36C26321R0003 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 26

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Andrew J. Schoenecker 316 Robert Street N. STE. 506 St. Paul MN 55101

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

Erica Morris 316 Robert Street N. STE. 506 St. Paul MN 55101

To all Offerors/Bidders 36C26321R0003

12-21-2020 X

X X

X 1

The purpose of this amendment is to provide the updated version of the Performance Work Statement (PWS). PWS paragraph

1.5.12 is amended to correct the number of hours for Full Time Equivalents (FTEs). PWS paragraph 4.4.3.6 is amended to add the surveillance method for the Timeliness in Prescription Review measure.

The amendment also provides the questions and answers for this solicitation.

Andrew J. Schoenecker Contracting Officer

See attached document: 36C26321R0003_PWS_0001.

See attached document: 36C26321R0003_0001 Questions and Answers.

36C26321R0003

B.3. PERFORMANCE WORK STATEMENT

1. GENERAL:

1.1. The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 23, has a requirement for virtual pharmacy services to the participating facilities listed below during the contract period. Services shall include the professional review and problem solving needed to assure safe and appropriate medication processing. Virtual pharmacy services include licensed pharmacist review of medication orders for patients by remote (computer) methods. No on-site pharmacy personnel will be required by this contract. Services furnished under the contract shall be ordered by issuance of a task order for services to be performed in accordance with standards of this document. One task order will be issued for each participating facility.

1.2. Place of Performance: The work will be performed remotely for Veteran Affairs Health Care System Pharmacies located at the following participating locations:

• Black Hills: 113 Comanche Road Fort Meade, SD 57741

• Fargo: 2101 North Elm Street Fargo, ND 58102

• St. Cloud: 4801 Veteran Dr. St. Cloud, MN 56303

• Sioux Falls: 2501 W 22nd St. Sioux Falls, SD 57105

1.2.1. The contractor will not utilize VA equipment or facilities in performance of this contract.

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

1.2.3. Contractors will sign into the system at least every 90 days to keep accounts active.

1.2.4. Contractor will not enter into a Business Associate Agreement.

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) Buying Authority with FAR Part 12 in combination with FAR Part 13.

1.4. Policy/Handbooks: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

1.4.1. VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

1.4.2. VHA Directive 2006-041 “Veterans’ Health Care Service Standards” (expired but still in effect pending revision) – See Section D

1.4.3. VHA Handbook 1100.17: National Practitioner Data Bank Reports – https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

1.4.4. VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards – https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

1.4.5. VHA Handbook 1100.19 Credentialing and Privileging –

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910

1.4.6. VHA Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

1.4.7. Privacy Act of 1974 (5 U.S.C. 552a) as amended

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.8. VHA Handbook 1108.11(1) Clinical Pharmacy Services

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3120

1.4.9. VHA Directive 1108.06 Inpatient Pharmacy Services

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5333

1.4.10. Privacy & Release of Information

http://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233

1.5. 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.

1.5.1. ACPE: Accreditation Council for Pharmacy Education

1.5.2. CMS: Centers for Medicare & Medicaid Services

1.5.3. 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

1.5.4. 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.

1.5.5. COP: Chief of Pharmacy

1.5.6. CPARS: Contractor Performance Assessment Reporting System

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

1.5.8. Credentialing: Credentialing is the systematic process of screening and evaluating qualification and other credentials, including licensure, required education, relevant training and experience and current competence and health status.

1.5.9. ED: Emergency Department

1.5.10. Error: An unintentional deviation from the appropriate prescription for the patient entered into the queue resulting in, but not limited to the following conditions:

1.5.10.1. Wrong dosage

1.5.10.2. Wrong frequency

1.5.10.3. Wrong quantity

1.5.10.4. Incorrect diluents/solution

1.5.10.5. Intravenous products entered contrary to the facility’s standard solutions (copy provided to the contractor)

1.5.10.6. Wrong medication order

1.5.10.7. Wrong route

1.5.10.8. Wrong or inappropriate rate of administration

1.5.10.9. Significant drug interaction not communicated to the healthcare professional

1.5.10.10. Incorrect information communicated to the healthcare professional

1.5.10.11. Delay in therapy

1.5.10.12. Incorrect patient

1.5.11. FAR: Federal Acquisition Regulation – the principal set of rules governing all procurements by the U.S. Federal Government

1.5.12. 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.

