36C26224Q1704.docx

36C26224Q1704

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Hestia Sim Hestia.Sim@va.gov

PLACE OF PERFORMANCE

VA Long Beach Healthcare System

Pharmacy Service

5901 East 7th Street

Long Beach CA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a combined synopsis/solicitation is unrestricted/full and open for commercial supplies prepared in accordance with the format in Subpart 12.6, as supplemented with the 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 is a request for quotes under solicitation number: 36C26224Q1704

The Department of Veterans Affairs Long Beach Healthcare System, Long Beach, CA 90822 has a purchase requirement for Compounded Chemotherapy. The Contractor shall furnish all supplies/services at The VA Long Beach Healthcare System located at 5901 East 7th Street, Long Beach, CA 90822 in accordance with B.2 STATEMENT OF WORK. Shipping must be included in cost.

NOTE: Potential offers must be aware that the items being acquired are procured as Brand Name or Equal. For those items that are “or equal”, a description of the salient characteristics are outlined below. The FAR Clause 52.211-6 Brand Name or Equal applies to this acquisition. Any items quoted as equal not confirming to the requirements of clause 52.211-6 will be considered non- responsive and not considered for award.

No remanufactures or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM.

Interested contractor must be able to supply and deliver all compounded chemotherapy medications listed below:

The solicitation will be in accordance with FAR Part 12, 13, and 19, Acquisition of Commercial Items, Simplified Acquisition Procedures, Small Business Programs, and Veteran Affairs Acquisition Regulations as supplemented with additional information in this notice. The North American Industrial Classification System (NAICS) code for this requirement is 325412, Size Standard 1,300 Employees. The Contractor shall adhere to all federal and state laws and regulations in effect during the term of this contract. The Government intends to award a firm-fixed-price contract. The Contract begins on the date of award.

Key solicitation milestones are: Submit any questions regarding this procurement via email to Hestia.Sim@va.gov no later than 10am Pacific Local Time Friday, August 9, 2024. No questions will be answered after this date/time unless determined to be in the best interest of the Government as determined by the Contracting Officer. Telephonic questions will not be accepted or returned. RFI responses will be responded to as necessary in amendment format which will be posted to contract opportunities at http://SAM.gov.

Due to time constraints, responses to the solicitation shall be due on Tuesday, August 20, 2024, at 10:00 Pacific Local Time. Offerors are advised that it is your responsibility to review and monitor the website frequently to ensure you have the most up to date information, including amendments. Correspondence or questions may be directed to Hestia Sim, Contracting Specialist at Hestia.Sim@va.gov with " 36C26224Q1704, Compounded Chemotherapy” in the subject line within 48 hours of release of this notice. Telephone inquiries will not be honored. Inquiries after the allotted period may not be responded to due to the time constraints of the procurement. All offerors must be registered in www.sam.gov to do business with the Government. Ensure your registration is correct, current and has not expired.

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Submit invoices electronically through https://portal.tungsten-network.com ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of Page 1 of Page 1 of

B.2 STATEMENT OF WORK

1. SCOPE

VA Long Beach Healthcare System (VALBHS) is seeking a vendor able to provide the manufacturing and delivery of compounded chemotherapy drugs from an FDA 503A-compliant facility for the treatment of patients receiving services at the VA Long Beach Healthcare System. The period of performance is below for base plus option four (4) years, and items will be ordered as needed by VA Long Beach Pharmacy.

PERIOD OF PERFORMANCE:

Base: 10/1/2024 – 9/30/2025 Option Year 1 (OY1): 10/1/2025 – 9/30/2026 Option Year 2 (OY2): 10/1/2026 – 9/30/2027 Option Year 3 (OY3): 10/1/2027 – 9/30/2028 Option Year 4 (OY4): 10/1/2028 – 9/30/2029

PARTICIPATING VA HEALTHCARE SYSTEMS:

VA Long Beach Healthcare System 5901 East 7th Street Long Beach, CA 90822

2. ROUTINE ORDERS

All medications must be delivered with no less than 12 hours remaining on the Beyond-Use-Date (BUD) and no sooner than 0600 AM PST/PDT on the date of delivery to allow adequate time for the administration to clinic patients during their regularly scheduled appointments.

3. EMERGENCY ORDERS

An emergency delivery requires same day delivery and with the time specified during the placement of order.

4. PACKAGING AND MARKING

· The contractor shall package, mark, and transfer all compounded chemotherapy in accordance with all applicable local, state, and federal regulations.

· Items must be adequately packaged to prevent damage during shipping, handling, and storage.

· All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

· Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered, and items/quality shipped.

