SOW Annual BD-PYXIS Service Contract FY22 - 23.docx

Veterans Affairs Southern Nevada Healthcare System

STATEMENT OF WORK - 2237#: ___________________________

1. CONTRACT TITLE:

BD-PYXIS Pharmacy Medication Dispensing Systems SMA

2. REQUIREMENTS/SCOPE:

2.1. Description of Services:

Customer service for BD-PYXIS Pharmacy Medication Dispensing Systems includes: Software upgrades and updates, hardware updates to fix BD-PYXIS Pharmacy Medication Dispensing Systems defined functionality problems, routine inspections and maintenance, drug database updates, virus protection updates, operating system patches, ongoing interface maintenance, telephone technical support offered twenty-four (24) hours a day seven (7) days a week for software, hardware, and all user questions, service technician will be dispatched if needed at no cost to customer. Contractor will have remote access to software. Contractor shall provide software and hardware maintenance and licensing agreement to include all applicable system and client upgrades and updates as well as technical and hardware support for each of the below listed government owned BD-PYXIS Pharmacy Medication Dispensing Systems and peripherals. Services shall be provided for the Department of Veterans Affairs Southern Nevada Healthcare System. All services shall be provided in accordance with the specifications, terms and conditions contained herein. Date/Times for preventative maintenance service to be coordinated with Chief of Pharmacy, Bryan Tarman, or his assigned Pharmacy representative.

2.2. Background:

The BD-PYXIS Pharmacy Medication Dispensing Systems and peripherals owned by VASNHS and installed in Pharmacy and throughout the Las Vegas VA Medical Center and Clinics 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 that the staff at VASNHS is not tooled up or factory trained to maintain the BD-PYXIS Pharmacy Medication Dispensing Systems and peripherals., or provide remote diagnostic support, therefore service contract with the OEM is recommended.

2.3. Equipment:

The equipment listed below included in the service agreement is located at the VA Southern Nevada Healthcare Systems Medical Center and its associated Primary Care Clinics (PCC’s) and Community Based Outpatient Clinics (CBOCS:

3. SPECIFIC TASKS:

3.1. Service Technician Personnel: All equipment and service-related activities need to be performed by technicians certified by ScriptPro for service to all components of the BD-PYXIS Pharmacy Medication Dispensing Systems and peripherals. Technicians must have successfully completed all BD-PYXIS Pharmacy Medication Dispensing Systems Equipment required training and the training courses must be led by a certified BD-PYXIS trainer.

3.2. Service Hours: Pharmacy is open 24/7. Hours of preventative maintenance service to be coordinated with Pharmacy Chief, Bryan Tarman, or his designee.

3.3. Service technicians are to check in with the VA Police Office upon arrival and departure from the VA Hospital.

3.4. Service technicians are to check in & out with Biomedical Engineering @ (702) 791-9000 x19079 upon arriving at the Hospital for performance of work. BioMed Staff or Pharmacy Staff will provide the service technician an escort. This to be determined when service date/times are determined in coordination with Pharmacy Chief, Bryan Tarman, or his designee.

3.5. Service Report. Contractor shall provide a written service report for the Government records of repair. The report shall include the repairs provided, parts replaced, and any additional maintenance information deemed necessary by the manufacturer to ensure the highest level of operation. This report shall be forwarded electronically to vhalasbiomed@va.gov utilizing Microsoft suite software or PDF no later than five (5) days after repairs.

3.6. Remote Diagnostics: Contractor shall provide evidence of ability to provide and perform remote diagnostic services utilizing OEM current version of remote service software.

3.7. Contractor shall perform annual Preventive Maintenance inspections, which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within BD-PYXIS or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM. Contractor will work around pharmacy schedule to perform routine maintenance when necessary or requested.

3.8. All required parts and labor shall be furnished. Any exceptions shall be noted by the contractor in writing prior to the initiation of the contract. Technician will be dispatched within twenty-four (24) hours if required, all costs included. The CO, COR or designated alternate has the authority to approve/request a service call from the contractor.

3.9. The contractor shall furnish and replace parts at no cost. The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be the original equipment manufacturer or equivalent and fully compatible with existing equipment. The contract shall include all parts except for consumable or expendable items. The contractor shall use new or used parts as described. Used parts, those removed from another system, shall not be installed without approval by the COR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the COR.

3.10. 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.

