Glove Testing RFP 75A50324R00016 9.5.2024.pdf

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NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting.

COMBINED SYNOPSIS SOLICITATION

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Proposals are being requested and a written solicitation document will not be issued.

ii. The solicitation number is 75A50324Q00016, which is being issued as a Request for Proposal (RFP). The

Government anticipates the award of a Firm Fixed Price (FFP) type contract for severable services.

iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular 2024-06, effective July 30, 2024.

iv. This acquisition is being posted as Full and Open and is not set aside for small businesses. NAICS 541380

(Testing Laboratories and Services). The size standard is $19.0 (millions of dollars).

v. The Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS)

Administration for Strategic Preparedness and Response (ASPR), has a requirement for Laboratory Testing, Statistical Sampling, and Reports for Disposable Nitrile and Vinyl Nitrile Blend Examination Gloves. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

vi. See below for description of requirements.

vii. The period of performance is anticipated to be 7 months, from September 28, 2024, to April 27, 2025. See below for place(s) of delivery and acceptance and FOB point(s).

viii. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP

2023), applies to this acquisition.

ix. The provision at FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

x. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representation and Certifications-

Commercial Products and Commercial Services (Feb 2024), with their Offers. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that effect in accordance with paragraph (b)(2) of this provision).

xi. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV

2023), applies to this acquisition.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

Commercial Products and Commercial Services (FEB 2024), applies to this acquisition and FAR clauses applicable are 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222- 37, 52.222-40, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See below for details.

xiii. There are no special contract requirements or terms and conditions related to contract financing arrangements.

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xiv. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

xv. Offers are due no later than September 20, 2024, 1:00 PM Eastern Standard Time (EST). Offerors must submit an electronic copy of the Technical Proposal and Price/Business Proposal via email to with the subject line “SUBMISSION RFP 75A50324Q00016,” via email to Lawrence McCoy at lawrence.mccoy@hhs.gov and Mattie Washington at mattie.washington@hhs.gov. The offeror’s complete Proposal (including all information required to be submitted as part of the offeror’s Volume I- Technical Proposal and Volume II- Price/Business Proposal) must be received by the date and time specified for receipt of offers. See Section L for additional details for the content of Proposals.

Electronics submissions only will be accepted and shall be submitted via email to the email addresses specified above. Email submissions are limited to 10MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

o All questions regarding this RFP of contractual or technical nature must be submitted electronically by email with the subject line “QUESTIONS RFP 75A50324Q00016” to Lawrence McCoy at lawrence.mccoy@hhs.gov and Mattie Washington at mattie.washington@hhs.gov. no later than 2:00 p.m.

Eastern Standard Time (EST) September 11, 2024. The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Unless the Government otherwise determines that it is in its best interest to provide a response, questions received after the deadline will not be answered.

xvi. The point of contact for information regarding this combined synopsis/solicitation is:

Contracting Officer Lawrence McCoy Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: lawrence.mccoy@hhs.gov

Please note this requirement is subject to the availability of funds (FAR 52.232-18) mailto:lawrence.mccoy@hhs.gov

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

Base Year: September 28, 2024 – April 27, 2025

CLIN Description QTY/UNIT

Unit Price TOTAL PRICE

1001 Laboratory Testing, Statistical Sampling, and Reports for Disposable Nitrile Examination Gloves in accordance with Section Three (3) of the Statement of Work (SOW)

Firm Fixed Price

1 LOT

1002 Laboratory Testing, Statistical Sampling, and Reports for Disposable Vinyl Nitrile Blend Examination Gloves in accordance with Section Three (3) of the Statement of Work (SOW)

Firm Fixed Price

1 LOT

1003 Other Direct Cost (ODC), to include travel and any other costs associated with laboratory testing services. Contractor shall provide an estimated cost for this CLIN.

Time and Material (T&M) - ODC

1 LOT

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Statement of Work (SOW)

U.S. Department of Health and Human Services (HHS)

The Strategic National Stockpile (SNS)

Administration for Strategic Preparedness and Response (ASPR)

Title: Strategic National Stockpile Nitrile and Vinyl Glove Testing

SECTION 1 - BACKGROUND:

The Strategic National Stockpile (SNS) of the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local medical supplies and equipment during public health emergencies. The supplies, medicines, and devices for lifesaving care contained in the SNS can be used as a short-term, stopgap buffer when the immediate supply of these materials may not be available or sufficient.