1.5.13. HHS: Department of Health and Human Services

1.5.14. HIPAA: Health Insurance Portability and Accountability Act

1.5.15. IAW: In accordance with

1.5.16. ISO: Information Security Officer

1.5.17. 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 serious or permanent dysfunction of any body-organ or part.

1.5.18. 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).

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

1.5.20. NP: Nurse Practitioner

1.5.21. NPPES: National Plan and Provider Enumeration System

1.5.22. PA: Physician Assistant

1.5.23. PBM: Pharmacy Benefits Management

1.5.24. PIV: Personnel Identity Verification. Personnel identity verification of federal employees and contractors that secures access to federal facilities and information systems.

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

1.5.26. POP: Period of Performance

1.5.27. PWS: Performance Work Statement

1.5.28. Privileging (Clinical Privileging): Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific.

1.5.29. QASP: Quality Assurance Surveillance Plan

1.5.30. Queue: A "bank or database" of prescriptions that have been entered into the computer by a licensed independent practitioner awaiting review and verification by a licensed pharmacist for proper disposition

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

1.5.32. VA FHCS: Veterans Affairs Fargo Health Care System

1.5.33. VA SCHCS: Veterans Affairs St. Cloud Health Care System

1.5.34. VA SFHCS: Veterans Affairs Sioux Falls Health Care System

1.5.35. Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, this term shall mean any or all of the VISN 23 Health Care Systems covered under this contract.

1.5.36. 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.

1.5.37. Veterans Integrated Services Network 23 (VISN23): The regional oversight for the VA medical centers in Minnesota, Iowa, Nebraska, North and South Dakota.

1.5.38. 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.

1.5.39. VETPro: A federal web-based credentialing program for healthcare providers

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: Virtual pharmacists assigned by the Contractor to perform the services covered by this contract shall have a current license to practice pharmacy in any State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses.

2.1.1.1. Every virtual pharmacist must be a graduate of a degree program in pharmacy from an ACPE-accredited college of pharmacy or university in the United States.

2.1.1.2. Contracted pharmacists who have an active, current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract.

2.1.1.3. Virtual pharmacists will not act as mid-level providers at VAMC.

2.1.2. Technical Proficiency: Virtual pharmacists 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. The 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. The contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract virtual pharmacist(s).

2.1.2.1. The contractor shall provide a sufficient number of licensed pharmacists to verify all orders during the hours specified in Section 3.

2.1.2.2. Due to the criticality of the service, in addition to the primary virtual pharmacists, the Contractor shall ensure that qualified pharmacists are available to cover vacancies caused for any reason. The contractor will submit a list of qualified pharmacists at contract award and throughout the period of performance if new pharmacists are added.

2.1.2.3. The virtual pharmacists must have a working knowledge of VISTA and CPRS and be able to process pending inpatient orders. Experience with VISTA and CPRS must have been gained within the last three (3) years. The contractor will assure competency to perform this work.

2.1.2.4. Virtual pharmacists must adhere to the VA formulary 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 are available via the intranet.

2.1.2.5. Virtual pharmacists must be able to obtain clearance from a Veterans Affairs Medical Center Information Security Officer.

2.1.3. Continuing Education (CE) Requirements: This is not monitored by the VAMC. Virtual pharmacists are required to attain CE to maintain licensure, as predetermined by the State in which they are licensed.

2.1.4. Mandatory VA Training: Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the virtual Pharmacists as required by the VA.

