36C26323Q0597 Solicitation.docx

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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

36C26323Q0597 04-27-2023 Joey Bloomer 515-699-5549 05-07-2023 17:00

CDT

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

3600 30th Street, Bldg 7M Des Moines IA 50310 X X 524292 $45.5 Million N/A X Department of Veterans Affairs Black Hills Health Care System 113 Comanche Road Fort Meade SD 57741 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

3600 30th Street, Bldg 7M Des Moines IA 50310

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 Provide Emergent First Fill Prescription services in accordance with the Statement of Work.

Email ALL required and completed documents to:

Joey Bloomer, joseph.bloomer@va.gov Review and follow INSTRUCTIONS TO OFFERORS in Section E - E.2 Addendum to FAR 52.212-1.

X X X Jeffrey Brown

VA-VHA-RPOC-2023-0062

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 36C366 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

3600 30th Street, Bldg 7M Des Moines IA 50310

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

TO FILL EMERGENT FIRST FILL PRESCRIPTIONS IN ACCORDANCE WITH THE STATEMENT OF WORK.

Contract Period: Base POP Begin: 06-01-2023 POP End: 05-31-2024 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

TO FILL EMERGENT FIRST FILL PRESCRIPTIONS IN ACCORDANCE WITH THE STATEMENT OF WORK.

Contract Period: Option 1 POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

TO FILL EMERGENT FIRST FILL PRESCRIPTIONS IN ACCORDANCE WITH THE STATEMENT OF WORK.

Contract Period: Option 2 POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

TO FILL EMERGENT FIRST FILL PRESCRIPTIONS IN ACCORDANCE WITH THE STATEMENT OF WORK.

Contract Period: Option 3 POP Begin: 06-01-2026 POP End: 05-31-2027 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

TO FILL EMERGENT FIRST FILL PRESCRIPTIONS IN ACCORDANCE WITH THE STATEMENT OF WORK.

Contract Period: Option 4 POP Begin: 06-01-2027 POP End: 05-31-2028 PRINCIPAL NAICS CODE: 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds

36C26323Q0597

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B.3 STATEMENT OF WORK

FIRST TIME EMERGENCY PRESCRIPTIONS FOR

BLACK HILLS HEALTH CARE SYSTEM, SOUTH DAKOTA

1. GENERAL:

1.1. Scope and Purpose of the Contract: Contractor to provide first time emergency medication fill for eligible veterans after pharmacy hours at Black Hills VA HCS located at Ft. Meade and Hot Springs, South Dakota and all Community-Based Outreach Clinics (CBOC) associated within this locality. The CBOCs are located in Mission, Pierre, Rapid City, and Winner, SD; Gordon and Scottsbluff, NE; and Newcastle, WY. Medication counseling will be provided per OBRA-90 requirements by contractor or contracted pharmacy utilized by the veteran. No support or on-site pharmacy personnel will be required by this contract unless medication is not on contracted medication formulary and must be approved by local VA pharmacist at Ft. Meade or Hot Springs.

1.2. Place of Performance: The work will be performed remotely for Veteran Affairs Black Hills Health Care System (VA BHHCS) pharmacy, located at 113 Comanche Rd, Fort Meade, SD and 500 N. 5th Street, Hot Springs, SD. The contractor will not utilize VA equipment or facilities in performance of this contract.

Contractors must be located within a reasonable driving distance from the VA facilities and Community Based Outreach Clinics (CBOCs) located at the following locations.

1.2.1. Fort Meade VAMC, 113 Comanche Rd, Ft. Meade, SD 57741

1.2.2. Hot Springs VAMC, 500 N. 5th St., Hot Springs SD 57747

1.2.3. Rapid City CBOC, 3625 5th St. Rapid City, SD 57701

1.2.4. Scottsbluff CBOC, 601 S. 5th Ave, Scottsbluff NE 69361

1.2.5. Pierre CBOC, 1601 N. Harrison STE 6, Pierre SD 57501

1.2.6. Winner CBOC 660 W. 2nd St, Winner SD 57580

1.2.7. Mission CBOC, 161 South Main St., Mission, SD 57555

1.3. VA sensitive data will not be stored on hard drives or a non-VA network.

1.4. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

1.5. Policy/Handbooks:

1.5.1. VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347

1.5.2. VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443

1.5.3. VHA Handbook 1100.17: National Practitioner Data Bank Reports http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.5.4. VHA Handbook 1100.18 Reporting And Responding To State Licensing Boards - http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.5.5. VHA Handbook 1100.19 Credentialing and Privileging - http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.5.6. VHA Handbook 1907.01 Health Information Management and Health Records: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

