36C25024Q0448.pdf

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. UEI: EFT:

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 ATTACHED

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. SIGNATURE 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

583-24-1-081-0436

PO Number: TBD

36C25024Q0448

Teri Miller - Teri.Miller@VA.gov 04-05-2024

13:30 EDT

36C250 Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis IN 46240

X

456110

$37.5 Million

N/A

X

36C250

Department of Veteran Affairs VHA VISN 10 Pharmacies Multiple Medical Centers Please See PWS for location Details.

36C250

Department of Veterans Affairs Network Contracting Office 10 8888 Keystone Crossing

Financial Management System P O Box 149971 Austin TX 78714-9971

512-242-7300 N/A

See CONTINUATION Page

This is a solicitation for a Requirements Contract for VHA (Veterans Integrated Service Network) VISN-10 Hazardous Compounding contract.

This is a FAR Part 13 Solicitation. Please see provisions in 52.212-1 Quote Preparation Instructions AND FAR 52.212-2 Evaluation for important information regarding submitting your quote and how it will be evaluated.

All Responses are due to Teri Miller, Teri.Miller@VA.gov no later than the due date/time in Box 8, No Questions or follow-up questions will be accepted after 1:30 PM EST on 3/28/2024.

Service Contract Labor Standards are applicable to this requirement per FAR 52.222-49, Service Contract Labor Standards - Place of Performance unknown.

See CONTINUATION Page

X X

36C25024R0092

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-21 REQUIREMENTS (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.7 52.222-49 SERVICE CONTRACT LABOR STANDARDS—PLACE OF PERFORMANCE

UNKNOWN (MAY 2014)

C.8 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.9 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.10 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.11 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL

BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN 2023) (DEVIATION)

C.12 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA BREACH

COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.13 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL

BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)

C.14 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.15 VAAR 852.219-70 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM

REQUIREMENTS (JAN 2023) (DEVIATION)

C.16 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

C.17 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

C.18 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

C.19 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.20 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC

2023) (DEVIATION) (JAN 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 QUOTE PREPARATION INSTRUCTIONS

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) 41

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 VAAR 852.273-70 LATE OFFERS (NOV 2021)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV

2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

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 36C250 Josh Kovar

Network Contracting Office 10 8888 Keystone Crossing

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award

Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] Monthly 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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PERFORMANCE WORK STATEMENT

VA Healthcare System Serving Indiana, Michigan, and Ohio (VISN 10) Pharmacy Service Compounded Sterile Hazardous Pharmaceuticals BACKGROUND: VISN 10 has identified a need for a contractor to compound hazardous drugs such as chemotherapy agents based on patient-specific prescriptions for VISN 10 locations. These compounding services are necessary to provide treatment to Veterans diagnosed with specific medical conditions. The compounding must be done at a Food and Drug Administration (FDA) 503A compliant facility and meet all state and federal laws.

VISN 10 Pharmacy would like to award a “requirements” contract. A participating VISN 10 facility would activate or begin using the contract as a contingency when they are not able to compound these agents on their own for a variety of reasons. When the contract is used, it will be needed on an urgent basis. This would occur when contracting issues a task order against this contract. No compounding orders should be placed or provided until the task order is signed by the Contracting Officer.

Prices received during the period of activation are firm-fixed and should include the cost of the drug, compounding fee, and/or shipping costs. There is not guaranteed minimum value over the life of this contract.

The Government makes no guarantees regarding orders. The maximum value of this contract, including all orders placed against it is limited to $5,000,000.00 This amount shall not be exceeded by any individual order or combination of orders placed.

SCOPE: Contractor shall provide all chemotherapy agents, intravenous (IV) tubing, closed system drug transfer devices (brand specified by the facility), and any other items deemed necessary. All Hazardous Chemotherapy Agents will be aseptically compounded based on patient specific orders.

The Government reserves the right to add or remove any additional Medical Centers, CBOC’s or other facilities to the contract as they become available. Furthermore, the Government reserves the right to increase or decrease quantities to allow for fluctuations of client demand that are otherwise unknown at time of solicitation.

The total contract value may increase up to 20%, however it shall not exceed the contract ceiling amount.