4. PERIOD OF PERFORMANCE/SCHEDULE:

A. The POP for this contract shall be a Base + 4 Option Years:

· Base Year: 3/1/2023 thru 2/29/2024

· Option Year 1: 3/1/2024 thru 2/28/2025

· Option Year 2: 3/1/2025 thru 2/28/2026

· Option Year 3: 3/1/2026 thru 2/28/2027

· Option Year 4: 3/1/2027 thru 2/28/2028

B. Normal daytime work hours are 0730 to 1600 Monday through Friday. After hours monthly PMs may be scheduled in coordination with Chief of Pharmacy or designee.

5. PARTICIPATING FACILITY AND CLINICS LOCATIONS:

Place of performance is located at the VA Medical Center and its associated Primary Care Clinics (PCC’s) and Community Based Outpatient Clinics (CBOCS):

Addresses as follows:

· VA Medical Center 6900 North Pecos Road, North Las Vegas, NV 89086

· Northeast PCC: 4461 East Charleston Blvd., Las Vegas, NV 89104

· Northwest PCC: 3968 North Rancho Drive, Las Vegas, NV 89130

· Southeast PCC: 1020 S. Boulder Highway, Las Vegas, NV 89015

· Southwest PCC: 7235 Southwest Buffalo Drive, Las Vegas, NV 89113

· Pahrump CBOC: 220 South Lola Lane, Pahrump, NV 89048

· MCPO Jesse Dean VA Clinic; Laughlin CBOC: Laughlin Professional Plaza, 3650 South Point Circle, Bldg. D, 2nd floor, Suite 200, Laughlin, NV 89029

· Veterans Recovery Center; 3525 W. Cheyenne Ave, North Las Vegas, NV 89032

6. CONTRACTING OFFICER REPRESENTATIVE:

The Contracting Officer Representative (COR) shall provide general instructions and shall be responsible for administrating the contract and ensuring invoices are certified for payment in a timely manner.

6. CONTRACTOR POINT OF CONTACT:

a. Contractor shall designate one employee as the Point of Contact (POC) responsible for administrative matters in the performance of services under this contract. The POC shall have full authority to act for the Contractor on all matters relating to the daily performance of this contract.

b. The POC shall be available by telephone Monday through Friday, between 7:30 a.m. and 4:00 p.m. excluding national holidays.

c. Contractor shall provide the name and telephone number of the person designated as Point of Contact, Alternate Point of Contact, and the name, location and telephone number of the office where normal and emergency service calls are to be placed:

Point of Contact (Full Name):

Telephone Number:

E-mail Address:

Alternate Point of Contact (Full Name):

Telephone Number:

E-mail Address:

Emergency Service Contact Information:

Emergency Service Telephone Number:

7. U.S. GOVERNMENT FURNISHED MATERIALS AND SERVICES:

The VASNHS will not provide any GFE.

8. CONTRACTOR FURNISHED ITEMS AND SERVICES:

Since this equipment is BD-PYXIS proprietary equipment/hardware, software, and firmware. All persons involved from the contractor should have extensive knowledge of the BD-PYXIS Pharmacy Medication Dispensing Systems Equipment and be trained by BD-PYXIS.

9. CONTRACTOR RESPONSIBILITIES:

Contractor Employees. The contractor shall not employ personnel for work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

The Contractor shall furnish service manuals and/or test equipment for the performance of this contract. It is the responsibility of the Contractor to bring the appropriate equipment, parts and/or supplies necessary to complete the work as required. The Contractor shall be familiar and follow maintenance guidelines contained in current technical service manuals for all equipment and sub-assemblies listed. Manuals shall include but not be limited to schematics, diagrams, written procedures, and parts lists.

All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer’s/industry standards, the latest published edition of NFPA-99, FDA, OSHA, Joint Commission, and other applicable national standards. The COR may facilitate a copy of VA safety standards to the Contractor upon request.

Contractor personnel shall present a neat appearance and be easily recognized as contractor employees. This may be accomplished by wearing distinctive clothing bearing the name of the company or company ID badge. Contractor field service personnel shall be dressed to present a clean, neat appearance at all times when performing under this contract.

Personnel performing maintenance and repair services must be fully qualified, competent, technicians. “Fully qualified and competent” is defined as factory trained and verified by BD-PYXIS.

10. SERVICE RESPONSE TIMES:

The following service response times shall be adhered to at all times identified below.

a. 24/7/365 remote phone or e-mail support.

b. Remote Diagnostic Service within 2 hours of call.

c. On-Site Emergency Service for critical service within 24-hours of notification and determination by VA the service is critical.