The mission of the SNS is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters, or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical authorities request federal assistance to support their response efforts, the SNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event.

Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. Disposable, nitrile and vinyl, non-sterile, powder-free patient examination gloves are one part of an infection control strategy and are examples of personal protective equipment (PPE), which are disposable devices intended for medical purposes to protect both the patient and health care personnel from transfer of microorganisms, body fluids, and particulate material. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines.

SECTION 2 - PURPOSE:

The U.S. Government is interested in purchasing third-party testing services for Disposable Nitrile and Vinyl Examination Gloves used in healthcare settings as described in the Scope of Work. Glove testing is needed to validate Disposable Nitrile and Vinyl Nitrile Blend Examination Gloves in the SNS to meet the required standards for the gloves to be safely and effectively used by medical providers in healthcare settings.

Disposable Nitrile and Vinyl Examination Gloves are a disposable device intended for medical purposes that is worn on the examiner’s hand to promote infection control practices and help protect healthcare workers and patients against microorganisms, body fluids, and from the spread of infection or illness during routine care, medical procedures, and examinations. Examination gloves are reviewed and cleared by the Food and Drug Administration (FDA) as Class I reserved medical devices that require a 510(k) premarket notification and listing under 21 CFR 880.6250.

SECTION 3 - SCOPE OF WORK:

The Contractor, as an independent organization and not as an agent of the Government, shall furnish all labor, materials, supplies, facilities, and equipment, necessary to test Disposable Nitrile Examination Gloves, and Vinyl Examination Gloves. Multiple Contractors may be needed to conduct the required medical glove testing, depending on the Contractors capability to test the medical gloves using specific glove standards.

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The Contractor will provide a one-time service for testing both nitrile and vinyl nitrile blend medical gloves to validate glove material and determine if the gloves meet the appropriate American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards. The Contractor will determine and provide the appropriate statistical sample size needed to test each glove type (nitrile and vinyl nitrile blend) based on lot quantities and manufacturer illustrated in Table A and Table B.

Table A: Nitrile Examination Gloves requiring testing to ASTM D6319(2023) and Biocompatibility Standards.

Lot Number* Manufacturer*

Approximate Glove Quantity (in

Each/Singles) **by Lot Number

Quantity of Gloves (in Each /Singles) Needed to Test by Lot Number

(vendor to Fill In)

Quantity of Gloves (in Each /Singles) Needed to Test for Each Manufacturer Within the Lot Number - Assuming Equal Split

(Vendor to Fill In)

1 A 350,000 2 A 128,000 3 B 242,000 4 B 9,898,000 5 B 7,614,700 6 C, D, E, F, G, H 50,141,600 7 C, D, E 16,838,100 8 C, D 20,703,999 9 G, H 1,852,000

*Actual Lot Numbers and Manufacturer Names (or representative QC numbers) will be provided at contract award. There may be a manufacturer product variance of +/-1 for any given lot.

**Gloves sizes are small, medium, large, and x large. Every glove size may not be represented within each lot.

Table A: The Contractor shall determine the appropriate statistical sample size for each lot identified as 1-9 based on the corresponding glove quantity, complete the fourth column in Table A to illustrate how many single gloves will be needed to test for ASTM D6319 and ISO 10993-5, ISO 10993-10, and ISO 109930-23. For lots illustrating more than one manufacturer (e.g., lots 6-9), the Contractor shall further determine how many gloves per lot and per each manufacturer will be needed to test for ASTM D6319 and ISO 10993-5, ISO 10993-10, and ISO 109930-23. The Contractor will complete the fifth column in Table A accordingly. Additionally, each glove lot will include multiple glove sizes ranging from small to extra-large but may not include all sizes.

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Table B: Vinyl Nitrile Blend Examination Gloves requiring testing to ASTM D5250-19(2023) and Biocompatibility Standards.

