75A50324R00016 Amendment 0001 Testing.pdf

0001 October 4, 2024

ASPR/SNS

2945 Flowers Road Atlanta, Georgia 30341

ASPR

Same as Block 6

ASPR

X 75A50324R00016

September 6, 2024

X X

Solicitation 75A50324R00016 is hereby amended in its entirety. See the following pages:

1 47

COMBINED SYNOPSIS SOLICITATION

Amendment 0001 to Solicitation 75A50324R00016

The solicitation document for RFP 75A50324R00016, posted to the Governmentwide point of entry (GPE) (sam.gov) September 6, 2024 is hereby superseded in their entirety by the attached RFP 75A50324R00016, Amendment 0001, dated October 4, 2024, indicating a proposal due date of October 21, 2024. See below for a list of additional changes. Offerors are directed to use the RFP attached to this amendment for their response to this solicitation. Responses to the original RFP will not be further evaluated or considered for award. In accordance with FAR 52.212-1(b)(9) acknowledgment of solicitation amendments is required.

The attached solicitation document for RFP 75A50324R00016 incorporates the following changes to the solicitation:

1. Changes the due date of the proposal to 1:00 PM Eastern Standard Time, October 21, 2024. The offeror’s complete proposal (including all information required to be submitted in Volume A – Technical Proposal, and Volume B – Price/Business Proposal) must be received by the date and time specified for receipt of offers. Only electronic submissions will be accepted. Complete proposals must be submitted via email. Offers are due no later than October 21, 2024, by 1:00 PM. Eastern Standard Time, with the Subject Line “RFP 75A50324R00016, Amendment 0001 – Laboratory Testing, Statistical Sampling, and Reports for Disposable Nitrile and Vinyl Nitrile Blend Examination Gloves by email to Lawrence.McCoy@hhs.gov, and Mattie.Washington@hhs.gov Email submissions are limited to 2 MB.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

2. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested.

3. The solicitation number is 75A50324R00016 which is being issued as a Request for Quote (RFP). The Government anticipates the award of a Firm Fixed Price (FFP) type contract for severable services.

4. The solicitation document and incorporated provisions and clauses are currently in effect through Federal Acquisition Circular 2024-07, effective August 29, 2024.

5. 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).

6. 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.

7. See below for description of requirements.

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

9. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (SEP 2023), applies to this acquisition.

10. The provision at FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV

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2021), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

11. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representation and Certifications- Commercial Products and Commercial Services (May 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).

12. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (NOV 2023), applies to this acquisition.

13. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (May 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.

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

15. 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.

16. Offers are due no later than October 21, 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 75A50324R00016,” 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 75A50324R00016” 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) October 10, 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.

ii. 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

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

CLIN Description QTY/UNIT Unit Price TOTAL PRICE

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

Firm Fixed Price (FFP) 1002 Laboratory Testing, Biocompatibility Testing (if capability exist), 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 (FFP) 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

Note: The Contractor shall provide pricing per each CLIN to include an itemized price list that resulted in the final total.

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SECTION C- 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

C.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.

C.2 - PURPOSE:

The U.S. Government is interested purchasing a one-time third-party testing service 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 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.

C.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 manufacturers 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 10993-23. 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 10993-23.

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.

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) 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.

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 10993-23. 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 10993-23.

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.

C.4 - TASKS TO BE PERFORMED:

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

Reporting Results

Task 4.5:

Product

Photographs

Task 4.4:

ISO 17025

Accreditation

Task 4.3:

Statistical Sampling

Task 4.2:

Validation

Testing Task 4.1: Project

Management

Glove Testing for ASPR/SNS

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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, and if capable 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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• If the Contractor has the capability, 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 lot and each manufacturer producing the 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).

• If the Contractor has the capability, 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 and each manufacturer 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.

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.

**Glove sizes are small, medium, large, and x large. Every glove size may not be represented within each 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), and if capable ISO 10993-5, ISO 10993-10, and

ISO 10993-23.

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• 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:

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.

• If the Contractor has the capability, 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 lot and each manufacturer producing the 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).

• If the Contractor has the capability, 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 and each manufacturer 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.

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) 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

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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.

• 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.

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 gloves tested along with their corresponding outer case and inner carton(s) to illustrate the glove color, glove integrity, labeling, and manufacturer. This photo requirement is for one pair of tested gloves per case.

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• 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).

C. 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 November 1, 2024, to May 31, 2025.

C. 6 - PLACE OF PERFORMANCE:

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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.

C. 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.

C.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.

C. 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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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

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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 Nitrile and Vinyl Nitrile Blend Gloves are GFP to be return at contractor's expense.

Physical Distribution Due within 2 weeks of contract end date.

