N6817126QS0010003 SF 30.pdf

R

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBE

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Continuation of Description

Miscellaneous text in this section has been modified to:

PERFORMANCE WORK STATEMENT

SECTION 1 - BACKGROUND

Legislative Decree (Decreto Legislativo) 9 Aprile 2008, n.81, art.41 requires employers to establish a Medical Surveillance that includes clinical and biological examinations and diagnostic tests. The number and volume of testing shall vary depending on the number of patient's samples for test referrals. The order will be based on the requirement at the given time. The charges of each lab test is dependent on the price upon issue of the purchase order award. The total delivery value shall not exceed on the total purchase value at the given period of performance. The contractor is required to track the deliveries and final reporting completion.

SECTION 2 - REQUIREMENTS & QUALIFICATIONS

The Contractor shall perform and provide general clinical and microbiology laboratory testing services to include technical skills and labor, provision of required collection supply items, specimen handling guidance, analytical testing and consultation, specimen (blood, urine, stool, etc. samples) laboratory testing, writing test results and reporting and delivery of final reports and documents via website, email or fax according to industrial laboratory testing standard and applicable laws and regulations of such services.

The Local Laboratory performing the testing services must be located within 150 km by the Sigonella area.

The laboratory sampling shall be conducted at the US Navy Air Station of Sigonella facilities, NAS 1 and/or

NAS 2.

When recommended by the Government, the laboratory sampling can be conducted occasionally at the Contractor lab analysis center.

Testing shall not be sent to and performed by a third party laboratory which is not specified in the quote.

If the Contractor will perform the Chest X-ray (CLIN 0007) through a third party, the qualifications of the third party lab must be provided during the solicitation phase.

The comprehensive list of tests under this purchase order is as listed on the following table (SECTION 3), which are part of the Not-To-Exceed (NTE) CLIN Item.

The contractor shall charge each test as per the identified and established rate upon award (including options if needed). The Government is not obligated to use all the lab tests listed, the Base Competent Physician will provide the kind of tests that each Employee has to perform.

The Government reserves the right to request and add any other tests that are not included on the current listing when needed in the future (if permitted by the contracting regulations and legally approved).

The Contractor must maintain quality assurance (QA) standards:

a. As outlined by the International Organization for Standardization (ISO) 9001/2015 Standards Contractor shall provide a copy of the most current ACCREDIA accreditation certificate to the Government and must be

N6817126QS0010003

maintained during the performance under this contract. Laboratory must be compliant with European Regulation 765/2008 governing regulation of medical devices.

b. The Contractor must have an established Quality Plan and Standard Operating Procedures (SOPs) for all testing sections of the laboratory. The Contractor must have performed performance validations of all instruments and testing kits used to perform clinical testing before clinical results are released Contractor can produce validations.

c. All the equipment used to accomplish the contract service must comply with all the European conformity criteria, directives and regulations.

d. All the personnel that will execute the sampling have to be qualified in accordance with the Italian Law (i.e.

Doctors, nurses, biologists, etc.).

e. Contractors must demonstrate that they have been awarded similar contracts with Federal, State and local Government and private companies with the capability of at least 700 laboratory testing per year.

Same requirement is due by any third party laboratory.

All the testing must be executed in accordance with the procedure described by the latest legislation in force.

All the certifications above have to be provided during the solicitation phase and have to be maintained valid for the entire duration of the contract.

Personal Identifiable Information (PII). The clinical records of patients related to the ordering of laboratory tests and/or the Test Reports (collectively the "Data") shall be regarded as confidential. The Contractor shall comply with all applicable Host Nation laws and regulations regarding the use and disposition of such PII data.

It is understood that the records maintained by the Contractor are and shall remain the property of the Contractor, and will not be removed or transferred from the Contractor's possession, except in accordance with the Contractor's policies and procedures, or as required by law.

The Contractor shall ensure that each laboratory specimen collected are completely and properly labeled (Full patient name, Date of Birth and Patient Identification Number) for laboratory testing at the time of pick up from NAS Sigonella. The Contractor shall be responsible for re-labeling (i.e. barcoding) the laboratory specimen for identifying and tracking purposes and tests preparation at the contractor's laboratory in accordance with their own internal policy to maintain specimen tracking at all times.

