36C26326Q0055.docx

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

n/a

36C26326Q0055 12-23-2025 Michael Wicht

(402) 996-3630 12-29-2025 09:00

CST

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

111 SOUTH 18TH PLAZA, SUITE C125

Omaha NE 68102

X

524292 $45.5 Million

N/A

DEPARTMENT OF VETERANS AFFAIRS

Sioux Falls VA HCS

2501 West 22nd Street Sioux Falls SD 57105 36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

111 SOUTH 18TH PLAZA, SUITE C125

OMAHA NE 68102

DEPARTMENT OF VETERANS AFFAIRS

FMS-VA-2(101)

FINANCIAL SERVICES CENTER

PO BOX 149971

AUSTIN TX 78714-9971

See CONTINUATION Page Provide Pharmacy Emergent First Fill Services at the VA Sioux Falls Health Care System Price/Cost Schedule (VASFHCS) in accordance with the Price/Cost Schedule and the Statement of Work.

Prior to submitting a quote, review ALL documentation in this solicitation.

Review and follow INSTRUCTIONS TO OFFERORS IN Section E.1.

See also E.5 52.212-2 EVALUATION – SIMPLIFIED ACQUISITION Email ALL required and completed documents to:

Michael Wicht at Michael.Wicht@va.gov

See CONTINUATION Page n/a

Alisha Milander Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

111 SOUTH 18TH PLAZA, SUITE C125

Omaha NE 68102

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Fill and dispense original prescriptions that are written by Veteran Affairs (VA) approved prescribers assigned to the Veteran Affairs Community Based Outpatient Clinic (CBOC) in accordance with the Statement of Work.

Contract Period: Base Year POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds PRODUCT/SERVICE CODE: Q517 - Medical - Pharmacy Services

Fill and dispense original prescriptions that are written by Veteran Affairs (VA) approved prescribers assigned to the Veteran Affairs Community Based Outpatient Clinic (CBOC) in accordance with the Statement of Work.

Contract Period: Option Year 1 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

Fill and dispense original prescriptions that are written by Veteran Affairs (VA) approved prescribers assigned to the Veteran Affairs Community Based Outpatient Clinic (CBOC) in accordance with the Statement of Work.

Contract Period: Option Year 2 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

Fill and dispense original prescriptions that are written by Veteran Affairs (VA) approved prescribers assigned to the Veteran Affairs Community Based Outpatient Clinic (CBOC) in accordance with the Statement of Work.

Contract Period: Option Year 3 POP Begin: 01-01-2029 POP End: 12-31-2029 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

Fill and dispense original prescriptions that are written by Veteran Affairs (VA) approved prescribers assigned to the Veteran Affairs Community Based Outpatient Clinic (CBOC) in accordance with the Statement of Work.

Contract Period: Option Year 4 POP Begin: 01-01-2030 POP End: 12-31-2030 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

B.3 STATEMENT OF WORK

1. Description of Service:

The VA Sioux Falls Health Care System (VASFHCS) requires a Contractor to provide pharmacy benefit management first-fill services. The Contractor shall fill first-time prescriptions for patients seen at these facilities and the associated Community-Based Outreach Clinics (CBOCs) and provide medication counseling per Omnibus Budget Reconciliation Act of 1990 requirements (OBRA-90). Prices shall be offered with respect to Average Wholesale Price (AWP).

2. Locations Covered:

VA Sioux Falls Health Care System 2501 West 22nd St Sioux Falls, SD 57105

And associated CBOCs:

Aberdeen CBOC 3307 SE 10th Ave Aberdeen, SD 57401

Sioux City CBOC 380 West Anchor Drive Dakota Dunes, SD 57049

Spirit Lake CBOC 1850 Royal Avenue Spirit Lake, IA 51360

Wagner CBOC 400 West Highway 46 Wagner, SD 57380

Watertown CBOC 4 19th St NE Watertown, SD 57201

3. Period of Performance:

This is a single award for a Base + 4 Option Years contract:

Option years will be executed by the Government at its discretion based on the continued need for services, Contractor performance, and availability of fiscal year funds.

4. Scope of Work:

The Contractor shall provide an open pharmacy network that will allow Veterans to receive medications at a pharmacy of their choice. The medical facility will provide a list of formulary medications that will be approved for reimbursement. Any medications not on the formulary list would require an override approval. The medical facility will provide and maintain a list of approved prescribers. The provider network shall be limited to providers approved by the medical center.

