36C26119Q0692-003.docx

36C26119Q0692

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9.

ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE

WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15

CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTA

CHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

570-20-1-625-0003 36C26119Q0692 11-07-2019 Larry Facio

(916) 923-4553 11-13-2019 12:00pm (PST)

612MCP

Department of Veterans Affairs

VA

Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609 X 446110 $30 Million N/A X

VA

Central California HCS 2615 E. Clinton Avenue Fresno CA 93703

612MCP

Department of Veterans Affairs Department of Veterans Affairs VA Northern California HealthCare System 3230 Peacekeeper Way, Bldg. 209 McClellan CA 95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin TX 78714-9971 Contactor Shall Provide Pharmaceutical Compounding Services In Accordance to the Statement of Work for VACCHCS.

This Will Be A Multiple-Award, Blanket Purchase Agreement (BPA).

570-3600160-625-822400-2560 0100224V1 X X 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 36C261 MARK J. MIKUS Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

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.

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PHARMACEUTICAL COMPOUNDING PREPARATION SERVICES

Contract Period: Base POP Begin: 11-12-2019 POP End: 11-11-2020

PHARMACEUTICAL COMPOUNDING DELIVERY FEES

Contract Period: Base

Contract Period: Base

Contract Period: Base

TOTAL FOR BASE ORDERING PERIOD:

PHARMACEUTICAL COMPOUNDING PREPARATION SERVICES

Contract Period: Ordering Period 1 POP Begin: 11-12-2020 POP End: 11-11-2021

PHARMACEUTICAL COMPOUNDING DELIVERY FEES

Contract Period: Ordering Period 1

Contract Period: Ordering Period 1

Contract Period: Ordering Period 1

TOTAL FOR ORDERING PERIOD #1:

PHARMACEUTICAL COMPOUNDING PREPARATION SERVICES

Contract Period: Ordering Period 2 POP Begin: 11-12-2021 POP End: 11-11-2022

PHARMACEUTICAL COMPOUNDING DELIVERY FEES

Contract Period: Ordering Period 2

Contract Period: Ordering Period 2

Contract Period: Ordering Period 2

TOTAL FOR ORDERING PERIOD #2:

PHARMACEUTICAL COMPOUNDING PREPARATION SERVICES

Contract Period: Ordering Period 3 POP Begin: 11-12-2022 POP End: 11-11-2023

PHARMACEUTICAL COMPOUNDING DELIVERY FEES

Contract Period: Ordering Period 3

Contract Period: Ordering Period 3

Contract Period: Ordering Period 3

TOTAL FOR ORDERING PERIOD #3:

PHARMACEUTICAL COMPOUNDING PREPARATION SERVICES

Contract Period: Ordering Period 4 POP Begin: 11-12-2023 POP End: 11-11-2024

PHARMACEUTICAL COMPOUNDING DELIVERY FEES

Contract Period: Ordering Period 4

Contract Period: Ordering Period 4

Contract Period: Ordering Period 4

TOTAL FOR ORDERING PERIOD #4:

GRAND TOTAL:

ESTIMATED QUANTITIES

For Community Home Infusion Services

Base Year/Base Ordering Period: November 12, 2019 to November 11, 2020

Quantity (Weekly) Estimated Quantity (Annually) Unit

Option Year #1/Ordering Period #1: November 12, 2020 to November 11, 2021

Quantity (Weekly) Estimated Quantity (Annually) Unit

Option Year #2/Ordering Period #2: November 12, 2021 to November 11, 2022

Quantity (Weekly) Estimated Quantity (Annually) Unit

Option Year #3/Ordering Period #3: November 12, 2022 to November 11, 2023

Quantity (Weekly) Estimated Quantity (Annually) Unit

Option Year #4/Ordering Period #4: November 12, 2023 to November 11, 2024

Quantity (Weekly) Estimated Quantity (Annually) Unit

Page 1 of

Statement of Work Pharmaceutical Compounding VA Central California Health Care System