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

2.1.4.2. CPRS and Vista Computer programs: Contractor employees (including any sub-contract employees) providing medical services will be required to document patient care in CPRS or Vista to comply with all VHA and Joint Commission standards;

2.1.4.3. Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required security training;

2.1.4.4. Successfully complete the VHA Privacy Policy training and annually complete required privacy training; and;

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

2.1.4.6. The Contractor shall provide a copy of the training certificate and certification of signing the Contractor Rules of Behavior for each applicable employee to the VA COR within one week of the initiation of the contract.

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

2.1.4.8. All contractor personnel providing services under the contract must have a current VA PIV (personnel identification verification) badge and comply with all privacy and information security requirements.

NOTE: As the VA routinely reviews and updates policies and procedures covering contractor computer access, security requirement may change during the term of this contract and new policies and procedures may be implemented unilaterally during the term of this agreement.

2.1.5. 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services National Plan and Provider Enumeration System shall be provided to the Contracting Officer with the proposal.

2.1.6. Conflict of Interest: The Contractor and all contracted virtual pharmacists 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.

2.1.7. Citizenship Related Requirements:

2.1.7.1. 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.

2.1.7.2. 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.

2.1.7.3. 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 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.

2.1.7.4. 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.

2.1.7.5. 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.

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

2.1.8.1. 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 contracted virtual pharmacists are 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. CMPs may also be imposed against any Contractor that employs or enters into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

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

2.2. 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 VAMC Chief of Pharmacy or his/her designee for each location. 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.

2.3. Non-Personal Healthcare Services: The parties agree that the Contractor and all contracted virtual pharmacists shall not be considered VA employees for any purpose.

2.4. Inherent Government Functions: The Contractor and virtual pharmacists 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.

2.5. No Employee status: The Contractor shall be responsible for protecting the contracted virtual pharmacists providing services. 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:

2.5.1. Workers’ compensation;

2.5.2. Professional liability insurance;

2.5.3. Health examinations;

2.5.4. Income tax withholding; and

2.5.5. Social security payments.

2.6. Tort Liability: The Federal Tort Claims Act does not cover the Contractor or contracted virtual pharmacists. When a Contractor or contracted virtual pharmacist 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 the action or non-action of the Contractor or contracted virtual pharmacist shall be the responsibility of the Contractor and/or insurance carrier.

2.7. Personnel:

2.7.1. The Contractor will ensure that there is appropriate coverage as listed in Section 3.2 and ensure that the contractor’s personnel providing work on this contract are fully trained and fully competent to perform the required services for the duration of the contract period. All contracted personnel working on this contract must meet the qualifications stated in Section 2.

2.7.2. The Government reserves the right to refuse acceptance of any of the Contractor’s personnel at any time after performance begins, if personal or 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 directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA Chief of Pharmacy or designee show documented clinical problems or continual unprofessional behavior/actions with any contracted virtual pharmacist, the VA Chief of Pharmacy may request, without cause, immediate replacement of that virtual pharmacist.

2.7.3. The CO and COR shall deal with issues raised concerning the conduct of contracted virtual pharmacists. The final arbiter on questions of acceptability is the CO.

2.8. Emergency Contact Procedure:

2.8.1. The Contractor will provide primary and back-up contact phone numbers for health care professionals and designated pharmacy staff to reach the virtual pharmacists during the designated work times in Section 3.

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

2.9. Contingency Plan: Because continuity of care is an essential part of VAMC medical services, The Contractor’s Management Plan shall include a contingency plan in place to be utilized if contracted virtual pharmacists leave the Contractor’s employment or are unable to continue performance in accordance with the terms and conditions of the resulting contract.

3. HOURS OF OPERATION:

3.1. 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.

