36C24425Q0011 - Solicitation Glove Test.docx

Solicitation Number / RFQ – 36C24425Q0011 USP 797 Gloved Fingertip Test / Off Site Philadelphia VAMC (CMCVAMC), Philadelphia, PA

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

This Solicitation is being issued as Request for Quote (RFQ) 36C24425Q0011. The government anticipates awarding a single five (5) year Fixed Priced Indefinite Delivery/Indefinite Quantity (IDIQ) contract resulting from this solicitation. The 5-year Ordering Period has the approximate start date of January 15, 2025, through January 14, 2030.

This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-01 (11/12/2024) and can be found at FAR | Acquisition.GOV.

The North American Industrial Classification System (NAICS) code for this procurement is 621511 with a small business size standard of $25.5 Million dollars annually (yearly). This solicitation is Service-Disabled Veteran Owned Small Business Set-Aside (SDVOSB).

This solicitation requires registration with the System for Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines. Registration information is at www.sam.gov. Confirmation of SAM registration will be validated prior to awarding one IDIQ.

The Contractor shall provide services in accordance with the Performance Work Statement (PWS), (Attachment A).

A complete description of the services to be acquired, and/or applicable Government need(s) as follows:

See Attachment A: PWS.

Quotations in response to this RFQ are due on 11:00 AM EST, Thursday, January 2nd, 2025. Quotations shall be submitted via email to Contract Specialist, Kevin Lake at Kevin.Lake1@va.gov AND Contracting Officer, Cynthia Laemmerhirt at cynthia.laemmerhirt@va.gov. Please insert “Solicitation Number 36C24425Q0011 – “USP 797 Gloved Fingertip Test / Off Site” in the subject line of your email. If the email is more than 5MB, please submit multiple emails labeling them 1 of XX, 2 of XX, etc. Any questions or concerns regarding this solicitation shall be e-mailed to the Contracting Specialist Kevin.Lake1@va.gov AND Contracting Officer cynthia.laemmerhirt@va.gov by 11:00 AM EST, Friday, December 27, 2024. Questions will not be accepted after this date. Responses to offeror question(s) will be posted via an amendment to the solicitation on Home | SAM.gov.

See Attachment B: Price Schedule. All pricing fillables shall be completed in Attachment B and included with your quotation.

Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (Sep 2023):

Offerors shall include the following as part of their overall quotation:

Submission Information/Instructions:

Offerors shall submit their quotations in four volumes. Volume 1 (Introductory), Volume 2 (Price), Volume 3 (Technical Capability), and Volume 4 (Past Performance). Failure to follow these instructions may result in Offerors being determined as non-responsive and be removed from this competition.

of the certification with their quotation.

A. Volume 1 Introductory Folder:

The Introductory Folder shall include the information listed below and any other items for which a location has not otherwise been specified.

a. Cover Letter. Offerors shall submit a cover letter identifying their Company name, contact information, CAGE Code, UEI number of the prime and any teaming partner/subcontractor.

b. FAR 52.212-3 Offeror Representations and Certifications- Commercial Products and Commercial Services (May 2024).

Offerors shall include a completed copy of the provision with their offer if the Offeror has not completed electronically in the System for Award Management (SAM) accessed through https://www.sam.gov/SAM/.

c. All quotes shall be valid for at least 60 days from the quote response date.

B. Volume 2 – Price Offerors shall complete the Price Schedule. See Attachment B.

Pricing shall represent the offeror’s best offer and discounts. To be eligible for award, Offerors must submit pricing that the Contracting Officer determines to be fair and reasonable. The Contracting Officer will analyze the Offeror’s total evaluated price to ensure the prices are fair and reasonable. Offeror should consider that requests for price adjustment, other than for wage increases due to Wage Determination, will be denied. Pricing shall take into consideration all adjustments for normal economic inflation for the entirety of the five (5) year ordering period.

*If pricing is not completed in the Price Schedule (Attachment B) then a quotation may not be considered complete or acceptable.

C. Volume 3 - Technical Capability:

Offerors shall submit a Technical Capability Statement that address ALL areas of the PWS and provides an answer to the below statements:

Technical Capabilities:

1. ACCREDITATION AND COMPLIANCE

· Explain your staff and facilities accreditation. Please provide a copy of your staff’s certifications and facility’s accreditation.

· Describe your process for maintaining and updating compliance with relevant local and national regulations.

· Explain the results of your latest audit and when it was completed.

2. TECHNICAL EXPERTISE

· Please explain how you will fulfill the VA’s requirements per the PWS.