5. Hours of Operation:

Pharmacies should have standard operating hours that would allow Veterans the opportunity to fill prescriptions without significant inconvenience.

Federal Holidays:

New Year’s Day Martin Luther King Jr.'s Birthday President’s Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

Any day specifically declared by the President of the United States to be a national holiday.

6. General Requirements – Prescription Fill Process:

A. Description of Work/Specifications:

a. Prescriptions filled shall be in written, verbal, or faxed form provided by authorized providers.

b. The authorized voucher for that specific location must accompany the patient’s prescription. The Contractor shall provide voucher forms with appropriate billing and customer service information as well as have the ability to track utilization by VA specific location.

c. Prescriptions shall be filled and dispensed only for prescription drugs as VA authorized providers.

d. The VASFHCS will create a formulary also called an Emergent Drug List (EDL). Any medications not on the EDL will require approval by a Sioux Falls pharmacist prior to being filled. The VASFHCS’s formulary will be forwarded to the Contractor after each update by the Chief, Pharmacy, or his/her designee.

e. The VASFHCS will provide a list of approved VA providers that can have prescriptions filled through this contract. This list will be updated by the facility as needed.

f. Prescriptions shall be filled and limited to a maximum of ten (10) days’ supply with the exception of: one vial of insulin on local formulary, one inhaler on local formulary, and a maximum of fourteen (14) days’ supply of antibiotics on local formulary or limited to restricted quantities as listed in the formulary.

g. No refills will be authorized. The Contractor shall fill new prescriptions only.

h. Reimbursement shall be determined by the AWP discounted by the applicable percentage plus the applicable dispensing fee. The total price charged to the VASFHCS shall not exceed that charged to the general public and shall not exceed the price charged by the Contractor’s lowest third-party reimbursement.

i. AWP shall be based on the current Pharmacy Fundamental Reference REDBOOK and REDBOOK Updates published by Medical Economics Data, Inc., the AWP Medispan, or First DataBank pricing schedule and whichever is most advantageous to the government.

j. Cost, dispensing, override approvals, and location reports will be provided to the Contracting Officer’s Representative (COR) on a monthly basis.

k. Prescriptions filled under this contract shall be generic drugs ONLY. If medication is available from a manufacturer in generic form, it should be provided to the patient. If the generically manufactured product is unavailable at the time of Veteran need (i.e. shortage), Contractor staff are to obtain prior authorization approval from a VASFHCS Pharmacist prior to filling that medication for the Veteran.

l. The VASFHCS 's beneficiaries will pick up their own prescriptions at the dispensing pharmacy. No prescriptions are to be mailed. No prescriptions are to be delivered. Veterans are not to be charged by the contracted pharmacy under this contract for the prescription dispensed under this contract.

m. The VASFHCS will randomly audit prescription fills. The VASFHCS will have free access during regular business hours, and upon reasonable notice, to such books, records, invoices, and prescription files as deemed necessary to verify claim information, prescription volume, and the usual and customary charges to the general public for covered prescriptions. The Contractor shall make all prescription records and invoices available at the time of the audit.

n. Contract pharmacies shall maintain a log of VASFHCS prescriptions filled and have the patient sign next to each prescription number for each prescription received. A copy of the log shall be maintained at the contract pharmacy and be readily accessible for random VA audit.

o. All prescriptions must have proper auxiliary labels attached and appropriate counseling and drug interaction sheets provided.

p. Customer service complaints will be reviewed by the COR, and when substantiated, will be provided to the Contractor for resolution. Complaints will be resolved as appropriate and in a timely manner.

q. The Contractor and his/her contract pharmacies shall keep all information concerning the VASFHCS 's beneficiaries confidential and shall not release or disclose information to any person, except as authorized in writing and according to all applicable laws. The Privacy Act of 1974, Public Law 93-579, February 31, 1974 (S U.S.C. 552a) applies to this procurement.

r. Pharmacies authorized to fill prescriptions under the Contractor's plan shall agree to the following conditions:

i. All information concerning the VASFHCS's beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing and according to all applicable laws.

ii. Representatives of the VASFHCS are authorized to visit the Contractor's site and the premises of any pharmacy filling VASFHCS prescriptions during regular business hours for the purposes of auditing and evaluation, which may include the inspection of clinical records.

