Solicitation 36C24723Q0343.pdf

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Q517--Emergent Prescription Dispensing Services
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36C24723Q0343
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36C24723Q0343

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 24

C.3 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.6 VAAR 852.219-77 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021)

(DEVIATION)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 28

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEC 2022)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

52.212-1 Instructions to Offerors – Commercial Products and Commercial Services (Nov 2021)

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

1998) E.3 ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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 36C247

DEPARTMENT OF VETERANS AFFAIRS

VETERANS HEALTH ADMINISTRATION

Network Contracting Office (NCO) 7

2957 CLAIRMONT ROAD NE, Suite 1200

Atlanta GA 30329

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

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.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR

Name Brand Drugs Percentage Discount off of Average Wholesale Price (AWP) ____________

Contract Period: Base POP Begin: 04-01-2023 POP End: 03-31-2024

Generic Drugs Percentage Discount off of Average Wholesale

Price (AWP) ____________

Contract Period: Base

1.00 EA ___________ ___________

Prescription Dispensing Fee

Contract Period: Base

INFO ONLY LIN: Pharmacy Services for Emergent Prescriptions

Annually for Eight VA Clinics.

Contract Period: Base

Wholesale Price (AWP) ____________

Contract Period: Option 1 POP Begin: 04-01-2024 POP End: 03-31-2025

Price (AWP) ____________

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Wholesale Price (AWP) ____________

Contract Period: Option 2 POP Begin: 04-01-2025 POP End: 03-31-2026

Price (AWP) ____________

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Wholesale Price (AWP) ____________

Contract Period: Option 3 POP Begin: 04-01-2026 POP End: 03-31-2027

Price (AWP) ____________

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Wholesale Price (AWP) ____________

Contract Period: Option 4 POP Begin: 04-01-2027 POP End: 03-31-2028

Price (AWP) ____________

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

GRAND

TOTAL

B.3 DELIVERY SCHEDULE

ITEM NUMBER

DELIVERY

DATE

0001 - 4004 SHIP

TO:

Ralph H. Johnson VA Medical Center 109 Bee Street Charleston Charleston, SC 29401 5703

USA

IAW POP

MARK

FOR:

TBD

STATEMENT OF WORK – EMERGENT PRESCRIPTIONS

OBJECTIVE

To obtain a contracted service to facilitate emergent prescription fills for Veterans seen at the Community Based Outpatient Clinics (CBOCs) and affiliated clinics to the Ralph H. Johnson VA Medical Center in Charleston, SC listed below.

• Beaufort CBOC: 1 Pinckney Blvd., Beaufort, SC 29902

• Goose Creek CBOC: 2418 NNPTC Circle, Goose Creek, SC 29445

• Hinesville CBOC: 500 East Oglethorpe Highway, Hinesville, GA 31313

• Myrtle Beach VA Clinic- Market Common: 1101 Johnson Avenue, Myrtle Beach, SC 29577

• Myrtle Beach CBOC: 1800 Airpark Drive, Myrtle Beach, SC 29577

• North Charleston CBOC: 6450 Rivers Avenue, North Charleston, SC, 29406

• Savannah CBOC: 1170 Shawnee Street, Savannah, GA 31419

• Trident CBOC: 9237 University Blvd., North Charleston, SC 29406

AGENCY BACKGROUND

Ralph H. Johnson VAMC is a 152 authorized bed tertiary care teaching hospital and is dedicated to providing the highest quality of patient care and services to Veterans along the South Carolina and Georgia coasts. The Ralph H. Johnson VA Medical Center provides comprehensive health care through primary care, tertiary care, and long-term care in areas of medicine, surgery, psychiatry, physical medicine and rehabilitation, neurology, women's health and dentistry. Specialty services include Cardiothoracic Surgery, Neurosurgery, Orthopedics, Mental Health programs for PTSD, Substance Use Disorders, Military Sexual Trauma, Cardiology, Oncology, Nephrology, Pulmonary and Geriatrics. The VAMC includes five Community Based Outpatient Clinics (CBOC) located in Beaufort, Goose Creek and Myrtle Beach, South Carolina, and Savannah and Hinesville, Georgia, as well as an annex in North Charleston. The Ralph H. Johnson VA Medical Center also supports three Vet Centers located in Charleston and Myrtle Beach, South Carolina, and Savannah, Georgia.