3.2. Work Schedule: Provide virtual pharmacist coverage for the days and hours identified for each location below:

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

3.2.1.1. Monday – Friday: 5:15pm – 7:30am

3.2.1.2. Saturday – Sunday: 3:30pm – 7:30am

3.2.1.3. Federal Holidays: 3:30pm – 7:30am

3.2.2. VA FHCS: Veterans Affairs Fargo Health Care System

3.2.2.1. Monday – Friday: 12:00am – 7:30am

3.2.2.2. Saturday – Sunday: 12:00am – 7:30am

3.2.2.3. Federal Holidays: 12:00am – 7:30am

3.2.3. VA SCHCS: Veterans Affairs St. Cloud Health Care System

3.2.3.1. Monday – Friday: 4:30pm – 7:30am

3.2.3.2. Saturday – Sunday: 24 hours

3.2.3.3. Federal Holidays: 24 hours

3.2.4. VA SFHCS: Veterans Affairs Sioux Falls Health Care System

3.2.4.1. Monday – Friday: 10:00pm – 6:00am

3.2.4.2. Saturday – Sunday: 10:00pm – 6:00am

3.2.4.3. Federal Holidays: 10:00pm – 6:00am

3.3. 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 Day

• Christmas Day

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

3.4. Emergencies: The Chief of Pharmacy or representative will contact vendor to request additional support from the clinical pharmacy services outside of the established hours in times of emergency/disaster (e.g., weather – blizzards). If emergency services are provided the vendor will be paid at the same rate.

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

4. CONTRACTOR RESPONSIBILITIES:

4.1. Services Required: The Contractor shall provide virtual pharmacy services to complete medication orders for inpatients for VISN 23 Health Care System locations as requested. This includes the professional review and problem solving needed to assure safe appropriate medication processing.

4.1.1. Medication orders will be verified by the pharmacists.

4.1.1.1. The inpatient pending orders queue (Pending/non-verified Orders) will be checked and processed at least hourly.

4.1.1.2. Emergency orders will be processed within fifteen (15) minutes of contact.

4.1.1.3. Phone calls from nursing staff or providers will be dealt with in a timely manner to ensure prescriptions are reviewed and processed in accordance with the time standards in this document.

4.1.2. The virtual pharmacists will evaluate each prescription for drug-drug interactions, contraindications for recorded drug allergies, appropriate doses, and accurate directions and assure the final order will be understandable to the nurses administering medication.

Pending medication orders not meeting standards for completeness, restrictions, lacking clinical information and those requiring consults will be clarified with the prescriber prior to processing.

4.1.3. Virtual pharmacists shall evaluate the patient’s age and health status-related vulnerability to illness by review of the patient’s information in CPRS and through consultations with VAMC providers or nurses, if necessary, and assess the patient for the following:

4.1.3.1. Drug Interactions, including IV incompatibilities;

4.1.3.2. Altered metabolism in the liver;

4.1.3.3. Renal function increase or decline;

4.1.3.4. Altered end-organ effects;

4.1.3.5. Undesirable drugs for the elderly patient; and

4.1.3.6. Using formulary information provided by the VAMC, the virtual pharmacists will review orders and make efforts to utilize formulary agents. If a non-formulary agent is indicated and clinically appropriate, the virtual pharmacist shall review the patient chart in CPRS for an active non-formulary consult approval and evidence of outpatient prescription dispensing history indicating a continuance of established therapy. In the event that a non-formulary agent is being prescribed for the first time as an inpatient, the virtual pharmacist shall review the patient chart in CPRS for a new non-formulary consult placed by the provider and evaluate clinical appropriateness, formulary alternatives, Pharmacy Benefits Management (PBM) criteria for use, and discuss verbally with the provider, if appropriate, prior to completing the order. If necessary, the virtual pharmacist may contact the VAMC on-call pharmacist to further discuss the appropriateness of the non-formulary agent and how to proceed prior to completing the order. In all cases, the virtual pharmacist shall communicate via VISTA mail message to the inpatient pharmacy group all situations involving non-formulary agent orders for follow-up the next business day.

4.1.4. The contractor or virtual pharmacists shall communicate with a VAMC pharmacist regarding high priority or urgent issues.