· Explain your methods and technologies you use for incubation, identification, and sequencing.

· Explain how often your equipment is calibrated and/or requires preventative maintenance.

· Explain how you handle high throughput of specimens and the amount that can be processed per day to meet the demands of the VA.

3. TURNAROUND TIME

· Describe your average turnaround time for USP 797 microbiology tests. Explain how you can utilize your resources to meet deadlines and during high demand times.

· Explain your process on how you manage urgent requests for faster results and what processes you have in place to minimize delays in reporting.

· Explain how you will scale your resources to meet the additional workload.

4. QUALITY CONTROL AND ASSURANCE

· Provide your Quality Control Plan to ensure prompt, quality service, accuracy, and reliability of test results.

· Explain how you handle errors or discrepancies in test results.

· If possible, share the results of any external quality assessment (EQA) or proficiency testing programs that you participated in.

· Explain your Contingency Plan for emergency situations affecting the testing facility and/or equipment and in case of weather / natural disasters for completing the requirements in the PWS.

5. SAMPLE HANDLING AND TRANSPORTATION

· Describe your protocols for receiving of samples, storage, incubation, and analysis.

· Explain how you ensure the integrity of specimens, specifically the integrity for sensitive specimens.

· Explain if incubation and/ or analysis is performed in house or subcontracted to an external vendor. If subcontracted, please provide the subcontractor’s name and contact information.

· Explain your specific guidelines for handling hazardous or infectious samples to avoid contaminating other samples.

6. DATA MANAGEMENT AND REPORTING

· Name and describe the Laboratory Information Management System (LIMS) you use for tracking and reporting results.

· Describe how you ensure data security and confidentiality.

· Describe how your system completes storage and retrieval of data.

· Describe how long information is stored in your repository and how long before the information is archived.

· Explain your process for information destruction and what is the process for destroying information to include the length of time before the data is destroyed.

7. CLIENT SUPPORT AND COMMUNICATION:

· Describe your customer support services to include technical queries or troubleshooting, availability, and communication process.

· Explain how you handled discrepancies or disputes over test results with clients in the past.

· Describe your process for ongoing communication, service updates, and provide Point of Contact information.

8. COSTS:

· Describe your policy for re-testing or re-sampling in case of errors or contamination. Explain who covers the cost.

9. SUBCONTRACTING:

· Describe your Subcontracting Plan, if applicable.

10. ADDITIONAL REQUIRED DOCUMENTS:

· CLIA License

· CETA Certification

· ISO/IEC 17025 Certification

· State Licenses

Note: Under no circumstances shall pricing information be included in the Technical Capability Statement.

D. Volume 4 - Past Performance:

Past performance will be evaluated based on recent references (work performed within the past 3 years from the issuance date of the solicitation). Each offeror shall identify at least three (3) past performance references similar in scope (relevant work). Offeror must demonstrate experience providing USP 797 laboratory environmental microbiology testing of surfaces samples, media fill testing (MFT) and gloved fingertip (GFT) samples as required by Unites State Pharmacopeia (USP) Chapter 797 by identifying three (3) references for whom contracts of similar scope, size and complexity completed within the past three years. Include the following information:

Company name and address Name, telephone number and e-mail address of Company POC Dates of contract performance, aggregate award amount, and Contract number

As part of this solicitation a Past Performance Questionnaire (PPQ) (Attachment C) is included. All offerors shall provide up to 3 PPQs completed by a third-party. The third party evaluators shall submit the PPQs (Attachment C) directly to the Contract Specialist at Kevin.Lake1@va.gov AND Contracting Officer Cynthia.Laemmerhirt@va.gov prior to solicitation closing date. Past performance will be evaluated as part of the contractor responsibility determination to ensure the presence of an acceptable performance record in accordance with FAR 9.104-1. The Contracting Officer may also use past performance information obtained from all available records (e.g., PPIPRS and FAPIIS) as well.

The Government reserves the right to seek past performance information from any sources not included in your past performance references and available to the Government to include, but not limited to, CPARS or other databases, interviews with Program Managers, customers, and Contracting Officers.

E. Volume 5 - VAAR 852.219-75 VA Notice of Limitations on Subcontracting—Certificate SDVOSBs shall include evidence of compliance with VAAR clause 852.219-73 (VA Notice of Total Set Aside for Certified Service-Disabled Veteran-Owned Small Business set-aside) and 852.219-75 (VA Notice of Limitations on Subcontracting—Certificate of Compliance for Services and Construction). For an SDVOSB to be eligible for award, they shall include in their quotation evidence of VetCert certification via Veteran Small Business Certification. SDVOSB offerors must complete VAAR 852.219‐75 and submit a signed copy of the certification with their quotation.