Section 1: General Information

1.1 General: This is a non-personal service to prepare and deliver to VA Central California Health Care System (VACCHCS) pharmacy IV chemotherapy and other hazardous drug (HD) products. Contracted pharmacy is to prepare and deliver to VACCHCS pharmacy IV chemotherapy and other hazardous drug (HD) products as requested by the VACCHCS pharmacy on an on-demand basis. Contractor must be FDA 503A and possess USP 800 certification for hazardous drug sterile IV preparation suite and adhere to all USP 800, Joint Commission, FDA and other applicable regulations and standards for safely in preparing sterile HD IV solutions. Contractor shall have all licenses, permits, accreditation and certificates required by law including USP 800 certification for the HD preparation area and other areas of the pharmacy and facility as required by USP 800. Services are conditional on the building and certification process of VACCHCS hazardous medication preparation pharmacy and will be generated on an as-needed basis. No guarantee of need of the service can be provided to the contractor.

1.3 Place of Performance: Veterans Affairs Central California Health Care System 2615 E. Clinton Avenue Fresno, CA 93703

1.4 Hours of Operations: VACCHS pharmacy is a 24/7 operation however this service is only required during operation of the VA Ambulatory Infusion Clinic (AIC) when the VA pharmacy cannot provide the needed medications. Normal duty hours for the AIC are 7:30 A.M. TO 4:30 P.M. Monday through Friday. The contractor shall provide services on an as needed basis as scheduled by the VA Chief, Pharmacy Services.

1.5 Type of Contract: Multiple-Award, Blanket Purchase Agreement (BPA).

1.6 Invoicing and Payment:

1.6.1 Government-Wide Purchase Card:

Invoicing will be per order, per day, per patient. The VA will pay the vendor using a government credit card and will process the payment by patient. In order to protect patient information, only the last name and first initial will be provided as verification of service for auditing purposes and to ensure accountability of the drugs given to each patient.

At the end of each month, the VACCHCS Ordering Officers will provide an accounting of all Chemotherapy IV preparations ordered and received from contractor.

1.6.2 Electronic Funds Transfer:

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or

Tungsten, please contact the FSC at the phone number or email address listed below:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov

Contractor shall submit final invoice after the completion of repairs. Invoice shall include the Contract number, Purchase Order number, Order Date, Performance Period, Description of Services and itemized prices as negotiated.

Section 2: Definitions & Acronyms

2.1 Definitions:

Contracting Officer. The person with the authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government.

Note: The only individual who can legally bind the government

Contracting Officer Representative/Designated Representative. As delegated by the Contracting Officer; Responsible to approve and submit invoices, Maintain written and oral communications with the Contractor concerning technical aspects of the contract; Communicate with the Contracting Officer and the Contractor of any deficiencies; Coordinate availability of government furnished property; Provide site entry of Contractor personnel; Monitor and inspect Contractor’s performance Does not have authority to make changes in cost or price, estimates or changes in delivery dates and cannot authorize changes to any of the terms and conditions of the resulting order.

Ordering Officer. Ordering officers (OOs) are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

2.2 Acronyms:

Section 3: Government Furnished Property, Equipment, and Services The Government will provide the contractor with all labels, pharmaceutical medications, all additional non-medication supplies which may include but not limited to diluents, IV tubing sets and empty, sterile CADD cassettes.

Section 4: Contractor Furnished Items and Services The contractor shall provide all materials, equipment, supplies, management, supervision, personnel, and transportation necessary to assure that all services are in accordance with the contract and all applicable laws and regulations. The contractor shall ensure all work meets performance standards specified in this SOW and referenced documents. Contractor must use DOT licensed transportation and follow all applicable rules and precautions required to transport hazardous materials specifically IV chemotherapy products.

