36C25820Q0082-001.docx

36C25820Q0082

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25820Q0082 04-01-2020 Gary.Thompson@va.gov 520-792-1450 x12583 05-01-2020 4pm AZT Department of Veterans Affairs NCO22-Gilbert Network Contracting 3601 S. 6th Avenue Tucson

AZ

85723 X X 446110 $30 Million N/A X Department of Veterans Affairs Southern Arizona VA Healthcare System 3601 S. 6th Avenue Tucson

AZ

85723 Department of Veterans Affairs NCO22-Gilbert Network Contracting 3601 S. 6th Avenue Tucson

AZ

85723

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

See CONTINUATION Page Purchase of Virtual Pharmacy Services. Includes process pending medication/supply orders for the Northern Arizona VA Healthcare Medical Facility and it's Community Base outpatient Clinics (CBOCs) for both in-patients and out-patients, 24 hours a day, 7 days a week, as needed.

Procurement conducted under the authority 38 USC 8153 and FAR Part 13.

See price/cost schedule (B.3 page 12) and Performance Work Statement (PWS B.2 page 3) The government intends on awarding on July 1, 2020 with a base period of performance 10/1/2020 to 9/30/2021 to allow for background checks and credentialing.

POC for this solicitation is Gary.Thompson@va.gov See CONTINUATION Page X X Trevor Hood Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. CONTRACTOR: (Offerors are requested to designate a point of contact for prompt contract administration).

Name:

Title:

Name of Company:

Street Address:

City, State, Zip Code:

Email:

Phone:

b. GOVERNMENT: Contracting Officer (36C258) (505) 256-2856 Department of Veterans Affairs NCO 22 Gilbert Contracting Office Attn: Contract Specialist (505) 256-2856 3601 S. 6th Ave Tucson, AZ 85723

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor should be mailed to the following address: 52.232-33 Payment by electronic funds transfer – System for Award Management

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.

Payments are accomplished through the Tungsten Network located at http://fsc.va.gov/einvoice.asp This is the mandatory and sole Method of submitting invoices ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

VIRTUAL PHARMACY SERVICES NAVAHCS

A. INTRODUCTION

1. Contractor shall provide Virtual Pharmacy services to process pending medication/supply orders (henceforth referred to as “medication orders”) for The Northern Arizona VA Healthcare Medical Facility (NAVAHCS) and its CBOCs (list included) for both in-patients and out-patients, 24 hours a day, 7 days a week, as needed. Services include the professional pharmacist’s review and problem solving needed to assure medication orders are safe and accurate. Contractor must be a U.S.-based company capable of providing pharmacy services to be completed via a secure web-based system provided by the contractor. Contractor’s pharmacists will be required to use a Personal Identity Verification (PIV) card to log into the Citrix Access Gateway (CAG) by utilizing VA’s Virtual Private Network (VPN). Contractor’s pharmacists will have access to the necessary network and Electronic Health Records (EHR) for NAVAHCS. Contractor shall provide enough licensed pharmacists to process all orders accurately to completion and to support resolution of questions and consultations in a timely manner. The U.S. Department of Veterans Affairs prohibits the “offshoring” of work under this contract and for all telehealth contracts. No “offshoring” means that no contractor performance or work under this contract shall occur outside of the Continental United States, Alaska, Hawaii, or their territories or possessions of the U.S. All credentialing and PIV requirements must be accomplished prior to contract commencement. NAVAHCS is requesting a base plus four option year contract.

2. This contract is for non-personal services. It does not create employment rights with the U.S. Government whether actual, inherent, or implied. By agreeing to perform the services described in these specifications, the contractor acknowledges that he/she is not, and shall not become, an employee of the U.S. Government. Contractor agrees that contractor will not bring any cause of action in any forum claiming that a contract pharmacist has become an employee of the U.S. Government.

3. This contract is a “non-personal services contract” as defined in FAR 37.101. It is, therefore, understood and agreed that the contractor and/or the contractor’s employees or subcontractor:

a. Shall perform the services specified herein as independent contractors, not as employees of the government.

b. Shall manage and administer the work required and bear sole responsibility for complying with any and all technical, schedule, or financial requirements or constraints attendant to the performance of this contract.

c. Shall be free from supervision or control by any government employee with respect to the manner or method of performance of the services specified.

d. Shall, pursuant to the government’s right and obligation to inspect, accept, or reject the work, comply with such general direction of the Contracting Officer, or the duly authorized representative of the Contracting Officer as is necessary to ensure accomplishment of the contract objectives.

