36C26122Q0750_1.docx

SUBJECT*

36C261-22-AP-3895 | 654-23-1-068-0002, Robotic Prescription Dispensing System (VA-23-00001137)

GENERAL INFORMATION

SET-ASIDE

VA Sierra Pacific Network (VISN 21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721

POINT OF CONTACT*

Contract Specialist Mat Czeshinski mathew.czeshinski@va.gov

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

PERFORMANCE WORK STATEMENT

VA Sierra Nevada Health Care System Pharmacy Service

Automated Prescription Dispensing System for Outpatient Pharmacy

1. Services Required:

A lease and support agreement for an automated prescription dispensing system with collating control center which automatically collates all prescriptions for each patient. This system is for use in Outpatient Pharmacy at VA Sierra Nevada Health Care System.

2. Performance of Work:

a. The dispensing system software must interface with our pharmacy computer system (Vista) in order to fill, label and collate up to 150 prescriptions her hour.

b. Efficiency: the dispensing system must have multiple slots for filling patient prescriptions and use barcoding throughout the process for accuracy and quality control.

c. Patient Safety: Each slot must display the patient’s name for easy vial retrieval. Electronic displays should appear on both sides of the control center to show the contents of the slot. Must also include an on-screen drug image to verify the medication being dispensed.

d. The dispensing system must have the versatility to collate the prescriptions in various ways, (i.e. for a particular patient or by dispensing priority).

e. The dispensing unit must have at least 200 universal dispensing cells, which can easily be calibrated onsite by pharmacy staff, three vial dispensers or two bulk load vial dispensers.

f. The system must be able to dispense tablets and capsules of all shapes and sizes into the standard pharmacy vials. Must prevent cross-contamination by filling directly from the dispensing cells in the vial.

g. The system must be able to print and apply the prescription and auxiliary label and collate the uncapped vials into the slots for final inspection suing the on-screen drug image verification.

h. The system must support local, VISN and Joint Commission and regulatory compliance efforts.

3. Equipment:

a. See attached list of equipment.

4. Security Clause:

a. GENERAL

1) 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.

b. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1) 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.

2) 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.

3) 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.

4) 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.

5) 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.

c. VA INFORMATION CUSTODIAL LANGUAGE

1) 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).

2) 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.

3) 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.

4) 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.

5) 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.

6) 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.

7) 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.

8) 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.

9) 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.

10) 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.

11) 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.

12) 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 Contracting Officer Representative (COR).

d. SECURITY INCIDENT INVESTIGATION

1) 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.

2) 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.

3) 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.

4) 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.

e. LIQUIDATED DAMAGES FOR DATA BREACH

1) 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.

2) The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

3) Each risk analysis shall address all relevant information concerning the data breach, including the following:

a. Nature of the event (loss, theft, unauthorized access);

b. Description of the event, including:

1. date of occurrence;

2. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

c. Number of individuals affected or potentially affected;

d. Names of individuals or groups affected or potentially affected;

e. Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

f. Amount of time the data has been out of VA control;

g. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

h. Known misuses of data containing sensitive personal information, if any;

i. Assessment of the potential harm to the affected individuals;

j. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

k. Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

4) Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a. Notification;

b. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c. Data breach analysis;

d. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

f. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

f. TRAINING

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

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

b. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

c. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

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

3) 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.

g. Business Associate Agreement:

Subject: Sources Sought, Robotic Prescription Dispenser for Department of Veterans Affairs, Veterans Health Administration (VHA) VISN 21.

The purpose of this sources sought is to conduct market research to support the procurement of Robotic prescription dispenser system for VISN 21. This notice serves to survey the market in an attempt to ascertain whether or not sources are capable of providing the requested services. This notice allows potential contractors/vendors to submit a non-binding statement of interest and documentation demonstrating their capability. The sources sought effort is intended to assess industry capabilities and develop/support the intended direction of acquisition planning. The Network Contracting Office (NCO 21) is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 339112.