Section 5: General Tasks: The representative will drop-ff/deliver the finished-orders for infusion that day at the VA infusion center and to pick up requested-orders and supplies required for the following day (if applicable). The VACCHCS pharmacist will provide the contractor representative the patient specific order labels. The labels will contain all the information required by the contractor pharmacist to prepare the sterile HD medication order(s) for the VA patient(s). In addition, the VA Pharmacy will provide the contractor representative with all additional non-medication supplies to complete the order to a ready state for patient infusion, this may include but is not limited to diluent IV tubing sets and empty, sterile CADD cassettes. It is the contractor’s responsibility to prepare the HD IV medications as indicated on the VA order label then transport the completed order(s) to the VACCHCS pharmacy the following morning. The cutoff time for delivery of the completed orders is 8:00 A.M. Urgent orders requiring same day delivery will be provided as required by VA whenever practical (delivery plus compounding time is sufficient). At this moment VACCHCS Standard services consist of finished-orders delivered no-later than 8 a.m., these orders will have an expiration of 6p.m. of that same day. During standard services contractor will pick-up meds for next days, or Monday’s services.

Urgent (same day requests) will require contractor hours of operation to meet an urgent request. This would very likely be daytime hours during VA AIC business hours as stated above. In order to provide the needed products to the VA in time to satisfy patient needs (delivered same day prior to 3 P.M.) The contractor will not be required, to furnish such services on a national holiday. VA observes the established Federal Holidays and will not be impacted by Executive Declared Holidays.

5.1 Contractor Specific Tasks: Contractor shall compound IV chemotherapy/HD medication as ordered by VA supplied order (recipe) adhering to all relevant USP 797/800 standards in a timely fashion as defined by VA patient need: (http://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf).

a. Duties involve/include:

1) verifying medication(s) and diluent(s) supplied by VA are not expired and do not appear to have any defects (cracked container, leaks, precipitation or other debris, cracked stoppers/lids, inappropriate color changes),

2) verifying the medication was transported correctly between VA and the contractor,

3) verifying supplied medications and diluents supplied by VA against the supplied label,

4) drawing up correct quantities from the supplied medication stock,

5) removing an equal amount of diluent from the bag to account for the volume of medication required to compound the recipe,

6) inspecting all drawn-up and finished products for precipitation, cores or other defects,

7) labeling each product accurately, and

8) providing a final inspection and initialing each medication label.

b. The contractor is responsible for ensuring the medications supplied by VA are stored under conditions as recommended by the manufacturer for each medication once received, during compounding and after completion of compounding. Contractor will return any unused medication, diluent, IV tubing and CADD cassettes to VA pharmacy in the condition they were supplied to the contractor by VA pharmacy.

c. The contractor shall affix a label to the finished product that clearly lists all ingredients contained within the product (both active and inactive), add any recommended warning or storage requirement labels (Refrigerate/warning chemotherapy) and attach to the medication container a label that notes the item’s expiration date and time. Once properly labeled, they will place the finished product in a suitable transportation container (sealed plastic box or cooler) and enclose the National Drug Code, lot numbers and expiration date for all the ingredients used in the container.

d. The contractor will transport the finished product to the VA pharmacy using DOT licensed transportation and following all applicable rules and precautions required to transport hazardous materials specifically IV chemotherapy products.

5.2 Government (VACCHCS) Specific Tasks:

a) Scheduling:

1) Each Friday morning; VACCHCS Ordering Officer will fax the chemo schedule for AIC for the next week to contractor so they can plan appropriately.

b) Placing Orders: (If contractor is to acquire compounding materials from VACCHCS):

1) VACCHCS Pharmacy will prep meds for pick up by contractor by 8AM, Monday through Friday which will be picked-up by contractor sometime after 8AM.

2) Packaging of orders will be a large zip lock bag containing a small zip-lock bag which has the chemo agent in it by itself and sealed with remaining solutions and supplies needed to make each chemo. If the day calls for three CADD pumps, a syringe and two IVPB, each of those items should have its own zip-lock bag set up.