The Contractor is totally responsible in case of damage to the sampling during the transportation and shall retake the testing at the Contractor's expense, if needed.

Courier services: Sample collection cannot be carried out by government personnel or by the U.S. Navy. This activity must be performed exclusively by the personnel of the laboratory. Furthermore, the collection will not take place at their facility, but at the facilities located in Sigonella.

The contractor's representative shall collect laboratory specimens for testing at US Navy Air Station of Sigonella Facilities (NAS 1 and/or NAS 2) from 7:30 to 16:00 Monday through Friday as per specific request by the Competent Physician. The Contractor is not required to pick up specimens or deliver the test results on Italian holidays. The Contractor must notify the Government at the beginning of each calendar year which holidays will be recognized and also notify the Government with no less than 3 days notice (as soon as possible) on any other day where Courier services will not be available due to unforeseen, unexpected or unavoidable circumstances.

The contractor is responsible to maintain access validity through the performance period.

For each order of laboratory services performed, the Contractor shall provide a written analysis and test report result within 24 hours after completion of the test.

Due to the information sensitivity contained on the test report, an authorized or an accounted individual shall handle the documents. All documents must be handle fully confidential. Delivery methods acceptable are commercial shipment methods or courier and electronic transmissions (i.e. facsimile, email, web-based interface, or secured internet download).

Chest X-rays must be performed at external clinics accredited outside NAS II. Therefore, it will not be possible to use diagnostic equipment located within the base.

The Contractor will administer and maintain a customer service line during their business hours to respond to inquiries from U.S. NMRTC Sigonella for calls during normal business hours.

SECTION 3 - SERVICE AND PRODUCT DESCRIPTION

Service/Product Description

Y e a rl y Q t y

Yea rly Est.

min.

Qty

C L I N

Blood and Urinals Sampling, Complete blood count, Urine, Glucose, GOT, GPT, GAMMA GT, Total and fractionated bilirubin, BUN, Creatinine, Protein, Total cholesterol, HDL, LDL, Triglycerides. Cellular blood count, complete urine test, glucose, GOT, GPT, gamma GT, total and fractionated bilirubin, urea.

C L I N

PSA for over 45. must include total PSA, free PSA, and the ratio.

C L I N 0 Antibody Research: HIV, HCV

C L I N

HBSAG, Antibodies Anti HBV.

Both of the following are:

HBsAg (surface antigen), anti-HBs antibodies

C L I N

HAV, specifically IgG antibodies 3

C L I N

Tetanus test

C L I N

Chest X-ray.

The radiographic examination must be performed in two projections:

anteroposterior lateral

The expected frequency of the service is 2 times each week for at least 10 sampling per day. This is only an estimate, the Government reserves the right to request any additional test during the week.

A baseline laboratory profile is defined and applies to all employees (CLIN 0001). Additional laboratory tests are then requested based on job-related risks and specific occupational exposure, as determined by the Occupational Health Physician (CLINs 0002-0006).

The communication channel with the Contractor for service requests will be performed by emails. Phone call and in person meetings will be required during the contract service.

SECTION 4 - PERIOD OF PERFORMANCE

This is an Indefinite Delivery Indefinite Quantity, firm fixed price type of contract for the duration of two years.

SECTION 5 - ORDERING PREOCEDURES

1. Task orders issued against this contract will be issued by the awarding Contracting Office, NAVSUP FLCSI C200

2. All task orders issued hereunder are subject to the terms and conditions of this contract. This Contract shall control in the event of conflict with any task order. When a task order is sent by email to the Contractor or physically delivered to the Contractor the task order shall be considered "issued" for purposes of this Contract.