1.5.7. Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.5.8. VHA Handbook 1108.05 Outpatient Pharmacy Services

www.va.gov/vhapublications/viewpublication.asp?pub_id=3209

1.5.9. Privacy & Release of Information

www.va.gov/vhapublications/viewpublication.asp?pub_id=3233

1.5.10. VA Handbook 6500.6 Appendix D Contractor Rules of Behavior

1.6. Definitions/Acronyms: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

1.6.1. ACPE-Accreditation Council for Pharmacy Education

1.6.2. CMS: Centers for Medicare & Medicaid Services

1.6.3. Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

1.6.4. Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

1.6.5. COP- Chief of Pharmacy

1.6.6. CPARS: Contractor Performance Assessment Reporting System

1.6.7. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

1.6.8. ED: Emergency Department

1.6.9. Error: An unintentional deviation from the appropriate prescription for the patient entered into the queue resulting in, but not limited to the following condition(s):

1.6.9.1. Wrong dosage

1.6.9.2. Wrong frequency

1.6.9.3. Wrong quantity

1.6.9.4. Incorrect diluents/solution

1.6.9.5. Wrong medication order

1.6.9.6. Wrong route

1.6.9.7. Wrong or inappropriate rate of administration

1.6.9.8. Significant drug interaction not communicated to the healthcare professional

1.6.9.9. Incorrect information communicated to the healthcare professional

1.6.9.10. Delay in therapy

1.6.9.11. Incorrect patient

1.6.10. FAR: Federal Acquisition Regulation. Principal set of rules governing all U.S. Federal Government’s procurement processes

1.6.11. Full Time Equivalent (FTE): VA’s definition for full time- working the equivalent of 80 hours every two weeks, 2080 hours per year. In calculating FTE, any hours not worked on national holidays shall not be included.

1.6.12. HHS: Department of Health and Human Services

1.6.13. HIPAA: Health Insurance Portability and Accountability Act

1.6.14. IAW: In accordance with

1.6.15. ISO: Information Security Officer

1.6.16. Medical Emergency - a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in: Permanently placing a patient's health in jeopardy, causing other serious medical consequences, causing impairments to body functions, or causing serious or permanent dysfunction of any body-organ or part.

1.6.17. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

1.6.18. Non-Contract Provider - any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

1.6.19. PBM- Pharmacy Benefits Management

1.6.20. PO: Privacy Officer. Individual within the VA who is responsible for managing the risks and impacts of privacy laws and policies.

1.6.21. POP: Period of Performance

1.6.22. PWS: Performance Work Statement

1.6.23. QASP: Quality Assurance Surveillance Plan

1.6.24. Scope of Practice: A clinical pharmacist scope of practice is required for any positions in which the clinical pharmacist has patient care activities and serves as a non-physician provider, as part of collaborative medication management, to initiate, modify, renew, or discontinue medication therapy.

1.6.25. SOW: Statement of Work

1.6.26. VA BHHCS: Veterans Affairs Black Hills Health Care System

1.6.27. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean VA Black Hills Health Care System.

1.6.28. Veterans Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

1.6.29. Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

1.6.30. VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

2. QUALIFICATIONS:

2.1. Staff/Facility should be aware of VA formulary being used and pharmacies that can be used after hours for first time emergency medication fills.

2.1.1. Formulary: Contracting staff should be aware of local medication formulary being used. The formulary can be changed, at the discretion of VA BHHCS, at any time with notification to contractor with any updates. Notification will be by email to current contractor representative. It will be the responsibility of the contractor representative to update their formulary list.