3) The day prior to needed services; the VACCHCS Ordering Officer will fax orders needed for Mondays on Friday before. Include instructions for Monday early morning delivery on the fax sheet (an affirmation of the Friday’s faxed schedule).

4) Fill out the Contractor Hazardous Drug Compounding Form, Attachment # 1 completely; stability needs to be checked by VACCHCS oncology or staff pharmacist and typed on the fax form; verified to ensure correct expiration date.

5) Fax completed form and cover sheet to contractor no later than 11AM.

6) Call contractor about 15-30 minutes after fax sent to confirm the fax was received. Repeat fax if necessary.

7) VACCHCS Pharmacy shall ensure staff is readily available for contractor’s courier drop-off/deliver , before 5PM.

8) Meds should be stored in an appropriate place (in IV room in yellow box or in refrigerator in yellow container).

An alternate means of verifying orders will be electronically, email. Contractor and VACCHCS will provide a listing of point-of-contacts that will be responsible for confirming orders are received. This roster will be updated each month or during changes of point-of-contact personnel. See Attachment #2, VACCHCS Compounding Services, POC Roster. When sending emails ensure all messages are encrypted due to security and HIPAA concerns.

c) Placing Orders: (If contractor is to obtain materials from distributor/manufacturer):

1) The day prior to needed services; the VACCHCS Ordering Officer will fax orders needed for Mondays on Friday before. Include instructions for Monday early morning delivery on the fax sheet (an affirmation of the Friday’s faxed schedule).

2) Fill out the Contractor Hazardous Drug Compounding Form, Attachment # 1 completely; stability needs to be checked by VACCHCS oncology or staff pharmacist and typed on the fax form; verified to ensure correct expiration date.

3) Fax completed form and cover sheet to contractor no later than 11AM.

4) Call contractor about 15-30 minutes after fax sent to confirm the fax was received. Repeat fax if necessary.

5) VACCHCS Pharmacy shall ensure staff is readily available for contractor’s courier drop-off/deliver , before 5PM.

6) Meds should be stored in an appropriate place (in IV room in yellow box or in refrigerator in yellow container).

5.3 Licensing and Accreditation: The Contractor shall maintain current request.

a. Contractor shall have all licenses, permits, accreditation and certificates required by law including USP 797/800 certification for the HD preparation area and other areas of the pharmacy and facility as required by USP 797/800.

b. Contractor/Sub-Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA if contractor is engaged in interstate commerce.

5.4 Contract Personnel: Contractor shall provide the services of a fully trained, registered and licensed Pharmacist trained and certified competent in preparing If a technician is used by the contractor to prepare the medication documentation

a. Perform the services covered by this contact, the contractor's personnel shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. Qualifications shall be subject to the review by the VA Pharmacy Chief of Staff and approval by the VA facility Director.

b. The contractor's personnel shall be responsible and able to show evidence of reliability, ability and experience. Verified references of ability and qualifications may be accepted by the Contracting Officer to satisfy these requirements. This includes all current external and internal IV suite testing and certification for sterility and functionality of equipment and of rooms used in the preparation of chemotherapy and other HD. The contractor will provide up to date training and certification records for those staff involved in the preparation, finished product checking (Verification of all aspects of the completed product are as required in the VA order, correct medications, strengths, diluents and volume) and transport of chemotherapy and other HD. The contractor will provide documents indicating active and current licensure of all staff involved in the transport, preparation and checking of chemotherapy and other H.D.

c. The contractor Pharmacist shall work and communicate effectively while remaining courteous, tactful, and understanding when interacting with others, even in potentially difficult situations.

