety standards, specifically those established by ASTM and ISO. Key changes include submitting proposals electronically and a clear timeline for testing services, starting from November 2024 to May 2025. The solicitation emphasizes the importance of protecting healthcare providers from infection, underscoring the role of appropriate personal protective equipment (PPE). Contractors are required to demonstrate capabilities, including ISO 17025 accreditation and a rigorous project management framework. The document stipulates thorough testing methodologies, regular communication with the SNS, and an emphasis on timely reporting of results. Each contractor must provide details on sample sizes, testing processes, and deliverables, ensuring alignment with federal guidelines and health regulations throughout the contract duration. This solicitation reflects the government’s commitment to ensuring healthcare safety through stringent evaluation of essential medical supplies.
    Glove Testing RFP 75A50324R00016 9.5.2024.pdf
    The U.S. Department of Health and Human Services (HHS) seeks proposals for laboratory testing services of disposable nitrile and vinyl examination gloves as part of a combined synopsis/solicitation (RFP #75A50324Q00016). This RFP anticipates a Firm Fixed Price contract for a duration of 7 months, from September 28, 2024, to April 27, 2025. The testing will validate these gloves to ensure they meet applicable ASTM and ISO standards, crucial for healthcare settings to protect workers and patients from infection risks. Key tasks include project management, validation testing, statistical sampling, and ensuring laboratory accreditation under ISO 17025. Proposals must include completed pricing and technical documents, and the expected sample sizes for testing must align with specified guidelines. The RFP is open to all businesses, not limited to small entities, and responses are due by September 20, 2024. The overarching goal is to maintain resilience in U.S. healthcare during emergencies by ensuring the supply of effective personal protective equipment through proper testing and compliance verification.
    Questions with Answers_Nitrile Glove Testing.pdf
    The document addresses questions and responses related to RFP 75A50324R00016 concerning the testing of nitrile and vinyl gloves. It clarifies that testing for ISO 10993 (biocompatibility) may differ from ASTM testing methods. Notably, USP sterility testing is confirmed as unnecessary since the gloves are non-sterile. The RFP specifies that all testing must occur at an ISO 17025 accredited laboratory, with no onsite services required except for validation of glove samples by lot number. Logistics surrounding glove pickup will be communicated post-award, ensuring compliance with government protocols. In terms of testing parameters, lot sizes are established in referenced tables, with an Acceptable Quality Level (AQL) of 2.5 mandated for examination gloves as per FDA regulations. The government will typically ship glove samples unless otherwise specified by the contractor's chain of custody process. This document serves to clarify critical logistical and operational details essential for contractors responding to the RFP.
    Lifecycle
    Title
    Type
    Nitrile and Vinyl Glove Testing
    Currently viewing
    Combined Synopsis/Solicitation
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