iii. The Contractor shall report all adverse drug events reported by the VASFHCS 's beneficiaries to the Pharmacy Department at the VASFHCS, and to the prescribing provider. Any known patient safety incidents are to be reported to the Contractor, and after conducting fact finding, the Contractor will report back to the COR within three business days.

s. The Government reserves the right to fill any prescription covered under this contract through the use of its own resources and/or staff.

t. Services provided under this contract will be monitored by the COR as designated.

u. If the contract pharmacy is having difficulty with any claim or any other situation, they will contact the Contractor. The contract pharmacy will not contact employees of the facility.

v. The Contractor shall not make authorizations to the contracted pharmacies for prescriptions that fall outside of the normal constraints as stated within. If this occurs, the Contractor will be responsible for reimbursing the local pharmacy for the prescription.

7. Performance:

Performance of the Contractor will be determined by the Quality Assurance Surveillance Plan (QASP).

8. Audits:

Pharmacy Services at the facility shall review the monthly statements provided by the Contractor regarding fills at the local emergent fill pharmacies. Should discrepancies occur in the billing, a request will be made by the facility to the Contractor to provide a copy of the consult in question.

If the prescription in question is not able to be produced within 10 calendar days the Contractor will adjust the statement by the amount in question. This review process will only be available for 90 days after the date of the prescription fill in question. Thus, the contract pharmacies will only be required to keep the hard copies available for 90 days.

9. Privacy Requirements:

The Contractor shall comply with the requirements of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 83-255), as well as other statues regarding confidentiality of patient information during and after the execution of this contract.

The Contractor and the contracted pharmacies shall keep all information concerning VA beneficiaries confidential and shall not release or disclose information to any person, except as authorized in writing and according to all applicable laws.

The Contractor shall not store patient information on a mobile device. A verbal contact is sufficient to obtain prior authorization when needed. The Contractor is prohibited from transferring Personal Health Information (PHI) by fax or email to and/or from a VA facility.

The contracted pharmacies including subcontracted pharmacies that are authorized to fill prescriptions under the contract must agree to the following conditions:

A. All information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing from VA, and according to all applicable laws.

B. Representatives of the VA are authorized to visit the Contractor’s sites and the premises of any pharmacy filling VA prescriptions during regular business hours for the purposes of auditing and evaluation, which may include the inspection of clinical records.

C. The Contractor shall report all adverse drug events reported by VA beneficiaries to both facilities’ Chief of Pharmacy, COR, to the prescribing CBOC provider, and Emergency Room provider if applicable.

D. Pharmaceutical services provided to VA beneficiaries shall meet all standards applicable to Medicaid recipients in the State where services are provided, and standards set forth in the current version of The Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services.

10. Licensing and Qualifications Requirements:

Pharmacies utilized by the Contractor shall be in good standing with their respective State Board of Pharmacy in Iowa, South Dakota, Minnesota, and Nebraska.

Pharmacies utilized by the Contractor shall have a current Drug Enforcement Administration (DEA) license, controlled substance license, and license from the respective State Board of Pharmacy.

Pharmacist Requirements:

· Graduate of an Accreditation Council for Pharmacy Education (ACPE) College of Pharmacy

· Licensed in the States of Iowa, South Dakota, Minnesota, and Nebraska (as applicable) and in good standing with the State Board of Pharmacy.

Pharmacy Requirements:

· Licensed pharmacy in the State of Iowa, South Dakota, Minnesota, and Nebraska

· Current DEA controlled substance license

11. Records Management Obligations:

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in paragraph b. below, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

a. includes VA records.

b. does not include personal materials.

c. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

d. may include deliverables and documentation associated with deliverables.

C. Requirements

a. The Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

b. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

c. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

d. The VA and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the VA or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to the VA. The agency must report promptly to NARA in accordance with 36CFR 1230.

e. The Contractor shall immediately notify the appropriate CO upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to the VA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the CO or address prescribed in the contract. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the CO's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA policy.

h. The Contractor shall not create or maintain any records containing any non-public VA information that are not specifically tied to or authorized by the contract.

i. The 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 from public disclosure by an exemption to the Freedom of Information Act.

j. The VA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which the VA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

D. Flow down of requirements to subcontractors

a. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

b. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

B.4 QUALITY ASSURANCE SURVEILLANCE PLAN

1. Introduction:

This Quality Assurance Surveillance Plan (QASP) is pursuant to the requirements listed in the Statement of Work (SOW) for the contract. This plan sets forth the procedures and guidelines that VASFHCS will use in ensuring the required performance standards or services levels are achieved by the Contractor.