4. Contractor shall provide enough pharmacists to review and process authorized medication orders for each site. Each contract pharmacist must have a full, current and unrestricted license to practice pharmacy in a State, Territory or Commonwealth of the United States or the District of Columbia. Contract pharmacist(s) must maintain current registration and must be proficient in verbal and written English.

5. The contractor’s pharmacists will review authorized provider medication orders at specified time periods identified in the Delivery Schedule. After review, contract pharmacist(s) will process and verify orders remotely.

6. Contractor shall provide and document a general orientation for all of the contractor’s pharmacists who provide work on this contract before commencement of work. Documentation of the orientation will be provided to the Contracting Officer. Contractor’s orientation should include, but is not limited to, the following topics:

a. Fire and safety policy and procedure

b. Infection control policy and procedure

c. Emergency Preparedness/Disaster policy and procedure

7. VA will monitor contractor performance to ensure compliance with the contract. Please refer to the Quality Assurance Surveillance Plan (QASP) on how vendor performance will be rated/evaluated.

8. The U.S. Department of Veterans Affairs credentials personnel nominated by the contractor to perform services under this contract in the same manner as VA’s own healthcare personnel through a process called VetPro. Therefore, notwithstanding other contract requirements, the Contracting Officer, in consultation with the Chief of the relevant pharmacy department, may suspend or terminate a pharmacist’s credentials and the IT access of any pharmacist who does not comply with orientation requirements or meet competency requirements for the work being performed. Upon suspension or termination of IT access, the pharmacist is not eligible to perform or work under this contract and the contractor shall not invoice for the pharmacist’s services or work.

B. OBJECTIVES

The contractor and Contracting Officer Representative (COR) will work together to increase the efficiency of the virtual pharmacy program, and both parties will collaborate to enhance services and increase effectiveness as it relates to the delivery of medication orders.

C. SCOPE OF VIRTUAL PHARMACY SERVICES

CURRENTLY NAVAHCS AVERAGES 20 SCRIPTS PER NIGHT. THIS INCLUDES INPATIENT AND EMERGENCY DEPARTMENT. (INPATIENT REQUIREMENT) NAVAHCS DOES HAVE IMO ORDERS FOR EMERGENCY DEPARTMENT ONLY (INPATIENT MEDICATIONS FOR OUTPATIENTS). (INPATIENT REQUIREMENT) NAVAHCS PHARMACY DEPARTMENT AVERAGE DAILY WORKLOAD IS 1530 PRESCRIPTIONS DAILY. IT HAS ITS OWN PHARMACISTS WORKING ON ALL ORDERS FROM 8AM-9PM WEEKDAYS, 8-4PM ON WEEKENDS AND HOLIDAYS. (OUTPATIENT REQUIREMENT)

NAVAHCS IS SEEKING:

A. 40-50% ASSISTANCE WITH PROCESSING ALL OUTPATIENT ORDERS

B. IN-PATIENT SERVICES DURING OFF HOURS, STAFFING SHORTAGES, EMERGENCIES (EMERGENCY PREPAREDNESS)

C. 24/7 SERVICES ON AN AS-NEEDED BASIS FOR BOTH IN-PATIENT AND OUTPATIENT

1. This is a 24/7 virtual pharmacy processing service. Also required are emergency preparedness coverage 24/7, as well as 24/7 staffing shortages. All Holidays are required in this service.

2. Services will be ‘charged by prescription’.

3. This requires vendor to process inpatient as well as outpatient prescription orders.

4. VA VistA savvy and/or already trained in VistA.

5. The contractor’s pharmacists shall provide drug knowledge resources and pharmacist medication order review and entry services. The contractor’s pharmacists will review authorized provider medication orders that are transmitted to or accessed by the pharmacist during the required time periods identified in the Schedule of Services.

6. The contractor’s pharmacists will check for medication orders in the Inpatient and/or Outpatient pharmacy package pending orders queue at least every thirty (30) minutes. After review, the contract pharmacist(s) will process and finish/verify orders via remote access. NAVAHCS representative shall work with the contractor to develop a contingency plan to accommodate the verification process in the event of downtime.

7. NAVAHCS may call in emergency orders and questions or consultation requests. Contract pharmacist(s) shall process emergency orders within 15 minutes of contact.

8. Contract pharmacist(s) shall evaluate each prescription for drug-drug interactions, therapeutic duplications, contraindications, recorded drug allergies, appropriate doses, appropriate route of administration, appropriate administration time(s), accurate directions, and, as applicable, appropriate order start time to ensure the final order will be active at the appropriate time and understandable to the medical practitioner administering, or patient taking, the medication. Contract pharmacist(s) shall clarify with the appropriate party prior to processing any pending medication not meeting standards for completeness, restrictions, lacking clinical information and those requiring consults.