Number* Manufacturer *

Approximate Glove Quantity (in

Each/Singles) **by Lot Number

Quantity of Gloves (in Each/Singles) Needed to Test by

Lot Number (Vendor to Fill In)

Quantity of Gloves (in Each) Needed to Test For Each

Manufacturer Within the Lot Number –

Assuming Equal Split (Vendor to Fill In)

0 B, I 220,000 11 I 80,000 12 J 4,110,000 13 J 1,264,000

*Actual Lot Numbers and Manufacturer Names will be provided at contract award. There may be a manufacturer product variance of +/- 1 for any given lot.

**Gloves sizes are small, medium, large, and x large. Every glove size may not be represented within each lot.

Table B: The Contractor shall determine the appropriate statistical sample size for each lot identified as 10-13 based on the corresponding glove quantity, complete the fourth column in Table B to illustrate how many single gloves will be needed to test for ASTM D5250 and ISO 10993-5, ISO 10993-10, and ISO 109930-23. For lots illustrating more than one manufacturer (e.g., lot 10), the Contractor shall further determine how many gloves per lot and per each manufacturer will be needed to test for ASTM D5250 and ISO 10993-5, ISO 10993-10, and ISO 109930-23. The Contractor will complete the fifth column in Table B accordingly. Additionally, each glove lot will include multiple glove sizes ranging from small to extra-large but may not include all sizes.

Tables A and B shall be completed, as applicable, and submitted with the Contractor’s proposal.

SECTION 4 - TASKS TO BE PERFORMED:

Glove Testing for ASPR/SNS

Task 4.1: Project Management

Task 4.2:

Validation

Testing

Task 4.3:

Statistical Sampling

Task 4.4:

ISO 17025

Accreditation

Task 4.5:

Product

Photographs

Task 4.6: Testing Processes, Timeframes, Delivery of Product and

Reporting Results

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Task 4.1: Project Management for Glove Testing

Objective: The Contractor shall designate a project manager (PM) to provide oversight on this contract. The PM shall serve as the principal point of contact (POC) with the Government. The PM shall manage the following efforts:

• Participate in a post-award kick-off meeting with the Government at a time and place scheduled, within ten

(10) calendar-days of award, by the ASPR SNS Contracting Officer (CO) and Contracting Officer Representative (COR). The kick-off meeting will provide an introduction between the contractor personnel and government personnel who will be involved with this requirement. The meeting will provide the opportunity to discuss expectations, technical, and management issues. The Contractor shall submit to the COR any items to discuss no later than two business days before the meeting for inclusion in the post-award kick-off meeting agenda. The Contractor shall keep detailed meeting minutes and resulting action items and submit them to the COR within three (3) calendar-days of the post-award kick-off meeting.

• Required to travel to the Government’s undisclosed warehouse location to oversee and verify chain of custody for gloves samples being pulled for testing during the period of performance of this contract. The warehouse location is located within the Central Time Zone and will be provided at contract award. The assigned PM must coordinate with ASPR/SNS COR for scheduling of on-site warehouse visits. A written COR approval must be received prior to traveling.

• Attend Weekly Touchpoint Teleconference Meetings with the COR and provide minutes from each session within five (5) business days after meeting date.

• Include as part of the technical proposal a proposed Project Management Framework describing how all tasks are to be performed. Provide a refined draft Project Management Framework to the COR for approval within ten (10) business days after the kick-off meeting. The Contractor shall provide a sample framework to include deliverables and due dates.

• Develop and provide a strategy that addresses both testing, sampling processes, and procedures.

• Engage in frequent communication with SNS COR, as needed, to assist with obtaining gloves and answering technical questions.

• Provide a draft content outline of monthly reports for approval within 10 calendar-days after the kick-off meeting.

• Resolve customer service complaints within 3-5 business days.

• Resolve performance issues within 3-5 business days after notification from the COR.

Task 4.2: Validation Testing

Table A (listed below), Objective: The Contractor shall provide validation testing services and test reports for disposable Nitrile Examination Gloves according to ASTM D6319-19, ISO 10993-5, ISO 10993-10, and ISO 10993-23.

• The Contractor shall test the Government’s disposable Nitrile Examination Gloves, using ASTM D6319- 19(2023) Standard Specification for Nitrile Examination Gloves for Medical Application. This includes testing for:

o Freedom of holes, per ASTM D5151 o Dimensions and tolerances (width, length, finger, and palm thickness) per ASTM D412 and

ASTM D3767

o Physical properties (before aging), per ASTM D412 and ASTM D573. Per ASTM D6319

(7.5.2.3), accelerating aging shall not be performed for gloves that are older than 6 months from the date of manufacture. All gloves provided for testing will be older than 6 months from the date of manufacture.

o Powder residue, per ASTM D6124.