4.1.5. At the end of each work period, the contractor shall email the VAMC pharmacy group via VISTA with an “end of shift” report. This will give a daily summary of the prescriptions completed; allowing them to be reviewed for correctness by the VA inpatient pharmacists.

4.1.6. Access to the VISTA and CPRS computer system is required and virtual pharmacists will have to meet all information security requirements as required by the Department of Veterans Affairs.

4.1.7. Virtual pharmacists must have knowledge of the VA formulary and the VISTA computer system. Virtual pharmacists must also have a working knowledge of the processing requirements for proper completion of medication orders and understand and be competent in accessing CPRS to read notes, check labs, etc., prior to completing prescriptions that have questionable doses, special needs, etc.

4.1.8. The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility.

4.1.9. Orders will be entered accurately with a goal of a ZERO error rate. The virtual pharmacists will follow the procedures outlined and provided to the Contractor and virtual pharmacists.

4.1.10. A VAMC pharmacist will review the orders processed by the contractor and make corrections during their shift as appropriate, forwarding all corrections to the COR. VAMC Pharmacy will be provided a monthly summary of the orders entered incorrectly. The contractor pharmacy will not bill for the orders entered incorrectly. COR will review number of prescriptions finished each month and provide a detailed list to contractor for billing by the 5th of each month.

4.1.11. Complies with all appropriate and applicable policies, procedures and regulations of VHA and VAMCs to ensure compliance with Joint Commission guidelines and standards.

Examples include rules and regulations for narcotic control and use, personnel policies, management relations, medical records, education requirements for privacy, security, and ethics training.

4.1.12. Virtual pharmacists must maintain professional conduct and the highest standards of integrity and mutual respect during interactions with patients, patients’ families, nurses, residents, physicians, medical students, and other health care professionals.

4.1.13. Virtual pharmacists must complete VA CPRS (electronic medical record), privacy, security, ethics and fire prevention training before performing any patient care.

4.1.14. The Contractor shall provide virtual pharmacists who are competent and qualified per this performance work statement and adequately trained to perform assigned duties.

4.1.14.1. Virtual pharmacists shall be responsible for checking in at scheduled times.

Deviations from scheduled times will be logged and used by the COR to confirm schedule compliance.

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

4.2. Standards of Care: The standard of care of the Contractor and its employees 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 VAMC to ensure compliance with Joint Commission (or equivalent) guidelines and standards.

4.3. Medical Records:

4.3.1. Authorities: The Contractor’s personnel 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).

4.3.2. 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. The 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. The Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one

(21) calendar days after the contract expiration date.

4.3.3. Disclosure: Virtual pharmacists may have access to patient medical records, however the 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.

4.3.4. 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 and all guidelines provided by the VAMC.

4.3.5. 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 http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1469 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1423 http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/va/pdf/VA3288.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf http://www4.va.gov/vaforms/medical/pdf/vha-10-5345-fill.pdf 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 (Black Hills), 113 Comanche Road Fort Meade, SD 57741

• Privacy Officer (Fargo), 2101 North Elm Street Fargo, ND 58102

• Privacy Officer (St. Cloud), 4801 Veterans Drive, St. Cloud, MN 56303

• Privacy Officer (Sioux Falls), 2501 W 22nd St. Sioux Falls, SD, 57105

4.3.6. Indirect Patient Care: 80% of the time involved in indirect patient care

4.3.6.1. Contractor shall be responsible for reviewing prescriptions as described by the

PWS.

4.3.7. Administrative: 20% of time not involved indirect patient care

4.3.7.1. Contractor shall be responsible for:

4.3.7.1.1. Maintaining training requirements

4.3.7.1.2. Invoicing and program management

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

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

4.4.1. Quality Management/Quality Assurance Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) 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. (See attached Quality Assurance Surveillance Plan)

4.4.2. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. If the Contractor or their employee 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.