SCOPE and GENERAL REQUIREMENTS

The contractor shall provide emergent prescription fills for Veteran beneficiaries of the Ralph H.

Johnson VA Medical Center CBOC's as follows:

1. Only new prescriptions shall be filled. A new prescription is defined as a written, verbal, or electronically transmitted, prescription for a drug product and strength that has not been previously dispensed to the beneficiary in the past 12 months. A repeat order for the same drug product within 12 months, even if transmitted as a new prescription order is not considered a new prescription. Exception may be made for second courses of antibiotic therapy and emergent doses of maintenance medications as deemed necessary by the provider. No refills may be authorized.

a. Only prescriptions from VA authorized practitioners shall be filled under the contract. Prescriptions will be written on VA prescription form 10-2577F, and hand carried by the beneficiary. The prescription will accompany an approved authorization voucher. Prescriptions from practitioners that have not been authorized by the VA shall not be filled under the contract. Prescriptions that are non-emergent that the provider wrote for the patient to purchase at his/her own expense shall not be filled under the contract.

b. Prescriptions shall be filled for legend drugs listed in the VA emergent formulary drug list. A copy of the emergent formulary drug list will be provided upon award to the Contractor. The Contractor shall review all prescriptions to ensure that the product is listed on the emergent formulary. The VA reserves the right to add or delete drugs from the emergent formulary.

c. The VA is not responsible for payment of any prescription for products not on the emergent formulary even if ordered by VA authorized practitioners. If a VA authorized practitioner prescribes a product not on the emergent formulary the pharmacist shall notify the patient that the prescription is not covered and that the patient will be responsible for the cost, payable at that time.

d. Any other exceptions to the prescription requirements of the contract must be pre-authorized by the respective Clinic Consultant at the responsible VA Medical Center. Decisions of the Medical Center are final. Medical Centers may retroactively approve exceptions but the decisions to retro actively consider, review or approve retroactive request for exceptions is solely at the discretion of the Medical Center.

2. Unless otherwise pre-authorized, prescription fills shall be limited to a maximum of a 10 day supply (unless repackaging is not an option example: insulin, oral inhalers, etc. in which cases the minimum available package size will be dispensed) with no refills.

3. Prescriptions shall be filled within one hour of delivery to the pharmacy. The mailing and delivery of prescriptions are not authorized.

4. Prescriptions filled under this contract shall be the extent permitted by law, the least expensive generic equivalent drug product the pharmacy has in stock.

a. Generic drugs shall be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quality, and dosage are the same as the brand name. The generic name shall be displayed on all labels for all medications.

b. Brand name products will be dispensed only if there is no therapeutic equivalent product listed as (AB) equivalent.

5. The filling of prescriptions shall be inclusive of patient medical profile review and proper filling and labeling in accordance with proper pharmacy practices and state requirements.

Procedures shall include necessary patient education and counseling consistent with the Omnibus Budget Reconciliation Act (OBRA) 1990 requirement to ensure appropriate use and optimal outcomes from drug therapy. Counseling includes the following information at a minimum:

• Name, description and use of the medication

• Dose, dosage form and route

• Special directions and precautions

• Common side effects and action required if they occur

• Techniques for self-monitoring drug therapy

• Action to be taken if a dose is missed

• Proper storage

• What the patient can expect from the medication

a. All prescriptions MUST have appropriate auxiliary labels attached to the containers.

Consideration must be given to a patient's ability to open "childproof' containers.

Generic name must be indicated on drug label for all medications. Beyond use dating and lot numbers should be present on all dispensed containers.

6. Pharmacists must collect, synthesize and interpret patient, prescription and disease data in monitoring for therapeutic duplication, drug-disease contraindications, drug-drug interactions (including those with OTC medications), incorrect drug dosage, inappropriate duration of treatment, drug-allergy interactions, and clinical abuse-misuse. Adverse event reporting: All medication errors, adverse drug reactions or allergy reactions related to medications dispensed under this contract shall be reported to the Contracting Officer's Technical Representative of the responsible VA Medical Center. The Contractor shall notify the VA in writing whenever a malpractice claim involving a VA patient has been filed against the contract within three (3) working days.