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• The Contractor shall test the Government’s Nitrile Examination Gloves using Biocompatibility (ISO 10993- 1), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), and Cytotoxicity (ISO 10993-5).

• The Contractor shall test the Government’s Nitrile Examination gloves from each manufacturer lot to identify and verify the material component (e.g., nitrile, vinyl, nitrile vinyl blend).

• All glove testing shall be performed in compliance to the ASTM and ISO standards identified in Task 4.2.

• The Contractor shall confirm in their proposal which above glove tests they are able to perform.

• The Contractor shall test for all specified requirements above that are incorporated into ASTM D6319-

19(2023).

• The Contractor shall test the Government’s Nitrile Examination Gloves for cytotoxicity (ISO 10993-05), irritation (ISO 10993-23), and sensitization (ISO 10993-10), and not just one of the biocompatibility tests.

• If certain glove tests (e.g., biocompatibility tests) are routinely outsourced, the Contractor shall inform the

Government of which glove tests those are, the name of the subcontractor/company that will be performing those tests and provide a commitment letter in the proposal from the outsourced company.

• The Contractor shall provide the Government with test results and test reports, including specified photographs in Task 4.5, for each lot tested within 7 days of completion. The final test results and test reports with required photographs shall be provided electronically to the Government.

o Test results for ASTM D6319 and biocompatibility shall be provided using the Contractor’s standard report forms with necessary photographs referenced in Section 4.5 being included in the ASTM D6319 report. A copy of the Contractor’s standard report form(s) shall be provided in the proposal.

Table A: Nitrile Examination Gloves requiring testing to ASTM D6319(2023) and Biocompatibility Standards.

Number* Manufacturer*

Approximate Glove Quantity (in

Each/Singles) **by Lot Number

Quantity of Gloves (in Each /Singles) Needed to Test by Lot Number

(vendor to Fill In)

Quantity of Gloves (in Each /Singles) Needed to Test for Each

Manufacturer Within the Lot Number -

Assuming Equal Split (Vendor to Fill In)

1 A 350,000 2 A 128,000 3 B 242,000 4 B 9,898,000 5 B 7,614,700 6 C, D, E, F, G, H 50,141,600 7 C, D, E 16,838,100 8 C, D 20,703,999 9 G, H 1,852,000

*Actual Lot Numbers and Manufacturer Names (or representative QC numbers) will be provided at contract award.

There may be a manufacturer product variance of +/-1 for any given lot.

Table B (listed below):

Objective: The Contractor shall provide validation testing services and test reports for disposable Vinyl Nitrile Blend Examination Gloves according to ASTM D5250-19(2023), ISO 10993-5, ISO 10993-10, and ISO 10993-23.

• The Contractor shall test the Government’s disposable Vinyl Nitrile Blend Examination gloves, using ASTM D5250-19(2023) Standard Specification for Poly (vinyl chloride) Gloves for Medical Application. This includes testing for:

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Freedom of holes, per ASTM D5151 Dimensions and tolerances (width, length, finger, and palm thickness) per ASTM D412 and

ASTM D3767

Physical properties (before aging), per ASTM D412 and ASTM D573. Per ASTM D5250 (7.5.3), accelerating aging shall not be performed for gloves that are older than 6 months from the date of manufacture. All gloves provided for testing will be older than 6 months from the date of manufacture.

Powder residue, per ASTM D6124.

• The Contractor shall test the Government’s Vinyl Nitrile Blend Examination gloves using Biocompatibility (ISO10993-1), Sensitization (ISO 10993-10), Irritation (ISO 10993-23), and Cytotoxicity (ISO 10993-5).

• The Contractor shall test the Government’s Vinyl Nitrile Blend Examination gloves from each manufacturer lot to identify and verify the material component (e.g., nitrile, vinyl, nitrile vinyl blend).

• All glove testing shall be performed in compliance to the ASTM and ISO standards identified in Task 4.2.

• The Contractor shall confirm in their proposal which above glove tests they are able to perform.

