ATTACHMENT D.1 STATEMENT OF WORK.pdf

Department of Veterans Affairs Amarillo VA Health Care System

Automated Medication Pill Packager System Statement of Work (SOW)

1. Background:

1.1 The Amarillo VA Health Care System requires the procurement and installation of a fully integrated Automated Medication Pill Packager System to support Pharmacy Department operations. The requirement shall include the unit dose packager, supplemental lower packaging unit, tray system, canisters, canister calibration options, inspection system, and all software and interfaces required to integrate into the existing pharmacy information system. The procurement shall include all parts, materials, labor, software/licenses, and travel to complete the full installation of the unit dose packaging machines.

1.2 The contractor shall perform all required set-up, calibration, and system integration activities, including any connectivity with existing VA pharmacy technologies / networks. The contractor shall also provide user training to ensure safe, effective, and efficient operation of the system by VA pharmacy personnel. Training shall cover system operation, troubleshooting, safety procedures, and workflow best practices.

1.3 Final acceptance shall occur only after the contractor has completed delivery, installation, configuration, integration, user training, implementation support, and turnover/go-live of the Automated Medication Pill Packager System. The system must be fully functional and meet all performance requirements prior to acceptance.

1.4 Table 1 – Location/Delivery Address:

Health Care System Address

Amarillo VA Health Care System

6010 W. Amarillo Blvd.

Amarillo, TX 79106

2. Deliverables:

2.1 The Automated Medication Pill Packager System must include the following items

(BRAND-NAME OR EQUAL):

BRANDNAME: PARATA ATP2 Packager

MANUFACTURER PART

NUMBER:

DESCRIPTION:

901-0236 Parata ATP2-E320 Narrow including maximum 400 Canisters 650-0679 Parata LPU, Standard Narrow 650-0668 Parata TCGRX Calibration Kit 901-0232 Parata Universal Lighted Tray

650-0874 Parata Kit Prepped AVF-1 S2BayStdW0 PARATA ATP Workflow Unit - 2-Bay Workstation 650-0639 Kit, Smart Drawer, Manufacturing Upgrade, ATP2 650-1093 Parata Kit Calibration Tool, ATP2 (Adjustable Canisters

Quantity 5) PERL Parata Perl 1 - Two licenses INSTALL/TRAINING Installation and Training for PERL INSTALL/TRAINING INSTALL & TRAINING for ATP2 64-320

3. Functional System Salient Characteristics include:

1. Automated Unit Dose Packaging Capability

a) System must automate the preparation of unit dose medication pouches.

b) Accurate dispensing of oral solid medications.

c) The medication packager will have a touchscreen display and input.

d) The medication packager will have automatic canister recognition chip available which will enable that any canister may be seated in any location in the packager.

e) The system shall come with removable main frame (packaging unit) to decrease downtime.

f) The system shall come with a redundant (back up) main frame

g) The system shall have easy access to allow for cleaning

h) One device will be necessary for the Amarillo campus

2. Scalable / Expandable Hardware Platform

a) Minimum of 400 canisters.

b) Must support AutoSense / Smart canisters for expanded formulary coverage.

c) Equipment must support addition of hardware to include additional packaging units, trays, and canisters after installation.

d) The medication packager will have infrared light detection of tablet to ensure unit dose packages have been filled.

3. Canister Technology & Calibration Canisters must be:

a) Re-calibratable onsite via canister calibration kit.

b) The medication packager shall have a canister calibration kit to manipulate canisters to fit the facilities evolving formulary

c) Adjustable for different medication pill shapes/sizes.

d) System must include quality control tools such as the AVF‑1 device for verifying canister accuracy.

4. Dual or Supplemental Tray Systems

a) Must include a dual pre-fill tray system, enabling continuous throughput.

b) Lighted tray system must support barcode-based medication verification for non-canister medications.

c) The medication packager will have a special tablet system (STS) tray and half-tablet support for non-canistered medications.

5. Packaging Flexibility

a) Ability to produce narrow and wide pouches.

b) Multiple pouch sizes available.

c) Use of pre‑folded paper with clamp‑and‑seal technology to reduce errors and improve seal quality.

d) Each medication will be dispensed in an individual unit dose package

e) Packages are available in more than one size.