1. Periods of Performance

a. BASE Year – 5/1/2024 – 4/30/2025

b. Option Year 1 – 5/1/2025 – 4/30/2026

2. Orders will be submitted via a secure network and will include the information listed below. Once submitted, VA staff will confirm receipt of order with the Contractor via phone or email.

a. Patient name

b. Gender

c. DOB

d. Height

e. Weight

f. Allergies

g. Drug dosage

h. Diluent and Volume

i. Infusion Rate (if not noted, label will read ‘Infuse per hospital protocol’)

j. Procedure date

k. Prescribing physician

3. Orders from the VA will be submitted by 3:00 PM EST the day prior to the needed chemotherapy infusion.

4. Compounded orders shall be transported via courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time indicated.

5. Items shall be delivered to the VA location by 9:00 AM EST, the day after orders are submitted.

6. Compounding, labeling, and beyond use dating/expiration dating will be based on manufacturer labeling, United States Pharmacopeia (USP) 797, USP 800 and Federal Law.

7. Finished product should be labeled with proper beyond use dating based on manufacturer labeling or documentation for extended stability.

8. All drugs are to be supplied by the Contractor. Each facility will provide a list of common chemotherapy agents used at the time the task order is issued for that facility. This list is not inclusive, and other agents may be used as needed for patient needs without modification of this contract.

9. The amount billed for the drugs should not exceed AWP at the time of order +/- the discount or surcharge quoted in the Price Evaluation.

10. Shipping is included with the order and there is no additional cost for any items delivered during the weekend or a holiday. All shipments for weekend and/or holiday delivery will be arranged as needed to ensure delivery can be successfully completed.

11. Contractor shall provide all current and future certification reports for the sterile compounding areas and compounding hoods during the time period that the contract is utilized. Additionally, the contractor shall provide 12 months of certification reports to the facility and VISN prior to utilization to ensure that there are no issues. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected.

12. Contractor shall update and provide the “Veterans Health Administration Pharmacy Benefit Management Assessment Guide for Compounded Sterile Preparations within Veteran Administration Medical Centers and Outsourced Compounding Pharmacies” at time of solicitation response and annually (See Attachment 1).

13. STAT orders are considered orders sent to the vendor after the 3:00 PM EST cut off time. STAT orders shall be handled on a case-by-case basis. Any STAT order must be verified and validated with the originating facility Point of Contact prior to being filled. The use of STAT orders is uncommon and is estimated to be rarely used, if ever.

14. The Exact Volume Fee is added to the dose when additional manipulation to the infusion bag is required or requested, (I.E. the facility requests that an amount equal to the drug volume is removed from the diluent bag prior to adding the drug). Any order that is considered Exact Volume must be verified and validated with the originating facility Point of Contact prior to being filled.

15. A Task Order will be issued with a Not to Exceed Amount (NTE) for the period of performance. The contractor shall notify the VA VISN 10 COR when 80% of the amount obligated has been expended. The Contractor shall not perform any requirements that exceed the obligated amount for any reason. If additional funding is required a separate contract modification or Task Order will be issued and only valid when signed by a Warranted Contracting Officer.

INVOICING PROCEDURES:

1. Contractor shall invoice electronically through VA Tungsten network.

a. https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

2. Contractor shall invoice for the amount of medication utilized for each individual patient.

3. Contractor shall provide copies of invoicing reports directly to the facility and the COR.

4. All invoices shall be sent monthly in arrears.

SPECIFICATIONS BELOW FOR COMPATIBILITY NEEDS: Facility will define preferences and/or needs on the following items.

1. All hazardous compounded bags will be dispensed already spiked with infusion tubing primed with base fluid.

2. Manufacturer guidelines should be followed for specifications related to the need for in-line filters, low sorb tubing, and/or DEHP-free bags and tubing.

3. Refer to Facility Preference Document for specifics related to type of infusion tubing, closed system transfer device, total volume calculations, and Fluorouracil home infusion devices.