5.5 Administrative: Patient Safety Compliance and Reporting: Contract provider(s) shall follow all established patient safety and infection control standards of care. Contract providers(s) shall make every effort to prevent medication errors. All events related to medication errors, and other breeches of patient safety shall be reported to the OOs, COR per VA Safety Policy. As soon as practical as (but no later than 24 hours) contractor shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

Ordering Officers:

Christopher Cervantes Christopher.Cervantes@va.gov

(559) 225-6100 ext.: 5691

Bruce Manzo Bruce.Manzo@va.gov

(559) 225-6100 ext: 5685

COR: Frank Oliveira Frank.Oliveira2@va.gov

(559) 225-6100 ext.: 3495

5.5.1 Ordering officers (OOs) will be authorized to place orders against this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs, by separate memorandum upon issuance of the contract. When OOs are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs, by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs. Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders.

5.6 Security Badging

a. Prior to reporting to work, the contracted employee will need to contact the designated COR or designated VA program-specific contact who will take him/her to the on-site Police Dispatch.

b. Police staff will issue a temporary ID badge to the contracted employee, who in turn, will properly display the badge while working at VACCHCS.

c. Upon completion of the assignment, the employee will return the badge to Police Dispatch.

5.7 Parking

Parking is allowed only in those areas not designated for patient use. All traffic laws and parking rules on the grounds are strictly enforced. Failure to follow these laws and regulations may result in a citation being issued that will have to be resolved through the federal court system.

5.8 Misconduct or Security Concerns

a. The Government may, at its sole discretion, direct the contractor to remove their employee from the medical center facilities for misconduct or for security reasons.

b. Removal does not relieve the contractor the responsibility to continue providing the services required under this contract.

c. The Contracting Officer (CO) will provide the contractor with a written explanation to support any request to remove an employee.

5.9 Delays

a. In any instance where the contractor has knowledge that any actual or potential situation may delay or threaten to delay the timely performance of this contract, the contractor shall immediately notify the OOs and the CO.

b. In the event of delayed delivery, the contractor shall have staff and transportation readily available to accommodate the need for finished-orders and requested-orders.

c. This notice shall include all relevant information and corrective actions that are being taken. The Government reserves the right to hold the contractor fully accountable for problems incurred as a result of such delays, including denial of delivery time extensions, if such notification is not provided.

5.10 Security Requirements

a. The contractor will be responsible for ensuring compliance by its employees with the security regulations of Veterans Affairs where work is performed under this contract.

b. All contractor personnel and any subcontractors performing services under this contract must complete a confidentiality certification or Privacy Attestation, which must be renewed annually. Contractor is responsible for ensuring all personnel employed on this contract who handle the patient information sign a Privacy Attestation each year and renew annually. Contractor must email the signed copies of Privacy Attestations to the COR prior to providing each service and/or make them available on the secure website prior to providing each service. Under no circumstance can a service be performed by any personnel without signing a Privacy Attestation.

5.11 Quality Control

a. The contractor shall provide the reviews and quality checks necessary to ensure that the hazardous drug and IV medications are handled, processed, and delivered within Federal, State, City, and local law and mandates.

b. The contractor shall closely monitor its performance in meeting the requirements for timely delivery of pharmaceutical compounding services. The contractor shall advise the COR in advance if the stipulated standards cannot be met or if circumstances hinder full execution.

5.12 Additional Work Needed

To the utmost of their abilities, VACCHCS OOs will schedule and coordinate services that allows the contractor the ability to establish their processes. In the event of uncontrollable or unforeseeable circumstances (i.e. natural disasters, severe weather, emergencies, facility lock-down, etc.) the government expects all parties to exercise good faith practices in order to remedy a viable conclusion based on established contractual deliverables, pricing, and industry standards.

Section 6 Attachments and Links:

6.1 Attachments

Attachment #1 – Contractor Hazardous Drug Compounding Form

Page 1 of

B.3 BPA ORDER INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's BPA (including any agreement modifications) apply to task or delivery orders issued under the Blanket Purchase Agreement (BPA), otherwise called the agreement, as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the Agreement. Any unique terms and conditions of an order issued under the agreement that are not already part of the agreement, will govern. In the event of an inconsistency between the terms and conditions of a BPA and task/delivery order terms, other than those identified above, the terms of the BPA will take precedence.