012 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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SECTION D-PACKAGING, MARKING AND SHIPPING PACKING

All postage and fees related to submission of information, including forms, and reports, etc., to the Contracting Officer or Contracting Officer’s Representative (COR) or other persons designated to receive shall be paid by the Contractor.

The Isolation Gown must be folded and packaged in such a way that the size and level of barrier performance is visible.

Gowns shall be individually wrapped or packaged with up to 10 gowns per bag. Outer cartons/Cases shall have no more than 100 individual gowns in total.

D.1 MARKINGS

All product delivered under this contract shall be packaged, marked, and shipped in accordance with Government specifications and FDA regulations. At a minimum, each deliverable shall include the following information at time of delivery:

1. Ordering Agency

2. Packing Slip with Contract number

3. Description of product

4. Contract Number

5. Contract Name and Address

6. Storage Requirements shall be on all packing’s lists.

7. FDA’s general device labeling requirement per 21 CFR Part 801 and ASTM F3352-19 Section 11.1 and

11.2 Labeling Requirement (see also Section C.3: Labeling and Packaging)

8. Shelf life and expiration/use by date

9. For products with an issued National Stock Number (NSN), product cases shall have applicable NSN annotated on case and inner package labels.

D.2 DELIVERY LOCATION & SHIPPING REQUIREMENTS

Products shall be shipped FOB Destination. The address(es) will be provided by the COR after award and will be to a Government designated location within the continental United States (CONUS). The contractor shall adhere to the following shipping requirements:

a. No partial case or package quantities will be accepted unless approved by SNS in advance.

b. No mixed lot numbers per case or per packages will be accepted.

c. No mixed sizes (e.g., larges or extra larges mixed in on one pallet) will be accepted.

d. One lot number will be used per pallet. Only one pallet may contain multiple lot numbers per order.

e. Lots must be clearly identified.

f. Duplicate lots must only have one expiration date (i.e., the same two lot numbers must not have different expiry dates).

g. Contractor shall contact designated POC (for the respective address items are being delivered to) to schedule delivery appointments NLT 48 hours prior to shipping any product but as far in advance as possible (delivery times are Mon – Fri 8:00 AM – 3:30PM).

h. All pallets are to have the identical TI-HI stack pattern for all deliveries throughout this contract except for the final pallet.

i. The product/case packaging configuration shall be identical for all deliveries throughout this contract.

j. All product to be delivered on Heat Treated 48" by 40" pallet, not to exceed 60” in height, stretch wrapped, and secured to pallet for safe transport.

k. Product is to be stacked in such a way that no portion of the cased materials may exceed the dimensions of pallet.

l. All cases must be positioned on the pallet in a way that allows for labels to be viewable.

m. The exact delivery locations shall be provided by the COR; Delivery will be within the CONUS.

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SECTION E- INSPECTION AND ACCEPTANCE

E.1 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://farsite.hill.af.mil/

(End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions-Commercial Products and Commercial Services

(Nov 2023) 52.245-1 Government Property (Sep 2021) 52.246-4 Inspection of Services-Fixed Prices (Aug 1996)

“Notwithstanding the clause at FAR 52.212-4(a), inspection and acceptance shall be governed in accordance with

FAR 52.246-2”.

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SECTION F- DELIVERIES AND PERFORMANCE

F.1 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://farsite.hil.af.mil/(End of Clause)

FAR 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 (Apr 1984) 52.247-34 F.O.B. Destination (Nov 1991)

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SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR/SNS personnel:

Contract Specialist Lawrence McCoy Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: Lawrence.McCoy@hhs.gov:

Contract Specialist/Contracting Officer Annette Wright, Team Lead Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: Annette.Wright@HHS.gov

Contracting Officer’s Representative (COR) Donna Winslow Office of Logistics, Strategic National Stockpile (SNS) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: donna.winslow@hhs.gov, G.2 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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G.3 Electronic Invoicing and Payment Requirements - Invoice

• 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):

• 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.

• 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.

• Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to:

IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

• The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

If your company is already registered to use IPP, you will not be required to re-register. If the Contractor is unable to comply with the requirement to use IPP for submitting I invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

Additional Office of the Administration for Strategic Preparedness and Response (ASPR) requirements:

I. The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties.

II. Invoices must break-out price/cost by contract line number (CLIN) as specified in the pricing section of the contract.

III. Invoices must include the Dun & Bradstreet Number (DUNS) of the Contractor IV. Invoices that include time and materials or labor hours CLINS must include supporting documentation to

(1) substantiate the number of labor hours invoices for each labor category, and (2) substantiate materials costs incurred (when applicable).

V. Invoices that include cost-reimbursement CLINs must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)-show rate, base, and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

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• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

(End)

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