4. DELIVERY LOCATIONS:

VA Medical Center (VAMC) or facility Point of Contact

Name, email address, and telephone number

Lieutenant Colonel Charles S. Kettles

VAMC

2215 Fuller Rd Ann Arbor, MI 48105

POC Will be Identified at the time of Award

Battle Creek VAMC 5500 Armstrong Rd

Battle Creek, MI 49037

Chillicothe VAMC 17273 State Route 104 Chillicothe, OH 45601

Cincinnati VAMC 3200 Vine St

Cincinnati, OH 45220

Louis Stokes VAMC 10701 East Blvd

Cleveland, OH 44106

Chalmers P. Wylie Outpatient Clinic 420 North James Rd Columbus, OH 43219

Dayton VAMC 4100 West Third St Dayton, OH 45428

John D. Dingell VAMC 4646 John R St

Detroit, MI 48201

Richard L. Roudebush VAMC

1481 West 10th St Indianapolis, IN 46202

Northern Indiana Healthcare System

Marion 1700 East 38th St Marion, IN 46953

Fort Wayne

2121 Lake Ave Fort Wayne, IN 46805

VISN 10

Pharmacy Benefits Management (119)

Not a compounding location

WORK HOURS: VA locations pharmacy can receive medications between 08:00 and 16:00 Monday-Friday.

Special arrangements will be made for any deliveries that are needed on weekends and/or holidays.

CONTINGENCY PLANNING: The Contractor shall have a contingency backup plan if compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must be provided and meet the same criteria as stated herein.

CONTRACTOR QUALIFICATIONS: Compounding must be done at an FDA 503A compliant facility and meet all applicable federal, state, and local laws. Compounding, labeling, and beyond use dating/expiration dating will be based on manufacturer labeling, USP 797, USP 800 and Federal Law.

COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS: The Contractor shall ensure that services provided to the Government under this contract comply with all applicable federal and state laws, statutes, regulations, and guidelines. The Contractor shall also ensure that all services provided to the Government under this contract comply with all applicable Government mandated procedures, standards, and requirements.

QUALITY CONTROL AND QUALITY ASSURANCE FOR CONTRACT SERVICE: The contractor shall be responsible for effective implementation of their Quality Control Program, and shall be responsive to the requirements of the Government’s Quality Assurance Plan conducted by the COR.

1. The contractor shall have a Quality Control program to assure that the requirements of the contract are provided as specified. One copy of the Contractor’s basic Quality Control Program shall be submitted for approval by the COR.

Subsequent changes to the approved Quality Control Program must also be reviewed and approved by the COR with final approval by the Contracting officer. The program shall include, but not be limited to the following.

2. An inspection system covering the performance indicators given in the Quality Assurance/Performance Requirements table below.

3. A method for identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable.

4. A file of all quality control inspections inspection results, and any corrective action required shall be maintained by the Contractor throughout the duration of this contract. This file shall be the property of the Government and shall be available to the COR during normal working hours. The file shall be turned over to the Government within 14 days of completion of termination of the contract.

5. QASP: A (Quality Assurance Surveillance Plan (QASP) has been developed for in-house operations or to implement a service contract. It is designed to aid the Government in providing effective and systematic surveillance of all aspects of document and media destruction. This plan provides for monitoring all contract requirements through a combination of methods. These are:

a. Random observation

b. Client/Customer Complaints

c. Surveillance Activity Checklist

The QASP is a “living document” and the Government may review and revise it on a regular basis.

However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities. The objective of this surveillance plan is to evaluate how the Government or contractor is performing in key areas.

QUALITY ASSURANCE/PERFORMANCE REQUIREMENTS: The Government will monitor the Contractor’s performance under this contract with the below performance objectives:

Task # Indicator Standard Acceptable

Quality Level

Method of Surveillance Incentive

General

1 Orders processed accurately

Contractor shall ensure all orders are processed per prescription order

100% Labeling Positive Past Performance & Exercise of Option Period

2 Orders received prior to infusion date/time

Contractor shall comply with all safety requirements

100% Validated receipt of order

Positive Past Performance & Exercise of Option Period

3 Contractor maintains certifications required for compounding

Contractor shall furnish copies of certificates and complete VHA

PBM Assessment Annually

100% Validated receipt of certificates and/or assessment

Positive Past Performance & Exercise of Option Period

PERFORMANCE MONITORING:

1. The government will periodically evaluate the contractor's performance by appointing representative(s) from serviced facilities to monitor performance to ensure services are received.