This sources sought is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, or large business) relative to NAICS 339112. Responses to this notice, will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this notice are not considered adequate responses to any corresponding solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this notice.

Background: The Department of Veterans Affairs is seeking vendors who can a robotic prescription dispenser system per the attached draft performance work statement (PWS). The vendors must demonstrate the ability to meet all requirements for this notice. See attached draft PWS.

INSTRUCTIONS:

Submit a brief description, two-three (2-3) pages (including cover letter) that demonstrates how your company can provide the requested services that are required in the attached draft PWS. Include past experience in providing this requirement to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability and your address. The attached PWS is a draft, and is NOT finalized. If any portions seem unclear, prohibited, and/or you are unsure about the draft description of the requirement please list your comments and/or concerns in your response so they can be addressed. PLEASE INDICATE WHETHER YOU HOLD A GSA FEDERAL-SUPPLY SCHEDULE CONTRACT THAT COVERS THESE SERVICES AND, IF SO, THE CONTRACT NUMBER. Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS; (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantages business (c) If disadvantages, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetBiz Registry at http://vip.vetbiz.gov. If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry (i) provide current commercial pricing for all items listed in the attached PWS and any applicable discounts. (j) link to the respondent’s General Services Administration (GSA) schedule, or attached file of same, if applicable (k) citation of any current or past customers (i.e., within the past two (2) years) to include contract number, point of contact telephone number or e-mail address; and (l) other material relevant to establishing core competencies of the firm.

Response is due by 15:00 EST Thursday, June 30, 2022. Please submit e-mail responses to Mat Czeshinski, Contract Specialist, at email address: mathew.czeshinski@va.gov . Your response should include a STATEMENT OF CAPABLILITY, GSA SCHEDULE INFORMATION, DUNS#, BUSINESS SIZE, AND SOCIO-ECONOMIC STATUS information as explained above. Please place “Attention: Robotic Prescription Dispenser System - VA Sierra Nevada Healthcare System” in the subject line of your email. This notice is to assist the VA in determining sources only.

NOTES: Issuance of this notice does not constitute any obligation whatsoever on the part of the Government to procure these services, or to issue a solicitation, nor to notify respondents of the results of this notice. No solicitation documents exists at this time; however, in the event the acquisition strategy demonstrates that GSA is a viable option for procuring a solution, the RFQ shall be posted to GSA eBuy where only those firms who currently hold a GSA Schedule with the applicable SIN will be able to respond. The Department of Veterans Affairs is neither seeking quotes nor accepting unsolicited quotes, and responses to this notice cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative costs incurred in response to this RFI.

ITEM INFORMATION

Robotic Prescription Dispensing System with 6 slot Collating Control Center; Platform for Rental and support of robotic prescription dispensing system.

Contract Period: Base POP Begin: 10-01-2022 POP End: 09-30-2023 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

Robotic Prescription Dispensing System with 6 slot Collating Control Center; Platform for Rental and support of robotic prescription dispensing system.

Contract Period: Option 1 POP Begin: 10-01-2023 POP End: 09-30-2024

Robotic Prescription Dispensing System with 6 slot Collating Control Center; Platform for Rental and support of robotic prescription dispensing system.

Contract Period: Option 2 POP Begin: 10-01-2024 POP End: 09-30-2025

Robotic Prescription Dispensing System with 6 slot Collating Control Center; Platform for Rental and support of robotic prescription dispensing system.

Contract Period: Option 3 POP Begin: 10-01-2025 POP End: 09-30-2026

Robotic Prescription Dispensing System with 6 slot Collating Control Center; Platform for Rental and support of robotic prescription dispensing system.

Contract Period: Option 4 POP Begin: 10-01-2026 POP End: 09-30-2027

ITEM NUMBER

975 Kirman Ave.

Reno, NV 89052

USA

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ScriptPro business associate agreement.pdf

BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF

VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION AND

SCRIPTPRO USA, INC.