· The temperature logger must be included in shipments to monitor temperature of drugs for quality assurance. Shipping fees must be inclusive (cost per week) within the hazardous compounded chemotherapy drug.

5. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the hospital and Contracting Officer (CO) of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor is responsible for costs of processing recalls replacing recalled/defective products.

6. CERTIFICATION AND LICENSING REQUIREMENT

The Pharmacy of the Contractor must have a certified 503A pharmacy(s) with an active board of pharmacy license that are licensed to ship/within the State of California.

7. SAFETY GUIDELINES AND REQUIREMENTS

Delivery personnel shall be trained in Compounding Safety Techniques, Compounding Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements.

8. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the referenced site above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

9. CONTRACTOR DELIVERY PERSONNEL

All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English.

· Contractor shall provide the hospital point of contact with a list of contractor personnel expected to enter the buildings. While on VALBHCS premises or off-site parking locations, all contractor personnel shall comply with the rules, regulations, and procedures governing the conduct of personnel and the operation of the facility.

· Contractor personnel shall comply will all VALBHCS policies regarding health and security measures to enter VALBHCS facility. Measures may include but are not limited to answering health screening questions, having temperature taken, or any other measures PVAHCS may use to maintain health and safety of public entering facility.

· Current policies shall be distributed and updated as needed by the hospital point of contact.

· It is the responsibility of the contractor’s personnel to park in the appropriate designated parking areas. Parking information shall be coordinated with facility point of contact.

· VALBHCS shall not validate or make reimbursement for parking violations of the contractor’s personnel under any circumstance.

· Contractor shall comply with all security policies/requirements. All security policies/requirements must be met, and personnel cleared prior to the contractor performing work under this contract. Personnel that cannot meet the security and clearance requirements shall not be allowed to perform work under this contract.

10. Identification, Parking, Smoking, and VA Regulations:

Contractor personnel shall wear visible identification issued by VALBHCS Police Section at all times while on the premises of VALBHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. VALBHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at VALBHCS. Contractor may smoke in designated smoking area on premises. Possession of weapons is prohibited. Enclosed containers, including tool kit, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

11. PLACEMENT OF VERBAL ORDERS

Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders.

12. PERSONNEL POLICY

The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

The government is seeking a vendor able to provide the manufacturing and delivery of compounded chemotherapy drugs from an FDA 503A-compliant facility for the treatment of patients receiving services at the VA Long Beach Healthcare System.

Vendor shall provide proof of required licensing and certification at the time of bid submission.

13. REQUIREMENT

· The Vendor must be able to compound and provide the hazardous medications, including supportive medications, for the VA Long Beach Pharmacy; approximately thirty patients on any given day throughout the performance period. The medications required are included in, but not limited to, the list below.

· All medications must be delivered with no less than 12 hours remaining on the Beyond-Use-Date (BUD) and no sooner than 6 AM PST/PDT on the date of delivery to allow adequate time for the administration to clinic patients during their regularly scheduled appointments.

· Vendor must have a certified 503A pharmacy(s) with an active board of pharmacy license that are licensed to ship into/within the State of California.

· The vendor must complete and meet all requirements for national VA Pharmacy Benefits Management (PBM) Compounded Sterile Products Assessment guidelines.

· The vendor must be able to provide documentation of compliance with the standards outlined in the current version of USP 797.

· The vendor must provide any current or past survey or inspection results and responses from the Joint Commission, Board of Pharmacy, FDA, or any other governing body.

· The vendor must be able to provide stability data for all medications upon request.

· Medications shall not be delivered until ordered by the authorized point of contract.

· Vendor shall notify the government of any anticipated shortages, recalls, or discontinuation of the medications.

· Vendor must be able to ensure and provide documentation that medications are handled appropriately per the manufacturer’s specifications prior to the receipt of the medication by VA Long Beach.

· Medications must meet the technical specifications stated in the FDA-approved package.

· Medication must be stored and used according to the directions on the labeling. If deviating from the FDA-approved package insert, the vendor must submit supporting evidence of practice and must be approved by the government before implementation.

Vendor must be able to supply and deliver all compounded chemotherapy medications listed below:

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Compounded Chemotherapy Contract Period: Base POP Begin: 10-01-2024 POP End: 09-30-2025

LOCAL STOCK NUMBER: 0001

Compounded Chemotherapy Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026

Compounded Chemotherapy Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027

Compounded Chemotherapy Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028

Compounded Chemotherapy Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029

B.4 DELIVERY SCHEDULE

52.00

52.00

52.00

52.00

52.00

SECTION C - CONTRACT CLAUSES

C.1 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):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and…