BLANKET PURCHASE AREEMENT TERMS AND PROCEDURES

1. Description of Agreement: Prepare and deliver to VA Central California Health Care System (VACCHCS) pharmacy IV chemotherapy and other hazardous drug (HD) products. Contracted pharmacy is to prepare and deliver to VACCHCS pharmacy IV chemotherapy and other hazardous drug (HD) products as requested by the VACCHCS pharmacy on an on-demand basis.

2. Extent of Obligation: Services are conditional on the building and certification process of VACCHCS hazardous medication preparation pharmacy and will be generated on an as-needed basis. No guarantee of need of the service can be provided to the contractor and the Government is obligated only to the extent of authorized purchases actually made under the BPA.

3. Purchase Limitation: Limitation for each individual purchase will be $10,000.00

4. Individuals authorized to purchase under the BPA. The following personnel will be authorized to purchase under the BPA as order. If a call is not made by an individual listed on the authorized list, the call will be at the sole responsibility of the contractor.

(559) 241-6419

Christopher Cervantes, VACCHCS Pharmacy Christopher.Cervantes@va.gov

(559) 225-6100 ext.: 5691

Bruce Manzo, VACCHCS Pharmacy Chief Bruce.Manzo@va.gov

(559) 225-6100 ext: 5685

5. Delivery Tickets: Each delivered compound should under this agreement shall contain the following data:

(i) Name of supplier.

(ii) BPA number.

(iii) Date of purchase.

(iv) Purchase number.

(v) Itemized list of supplies or services furnished.

(vi) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show this information).

(vii) Date of delivery or shipment.

6. Invoices. A summary invoice shall be submitted at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period, identifying the delivery tickets covered therein, stating their total dollar value, and supported by receipt copies of the delivery tickets.

(i) Company name and address

(ii) Invoice date and number

(iii) Contract (BPA) number, contract 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

(ix) Electronic funds transfer (EFT) banking information (if you request payment by EFT and the paying CPTS can accommodate EFT payments)

7. BPA CALL Procedures: The Government may use oral quotes and streamlined procedures when selecting a contractor for the order (i.e. a review of standing pricelists). In addition, the Ordering Officer / Contracting Officer need not contact each of the Contractors under the Blanket Purchase Agreements before selecting the Contractor for a BPA Call if the Ordering Officer / Contracting Officer has information available to ensure that each Contractor is provided a fair opportunity to be considered for each BPA Call.

Contractor capabilities and capacity will be taken into consideration prior to assignment of a BPA Call along with the following elements:

(i) The Government’s needs for supplies or services are of such urgency that providing such opportunity would result in unacceptable delays;

(ii) Only one such Contractor can provide supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

(iii) The order may be issued on a sole-source basis in the interest of economy and efficiency as a logical follow-on to a BPA Call already issued if all Contractors were given a fair opportunity to be considered for the original BPA Call.

(iv) The work to be accomplished under this contract will be performed by issuance of a BPA Call. BPA Calls may be fixed price or time and materials. Contractor shall coordinate all work with the Contracting Officer in order that there will be a minimum of interruption and inconvenience to the Government.

36C26119Q0692

Page 1 of Page 1 of

SECTION B - CLAUSES & PROVISIONS

B.4 52.232-37 MULTIPLE PAYMENT ARRANGEMENTS (MAY 1999)

This contract or agreement provides for payments to the Contractor through several alternative methods. The applicability of specific methods of payment and the designation of the payment office(s) are either stated—

(a) Elsewhere in this contract or agreement; or

(b) In individual orders placed under this contract or agreement.

36C26119Q0692 (End of Clause) Page 1 of Page 1 of

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

See attached document: Attachment #1 VACCHCS Hazardous Drug Compounding Form.