3. Modifications to task orders shall be issued using a Standard Form 30.

4. The ordering process is as follows:

(a) The Ordering Officer from NAVSUP FLCSI will issue a task order by using the Standard Form (SF) 1449 which will contain the following information:

(b) Date of order;

(c) Contract number and Task Order number;

(d) CLIN ordered to include description, quantity, and unit price;

(e) Delivery or Performance Schedule;

(f) Place of Delivery or Performance;

(g) Packaging, packing, and shipping instructions, if applicable;

(h) Accounting and Appropriation Data;

5. GUARANTEED MINIMUM

The guaranteed minimum of $10,000.00 will be obligated on the same date the Contract is released under a single task order. However, the Government intends to issue a task order already above the guaranteed minimum

6. CONTRACT MAXIMUM

The total of all orders issued cannot exceed the contract maximum ceiling per FAR 16.504. The contract maximum is the contract ceiling.

SECTION 6 - Partnership with local laboratories

When laboratory testing services are performed in partnership with a local certified and accredited laboratory partner, the Contractor is required to include the following documentation within the quote:

Copy of the agreement demonstrating the partnership with a local party laboratory for all the duration of the contract;

Demonstrate that local laboratory maintains the quality assurance (QA) standards specified under Section 2 a),b),c),d);

During the duration of the contract, The Contractor is not allowed to provide a laboratory testing services from a different laboratory partner unless authorized by the Contracting Officer.

ADDENDUM TO THE STATEMENT OF WORK

POINTS OF CONTACT

2. Contract Administration Point of Contact:

Name: Alessandra Pulvirenti

Phone: 095-865727

E-Mail: Alessandra.pulvirenti.ln@us.navy.mil

3. Technical Point of Contacts:

Name: Mr. Marco Marino

Phone: 095-56 6266

E-Mail: marco.marino3.ln@us.navy.mil

N6817126QS0010003

mailto:Alessandra.pulvirenti.ln@us.navy.mil

List of Contract Documents, Exhibits, or Attachments

Miscellaneous text in this section has been modified to:

QUESTIONS & ANSWERS

Q1. Specimen Collection Procedure: regarding the sampling requirements outlined in Section 2, could you please clarify if the specimen collection can be performed directly by Government personnel (US Navy staff) at the Base? Alternatively, is it permissible to conduct the sampling at our facility instead of the NAS Sigonella facilities?

A1. Sample collection.

Sample collection cannot be carried out by government personnel or by the U.S. Navy. This activity must be performed exclusively by the personnel of the laboratory participating in the tender. Furthermore, the collection will not take place at their facility, but at the facilities located in Sigonella.

Q2. CLIN 0007 (Chest X-ray): regarding the performance of Chest X-rays, is this exam expected to be performed at our accredited facility? Or does the Government provide an ambulatory room equipped with the necessary X-ray instrumentation at the Base for the contractor's use?

A2. Chest X-ray

Chest X-rays must be performed at external clinics accredited outside NAS II. Therefore, it will not be possible to use diagnostic equipment located within the base.

Q3. CLIN 0006 (Tetanus): Could you please specify the exact type of test required for this line item? Specifically, does "Tetanus" refer to the quantitative determination of Tetanus IgG antibodies (Antibody Titer) to verify vaccination coverage or tetanus prophylaxis, i.e. the inoculation of the vaccine (tetanus toxoid)?

A3. Only the Tetanus Test is required.

Q4. Item 0002 PSA for over 45: can you specify if we have to perform only the total PSA o perform also the free PSA fraction with the relative ratio?

A4. The requested testing must include total PSA, free PSA, and the ratio.

Q5. Item 0004 HBSAG, Antobodies Anti HBV: can you please specify when you are asking for Antibodies HBV if we have to perform the HBSAB only with title or we need to add some other tests related to Hepatitis B (HBcAb, HBcAb IgM, HBeAb, HBeAg).

A5. Both of the following must be requested:

HBsAg (surface antigen), anti-HBs antibodies, in order to allow a complete evaluation of the serological status.

Q6. Item 0005 HAV: Can you please specify if we have to perform HAV IgG only or if we need to add also HAV IgM?

A6. The following must be determined:

IgG antibodies.

Q7. Item 0007 Chest X-ray: Can you specify if we have to perform 1 or 2 projections?

A7. The radiographic examination must be performed in two projections:

anteroposterior lateral.

Service Frequency and Logistics: could you please clarify the expected frequency of the service? Specifically, we would like to know how many Q8.

days per week the laboratory personnel are expected to be on-site at NAS Sigonella and if the sampling visits are limited to a single daily appointment.

