ScriptPro SOW.doc

PERFORMANCE WORK STATEMENT

VA Sierra Nevada Health Care System

Pharmacy Service

Automated/Robotic Prescription Dispensing System for Outpatient Pharmacy

1. Services Required:

A 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 (VASNHCS).

Contractor shall provide Technical and maintenance Support Service Agreement that includes factory service, labor, parts, and shipping for the ScriptPro Pharmacy equipment system. Maintenance Services shall be provided for the VASNHCS. All services shall be provided in accordance with the specifications, terms and conditions contained herein. The vendor’s Robotic Prescription Dispensing Machine software needs to be compatible with Endicia software.

Period of Performance:

Base: February 1, 2025 to March 31, 2026.

Option year one: February 1, 2026 to March 31, 2027

Option year two: February 1, 2027 to March 31, 2028

Option year three: February 1, 2028 to March 31, 2029

2. Background:

The ScriptPro Medication Dispensing system and peripherals owned by VASNHS and installed in Pharmacy needs to be maintained to OEM Specifications. Due to the propriety nature of the hardware, software, and firmware complexity, specialized test equipment and requirements that only OEM trained/authorized personal service the equipment and the staff at VASNHS is not tooled up or factory trained to maintain the ScriptPro Medication Dispensing system and peripherals, or provide remote diagnostic support, therefore service contract with the OEM is necessary.

3. 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.

4. Conformance Standards:

A. Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

5. Emergency Maintenance:

A.

Factory service, labor, parts, and shipping are provided and included in this agreement.

B.

Equipment functional verification is included

5. Hours of Coverage, Shipping, and Turn Around Time:

Hours of coverage is dependent on vendor service hours. All service tickets must be addressed with in two business days with a resolution.

6. Service Manuals:

The VASNHCS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its Field Service Employees (FSEs) all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the Contracting Officer (CO) upon request.

7. Documentation/Reports:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, if applicable each Electronic Subcontracting Report (ESR) must at a minimum document the following data legibly and in complete detail:

A.

Name of Contractor.

B.

Name of FSE who performed services.

C.

Contractor Service ESR Number/Log Number.

D.

Date, Time (starting and ending), Hours-On-Site for service call.

E.

VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

F.

Description of Problem Reported by Contracting Officer Representative (COR)/User.

G.

Identification of Equipment to be serviced to include the following: Equipment ID # or MX/EE# from the barcode, Manufacturer's Name, Device Name, Model #, Serial #, and any other Manufacturer's identification numbers.

H.

Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services) including Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

I.

Total Cost to be billed.

J.

Signatures from the following:

1.

FSE performing services described.

2.

VA Employee who witnessed service described.

K.

Equipment downtime calculated in accordance with Conformance Standards.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE CONTRACTING OFFICER BEFORE SERVICE IS COMPLETED!

8. Reporting Requirements:

The contractor shall report to the VA Police Department to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the VA Police Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within 5 business days of work completion.

FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

9. Additional Charges:

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

10. Reporting Required Services Beyond the Contract Scope:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

11. Condition Of Equipment:

The contractor accepts responsibility for the equipment described in the PWS, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

12. Competency Of Personnel Servicing Equipment:

A.

Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B.

"Fully Qualified" is based upon OEM training and on experience in the field. For training, the FSE(s) shall have successfully completed an OEM formalized training program, for the equipment identified in the SOW. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in the SOW.

C.

The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VAMC. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAMC equipment. The CO and/or the COR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAMC equipment.

13. Test Equipment:

Prior to commencement of work on this contract, the contractor shall make available, if requested, a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

14. Identification, Parking, Smoking, Cellular Phone Use and VA Regulations:

The service contractors must check in at the VA Police-Security Service and shall always wear visible identification while on the premises of the VASNHSC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VASNHCS will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VASNHCS. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

15. Compliance With Osha Bloodborne Pathogens Standard:

The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

A.

Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B.

Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

C.

Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D.

Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

16. 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:

RECORDS MANAGEMENT LANGUAGE

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

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

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

The VA Sierra Nevada Healthcare System (VASNHS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VASNHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the contractor must report to VASNHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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

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

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

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

The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the FOIA.

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

Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Flowdown of requirements to Subcontractors:

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

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

_1792928196.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.

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(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.

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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.

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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.

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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.

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