7. The contractor must have a minimum of one pharmacy within a 10-mile radius of each VA Community Based Outpatient Clinic (CBOC). The facility must be handicapped accessible, have handicapped parking spaces available and have seating available for patients waiting for prescriptions.

8. Additional areas may be added to this contract by mutual agreement as services are needed for new CBOC's in the service area. Contract requirement and rates will be as stated in the proposal and subsequent contract.

a. Offeror shall provide all prescribed therapeutic agents to patient at wholesale pricing per price list minus discount listed in the Price Schedule. Any dispensing fees must be included in pricing or listed by the offeror as a separate line item. The total cost charges to the VA shall be the same or lower than that charged to their best customer and in no case, more than charged to the general public.

b. The contractor must provide a price list to the Contracting Officer showing pricing of the pharmaceuticals. As price list changes the contractor must submit the revised price list to the Contracting Officer.

9. The contractor shall invoice for reimbursement at the prices stated in the Schedule of Supplies of this contract. The Contractor shall bill the appropriate Billing Contact (to be provided when contract is awarded) monthly for services rendered. More frequent billing cycles are negotiable. The VA will randomly audit all billings. Pharmacies under contract shall make records available to the VA auditor in a timely manner at the location where dispensed.

10. All invoices and reports shall be furnished by the 5th business day of each month and reference the following information:

• Name and Address of Contractor

• Name, title and phone number of person to be notified in event of questions

• Name and address of official to whom payment is to be sent

• Contract Number

• Date of Invoice

• Billing Pharmacy

• Beneficiary Name

• Beneficiary Social Security Number

• Authorized providers name

• Prescription Number

• Date of Fill

• Drug Generic Name

• Drug Strength

• Quantity Dispensed

• NDC number of Product Dispensed

• Cost of Drug Dispensing Fee

• Total cost of Invoice

• If the prescription was an approved exception to the VA emergent formulary drug list, the name of the approving official (clinic contact or designee) must be included on the invoice.

• Medication errors or medication related incidents.

11. The Parties agree that the Contractor's personnel will not be considered VA employees for any purpose and shall be considered employees of the Contractor.

12. Contractor employees are not covered by the Federal Tort Claim Act. When Contractor employee has been identified as a provider in a tort claim, the Contractor employee is responsible for notifying the Contractor's legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor employee's action or non-action is the responsibility of the Contractor and/or insurance carrier. The Contractor shall notify the VA of the action or non-action.

13. The standard VA pharmacy prescription claim form shall be utilized for billing purposes.

14. A comprehensive record keeping system shall be approved by the Contracting Officer and be in place prior to initiation of the contract. The Contractor shall submit with their proposal a sample of their proposed record keeping system. A computerized system is preferred.

15. Pharmacy services shall be available between the hours of 9:00AM and 7:00PM, Monday through Friday, at a minimum. Deviations from these hours should be provided and justified in the proposal. The Contractor will not be required to be open on Federal holidays. A pharmacist will be available to answer any drug related questions that a patient may have after the prescription is filled. This may be in the form of written and/or verbal information

16. Each dispensing pharmacy will maintain a log of VA prescriptions filled and have the patient sign next to each prescription number of each prescription received. A copy of this log must be available for review if there is a question of eligibility or identification of the individual that picked up a particular prescription. Invoices are to be mailed to:

17. The Contractor must abide by all HIPPA regulations and understands that all information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except in accordance with applicable Federal laws and when authorized in writing.

The Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of a breach of confidentiality. Breach of confidentiality is grounds for termination of this contract. Contractor is subject to all federal and state statutes, rules, and regulations regarding patient privacy. Said statues, rule and regulations which include, but are not limited to, 5 USC Section 552(a), 38 USC Section 5319, 38 USC Section 7332 are available from the contracting officer upon request.

a. Information, including but not limited to veteran individually-identifiable information and personal healthcare information (PHI), gathered or created by the contractor in the performance of this contract is the exclusive property of VA and must be received, gathered, stored, backed up, maintained, used, disclosed and disposed of in accordance with the terms of this contract and applicable federal and VA information confidentiality and security laws, regulations and policies, including VA Directive and Handbook number 6500.