Purpose. The purpose of this Business Associate Agreement (Agreement) is to establish requirements for the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) and ScriptPro USA, Inc. in accordance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH) Act, and the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), 45 C.F.R. Parts 160 and 164, for the Use and Disclosure of Protected Health Information (PHI) under the terms and conditions specified below.

With respect solely to the subject matter herein, the terms and conditions in this National Business Associate Agreement supersede any previous Agreement, as well as any local Business Associate Agreement between ScriptPro USA, Inc. and a component of VHA. Accordingly, this Agreement, unless otherwise provided, will control and cannot be superseded, modified, or nullified by any local Business Associate Agreement.

Scope. Under this Agreement and other applicable contracts or agreements, ScriptPro USA, Inc. will provide pharmacy technology services to, for, or on behalf of VHA.

In order for ScriptPro USA, Inc., to provide such services, VHA will disclose Protected Health Information to ScriptPro USA, Inc., and ScriptPro USA, Inc., will use or disclose Protected Health Information in accordance with this Agreement.

Definitions. Unless otherwise provided, the following terms used in this Agreement have the same meaning as defined by the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information (PHI), Required by Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.

“Business Associate” shall have the same meaning as described at 45

C.F.R. § 160.103. For the purposes of this Agreement, Business Associate shall refer to ScriptPro USA, Inc., including its employees, officers, or any other agents that create, receive, maintain, or transmit PHI as described below.

“Covered Entity” shall have the same meaning as the term is defined at 45

C.F.R. § 160.103. For the purposes of this Agreement, Covered Entity shall refer to

VHA.

“Protected Health Information” or “PHI” shall have the same meaning as described at 45 C.F.R. § 160.103. “Protected Health Information” and “PHI” as used in this Agreement include “Electronic Protected Health Information” and “EPHI.” For the purposes of this Agreement and unless otherwise provided, the term shall also refer to PHI that Business Associate creates, receives, maintains, or transmits on

Revised October 2013 1 behalf of Covered Entity or receives from Covered Entity or another Business Associate.

“Subcontractor” shall have the same meaning as the term is defined at 45

C.F.R. § 160.103. For the purposes of this Agreement, Subcontractor shall refer to a contractor of any person or entity, other than Covered Entity, that creates, receives, maintains, or transmits PHI under the terms of this Agreement.

Terms and Conditions. Covered Entity and Business Associate agree as follows:

1. Ownership of PHI. PHI is and remains the property of Covered Entity as long as

Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate agreement is in place.

2. Use and Disclosure of PHI by Business Associate. Unless otherwise provided, Business Associate:

A. May not use or disclose PHI other than as permitted or required by this Agreement, or in a manner that would violate the HIPAA Privacy Rule if done by Covered Entity, except that it may use or disclose PHI:

(1) As required by law or to carry out its legal responsibilities;

(2) For the proper management and administration of Business Associate; or

(3) To provide Data Aggregation services relating to the health care operations of Covered Entity.

B. Must use or disclose PHI in a manner that complies with Covered Entity’s minimum necessary policies and procedures.

C. May de-identify PHI created or received by Business Associate under this Agreement at the request of the Covered Entity, provided that the de-identification conforms to the requirements of the HIPAA Privacy Rule.

3. Obligations of Business Associate. In connection with any Use or Disclosure of

PHI, Business Associate must:

A. Consult with Covered Entity before using or disclosing PHI whenever Business Associate is uncertain whether the Use or Disclosure is authorized under this Agreement.

B. Implement appropriate administrative, physical, and technical safeguards and controls to protect PHI and document applicable policies and procedures to prevent any Use or Disclosure of PHI other than as provided by this Agreement.

C. Provide satisfactory assurances that PHI created or received by Business Associate under this Agreement is protected to the greatest extent feasible.

Revised October 2013 2

D. Notify Covered Entity within twenty-four (24) hours of Business Associate’s discovery of any potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement, including any Breach of PHI.

(1) Any incident as described above will be treated as discovered as of the first day on which such event is known to Business Associate or, by exercising reasonable diligence, would have been known to Business Associate.