6. Advanced Software & Workflow Features Must include Windows-based software with:

a) National Drug Code swapping ability.

b) Batch pause/resume functionality.

c) Skip‑med logic to split orders automatically.

d) Daisy chaining/grouping of canisters for high-volume meds.

e) Full label creation tools with graphic printing and barcode support.

f) The system will have the ability to print custom labels (color included).

g) Each package must have (at a minimum: Drug name, dose, dosage form, lot number, expiration date, barcode medication administration compatible barcode.

h) The medication packager will have the ability to print current inventory reports, expiring drug reports, and drug usage reports.

i) Software must be compatible and integrate with VISTA and Pyxis Automated Dispensing

Cabinets.

7. Verification & Imaging System Integrated imaging verification must:

a) Use dual cameras to check both print and content sides.

b) Provide full batch / daily reporting.

c) Allow remote access for checking images.

d) Sort pouches needing inspection automatically.

8. Interoperability & Interfaces Must be capable of two-way communication with:

a) VA pharmacy systems (VISTA).

b) Pyxis Automated dispensing cabinets, owned by the VA.

c) Must support VPN remote access.

9. Training & Implementation Requirements Vendor must provide:

a) Online training modules.

b) On-site hands-on training.

c) Installation support by trained specialists.

10. Maintenance, Support & Warranty

a) Full 12-month warranty for equipment.

b) 24/7 support with remote diagnostics and on-site service when needed during warranty period.

c) Use of paper and ribbon required to maintain warranty.

11. Physical / Space / Power Requirements Equipment must:

a) Fit through standard doorways.

b) Be front-loading to minimize required clearance.

c) The equipment must fit within the following footprint: 87 inches tall, 31 inches deep and width can vary.

d) Include workstations.

12. Safety, Security, and Recordkeeping Must include:

a) Biometric access controls.

b) Secure data storage on VA servers only.

c) Auditing/reporting of user actions.

d) Compliance with medication verification and traceability standards.

4. Federal Holidays:

4.1 Work at the government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). The following holidays are observed by the Federal Government:

New Year’s Day Jan 1st Martin Luther King’s Birthday Third Monday in January

President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

4.2 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.

4.3 For additional information regarding Federal holidays, please refer to the Office of Personnel Management’s website at: https://www.opm.gov/policy-data-oversight/payleave/federal-holidays.

5. Requirements:

5.1 The contractor must meet the following requirements:

1. Must be an authorized distributor of the OEM.

2. Must ensure that all technicians are certified and have the necessary qualifications from the OEM.

3. Must adhere to all applicable regulations and guidelines for medical equipment installation and use.

5.2 The automated pill packaging device will be updated to a Windows 11 operating system to meet OIT requirement and be able to communicate with VISTA, future Oracle/Cerner integration, and pharmacy automated dispensing cabinets (Pyxis).

6. Contractor Responsibility

6.1 The contractor shall provide enough CAT5 data lines to support manipulation and connection of devices to existing computer port connections, and Uninterruptable Power Supplies (UPS) and/or surge suppressor devices for all equipment.

6.2 All information and data related to this project that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract.

7. Government Responsibility

7.1 The Government will provide contractor access to an intact, operational data network and server host site capable of effectively supporting day to day operation of the Pyxis system. The Government will also furnish connectivity via computer ports for those patient care areas receiving deployed equipment and not currently having an adequate connection. Power (emergency red plug) and network receptacles for operation of the devices will also be provided by the Government.

https://www.opm.gov/policy-data-oversight/payleave/federal-holidays

7.2 The Government will obtain the Vista Interface License required to allow non-VA vender technology communications with VA systems.

7.3 All Government personnel involved with the installation, configuration, and day-to-day operation of the packager and verifications system will be properly trained on the system’s operation and current on training necessary for the protection of sensitive information while using the devices.

8. Security Requirements

8.1 Medication Packaging and Pouch Verification devices will communicate over network connections considered secure as measured against Department of Veterans Affairs National, regional, and local guidelines. The contracted maintenance requirement of the automated medication packager and pouch verification system will allow and require remote access to the various systems by each vendors technical personnel. Vendor will set up an account with the Department of Veterans Affairs that permits communication with the local system via Virtual Private Network (VPN). During specific critical situations or under circumstances considered catastrophic, communication via modem MAY be permitted by the facility ISO ONLY.

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

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

8.4 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 Freedom of Information Act.