A. Purpose:

This QASP provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

a. What will be monitored?

b. How monitoring will take place.

c. Who will conduct the monitoring?

d. How monitoring efforts and results will be documented.

This QASP does not detail how the Contractor accomplishes the work. Rather, the QASP is created with the premise that the Contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This 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 through contract modification. Copies of the original QASP and revisions shall be provided to the Contractor and Government officials implementing surveillance activities.

B. Performance Management Approach:

a. This QASP will define the performance management approach taken by VASFHCS to monitor and manage the Contractor’s performance to ensure the expected outcomes or performance objectives communicated in the SOW are achieved. Performance management rests on developing a capability to review and analyze information generated through performance assessment. The ability to make decisions based on the analysis of performance data is the cornerstone of performance management; this analysis yields information that indicates whether expected outcomes for the project are being achieved by the Contractor.

b. Performance management represents a significant shift from the more traditional Quality Assurance (QA) concepts in several ways. Performance management focuses on assessing whether outcomes are being achieved and to what extent. This approach migrates away from scrutiny of compliance with the processes and practices used to achieve the outcome. A performance-based approach enables the Contractor to play a large role in how the work is performed, as long as the proposed processes are within the stated constraints. The only exceptions to process reviews are those required by law (federal, state, and local) and compelling business situations, such as safety and health. A “results” focus provides the Contractor flexibility to continuously improve and innovate over the course of the contract as long as the critical outcomes expected are being achieved and/or the desired performance levels are being met.

C. Performance Management Strategy:

a. The Contractor is responsible for the quality of all work performed. The Contractor measures that quality through the Contractor’s own Quality Control Program (QCP). A QCP is work output, not workers, and therefore includes all work performed under this contract regardless of whether the work is performed by Contractor employees or by subcontractors. The Contractor’s QCP will set forth the staffing and procedures for self-inspecting the quality, timeliness, responsiveness, customer satisfaction, and other performance requirements in the SOW. The Contractor will develop and implement a performance management system with processes to assess and report its performance to the designated Government representative. This QASP enables the Government to take advantage of the Contractor’s QCP.

b. The Government representative(s) will monitor performance and review performance reports furnished by the Contractor to determine how the Contractor is performing against communicated performance objectives. The Government will inform the Contractor in writing regarding matters of poor performance. The Contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

2. Roles and Responsibilities:

A. The Contracting Officer:

The Contracting Officer (CO) is responsible for monitoring contract compliance, contract administration, and cost control and for resolving any differences between the observations documented by the Technical Point of Contact (TPOC), COR, and the Contractor. The CO will designate one full-time COR as the Government authority for performance management. The number of additional representatives serving as technical inspectors depends on the complexity of the services measured, as well as the Contractor’s performance.

B. The Contracting Officer’s Representative:

The COR is designated in writing by the CO to act as his or her authorized representative to assist in administering a contract. COR limitations are contained in the written appointment memo. The COR is responsible for technical administration, with the TPOC if applicable, of the project and ensures proper government surveillance of the Contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action in coordination with COR. The COR will have the responsibility for completing QA monitoring forms used to document the inspection and evaluation of the Contractor’s work performance. Government surveillance may occur under the inspection of services clause for any service relating to the contract.

C. Technical Point of Contact:

The program office shall assign a TPOC to assist the COR in monitoring the technical effort being performed under the contract. Other than the CO and COR, the TPOC is the only Government employee who may direct the flow of technical matters between the Government and Contractor. The TPOC is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. Any changes that the Contractor deems may affect contract price, terms, or conditions shall be referred to the CO for action in coordination with COR and TPOC. While the COR is responsible for surveillance, the TPOC shall assist the COR in assessing Contractor performance.

3. Identification of Required Performance Standards/Quality Levels:

The required performance standards and/or quality levels are included in the Contractor QCP and in Attachment 1, “Performance Requirements Summary.” If the Contractor meets the required service or performance level, it will be paid the amount agreed on in the contract. Failure to meet the required service or performance level could result in legal remedies being considered by the Government.