The expected frequency of the service is 2 times each week for at least 10 sampling per day. This is only an estimation, the Government reserves A8.

the right to request any additional test during the week.

Clarification on Test Bundling and Pricing Structure: Section 2 states: "The Government is not obligated to use all the lab tests listed, the Base Q9.

Competent Physician will provide the kind of tests that each Employee has to perform."

Could you please clarify if CLIN 0001 (Routine Blood/Urine) is considered the baseline service for every patient visit, with other CLINs (0002-0006) added as supplemental tests?

Specifically, does the Government anticipate scenarios where a single CLIN (e.g., only CLIN 0006 - Tetanus) is requested in isolation, without CLIN 0001? This distinction is critical for our pricing strategy. If a dedicated on-site visit by laboratory personnel and sample transport is required for a single, individual test, we must incorporate the full operational costs (e.g., professional fees for on-site personnel, and logistics) into the unit price of every individual CLIN to ensure cost recovery. Confirming whether CLIN 0001 is the standard minimum for a visit will allow us to structure our quotation correctly without unnecessarily inflating unit prices.

A baseline laboratory profile is defined and applies to all employees (CLIN 0001). Additional laboratory tests are then requested based on job-A9.

related risks and specific occupational exposure, as determined by the Occupational Health Physician (CLINs 0002-0006).

Communication and Ordering Procedures: Could you provide further details regarding the communication channel for service requests? Q10.

Specifically, how will the individual Task Orders or daily requirements be communicated to the contractor (e.g., via email)?

The communication channel with the Contractor for service requests will be performed by emails. Phone call and in person meetings will be A10.

required during the contract service.

Guidance on whether submitting an offer would be permissible under a model where:Q11.

- Our company acts as the prime contractor

- All laboratory testing services are performed by a certified, accredited local laboratory partner.

Answer can be found in Section 6 of the Performance Work Statement, which has been modified according to your question.A11.

Addendum to 52.212-1, Instructions to Offerors - Commercial Products and Commercial Services

Miscellaneous text in this section has been modified to:

52.212-1 INSTRUCTIONS TO QUOTERS- COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

VOLUME I - Introduction.

Quoter shall provide the following information:

1. Contractor Name, Commercial and Government Entity (CAGE) Code, Unique Entity Identifier (UEI), and Tax Identification Number (TIN).

2. Name, telephone numbers, and email address of person(s) to be contacted for clarification or questions pertaining to the Proposal.

3. FILL IN CLAUSES: Quoter shall be registered in the System for Award Management (SAM) to be eligible for award. Proposals received without the completed copy of the provision at FAR 52.212-3 ALT I or completed SAM representation may be considered non-compliant. Proposals determined non-compliant may not be evaluated for award. Quoter must also provide all fill-ins for:

- 52.204-24 Covered Telecommunications Equipment or Services-Representation (OCT 2020)

- 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or A Felony Conviction Under Any Federal Law

(FEB 2016)

4. Terms and Conditions: The Quoter shall include a statement that it either (a) agrees to the terms and conditions of this RFQ (which consists of the entire RFQ, including all documents, exhibits, and other attachments that are incorporated therein by reference and made a part thereof) and any RFQ amendments; or (b) takes exceptions to any terms or conditions of the RFQ, and clearly identifies those exceptions. Exceptions to any of the terms and conditions of this RFQ may be considered by the Government to be unacceptable.

5. Specify Proposal validity period. The Proposal shall be valid for no less than 90 days from the date of RFQ closing.

VOLUME II

VOLUME II.A: Technical Capability

The Quoter shall provide a brief technical approach to clearly demonstrate to the Government that the Quoter meets the minimum requirements identified in Statement of Work (SOW) and that the contractor will successfully accomplish the objectives specified in the SOW. The Quoter shall limit the Technical Section to 2 pages, exclusive of Certificates.