b. The Contractor shall provide access to VA information only to employees, subcontractors, and affiliates only. (1) to the extent necessary to perform the services specified in this contract, (2) to perform necessary maintenance functions for electronic storage of transmission media necessary for performance of this contract, and (3) only to individuals who first satisfy the same conditions requirements and restrictions that comparable VA employees must meet to have access to the same VA information. These restrictions include the same level of background investigations where applicable.

c. ALL VA III AND PHI INFORMATION STORED ON BOTH VA AND NON-VA

EQUIPMENT MUST BE ENCRYPTED IN ACCORDANCE WITH THE FEDERAL

INFORMATION SECURITY MANAGEMENT ACT (FISMA). Federal standards established by U.S. Department of Commerce apply, including Federal Information Processing Standard 200 (FIPS200), and National Institute of Standards and Technology Special Publication 800-37, Guide for Security Certification and Accreditation. Contractors and subcontractors shall document compliance and make the document available upon request of the Contracting Officer or COR. Contractor and subcontractors shall allow physical inspection by VA personnel to assess its physical and environmental security controls.

d. Contractor and its subcontractors must ensure that VA III and PHI is always secure and will ensure proper security is used on contractor or subcontractor computers with VA III and PHI information is stored. To avoid risk of loss of theft., VA III and PHI shall NOT be transferred by contractor or its subcontractors to paper, diskettes, CDs, DVD, USB flash drives, external computers drives, computer notebooks, home computers or any other medium, and shall NOT be removed for the contractor or subcontractor site under any circumstances without specific written authorization of the VA Information Security Officer. The authorized VA III or PHI recipient shall back up files to protect their loss. Back-ups shall be locked and secured. VA III and PHI shall NOT be transferred between contractor or subcontractor computer unless permission is granted by the VA for such transfer of data and secure encrypted transmission methods approved by VA Information Security Officer are utilized.

Contractor employees shall be required to sign VA National Rules of behavior before they can be authorized access to VA information systems.

e. The contractor shall immediately (on the date of discovery of the incident) report any incident of theft, loss, or compromise of VA sensitive information to the Contracting Officer, the Contracting Officer’s Representative, and any other VA Official designated by the Contracting Officer. This report shall be in writing and contain the fullest explanation possible and all the details of the incident available to the contractor. VA must receive notice from the contractor on the date contractor discovers incident.

f. HIPPA Compliance: The contractor must adhere to the provisions of Public Law 104- 191, Health insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).

g. The contractor and third-party servicers accessing VA information sign the Contractor Rules of Behavior, the VA National Rules of Behavior do not need to be signed if the VA Contractor Rules of Behavior” are signed (VA Handbook 6500.6 Appendix D).

h. Background investigations of all contractors must adhere to the results of the PDAT per VA Directive and Handbook 0710, Personnel Suitability and Security Program.

i. Upon award, Contractor is required to enter and sign a Business Associate Agreement.

j. Security Considerations: A security clearance will not be required for this acquisition.

18. All prescriptions must be filled in a manner that meets and or exceeds current State of South Carolina and State of Georgia, and federal requirements that govern the filling and dispensing of prescriptions.

19. SECURITY / PRIVACY INFORMATION:

Contractor will be required to enter into a Business Associate agreement upon award of the contract or provide a copy of national BAA. The contractor shall provide/submit any national security requirements requested by the Information Security Officer(ISO), Privacy Officer(PO), Contracting Officer(CO), or other VA Authority.

A. VA HANDBOOK 6500.6 - APPENDIX B - VA ACQUISITION REGULATION SOLICITATION

PROVISION AND CONTRACT CLAUSE

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY

REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a) Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

b) In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause

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.

(END OF CLAUSE)

B. VA HANDBOOK 6500.6 - APPENDIX C

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a) A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b) Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c) Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

3. VA INFORMATION CUSTODIAL LANGUAGE

a) 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).

b) 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 on site 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.

c) 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.

d) 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.

e) 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.

f) 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.

g) 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.

h) 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.

i) 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.

j) 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.

k) 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

C. 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.

D. 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 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.

E. TRAINING

a) All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b) The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c) Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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 subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause…

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