• The Contractor shall test for all specified requirements above that are incorporated into ASTM D5250-19(2023).

• The Contractor shall test the Government’s Vinyl Nitrile Blend Examination gloves for cytotoxicity (ISO 10993-

05), irritation (ISO 10993-23), and sensitization (ISO 10993-10), and not just one of the biocompatibility tests.

• If certain glove tests (e.g., biocompatibility tests) are routinely outsourced, the Contractor shall inform the

Government of which glove tests those are, the name of the subcontractor/company that will be performing those tests and provide a commitment letter in the proposal from the outsourced company.

• The Contractor shall provide the Government with test results and test reports, including specified photographs in Task 4.5, for each lot tested within 7 days of completion. The final test results and test reports with required photographs shall be provided electronically to the Government.

o Test results for ASTM D5250 and biocompatibility shall be provided using the Contractor’s standard reports forms with necessary photographs referenced in Section 4.5 being included in the ASTM D5250 report. A copy of the Contractor’s standard report form(s) shall be provided in the proposal.

Table B: Vinyl Nitrile Blend Examination Gloves requiring testing to ASTM D5250-19(2023) and Biocompatibility Standards.

Number*

Manufacturer

Approximate Glove Quantity (in

Each/Singles) **by Lot Number

Quantity of Gloves (in Each/Singles) Needed to Test by Lot Number

(Vendor to Fill In)

Quantity of Gloves (in Each) Needed to Test For Each

Manufacturer Within the Lot Number - Assuming Equal Split

(Vendor to Fill In)

10 B, I 220,000 11 I 80,000 12 J 4,110,000 13 J 1,264,000

*Actual Lot Numbers and Manufacturer Names will be provided at contract award. There may be a manufacturer product variance of +/- 1 for any given lot.

**Gloves sizes are small, medium, large, and x large. Every glove size may not be represented within each lot

Task 4.3: Statistical Sampling

Objective: The Contractor shall determine and perform glove testing on a statistical sample size representative of glove quantities produced by each of the manufacturers for each lot identified in Table A and Table B.

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• The Contractor shall provide the quantity of gloves (in each, singles) required for testing that represents an appropriate statistical sample size for each manufacturer producing gloves for each of the nine (9) different lots listed in Table A, and for testing gloves on both the ASTM D6319 and ISO 10993 standards (as stated in Task 4.2).

• The Contractor shall provide the quantity of gloves (in each, singles) required for testing that represents an appropriate statistical sample size for each manufacturer producing gloves for the four (4) different lots in Table B, and for testing gloves to both the ASTM D5250 and ISO 10993 standards (as stated in Task 4.2).

• Glove sizes are small, medium, large, and extra-large; however, each glove size may not be represented within each lot. The sample size should also include the breakdown quantities by glove size needed to test by lot.

• The Contractor shall describe in the proposal how the representative statistical sample size was determined.

• The Contractor shall describe if separate glove samples will need to be submitted for ASTM D6319 testing and for each ISO Biocompatibility testing? Or if the same gloves used to test for ASTM D6319 can be also used to test for each ISO Biocompatibility test?

• The Contractor shall describe if separate glove samples will need to be submitted for ASTM D5250 testing and for each Biocompatibility testing? Or if the same gloves used to test to the ASTM D5250 can be also used to test for each ISO Biocompatibility test?

• The Contractor or subcontractor shall clearly demonstrate their ability to determine and provide the statistical representative sample size of the gloves required for testing.

Task 4.4: ISO 17025 Accreditation

Objective: The Contractor, and any subcontractors (e.g., outsourced testing laboratories), shall be an ISO 17025 accredited laboratory with each test performed being under the laboratory’s scope of accreditation.

• The Contractor, as a testing laboratory, shall provide a copy of their ISO 17025 accreditation and a copy of their accredited glove testing standards (include with technical proposal) to ensure that tests being performed meets the Government’s testing requirements specified in Task 4.2.

• If certain glove testing is routinely outsourced from the Contractor, a copy of the outsourced testing laboratory’s ISO 17025 accreditation is required (include with technical proposal), along with a list of their accredited testing standards to include those tests being performed to meet the Government’s testing requirements specified in Task 4.2.