11. RE-PERFORMANCE:

a. If performance does not conform to the contract specifications, the VA Healthcare Center’s COR or the Contracting Officer shall require the Contractor to perform the service again to conform to the contract specifications, at no cost to the Government. When the defects in service cannot be corrected by re-performance, the VA Medical facility may require the Contractor to call in a senior technical engineer from the manufacturer or from a different company. The Contractor shall incur and absorb all expenses for consultation outside the Contractor’s organization.

b. Repeated malfunctions of any system component or subsection more than three (3) times within one (1) quarter is not acceptable. The Contractor is responsible for repairing all faulty equipment and identifying the nature and cause of repeated failures. The Contractor in this situation must either:

1. Make repairs in such a manner that the identified problems are corrected to the extent that repeated failures are eliminated.

2. Prove that the equipment is not faulty and an external cause for the problem exists and provide recommendations for resolution.

12. CHECK–IN AND OUT ON SERVICE CALLS AT THE VA FACILITIES:

The VASNHS is an active hospital and therefore will require consideration to those areas with patients and staff. Service technicians are to check in & out with Biomedical Engineering @ (702) 791-9000 x19079 upon arriving at the Hospital for performance of work. BioMed Staff or Pharmacy Staff will provide the service technician an escort. This to be determined when service date/times are determined in coordination with Pharmacy Chief, Bryan Tarman, or his designee.

13. NATIONAL HOLIDAYS:

The Contractor is not required to provide delivery or pick up services on the following National Holidays.

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S. Government agencies. Also included would be any other day specifically declared by the President of the United States as a National Holiday.

14. OVERTIME AND HOLIDAYS:

Any overtime or holiday pay that may be entitled to Contractor personnel performing under this contract shall be the sole responsibility of the Contractor and shall not be billed to nor reimbursed by the Government.

15. PARKING POLICY:

It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not invalidate or make reimbursement for parking violations of Contractor's personnel under any circumstances.

16. SMOKING POLICY:

Contractor personnel may not smoke on VA property.

17. ORDERING ACTIVITY:

Contractor shall not accept any instructions issued by any person other than the CO or COR acting within the limits of his/her authority.

18. CHANGES TO CONTRACT:

Only those services specified herein are authorized. Before performing any service of a non-contractual nature, Contractor shall advise the CO of the reason(s) for the additional work and/or service.

19. COMPLAINTS:

Contractor shall promptly and courteously respond to complaints within 3 working days. Including complaints brought to Contractor’s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and Contractor’s response. Contractor shall permit the Government to inspect such records upon reasonable notice.

20. BADGES:

All Contractor personnel shall be required to wear company ID badges. If Contractor personnel are issued VA PIV Badges, they shall also be worn while on VA Property.

21. INVOICE REQUIREMENTS:

a. Payments will be broken out into twelve (12) monthly payments and paid in arrears.

b. No advance payments will be authorized.

c. The Government shall pay the Contractor, upon the submission of a properly prepared invoice for prices stipulated in this contract for services and supplies delivered and accepted.

d. Payment of invoices may be delayed if appropriate field service reports are not completed and submitted as specified herein.

e. The invoice shall be itemized to include the following minimum information:

1) Invoice Number and Date.

2) Contract Number.

3) Purchase Order/Obligation Number (to be assigned upon task order award).

4) Date of service.

5) Line item from Schedule of Service associated with each charge.

22. POST-AWARD PERFORMANCE CONFERENCE:

The CO may schedule a post-award performance conference with Contractor, if deemed necessary, for contract orientation purposes.

23. SECURITY REQUIRMENTS:

A. 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. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor 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." See VA Handbook 6500.6, Appendix C, paragraph 3.a.

C. A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

D. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

E. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

F. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems.

G. 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." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options.

H. Contracting Officials need to work with the COR and the ISO to:

· Ensure contractor understands and implements the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor.

· Ensure contractor understands their participation in IT security requirements for C&A of the VA system to which they connect.

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 Southern 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.

24. COVID-19 SUPPLEMENT:

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors statement inclusion to Statement of Work (SOW).

1. Contractor employees who work in or travel to VHA locations must comply with the following:

1. Documentation requirements:

0. If fully vaccinated, shall show proof of vaccination

0. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination

0. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

0. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

0. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

1. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the following website: COVID-19 Screening Tool. Regularly check the website for updates.

1. Contractor employees who work away from VA locations, but who will have direct patient contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

1. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.”

1. For indefinite delivery contracts: Contractor agrees to comply with FAR 52.232-99 and VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.