2. The government representative will evaluate the contractor's performance through intermittent observation and on-site inspections of the contractor's quality control program and receipt of complaints from facility personnel.

3. Routine collections and container movements will be observed by a government representative at random intervals no less than once per month.

4. The government representative may perform on-site inspections of the contractor's facility(s) if deemed necessary.

5. The government may increase the number of quality control inspections if deemed appropriate because of repeated failures discovered during quality control inspections or because of repeated customer complaints. The government will also receive and investigate complaints from various customers located on the installation.

6. The contractor shall be responsible for initially validating customer complaints. However, the government representative shall make final determination of the validity of customer complaint(s) in cases of disagreement with customer(s).

ACCEPTABLE PERFORMANCE: The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

UNACCEPTABLE PERFORMANCE: When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

1. When the COR determines formal written communication is required, the COR shall prepare a Contract

Discrepancy Report (CDR) and present it to the contractor's program manager.

2. The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

3. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

CONTRACTOR TRAINING REQUIREMENTS:

1. Completion of the VA Privacy and Information Security Awareness and Rules of Behavior (VA10176) will satisfy the annual privacy requirement for all employees and contractors. This course has automatically been assigned to all VA employees' training plans.

2. If employees have access to protected health information (PHI) or access to VA systems (e.g., CPRS, JLV, CAPRI, or VHIE) they are required to take the Privacy and HIPAA Focused training (VA10203), in addition to (VA10176). Options for taking the course include the web-based training or text version.

3. Privacy and HIPAA Focused Web-Based Training (VA10203) All individuals who have access to protected health information (PHI) in the performance of their official duties, including those whom have access to PHI in the VA systems; such as CPRS, VHIE, CAPRI, JLV, etc., are required to take the Privacy and HIPAA Focused training.

CONTRACTING WITH PARTIES LISTED ON THE OIG LIST OF EXCLUDED INDIVIDUALS/ENTITIES: In accordance with Health Insurance Portability and Accountability Act (HIPAA) and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the Office of Inspector General (OIG) web site at www.hhs.gov/oig.

INFORMATION SECURITY OFFICER, INFORMATION PROTECTION: The contractor will not have access to VA Desktop computers nor online resources belonging to the government while conducting services.

RECORDS MANAGEMENT: The contractor will have access to protected Patient Health Information (PHI), but it will not have the capability of accessing patient information during the services provided to VHSO. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services.

1. Citations to pertinent laws, codes, and regulations such as 44 United States Code (U.S.C) chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 Code of Federal Regulations (CFR) Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the United States (U.S.)

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government information technology (IT) equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

CONTRACT SECURITY:

1. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

2. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

3. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

4. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

5. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

6. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

7. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

8. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

9. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

10. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

11. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval.

The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

12. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

13. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures.

The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach.

Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

ATTACHMENT 1

Guidance Documents for Outsourcing of Compounded Sterile Products

Issued March 01, 2021

VHA PBM Template: Evaluation of Outsourced 503A Compounding Pharmacies

**Please note, this checklist is a guide and is not intended to be all inclusive. Facilities should evaluate 503A pharmacies based on local need and circumstances.

NAME License # DATE OF ASSESSMENT

DOING BUSINESS AS

STREET ADDRESS TELEPHONE # EXT

CITY COUNTY STATE/ZIP

Regulatory Requirements Yes No Comments

The pharmacy has a current active pharmacy license and is in good standing from their Board of Pharmacy.

The pharmacy is licensed to ship to my state (if other than the state in which the VAMC resides).

The Pharmacy applies the current USP <797> standards.

The Pharmacy applies the current USP <797> standards.

The pharmacy complies with HIPAA standards.

The pharmacy complies with federal and state EPA regulations related to disposal and handling of pharmaceutical and hazardous wastes per the

RCRA provisions.

The pharmacy has documented through a Certificate of Analysis (CoA) or purchase orders of obtaining active pharmaceutical ingredients

(APIs) from an FDA-and/or DEA-registered pharmaceutical supplier with a Standard Operating Procedures to verify supplier registration status.