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Task 4.5: Product Photographs in the Test Report

Objective: The Contractor shall have the capability to provide glove, carton, and case photographs as part of the test result and test report documentation.

• The Contractor shall provide photographs of the individual gloves tested along with their corresponding outer case and inner carton(s) to illustrate the glove color, glove integrity, labeling, and manufacturer.

• The Contractor shall provide photographs of the outer case and inner carton(s) of tested gloves, illustrating the glove type (nitrile, chemotherapy, vinyl nitrile blend), glove size, lot number, part number (if applicable) and manufacturer.

• The Contractor shall provide a photograph of, and or written notation, in the test reports of the QC number located on the inner flap of each case of the Government’s Nitrile Examination gloves tested. The QC number reflects the manufacturer that produced the case of gloves. QC numbers do not apply to the Governments Vinyl Nitrile Blend Examination gloves.

• The Contractor shall provide photographs in the ASTM test report of:

• Any overt glove color change identified (e.g., darker blue for some, lighter blue for some) when testing gloves from a manufacturer for the same lot number.

• Any significant glove length discrepancies noted when assessing gloves from the same carton or case.

• Any glove integrity findings (e.g., visual holes, sticking material, embedded bugs, or foreign objects).

• Any overt labeling discrepancies (e.g., glove cartons inside a case are labeled for chemotherapy use but the outer case does not state for chemotherapy use; outer case is labeled size large, but some or all the inner cartons are labeled size small; lot numbers on the outer case and inner carton labeling do not match).

• Any other concerns identified during the glove testing.

Task 4.6: Testing Processes, Timeframes, Delivery of Product, and Reporting Results

Objective: The Contractor shall provide information on glove testing processes, timeframes, delivery of product, and reporting results.

The Contractor shall describe the process required for obtaining the glove samples for testing (include within the technical proposal), process for returning or destroying tested glove samples, and provide the glove test reports. In the description, the contractor shall minimally include the following:

• The Contractor shall inform the Government on their process and protocol for receiving glove samples for testing and maintaining chain of custody.

• The Contractor shall inform the Government on their process and protocol for returning or destroying tested glove samples.

• The Government anticipates shipping the product to the Contractor unless the Contractor's protocol for chain of custody is for the Contractor to pick up glove samples from the Government facility.

• If it is allowable for the Government to ship the glove samples to the Contractor, the Contractor shall provide the shipping requirements, shipping location(s) and addresses, and any special delivery requirements in the proposal.

• The Contractor shall provide the earliest timeframe that the glove testing can begin and an estimated timeline for the completion of the glove testing as referenced in Task 4.2.

• The Contractor shall provide the glove testing results for each applicable standard (e.g., ASTM D6319, ASTM D5250, and biocompatibility testing as identified in Task 4.2).

SECTION 5: PERIOD OF PERFORMANCE

The period of performance of this contract shall be for 7 months from the effective date of the contract. The anticipated period of performance is September 28, 2024, to April 27, 2025.

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SECTION 6 - PLACE OF PERFORMANCE:

The Contractor shall perform most of the services at the Contractor’s offsite facility. The Contractor’s hours of operations for technical assistance and support services shall complement ASPR/ SNS core hours, 8:00 a.m. to 5:00 p.m. EST, during the duration of the contract excluding federal holidays and emergency closures.

The Contractor shall complete Task 4.2, 4.3 and 4.5 at the Contractor’s offsite facility.

SECTION 7 - TRAVEL/TRIP REQUIREMENTS:

The Contractor is required to travel the government undisclosed warehouse location to obtain glove samples during the period of performance of this contract. The Contractor shall request approval for travel and shall coordinate with ASPR/SNS COR for scheduling of on-site warehouse visits. A written COR approval must be received prior to traveling.

The Contractor shall request approval to travel 10-15 days in advance to travel and the COR shall approve before traveling to the SNS warehouse locations.

The Contractor is responsible for making all travel arrangements. The agency will reimburse the Contractor for travel-related expenses up to the maximum allowed in accordance with the Federal Travel Regulations. The Contractor must provide an itemized report that details all travel-related expenses, including the submission of copies of receipts and other supporting documents.

• Travel/Trip report that includes an itemized spreadsheet showing all costs associated with each travel/trip.