2.1.2. Technical Proficiency: Contractor staff shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed.

2.1.2.1. Adhere to the VA formulary for this contract and restrictions for Criteria for use of non-formulary drugs at all sites. Restrictions and formulary lists will be provided to the successful contractor after contract award and available via the intranet.

2.1.2.2. Be readily available via telephone during the working hours.

2.1.3. Conflict of Interest: The Contractor and all contract staff/facilities are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.4. Citizenship relate Requirements:

2.1.4.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals.

2.1.4.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with anyone who is not a US citizen. . Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.1.4.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.1.5. Annual Office of Inspector General (OIG) Statement:

2.1.5.1. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.5.2. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor is not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.5.3. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.1.6. Clinical/Professional Direction: The qualifications of Contractor personnel are subject to review by VA Medical Center Chief of Pharmacy (COP) or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional direction of all clinical personnel covered by this contract will be provided by the VA BHHCS Chief of Pharmacy or his/her designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.1.6.1. Non Personal Healthcare Services: The parties agree that the Contractor and all contract clinical Pharmacist (s) shall not be considered VA employees for any purpose.

2.1.6.2. Inherent Government Functions: Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.1.6.3. No Employee status: The Contractor shall be responsible for protecting Contract staff furnishing services on behalf of this contract. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.1.6.3.1. Workers’ compensation

2.1.6.3.2. Professional liability insurance

2.1.6.3.3. Health examinations

2.1.6.3.4. Income tax withholding, and

2.1.6.3.5. Social security payments.

2.1.6.4. Tort Liability: The Federal Tort Claims Act does not cover Contractor. When a Contractor or contract pharmacy has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract pharmacy) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.1.6.5. Key Personnel: Contractor will be responsible to ensure that the contractor personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period.

2.1.6.6. Emergency Contact Procedure:

2.1.6.6.1. The Contractor will provide primary and back-up contact phone numbers for health care professionals and designated pharmacy staff to reach the contract staff during the designated work time per Section 3.

2.1.6.6.2. The Contractor will provide an email address for communication during administrative hours and as a backup for telephone failure during the designated work hours.

2.1.6.7. Contingency Plan: Because continuity of care is an essential part of VA BHHCS’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract Clinical Pharmacist (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. DESCRIPTION OF WORK/SPECIFICATIONS:

3.1. The contractor's pharmacy {or pharmacies as applicable) shall fill and dispense original prescriptions that are written by physicians assigned to the VA Black Hills Health Care System and their respective Community Based Outpatient Clinics. Contractor pharmacies may include major chain and/or community-based availability with fully licensed and trained pharmacists.

3.2. The VA BHHCS and the CBOC’s operating hours are normally 8:00 a.m. to 4:30 p.m., Monday-Friday, excluding federal holidays; Only emergency, local formulary, first fill prescriptions will be filled through contractor when VA services are not available or cannot assist the patient in a timely manner. Anything not on the local formulary must be pre-approved by VA pharmacist.

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

3.4. Prescriptions shall be filled and dispensed only for prescription drugs as VA authorized providers. The VA Black Hills Health Care System's formulary will be forwarded to the contractor after each UPDATE by the Chief, Pharmacy, or his/her designee. Medications not found on the VA Black Hills restricted formulary require a prior authorization approval by a Black Hills pharmacist prior to dispensing.

3.5. 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.

3.6. No refills will be authorized. The contractor shall fill NEW PRESCRIPTIONS ONLY!

3.7. Reimbursement shall be determined by the average wholesale price (AWP) discounted by the applicable percentage plus the applicable dispensing fee. The total price charged to the VA Black Hills Health Care System shall not exceed that charged to the general public and shall not exceed the price charged by the contractor’s lowest third-party reimbursement.

3.8. 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 manufacturer product is unavailable at the time of Veteran need (i.e. shortage), Contractor staff is to obtain prior authorization approval from a VA BHHCS Pharmacist prior to filling that medication for the Veteran.

3.9. The VA Black Hills Health Care System'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, in any way, by contracted pharmacy under this contract for the prescription dispensed under this contract.

3.10. The VA Black Hills Health Care System will randomly audit all prescription fills. The VA Black Hills Health Care System 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.