9. Contracted pharmacists will demonstrate understanding of due dates and “Must Last Until” dating. These will be utilized for verification of controlled substances.

10. Using the VA National Formulary (VANF), which is updated monthly and accessible at http://www.pbm.va.gov/PBM/NationalFormulary.asp, contract pharmacist(s) shall review pending orders and make efforts to utilize formulary agents. Contractor’s pharmacists will check for prior Non-Formulary consults and medication history when reviewing Non-Formulary agents. If efforts are unsuccessful due to unavailability, then the vendor Pharmacist must flag the requesting Physician and the order remains in the que. In addition, email communication notifying the NAVAHCS PHARMACISTS/CORS/POCS required.

11. NAVAHCS’ expectation is that the vendor will already be trained and experienced in VA applications such as CPRS and VistA however; MOODLE training (which trains on VistA processing for pharmacy) will be available on an initial basis from the Medical Center Pharmacy Staff to the vendor. This training would have to be prescheduled during business hours only Monday through Friday excluding holidays. After MOODLE training is provided; the vendor will be expected to train any of its new incoming Pharmacists unless there is a software patch/change that would require additional training.

12. The contractor shall:

a. Provide monthly report of activities under the contract (i.e. number of orders, number of questions answered, etc.). Monthly reports are due by the 15th of the next month. Distribution shall be made to NAVAHCS COR/designated POC.

b. Provide quarterly reports on quality improvement indicators including:

i. Potential prescribing errors and other medication errors;

ii. Suspected adverse drug reactions or events; (these would come from NAVAHCS staff calls for example).

iii. Other reports as requested and agreed to by the contractor and VA;

iv. Information on educational needs for virtual pharmacists pertaining to station policies/procedures;

v. Quarterly reports are due no later than 30 days after the end of each quarter, unless a different date is agreed upon by the contractor and VA; and,

vi. Distribution shall be made to NAVAHCS COR/designated POC. The Quarterly report shall not be consolidated with the Monthly report (i.e. each report should be a separate file).

c. Provide contract supervisor or designee contact to discuss errors, near misses, and any customer service complaints related to virtual pharmacist services. Contractor shall be available to respond to concerns within 2 business days of contact by VA.

d. Provide backup secure contact (i.e., phone/fax) in the event of primary communication method failure or VA Network, Internet, or Contractor network downtime.

e. Pharmacists are responsible for knowing and complying with DEA, State Board, and Joint Commission policies, rules, and regulations. Any deviation from regulations or knowingly engaging in any activity detrimental to the patients and to the interests of the VA may result in contractual issues as well as potential punitive actions.

f. Comply with all applicable standards of the Joint Commission including maintenance of competency training for all staff providing services to the VA.

g. Complete and input all transcription notes directly into the Electronic Health Record.

h. Maintain a continuous Roster of Personnel pharmacist who the contractor nominates to perform under this contact. Contractor shall assemble and maintain this roster for the purpose of credentialing. NAVAHCS must authenticate and review each pharmacists’ qualifications to support a decision on his or her admission to practice within the VA system. The contractor shall submit a credentialing package for all new and replacement pharmacy personnel performing services under this contract as well as for re-credentialing the same pharmacists, which may need to occur during the contract term.

i. Provide remote trouble shooting to NAVAHCS staff for Pyxis/Omnicell, BCMA, and IV Pumps.

j. Must have 24/7 internal IT support to maintain operations, and an operational plan.

D. GOVERNMENT RESPONSIBILITIES

1. VA shall provide the following:

a. A suitability assessment of each contract pharmacist nominated by the contractor to perform under this contract, and upon successful adjudication, the issuance of a Personal Identity Verification (PIV) card to log into the Citrix Access Gateway (CAG).

b. Virtual access to applicable parts of VA’s network and electronic medical records.

c. List of clinical leadership, night nursing supervisors, pharmacy staff, and nursing unit contact.

d. List of necessary provider contact information for each site.

e. List of important points-of-contact for each site and may include, but is not limited to, Administrative Officer of the Day (AOD), Nursing Officer of the Day (NOD), on-call VA Pharmacist, Pharmacy Chief or designee, and Administrative Officer.

f. Supervisor or designee contact information in the event of an emergency or catastrophic down time.

g. Information on policies and procedures unique to each facility, which may include, but is not limited to, medications available in Automated Dispensing Cabinets, ward stock lists, restricted intravenous medications, and IV admixture standards and rates.

h. Contact information, backup contact information, hours of operation, and order processing instructions for regular and STAT orders specific for each site.