The pharmacy has a current Drug Enforcement (DEA) registration if compounding controlled substances products to VAMCs.

All pharmacy staff (pharmacists, technicians) at the pharmacy are licensed and/or certified by their respective Boards of Pharmacy.

All patient specific CSPs prepared are documented to meet USP <797> standards) of practice (whichever version they are practicing under) and the pharmacy is compliant the requirements of an FDA 503A outsourcing pharmacy.

All patient specific non-sterile compounded preparations prepared are documented to meet

USP <795> standards) of practice (whichever version they are practicing under) and the pharmacy is compliant the requirements of an FDA 503A outsourcing pharmacy.

If this is a hospital pharmacy, the pharmacy is in good standing with The Joint Commission or their accreditation body.

If the hospital pharmacy received a “finding” from The Joint Commission or their accreditation body, the hospital has resolved the finding and will provide summary to VAMC.

The facility has been issued an FDA 483, warning letter, or other FDA violation notification.

The facility has appropriately responded to FDA 483’s, warning letter or FDA violation notification and will share the corrective actions they have taken.

https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-action

The facility has no pending Consent Decree related to compliance with FDA requirements.

VAMC may not acquire compounded preparations from a facility with a Consent

Decree.

Procedural When no commercial source exists to prepare admixtures, the outsourcer uses USP grade bulk ingredients obtained from a cGMP compliant supplier and can provide a certificate of analysis and potency testing of all bulk ingredients used

The pharmacy provided to the VAMC upon request during a site visit all documentation of accreditation and licensure, adverse reaction reports, medication error reports, recalls and patient incident reports, if feasible, in an un-redacted form.

If a site visit can be conducted, the pharmacy will provide this information on request.

The pharmacy has documentation describing how CSPs will be prepared, including the CSPs are prepared from sterile.

https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-action

The pharmacy has established written policies and procedures to manage reporting of adverse reactions and end user problems to ensure tracking and trending of issues and resolution.

The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 or better-quality air using only sterile ingredients, products, components and devices

Low Risk-(Not applicable to CSPs prepared under Category 1 USP <797> 2019 version) -In the absence of sterility tests, BUDs assigned are compliant with USP <797> and are not more than 48 hours at controlled room temperature, 14 days at cold temperature (2 – 8 degrees C), and 45 days in a solid frozen state of -25° to -10° C.

Low and Medium Risk- In the absence of sterility tests, storage is not more than 30 hours at controlled room temperature, 9 days at cold temperature (2 – 8 degrees C), and 45 days in a frozen state of -25° to -10° C.

Category 2- In the absence of sterility tests, and prepared using sterile drugs products, controlled room temperature not more than 4 days, refrigerator not more than 10 days, freezer not more than 45 days.

Beta-Lactam production is separate from other CSP production; if the same PEC is used for

Beta Lactam production, the PEC is thoroughly cleaned before other CSPs are prepared.

Compounding manipulations are performed to minimize contact contamination of critical sites.

PECs are certified, maintained ISO Class 5 and located in an ISO Class 7 Sterile compounding space.

Sinks are not located adjacent to the ISO Class 5 PEC; sinks are separated from the immediate area of the ISO Class 5 PEC device

Quality assurance practices include routine disinfection and air quality testing, visual confirmation that personnel are appropriately garbing, review of all orders for correct identity and strength, and visual inspection of CSPs

Blood-derived or other biological material manipulations are clearly separated from routine material-handling procedures and equipment used in CSP preparation and are controlled by specific SOPs to avoid any cross-contamination.

Cleaning For ISO Class 5, cleaning and disinfecting practices and policies exist.

LAFWs, BSCs, CAIs, and/or CACIs are cleaned and disinfected frequently, including at the beginning of each work shift, before each batch preparation is started, every 30 minutes during continuous compounding periods, when spills occur and when surface contamination is known or suspected

Work surfaces in ISO Class 7 buffer areas, ISO Class 8 ante-areas and segregated compounding areas are cleaned and disinfected at least daily, and dust and debris are removed when necessary from storage sites.