4. Methodologies to Monitor Performance:

A. Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION – 100% surveillance: Reports obtained from Patient Safety Manager, Pharmacy staff, and customers.

b. PERIODIC INSPECTION – Inspections scheduled and reported quarterly per COR delegation or as needed. Inspection of submitted payments will be reviewed for appropriate medication and provider. Overrides can be reviewed to appropriate approvals. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. RANDOM SAMPLING – Ten (10) randomly selected patient prescription fills will be reviewed per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

B. Acceptable Quality Levels:

The Acceptable Quality Levels (AQLs) included in Attachment 1, Performance Requirements Summary Table, for Contractor performance are structured to allow the Contractor to manage how the work is performed.

5. Quality Assurance Documentation:

A. The Performance Management Feedback Loop:

The performance management feedback loop begins with the communication of expected outcomes. Performance standards are expressed in the SOW and here, and are assessed using the performance monitoring techniques shown in Attachment 1.

B. Monitoring Forms:

a. The Government’s QA surveillance, accomplished by the COR/TPOC, will be reported using the monitoring forms in Attachment 2 or other format mutually agreed to with the CO. The forms, when completed, will document the Government’s assessment of the Contractor’s performance under the contract to ensure that the required results are being achieved. These forms, in addition to other documented information, are used by the COR to provide performance evaluation annually to the CO during the life of the contract.

b. The COR/TPOC will retain a copy of all completed QA surveillance forms in their COR/TPOC files.

6. Analysis of Quality Assurance Assessment:

A. Determining Performance:

The Government shall use the monitoring methods cited to determine whether the performance standards/service levels/AQLs have been met. If the Contractor has not met the minimum requirements, it may be asked to develop a corrective action plan or mitigation plan to show how and by what date it intends to bring performance up to the required levels. Failure to meet the AQL may result in the consideration of legal remedies by the Government.

B. Reporting:

At the end of each quarter, the COR/TPOC will prepare a written report summarizing the overall results of the Contractor’s performance. This written report, the Quality Assurance Report (QAR), which includes the Contractor’s submitted monthly status reports and the completed QA monitoring forms (Attachment 2) or other format if mutually agreed to with CO, will become part of the QA documentation. It will enable the Government to demonstrate whether the Contractor is meeting the stated objectives and/or performance standards, including cost/technical/ scheduling objectives.

C. Reviews and Resolution:

a. The TPOC may require the Contractor’s project manager, or a designated alternate, to meet with the COR and other Government technical team personnel as deemed necessary to discuss performance evaluation. The COR will define a frequency of in-depth reviews with the Contractor, including appropriate self-assessments by the Contractor; however, if the need arises, the Contractor will meet with the COR as often as required or per the Contractor’s request. The agenda of the reviews may include:

i. Monthly performance assessment data and trend analysis

ii. Issues and concerns of both parties

iii. Projected outlook for upcoming months and progress against expected trends, including a corrective action plan or mitigation plan analysis

iv. Recommendations for improved efficiency and/or effectiveness

b. The QAR must coordinate and communicate with the Contractor to resolve issues and concerns regarding marginal or unacceptable performance.

c. The COR and Contractor should jointly formulate tactical and long-term courses of action. Decisions regarding changes to metrics, thresholds, or service levels should be clearly documented. Changes to service levels, procedures, and metrics will be incorporated as a contract modification at the convenience of the CO.

ATTACHMENT 1: PERFORMANCE REQUIREMENTS SUMMARY

ATTACHMENT 2: QUALITY ASSURANCE MONITORING REPORT

Contract Number:

Name of Contractor:

Period of Performance Begin:

Period of Performance End:

Surveillance Period Begin:

Surveillance Period End:

Contracting Officer Representative (COR)/Phone/E-mail

Technical Point of Contact (TPOC)/Phone/E-mail

SURVEILLANCE METHOD (Check all that apply):

|_| Direct Observation |_| Periodic Inspection |_| User Survey |_| Validated User/Customer Complaints |_| 100% Inspection |_| Periodic Sampling |_| Random Sampling |_| Progress/Status Meetings |_| Analysis of Contractor progress reports LEVEL OF SURVEILLANCE (Check all that apply):

|_| Weekly |_| Monthly |_| Quarterly |_| Annually |_| As Needed

Narrative of Performance During Survey Period:

SIGNATURE: __________________________________ DATE:_________________________

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY

1. GENERAL

This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE

This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer to all requests for demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information.