(2) Notification shall be sent to the Director, Health Information Governance, by email to VHABAAIssues@va.gov.

(3) Business Associate shall not notify individuals or HHS directly unless Business Associate is not acting as an agent of Covered Entity but in its capacity as a Covered Entity itself.

E. Provide a written report to Covered Entity of any potential access, acquisition, use, disclosure, modification, or destruction of either secured or unsecured PHI in violation of this Agreement, including any Breach of PHI, within ten (10) business days of the initial notification.

(1) The written report of an incident as described above will document the following:

(a) The identity of each Individual whose PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, used, disclosed, modified, or destroyed;

(b) A description of what occurred, including the date of the incident and the date of the discovery of the incident (if known);

(c) A description of the types of secured or unsecured PHI that was involved;

(d) A description of what is being done to investigate the incident, to mitigate further harm to Individuals, and to protect against future incidents;

and

(e) Any other information as required by 45 C.F.R. §§ 164.404(c) and 164.410.

Revised October 2013 3 mailto:VHABAAIssues@va.gov

(2) The written report shall be addressed to:

Director, Health Information Governance Department of Veterans Affairs – Veterans Health Administration Office of Informatics and Analytics (10P) 810 Vermont Avenue NW Washington, DC 20420 and submitted by email at VHABAAIssues@va.gov

F. To the greatest extent feasible, mitigate any harm due to a Use or Disclosure of PHI by Business Associate in violation of this Agreement that is known or, by exercising reasonable diligence, should have been known to Business Associate.

G. Use only contractors and Subcontractors that are physically located within a jurisdiction subject to the laws of the United States, and ensure that no contractor or Subcontractor maintains, processes, uses, or discloses PHI in any way that will remove the information from such jurisdiction. Any modification to this provision must be approved by Covered Entity in advance and in writing.

H. Enter into Business Associate Agreements with contractors and Subcontractors as appropriate under the HIPAA Rules and this Agreement.

Business Associate:

(1) Must ensure that the terms of any Agreement between Business Associate and a contractor or Subcontractor are at least as restrictive as Business Associate Agreement between Business Associate and Covered Entity.

(2) Must ensure that contractors and Subcontractors agree to the same restrictions and conditions that apply to Business Associate and obtain satisfactory written assurances from them that they agree to those restrictions and conditions.

(3) May not amend any terms of such Agreement without Covered Entity’s prior written approval.

I. Within five (5) business days of a written request from Covered Entity:

(1) Make available information for Covered Entity to respond to an Individual’s request for access to PHI about him/her.

(2) Make available information for Covered Entity to respond to an Individual’s request for amendment of PHI about him/her and, as determined by and under the direction of Covered Entity, incorporate any amendment to the PHI.

Revised October 2013 4 mailto:VHABAAIssues@va.gov

(3) Make available PHI for Covered Entity to respond to an Individual’s request for an accounting of Disclosures of PHI about him/her.

J. Business Associate may not take any action concerning an individual’s request for access, amendment, or accounting other than as instructed by Covered Entity.

K. To the extent Business Associate is required to carry out Covered Entity's obligations under Subpart E of 45 CFR Part 164, comply with the provisions that apply to Covered Entity in the performance of such obligations.

L. Provide to the Secretary of Health and Human Services and to Covered Entity records related to Use or Disclosure of PHI, including its policies, procedures, and practices, for the purpose of determining Covered Entity’s, Business Associate’s, or a Subcontractor’s compliance with the HIPAA Rules.

M. Upon completion or termination of the applicable contract(s) or agreement(s), return or destroy, as determined by and under the direction of Covered Entity, all PHI and other VA data created or received by Business Associate during the performance of the contract(s) or agreement(s). No such information will be retained by Business Associate unless retention is required by law or specifically permitted by Covered Entity. If return or destruction is not feasible, Business Associate shall continue to protect the PHI in accordance with the Agreement and use or disclose the information only for the purpose of making the return or destruction feasible, or as required by law or specifically permitted by Covered Entity. Business Associate shall provide written assurance that either all PHI has been returned or destroyed, or any information retained will be safeguarded and used and disclosed only as permitted under this paragraph.