3.11. Contract pharmacies shall maintain a log of VA Black Hills Health Care System 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.

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

3.13. AWP (average wholesale price) shall be based on the current Pharmacy Fundamental Reference REDBOOK and REDBOOK Updates published by Medical Economics Data, Inc. or the AWP Medispan pricing schedule and whichever is most advantageous to the government.

3.14. The contractor and his/her contract pharmacies shall keep all information concerning VA Black Hills Health Care System's beneficiaries confidential and shall not release or disclose information to any person, except as authorized in writing and accord ng 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.

3.15. Pharmacies authorized to fill prescriptions under the contractor's p la n shall agree to the following conditions:

3.15.1. All information concerning VA Black Hills Health Care System'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.

3.15.2. Representatives of the VA Black Hills Health Ca re System are authorized to visit the contractor's site and the premises of any pharmacy filling VA Black Hills Health Care System prescriptions during regular business hours for the purposes of auditing and evaluation, which may include the inspection of clinical records.

3.15.3. The contractor shall report all adverse drug events reported by VA Black Hills Health Ca re System's beneficiaries to the Associate Chief, Pharmacy Service, VA Black Hills Health Ca re System, and to the prescribing CBOC physician.

3.15.4. Pharmaceutical services provided to VA Black Hills Health Ca re System's beneficiaries under this contract shall meet all standards applicable to Medicaid recipients in the State where services are provided, and standards set forth in the current The Joint Commission accreditation manual for Ambulatory Ca re/Pharmaceutical Services.

3.16. The contractor shall accept a call from the CBOC clerk advising him/her of all existing and/or new physician's state license number and his/her federal and/or state drug license number. The contractor shall immediately notify its contract pharmacies of the physician information so as to avoid delay in patient services. Notification of physician information may occur on either the day the physician fills in at the CBOC or prior to CBOC duty as time allows.

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

3.18. Services provided under this contract will be monitored by the Contracting Officer's Technical Representative (COTR) as designated.

4. HOURS OF OPERATION

4.1. VA Business Hours: The services covered by this contract shall be furnished by the Contractor as defined herein. The Contractor will be required, except in case of emergency, to furnish services as described below.

4.2. Work Schedule: Contractor will assist in filling all emergent after VA pharmacy hour prescriptions not readily available through urgent care or CBOC first fill prescriptions needing immediate start per primary care provider and VA pharmacy. Questions from contractor should be directed to VA prior to filling any medication in which there is a question.

4.3. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

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

4.4. Cancellations: Contractor cancellation is not acceptable. Unless a state of emergency has been declared or services are otherwise cancelled by the VA BHHCS, the Contractor shall be responsible for providing services.

4.5. Standards of Care: Contract provider’s standard of care shall cover the same standards and range of services as would be provided in a civilian medical treatment facility and shall meet or exceed the standard of care required by all appropriate and applicable policies, procedures and regulations of the VHA and VA BHHCS to ensure compliance with Joint Commission (or equivalent) guidelines and standards.

4.6. Medical Records

4.6.1. Authorities: Contractor’s pharmacist(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.6.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

4.6.3. Disclosure: Contractor’s pharmacist(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.6.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VA BHHCS.

4.6.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: Privacy Officer, 113 Comanche Road, Fort Meade, SD 57741.

4.6.6. Direct Patient Care: 80% of the time involved in direct patient care

4.6.6.1. Contractor shall be responsible for reviewing prescriptions as described by this SOW.

4.6.7. Administrative: 20% of time not involved in direct patient care

4.6.7.1. Contractor shall be responsible for:

4.6.7.1.1. Maintaining training requirements

4.6.7.1.2. Invoicing and program management

4.6.7.1.3. Receiving and reporting important issues to VAMC pharmacy staff.

4.7. Performance Standards, Quality Assurance (QA) and Quality Improvement (QI)

4.7.1. Quality Management/Quality Assurance Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Statement of Work (SOW) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

4.7.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

4.7.3. Performance Standards: The contractor shall comply with the required standards as outlined in the SOW and the Quality Assurance Surveillance Plan (QASP). The QASP outlines required standards, defines the methods and frequency of surveillance, and will be a part of the resultant contract.