Service Contract Labor Standards Act (SCLS) applies IAW FAR 52.222-41 and can be found in Attachment E.

(End of Addendum to 52.212-1)

FAR 52.212-2 Evaluation Commercial Items (Nov 2021) applies to this acquisition:

Addendum to FAR 52.212-2: EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

The Government will perform an evaluation using a comparative evaluation of each quote. The Government will compare quotes to one another to select quote that best benefits the Government by fulfilling the requirement. Comparative evaluation will be conducted in accordance with FAR 13.106-2(b)(3). The following factors shall be used to evaluate Quoters:

The Government will award one, five-year fixed price Indefinite Delivery / Indefinite Quantity (IDIQ) resulting from this RFQ to the responsible Quoter whose quote conforming to the RFQ is most advantageous to the Government. The Government will evaluate technical capability, past performance, and price.

The Government will perform a comparative evaluation (comparing offers to each other) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation. Quoters should provide documentation with their quote that demonstrates their technical capability. The documentation should, at a minimum, demonstrate that the contractor is able to provide all the requirements listed within the Performance Work Statement. Additional capabilities above the minimum may also be included and may be reviewed by the Government by completing a one-to-one comparison of the quotes to each other. If the Government determines that there will be a benefit in selecting the contractor that exceeds the minimum requirements, the Government has the discretion to accept the other than lowest priced quote that provides additional benefits to the Government. This Comparative Evaluation will be conducted in accordance with FAR 13.106-2(b)(3).

A written notice of award or acceptance of a quote, emailed, or otherwise furnished to the successful Quoter within the time for acceptance specified in the quote, shall result in a binding IDIQ without further action by either party. Before the offer's specified expiration time, the Government may accept a quote, whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Failure to follow these instructions may result in offerors being determined as non-responsive and will be removed from competition.

The following solicitation provisions apply to this acquisition:

1. FAR 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEPT 2023)

2. FAR 52.252-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR)

3. FAR 52.204-7 SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

4. FAR 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (AUG 2020)

5. FAR 52.204-20 PREDECESSOR OF OFFEROR (AUG 2020)

6. FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

7. FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

8. FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

9. FAR 52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE AND REPRESENTATION (JUN2020)

10. FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)

Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Emailing Address:

Kevin Lake – Kevin.Lake1@va.gov

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

(End of Provision)

11. VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)

12. VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

(a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420 or Email: EDProtests@va.gov.

(b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer.

(End of Provision) PLEASE NOTE: The correct mailing information for filing alternate protests is as follows:

Or for solicitations issued by the Office of Construction and Facilities Management:

(End of Provision)

13. VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)

14. VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008)

15. FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) Quoters shall include a completed copy of the provision with their quote if the Quoter has not completed electronically in the System for Award Management (SAM) accessed through https://www.sam.gov/SAM/.

The following contract clauses apply to this acquisition:

16. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

FAR | Acquisition.GOV VA Acquisition Regulation (VAAR) - Office of Acquisition and Logistics (OAL)

17. FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

18. FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (Nov 2024) The following subparagraphs are applicable:

Subparagraph b 1/4/5/8/9/11/12/20/25/26/31/33/34(i)/35(i)/36(i)/37/38/39(i)/40/46/51/55/56/59/63.

Subparagraphs c 1/2/3/7/8.

19. FAR 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (JUN 2020)

20. FAR 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

21. FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020)

22. VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

23. VAAR 852.219-73 VA NOTICE TO TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

24. VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING – CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023) (DEVIATION)

25. VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

26. VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

27. VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

Clauses included in this solicitation in full text:

28. MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at http://www.va.gov/oig/contacts/hotline.asp and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

29. FAR 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from January 15, 2025, through January 14, 2030.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of Clause)

30. FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $50.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $1,000.00;

(2) Any order for a combination of items in excess of $175,000.00;

(3) A series of orders from the same ordering office within 3 day that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 2 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

31. FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after January 14, 2030.

(End of Clause)

Attachments:

See Attached document: Attachment A – PWS See Attached document: Attachment B – Price Schedule See Attached document: Attachment C – Past Performance Questionnaire See Attached document: Attachment D – VAAR 852.219-5 See Attached document: Attachment E – Wage Determination

End of Document