The Contractor must maintain quality assurance (QA) standards and provide related certifications:

a. As outlined by the International Organization for Standardization (ISO) 9001/2015 Standards Contractor shall provide a copy of the most current ACCREDIA accreditation certificate to the Government and must be maintained during the performance under this contract. Laboratory must be compliant with European Regulation 765/2008 governing regulation of medical devices.

b. The Contractor must have an established Quality Plan and Standard Operating Procedures (SOPs) for all testing sections of the laboratory. The Contractor must have performed performance validations of all instruments and testing kits used to perform clinical testing before clinical results are released Contractor can produce validations.

c. When laboratory testing services are performed in partnership with a local certified and accredited laboratory partner, the Contractor is required to include the documentation specified under Section 6 of the PWS within the quote.

VOLUME II.B: Past Performance

The contractor shall submit past performance data on similar contracts as this requirement. The contractor shall describe its past performance on directly related or similar Federal, State and local government, and private contracts which were ongoing or completed within the last three (3) years from the closing date of this RFQ, (not more than three references). The vendor shall provide a detailed explanation of services performed and explain how they are relevant to the requirements of this RFQ. The information must clearly identify if the work by the contractor was done as a prime contractor or a subcontractor.

If a quoter has no recent and relevant past performance, they must affirmatively state so in their quote.

VOLUME II.C: Price

The Quoter shall provide a Firm Fixed unit Price for the duration of the period of performance, to reflect all labor, material, and related costs to execute the requirements. The Quoter is required to submit CLINs pricing in the SF1449. Prices shall be in EURO. All prices will be evaluated for price reasonableness in accordance with FAR 13.106-3. There is no page limit to this volume.

If, there is no adequate price competition, the Government may require additional "other than cost and pricing data" prior to award, to the extent necessary for the Contracting Officer to determine the reasonableness and affordability of the price.

Quote Response Date & Time:

Each quoter must submit the following items to Alessandra Pulvirenti at FISCSI DET Sigonella by the RFQ closing date stated on Block 8 of the SF-1449 at the following email address:

Alessandra.pulvirenti.ln@us.navy.mil

Luciano.giuffrida.ln@us.navy.mil dana.m.rains.ln@us.navy.mil roberto.pipolo.ln@us.navy.mil and must clearly referencing Request for Quote (RFQ)#: N6817126QS001 in the subject line. All quoters are responsible for verifying if their quote was received by the contracting office. It is suggested to verify that the quote has been correctly received or by e-mail or calling Tel. Number 095 865727 - 095 865721 - 095 865725

Questions Response Date & Time:

Questions to this RFQ are due by and will be submitted electronically, in 1300 local time (Catania, Italy time) on 23 January 2026 writing to Alessandra.pulvirenti.ln@us.navy.mil and all the emails specified above, with RFQ# N6817126QS001 in the subject line.

Other methods of submitting questions are not authorized and will not be acknowledged or addressed. All items detailed below must be submitted for the quote to be considered complete. The Government reserves the right to not evaluate incomplete quotes.

NOTE: Quote Delivery: Offerors are advised that delays can be experienced with the Government's e-mail system. Additionally, the e-mail system capacity for each e-mail is 10MB (better if smaller). E-mails greater than 10MB will not be delivered and will not be considered. Therefore, quotes exceeding the size limit must be sent via multiple e-mails. Zipped files are not accepted.

QUOTE INSTRUCTIONS & REQUIREMENTS:

1. A quote will be accepted in the English language only. Any quote received in other than the English language will be rejected.

2. All quotes shall be in Euro Currency.

3. The Quoter agrees to hold the prices in its quote firm for 90 calendar days from the date specified for receipt of the Quote.

4. System for Award Management (SAM). The Contractor shall be registered in the SAM database prior to the award of this contract. Further information and guidance regarding SAM can be found at the SAM website: www.sam.gov.

N6817126QS0010003

mailto:dana.m.rains.ln@us.navy.mil

NAVAL REGIONAL CONTRACTING CEN DET, PSC 817 BOX 50

FPO, AE 09622-0050

UNITED STATES

Alessandra Pulvirenti, Email: alessandra.pulvirenti.ln@us.navy.mil Telephone: 3146245727 AdminBy:

SCD: PAS:

MODIFICATION TO 52.212-1 (ADDENDUM) INSTRUCTIONS TO QUOTERS.

DUE DATE REMAINS 3 FEB 2026 AT 11.00 AM.