4.4.3. Performance Standards: The contractor shall comply with the required standards as outlined in the PWS and the QASP. The QASP outlines required standards, defines the methods and frequency of surveillance, and will be a part of the contract. The QASP is attached in Section D.

4.4.3.1. The Government reserves the right to refuse acceptance of any of the Contractor’s personnel at any time after performance begins, if personal or 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 directed tasks, or other conduct resulting in formal complaints by patient or other 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 the conduct of the Contractor or the contractor’s personnel. The final arbiter on questions of acceptability is the CO.

4.4.3.2. Measure: Qualifications of virtual pharmacists

Performance Requirement: All virtual pharmacists shall be licensed pharmacists Standard: All (100%) of virtual pharmacists are licensed

- A graduate of a degree program in pharmacy from an ACPE-accredited college of pharmacy or university in the United States

- Virtual pharmacists who have an active, current, full and unrestricted licenses in one or more states, but who have, or ever had, a license restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract

- Virtual pharmacists will not act as mid-level providers at VAMC.

Acceptable Quality Level: 100% - No deviations accepted Surveillance Method: Random inspection of qualification documents Frequency: Annually and any time new staff are added Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation and removal of the virtual pharmacists from the contract until the virtual pharmacist meets the qualification standard

4.4.3.3. Measure: Patient Access

Performance Requirement: The Contractor shall provide virtual pharmacists in accordance with the operating hours outlined in this PWS Standard: All (100%) virtual pharmacists are on time and available to perform services Acceptable Quality Level: Virtual pharmacists are on-time and available to perform services 97% of the time Surveillance Method: Review of availability complaints Frequency: By exception Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.4.3.4. Measure: Patient Safety

Performance Requirement: Patient safety incidents shall be reported using Patient Safety Report. The contractor is responsible for completing fact finding and reporting back to the COR within 72 hours Standard: All (100%) of patient safety incidents are reported back to the COR within 72 hours of knowledge of the incident Acceptable Quality Level: All (100%) of patient safety incidents are reported back to the COR within 72 hours of knowledge of the incident Surveillance Method: Direct Observation and/or COR review Frequency: By exception Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.4.3.5. Measure: Mandatory Training

Performance Requirement: Virtual pharmacists shall complete all required training on time per VAMC policy Standard: All (100%) of required training is completed on time by the virtual pharmacists Acceptable Quality Level: 100% on-time completion Surveillance Method: Periodic review Frequency: Annually Incentive: Favorable contactor performance evaluation

Disincentive: Unfavorable contractor performance evaluation, suspension or termination of all physical and/or electronic access privileges and removal from contract until such time as the training is complete

4.4.3.6. Measure: Timeliness in Prescription Reviews

Performance Requirement: All prescriptions shall be reviewed within 1 hour of being written for inpatient medications and within 15 minutes for IMO medications if contacted by VAMC nursing staff or other medical professionals on duty Standard: All (100%) medications reviewed within the prescribed time standards Acceptable Quality Level: 90% of medication orders will be within the prescribed time standards Surveillance Method: Direct observation, returned emails/pages, and customer complaints Frequency: Annually Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.4.3.7. Measure: Appropriateness in Prescription Reviews

Performance Requirement: Prescriptions will be reviewed and processed accurately by virtual pharmacists in accordance with the requirements of the

PWS

Standard: All (100%) medications reviewed IAW the PWS Acceptable Quality Level: 95% of medication orders will be reviewed IAW the performance requirement Surveillance Method: Periodic Reviewing Frequency: Annually Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.4.3.8. 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 by customers Frequency: Random sampling and/or by exception Incentive: Favorable contactor performance evaluation Disincentive: Unfavorable contractor performance evaluation

4.4.4. Registration with Contractor Performance Assessment Reporting System (CPARS):

4.4.4.1. As prescribed in FAR Part 42.15, the VA evaluates past performance on all contracts that exceed $250,000 and shares those evaluations with other Federal Government contract…