On a minimum, the report must include the following information and/or costs (but not limited to):

o Date of travel/trip o Airfare (non-first class) and lodging o Local transportation/car rental and meals *incidental expenses o Other travel related expenses and copies of all receipts and invoices associated with the trip.

SECTION 8- COMPLETION

Upon conclusion of the contract, the Contractor shall provide all documentation to include test reports and return of the nitrile and vinyl nitrile blend gloves to the Government upon completion. The Contractor shall retain all official reports and records related to the performance and life of the contract. Records should be submitted to the Government within 10 days of contract completion and must be provided before contract ends. The communication products and materials shall become the property of the United States Government.

SECTION 9 - DELIVERABLES/REPORTING SCHEDULE

All contract award deliverables shall be electronically delivered to the attention of the COR and shall be subject to review and approval. The electronic files must be compatible with MS Office (2007) and Adobe 8.0 or current version.

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SECTION 10 - CONTRACT ADMINISTRATION DATA

Contracting Officer’s Representative (COR) Donna Winslow Office of Logistics Administration for Strategic Preparedness and Response (ASPR)

Task Number

Items Description Quantity/Format Delivery Date

001 Task 4.1 - Kick-off meeting agenda and notes/action items

Meeting agenda and notes to contain a detailed overview of discussion and resulting action items

Electronic copy- kick-off meeting with agenda and notes/action items

Due within 3 (three) business days of meeting being held

002 Task 4.1 Validation Testing Project Management Framework

Project Management Framework to include detailed description of specific tasks to be performed, the proposed process, methods, approach, resources, and milestone/deliverable timeline to successfully complete each task, and discussion of anticipated challenges likely to occur and plans for addressing them

Electronic copy of Project Management Framework

Include within proposal and within 5 business days after the post-award kick-off meeting; Updates as project changes occur

003 Task 4.1 Draft outline of Monthly Reports for approval

Reports to include comprehensive details of all testing and contract activities performed.

Electronic copy in Word/PDF of monthly and annual reports

Due within 10 calendar days of the kickoff meeting

004 Task 4.1 Weekly Touchpoint Teleconference meeting agenda and notes/action items

Meeting agenda and notes to contain a detailed overview of discussion and resulting action items

Electronic copy of meeting agenda and meeting notes/action items

Due within 5 business days of weekly meeting being held

005 Task 4.2 Validation Testing

Validation Testing to include proposed strategy, tactics, and engagements to effectively test gloves.

Electronic copy Include with proposal and 5 days after completion of test

006 Task 4.3 Statistical Sampling

Nitrile gloves: Statistical sample size representative of total gloves needed to test 9 different lots produced at 1 to 6 manufacturer per lot accordingly and per Table A.

Electronic copy Include within proposal and within 10 days after contract award.

007 Task 4.3 Statistical Sampling

Vinyl nitrile blend gloves: Statistical sample size representative of total gloves needed to test 4 different lots produced at 1 to 2 manufacturer per lot accordingly and per Table B.

Electronic copy Include within proposal and within 10 days after contract award.

008 Task 4.4 ISO 17025 Accreditation

Perform glove testing at an ISO 17025 accredited laboratory with each test performed being under the laboratory’s scope of accreditation.

Electronic copy Laboratory Accreditation Include with Technical and Business proposal

009 Task 4.5 Provide Photographs

Photographs of the tested gloves per lot and per manufacturer. Photographs of the individual gloves tested along with their corresponding outer case and inner carton, illustrating the glove color, glove integrity, the glove name (nitrile, nitrile for chemotherapy, vinyl nitrile blend), lot number, glove size, labeling, and manufacturer, and any noted concerns, as referred to in Task 4.5. A photograph of, and or written notation of the QC number located on the inner flap of each case of the nitrile gloves tested. (Does not apply to vinyl-nitrile blend gloves).

Final electronic copies must include high-resolution image files, all native graphic design files, and any supporting fonts, graphics, and photos.

Due within 5 days after completion of test.

010 Task 4.6 Provide Testing Process, Timeframes, Delivery of products and reporting results.

Provide information on glove testing processes, timeframes, delivery of product and reporting test results.

Electronic Copy- Presentation in Word format

Include within proposal and within 10 days post award

011 Final Report: Within 2 weeks of contract end date, a report encompassing all activities performed under this contract.