Page 1 of

Page 1 of

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Provision)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

SUBMISSION INSTRUCTIONS

(a) General Instructions

(1) Electronic Submissions: Contractors must email their quote to Larry Facio at Larry.Facio@va.gov with subject line: 36C26119Q0292 Pharmaceutical Compounding RFQ VACCHCS. Any attachments must be readable using Microsoft Office or Adobe PDF. Quotes must be submitted electronically and will not be accepted through fax or postal mail.

(2) All questions regarding this solicitation must be emailed to Larry.Facio@va.gov no later than TWO business days prior to the quote due date. Verbal inquiries or questions will not be addressed or accepted.

(b) Selection Process

(1) Evaluations will be conducted under the procedures of FAR Part 13.

(2) In accordance with FAR 13.106-2(b)(3), the quotes will undergo a comparative evaluation to determine which vendor provides the best value to the government in terms of high technical capability and past performance, while also providing a competitive price.

(C) Pricing Information

(1) The pricing information will consist of the contractor’s overall price to provide these services along with any necessary detailed information describing pricing, such as volume or delivery fees. The provided Estimate Quantity is an estimated number of pharmaceutical compounding services on an annual basis but in no way does this constitute the government having to adhere to this volume in any capacity for the base ordering year or follow on ordering periods, it is merely used to assess individual CLINs and overall pricing. CLINs ending in 001 and 002 within the Price/Cost Schedule are established for Compounding Services and Delivery Fees. Blank CLINs ending in #003 and 004 are provided for vendors that possess a pricing structure based on volume, if certain number of requests result in a certain price for both compounding and delivery fees. Please fill-in so that it is clear that the pricing reflects a specific volume for the base ordering period as well subsequent ordering periods.

(2) For vendors that possess a price listing for various hazardous drugs and related materials. It is requested, to their best ability, provide a total annual amount within the Price/Cost Schedule CLINS items. If it is not overtly apparent, please include amplifying information describing pricing structure in order for the reader to obtain full comprehension.

E.2 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible contractor whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate the quotes:

1) Factor #1, Price In accordance with FAR 13.106-2(b)(3), the quotes will undergo a comparative evaluation to determine which vendor provides the best value to the government in terms of high technical capability and past performance, while also providing a competitive price.

FACTOR 1 – Price The pricing information will consist of the contractor’s price for each ordering period and overall price to provide these services. In evaluating the contractor’s price, the Government’s determination will include whether the price reflects a clear understanding of the requirements, is consistent with the information provided in the contractor’s quote and is reasonable in comparison with other quotes that have been submitted in response to the solicitation. The Price/Cost Schedule of this RFQ will be used to provide contractor pricing. It is the contractor’s responsibility to provide accurate labor pricing which is in complete adherence to California State law and Federal mandates with regards to Services Contract Act, Health and Welfare, Executive Order 13706, Holiday Pay and Vacation Pay, and Wage Determination scales.

(End of Provision) E.3 52.232-38 SUBMISSION OF ELECTRONIC FUNDS TRANSFER INFORMATION WITH OFFER (JUL 2013) The offeror shall provide, with its offer, the following information that is required to make payment by electronic funds transfer (EFT) under any contract that results from this solicitation. This submission satisfies the requirement to provide EFT information under paragraphs (b)(1) and (j) of the clause at 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management.

(1) The solicitation number (or other procurement identification number).

(2) The offeror's name and remittance address, as stated in the offer.

(3) The signature (manual or electronic, as appropriate), title, and telephone number of the offeror's official authorized to provide this information.

(4) The name, address, and 9-digit Routing Transit Number of the offeror's financial agent.

(5) The offeror's account number and the type of account (checking, savings, or lockbox).

(6) If applicable, the Fedwire Transfer System telegraphic abbreviation of the offeror's financial agent.

(7) If applicable, the offeror shall also provide the name, address, telegraphic abbreviation, and 9-digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the offeror's financial agent is not directly on-line to the Fedwire and, therefore, not the receiver of the wire transfer payment.

(End of Provision)

Page 1 of