Floors in ISO Class 7 and 8 areas are cleaned daily when no compounding occurs; mopping is performed by trained personnel using approved agents and written procedures.

Clean area, ante-area and segregated compounding area, walls, ceilings, and shelving are cleaned and disinfected monthly

All cleaning materials are nonshedding and dedicated to use in the buffer or clean area, ante-area, and segregated areas and are not removed from these areas except for disposal

If cleaning materials are reused, SOPs ensure that the effectiveness of the cleaning device is maintained, and repeated use does not add to the bioburden of the area being cleaned

Sterile 70% IPA swabs do not contact any object before contacting the site to be cleaned.

No particle-generating material is used to disinfect the sterile entry points of packages and devices.

No shipping cartons are taken into the buffer area, clean area or segregated compounding area.

Personnel Training and Competency Prior to compounding, personnel are trained in garbing procedures, aseptic work practices, achieving and maintaining ISO Class 5 conditions and cleaning and disinfections procedures.

Media-fill testing of aseptic work skills are performed initially before beginning to prepare CSPs and at least annually thereafter for low-and medium-risk level.

Personnel demonstrate proficiency of proper hand hygiene, garbing and consistent cleaning procedures in addition to didactic evaluation of aseptic media fill and glove tip testing.

Personnel are visually observed during the process of performing hand hygiene and garbing procedures and appropriately documented and maintained to provide a permanent record.

Personnel successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure no less than 3 times before initially being allowed to compound CSPs.

All compounding personnel have technique and competency evaluated initially during the Media- Fill Test Procedure and subsequent annual or semi-annual Media-Fill Test Procedures.

Finished Preparation Release Checks and Tests All CSPs are visually inspected for being intact with no abnormal particulate matter, and prescriptions and written compounding procedures are reviewed to verify accuracy of correct ingredients and amounts, aseptic mixing, high-risk sterilization, packaging, labeling, and expected physical appearance before they are administered or dispensed.

A double-check system is in place that meets state regulations that includes label accuracy and accuracy of the addition of all ingredients used.

Quality Assurance Program Outsourced Compounding Pharmacy/Facility Yes No Comments A formal quality assurance program is in place that monitors, evaluates, corrects and improves activities and processes.

Vendor provides routine and periodic QA assurance data upon the request of the VAMC.

The facility has a process in place to immediately notify the VAMC in the event of product recalls or significant situations that would compromise the product they provided to the VAMC.

POC for Outsourced Pharmacy

Phone Date Other

VAMC

B.3 PRICE/COST SCHEDULE

This is a requirements contract with no minimum guaranteed amount. The maximum total value of the contract, inclusive of the base year and all options exercised, shall not exceed $5,000,000.00. Individual task orders shall be funded at the time that the need exists. The Contracting Officer is the only authorized individual that can place annual task orders against this contract for the estimated amount of services for the specific timeframe, and the task orders shall be issued to the contractor.

Task order minimums and maximums are addressed in clause FAR 52.216-19.

The items listed in the Price-Cost Schedule excel file are estimated quantities: for the base period of performance and for Option Year 1.

Vendor shall invoice monthly, for ONLY actual services rendered. DO NOT perform any services other than those identified in the price-cost schedule excel file, unless the ACO has issued a modification to the contract to add a CLIN for that specific action.

There is a CLIN (Row 175) in the Excel File that is listed as “Other (AWP +/- (? %) – Drugs not listed above,” with an estimated quantity of 50 for each period of performance. If a drug/therapy is needed that is not listed, the CO shall modify the contract to include the new drug. At that time, the CO will decrease the estimated quantity by the amount that is being added.

Contractor shall invoice for actual performance and shall indicate CLINs/SLINS Numbers from the contract on all Tungsten Network invoices.

Please see 24Q0488 – Price-Cost Schedule.xls file for estimated quantities for BASE and Option Year 1 (on different tabs), and to provide pricing. Vendor shall indicate discount or surcharge from AWP in FOW F2, then provide pricing in F178 – F183, and a discount for supplies in G183.

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

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)

FAR

Number

Title Date

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.237-3 CONTINUITY OF SERVICES JAN 1991

C.2 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 05/01/2024 through 04/30/2026.

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

(c) A delivery…