4.7.3.1. The Government reserves the right to refuse acceptance of contractor staff at any time after performance begins, if personal and professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing contract requirements, or other conduct resulting in formal complaints by patients or staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current Federal Personnel Regulations. The CO and COR shall deal with issues raised concerning contractor’s conduct and/or relations with Government employees or patients. The CO is the arbiter and the final authority on validating questions of acceptability of contractor conduct and complaint issues.

4.7.3.2. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report. All incidents reported immediately (within 24 hours).

Standard: All (100%) of patient safety incidents are reported to the contractor within 24 hours of knowledge of the incident. The contractor is responsible for completing fact finding and reporting back to the COR within 72 hours (three business days).

Acceptable Quality Level: All (100%) of patient safety incidents are reported to the contractor within 24 hours of knowledge of the incident (one business day). The contractor is responsible for completing fact finding and reporting back to the COR within 72 hours (three business days). No acceptable deviation.

Surveillance Method: Direct Observation and/or COR review.

Frequency: By exception Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation.

Deduction: NA

4.7.3.3. Measure: Submit Claims Reports

Performance Requirement: Contractor to submit monthly report to COR for review by 15th of the month for the previous month’s claims Standard: Report to be sent to COR for review to ensure appropriate emergent prescription fill using approved formulary.

Acceptable Quality Level: 98% Surveillance Method: Inspection Frequency: Monthly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.7.3.4. Measure: Timeliness and appropriateness in prescription review Performance Requirement: All prescriptions shall be reviewed within 1 (one) hour of being received from local pharmacy to ensure formulary compliance Standard: All (100%) medications reviewed IAW the performance requirement.

Acceptable Quality Level: 100% of medication orders will be reviewed IAW the performance requirement.

Surveillance Method: Inspection Frequency: Monthly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.7.3.5. Measure: Updated provider list in timely manner

Performance Requirement: Contractor to update provider list within 7 days of update from VA medical center.

Standard: All incidents reported to COR Acceptable Quality Level: 98% Surveillance Method: Inspection Frequency: Quarterly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.7.3.6. Measure: Customer service

Performance Requirement: Provides excellent customer service to patients, staff, and providers.

Standard: No substantiated complaints regarding customer service issues.

Acceptable Quality Level: 90% of contact incidents handled without substantiated complaints.

Surveillance Method: Review of complaints logged by customers.

Frequency: Yearly Incentive: Favorable contractor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.7.4. Registration with Contractor Performance Assessment Reporting System

4.7.4.1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed $150,000, and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

4.7.1.1. Each Contractor whose contract award is estimated to exceed $150,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the Contractor’s registered representative.

4.7.4.2. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

4.7.4.3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have thirty days to submit any comments and re-assign the report to the CO.

4.7.4.4. Failure to have a current registration with the CPARS database, or to re-assign the report to the CO within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond

5. GOVERNMENT RESPONSIBILITIES

5.1. VA Support Personnel, Services or Equipment: VA BHHCS will not supply laptop, Webcam & Jabber software to contract personnel.

5.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to contracting officer (CO).

5.2.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

5.2.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

5.2.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

5.3. COR RESPONSIBILITIES:

5.3.1. The COR/alternate COR for this contract is: Department of Veterans Affairs VA BHHCS, Pharmacy 113 Comanche Road Ft. Meade, SD 57741

5.3.2. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

5.3.3. After contract award, the COR shall be the VA official responsible for verifying contractor contract compliance. A record-keeping system of procedures will be maintained and reported monthly to the COR. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer or Administrative Contracting Officer

5.3.4. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: quality assurance incident reporting (including root cause and corrective action plan), complaints from patient/family/staff, complaints related to professionalism, and adherence to National Patient Safety Goals.

5.3.5. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing charges and referral testing documented on the VAMC record-keeping system with those listed on the invoice. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

5.3.6. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

5.3.7. All contract administration functions will be retained by the VA.

6. SPECIAL CONTRACT REQUIREMENTS

6.1. Reports/Deliverables: The Contractor shall be responsible for complying with all reporting requirements established by the Contract.