Electronic Copy Due within 2 weeks of contract end date.

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2945 Flowers Road Atlanta, GA 30341-4146 Phone: (404) 295-0507 Email: donna.winslow@hhs.gov

Contracting Officer Lawrence McCoy Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) 2945 Flowers Road Atlanta, GA 30341-4146 Phone: (404) 883-9-35745 Email: lawrence.mccoy@hhs.gov

Contracting Officer – CO (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

Contracting Officer’s Representative - COR

Statement of Work (SOW) under this contract is subject to the technical direction of the COR identified in Section 10, or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement.

The COR does not have authority to issue technical direction that:

i. Constitutes additional work outside the contract specification(s)/work statement;

ii. Constitutes a change as defined in the “Changes” clause of this contract;

iii. Causes an increase or decrease in the contract price, or the time required for contract performance;

iv. Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

v. Directs, supervises, or otherwise controls the actions of the contractor’s employees.

Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the contracting officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR. If, in the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the Contracting. Officer no later than the beginning of the next Government workday. Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract.

CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or

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commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under the contract and applicable law.

NON-DISCLOSURE AGREEMENT

All Contractor’s employees that will have access to non-public and procurement-sensitive information (photos, drawings, specifications, statements of work requirements, location data, etc.) or access to non- public ASPR facilities must sign a Non-Disclosure Agreement (NDA). The NDA will be made part of the contract file. The NDA requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with ASPR employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with ASPR/SNS), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves.

They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

1) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

2) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign an NDA, and it is submitted to the Contracting Officer prior to commencement of their work with ASPR/SNS.

3) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

4) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include contract number, employee’s name, position, date of hire and NDA requirement.

SECTION 11 - INVOICES

HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause)

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Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

a) All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions –Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

SECTION 12 - GOVERNMENT FURNISHED EQUIPMENT

No government furnished equipment will be provided for this requirement.

SECTION 13 – DELIVERIES AND PERFORMANCE

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov

(End of Clause)

FAR SOURCE TITLE AND DATE

52.242-15 Stop Work Order (Aug 1989) 52.242-17 Government Delay of Work (April 1984) 52.246-16 Responsibility for Supplies (April 1984) 52.247-34 F.o.b. Destination (NOV 1991)

SECTION 14- CONTRACT CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov HHS Acquisition Regulations (HHSAR) | HHS.gov

(End of Clause) http://www.acquisition.gov/ http://www.acquisition.gov/ http://www.acquisition.gov/ http://www.acquisition.gov/ https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

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FAR SOURCE TITLE AND DATE

52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-17 Ownership or Control of Offeror (Jul 2016) 52.204-18 Commercial and Government Entity Code (Aug 2020) 52.204-20 Predecessor of Offeror (Jul 2016) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance

Services or Equipment (Nov 2021) 52.209-7 Information Regarding Responsibility Matters (Oct 2018) 52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services

(NOV 2023)

52.212-4 Alt. I Contract Terms and Conditions-Commercial Products and Commercial Services

(Nov 2021) 52.222-56 Certification Regarding Trafficking in Person Compliance Plan (Oct 2020) 52.227-14 Rights in Data-General (MAY 2014) 52.227-15 Representation of Limited Rights Data and Restricted Computer Software (DEC

2007) 52.227-17 Rights in Data-Special Works (DEC 2007) 52.228-5 Insurance Work on Government Installation (Jan 1997) 52.232-18 Availability of Funds (APR 1984)

HHSAR SOURCE

352.203-70 Anti-Lobbying (Dec 2015) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

(Dec 2015) 352.223-70 Safety and Health (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) 352.224-70 Privacy Act (Dec 2015) 352.233-71 Litigation and Claims (Dec 2015) 352.237-74 Non-Discrimination in Service Delivery (Dec 2015) 352.239-74 Electronic and Information Technology (EIT) Acquisitions (Dec 2015) 352.242-70 Key Personnel (Jan 2006) 352.270-7 Paperwork Reduction Act (Jan 2006)

Clauses Incorporated in Full Text

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (May 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

https://www.acquisition.gov/far/part-52#FAR_52_203_19

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(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C.

3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

__(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

_x _(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509)).

__(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5).