N. Be liable to Covered Entity for civil or criminal penalties imposed on Covered Entity, in accordance with 45 C.F.R. §§ 164.402 and 164.410, and with the HITECH Act, 42 U.S.C. §§ 17931(b), 17934(c), for any violation of the HIPAA Rules or this Agreement by Business Associate.

4. Obligations of Covered Entity. Covered Entity agrees that it:

A. Will not request Business Associate to make any Use or Disclosure of PHI in a manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if made by Covered Entity, except as permitted under Section 2 of this Agreement.

B. Will promptly notify Business Associate in writing of any restrictions on Covered Entity’s authority to use or disclose PHI that may limit Business Associate’s Use or Disclosure of PHI or otherwise affect its ability to fulfill its obligations under this Agreement.

Revised October 2013 5

C. Has obtained or will obtain from Individuals any authorization necessary for Business Associate to fulfill its obligations under this Agreement.

D. Will promptly notify Business Associate in writing of any change in Covered Entity’s Notice of Privacy Practices, or any modification or revocation of an Individual’s authorization to use or disclose PHI, if such change or revocation may limit Business Associate’s Use and Disclosure of PHI or otherwise affect its ability to perform its obligations under this Agreement.

5. Amendment. Business Associate and Covered Entity will take such action as is necessary to amend this Agreement for Covered Entity to comply with the requirements of the HIPAA Rules or other applicable law.

6. Termination.

A. Automatic Termination. This Agreement will automatically terminate upon completion of Business Associate’s duties under all underlying Agreements or by termination of such underlying Agreements.

B. Termination Upon Review. This Agreement may be terminated by Covered Entity, at its discretion, upon review as provided by Section 9 of this Agreement.

C. Termination for Cause. In the event of a material breach by Business Associate, Covered Entity:

(1) Will provide an opportunity for Business Associate to cure the breach or end the violation within the time specified by Covered Entity;

(2) May terminate this Agreement and underlying contract(s) if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity.

D. Effect of Termination. Termination of this Agreement will result in cessation of activities by Business Associate involving PHI under this Agreement.

E. Survival. The obligations of Business Associate under this Section shall survive the termination of this Agreement as long as Business Associate creates, receives, maintains, or transmits PHI, regardless of whether a compliant Business Associate Agreement is in place.

7. No Third Party Beneficiaries. Nothing expressed or implied in this Agreement confers any rights, remedies, obligations, or liabilities whatsoever upon any person or entity other than Covered Entity and Business Associate, including their respective successors or assigns.

Revised October 2013 6

8. Other Applicable Law. This Agreement does not abrogate any responsibilities of the parties under any other applicable law.

9. Review Date. The provisions of this Agreement will be reviewed by Covered

Entity every two years from Effective Date to determine the applicability and accuracy of the Agreement based on the circumstances that exist at the time of review.

10. Effective Date. This Agreement shall be effective on the last signature date below.

Revised October 2013 7

SCRIPTPRO USA INC.

8. Other Aoolicable Law. This Agreement does not abrogate any responsibilities of the parties under any other applicable law.

9. Review Date. The provisions of this Agreement will be reviewed by Covered Entity every two years from Effective Date to determine the applicability and accuracy of the Agreement based on the circumstances that exist at the time of review.

10. Effective Date. This Agreement shall be effective on the last signature date below.

Department of Veterans Affairs

Veterans Health Administration

By:

Name: Charles E. Stroup, Jr.

Title: Deputy Director, National Data Systems

Date:

By:

Name:

Title: Executive VP and Chief Operating Officer

Date: 01 / z,4 / 7-DI Y.

Revised October 2013 7

2014-01-28T09:19:24-0500 charlie.stroup@va.gov