E. THE JOINT COMMISSION AND OTHER SPECIAL REQUIREMENTS

1. THE JOINT COMMISSION

Contractor will be responsible for ensuring contract pharmacists providing services on this contract are fully trained and completely competent to perform the required work. Although this contract does not require TJC accreditation or other regulatory requirements regarding worker competency, the contractor must perform the required work in accordance with the TJC standards. The contractor is required to provide a current performance evaluation (proficiency or competency) on each pharmacist providing services under the contract. The contractor will provide current copies of the performance evaluations at the time of contract award and annually on the anniversary date of contract award to the Contracting Officer, or upon request.

2. HEALTH AND HUMAN SERVICES (HHS)/OFFICE OF INSPECTOR GENERAL (OIG)

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the HHS - OIG, List of excluded individuals/entities on the OIG Website www.hhs.gov/oig for each person providing services under this contract. Further, the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract, the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

3. RECORDS MANAGEMENT

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

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government Records.

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

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

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

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of competition [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Agency Records Manager. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the Agency records schedules.

j. Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship (subcontractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The contractor (and any subcontractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

4. PRIVACY POLICY AND SECURITY TRAINING

Contractor personnel must complete VHA national Privacy Policy/Information Security training and/or other VHA approved privacy trainings for contractor-furnished trainings that meet the requirements of the HHS Standards for Privacy of Individually-identifiable Health Information as determined by the VHA. Each of the contractor’s pharmacists must also sign VA’s Contractor Rules of Behavior. Proof of training (i.e. training completion certificate) must be provided to the COR and the Information Security Officer (ISO) at each facility (to be named upon award) for each contract pharmacist providing the services under this contract.

5. PROTECTED HEALTH INFORMATION (PHI)

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information.

6. END OF CONTRACT RESPONSIBILITY

The contractor agrees to provide self-certification that the data destruction requirements have been met and sent to the VA Contracting Officer within 30 days of termination of the contract. Any final payment is contingent upon this certification.

F. QUALITY ASSURANCE SURVEILLANCE

Contractor personnel processing medication orders must have the education, training, and experience appropriate to perform the scope of services needed. It is the responsibility of the contractor to have an ongoing quality assurance (QA) program and written plan consistent with the standards that will support the expectations stated in the Performance Work Statement (PWS), and to resolve identified problems. The contractor’s written plan shall delineate the objectives of the quality assurance activities, scope of the activities, activities for monitoring and evaluation, methods of implementation of the monitoring and evaluation activities, methods for reporting results, mechanisms for taking follow-up action, and responsibilities of staff for each activity of the quality assurance program. Contractor must take into consideration any feedback from VA, including supervisors or designees from each site, with respect to staff performance for evaluations. Results of the contractor’s QA program will be forwarded to the COR on a quarterly basis or upon request within 48 hours. The plan shall be provided with the contractor’s proposal and a copy approved by VA will be included as a part of any subsequent award.

LOCATIONS

Northern Arizona VA Health Care System located in Prescott, Arizona, is comprised of:

Northern Arizona VA Health Care System 500 North Highway 89 Prescott, AZ 86313

Anthem CBOC41810 N Venture Dr, Bldg B Anthem, AZ 85086 Phone: 623-551-6092 Or 800-949-1005 X 7200

Cottonwood CBOC 501 S. Willard Cottonwood, AZ 86326 Phone: 928-649-1523

Flagstaff CBOC 1300 W. University Ave. Suite 200 Flagstaff, AZ 86001 Phone: 928-226-1056 Or 800-949-1005 X 7820

Kingman CBOC 2668 Hualapai Mtn Road Kingman, AZ 86409 Phone: 928-445-4860 X 6830 Or 800-949-1005 X 6830

Lake Havasu City CBOC 2035 Mesquite, Suite D Lake Havasu City, AZ 86403 Phone: 928-680-0090 Or 800-949-1005 X 7300

Holbrook PTOC 33 West Vista Drive Tele: 928-524-1050 POC: Shea Maestas (ext 5295)

Page PTOC 801 North Navajo Road Page, AZ 86040 Tele: 928-645-4966 (alternate 928-460-3855) POC: Anthony “Tony” Robertson (ext 2650 or 2654)

Tuba City PTOC 167 N Main St Tuba City, AZ 86045

Kayenta PTOC US Highway 160 Kayenta, AZ 86033

Polacca PTOC Highway 264 Mile Post 388 Polacca, AZ 86042

Chinle CCHCF Highway 191 & Hospital Drive Chinle, AZ 86503

POC/COR:

Melissa DiCamillo Northern Arizona VA Healthcare Facility 500 Highway 89N Prescott, AZ 86313 Melissa.dicamillo@va.gov 928-445-4860

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/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.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

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

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

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