D.1_STATEMENT OF WORK Unit Dose Packager.pdf

VA North Texas Health Care System

STATEMENT OF WORK

Pharmacy – iPack Rx Unit Dose Packager

1 Introduction

The VA North Texas Health Care System (VANTHCS) has a requirement to purchase Brand Name or Equal to iPack Rx Unit Dose Packager, manufactured by Pearson Medical Technologies, LLC, including the item(s) identified in Table 1 below. See below for a list of salient characteristics. This new technology will allow pharmacy to handle the current workload and future projected growth at the VANTHCS. Item(s) are to be delivered to the location specified in section 2.1.1.

Table 1 – Package Items Summary

Item Number Item Description Quantity iPack Rx-BIC iPack Rx Unit Dose Packager 1

PMT-100-1155 iPack Rx Calcium Carbonate Disc "Tums Disc" 1

200230 Print Premium Bar Code Label Printing Software w/third-party drug database

ACFS FS3000 Fill in Station 1

PMC Caliper Measure Tool 1

MKM-001 22" HDMI monitor, wireless keyboard, and wireless mouse 1

BS2D Anti-Microbial Bar Code Reader 1

FPS-1001 Biometric identification scanner for fingerprint 1

CRX Stainless steel utility table 1

X-UPS71 UPS-900W 1

ZD410 Zebra ZD410 Label Printer 1

EHD-1TB External Hard Drive 1

ZD421 Zebra ZD421 Roll Label Printer 1

SK-CLT clearTag Starter Supply Kit 1

SKiPRx-1 iPack Rx Starter Supply Kit 1 iPRx-iPackRx iPack Rx Premium Customer Support Agreement w/Annual On- Site Technician

IFD-iPackRx iPack Rx Installation & Delivery 1

2 General Conditions

2.1 Site Address

2.1.1 The address of the VA North Texas Health Care location is listed below. Additional information on delivery is located in section 2.4.

VA North Texas Health Care System 4500 S Lancaster Rd Dallas, TX 75216

2.2 Schedule and Order Management

2.2.1 The awardee will coordinate delivery dates with the VA POC.

2.2.2 Post-award the vendor will coordinate delivery prior to beginning any work (see section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the VA POC and the vendor. Schedule changes that are beyond the dates specified in the contract will require approval by the Contracting Officer and a contract modification.

2.3 Delivery and Receiving

2.3.1 Delivery and receipt of the proposed items is anticipated to be directed to the location identified below. Delivery must be coordinated with VA Logistics Warehouse (primary), Bldg 44 prior to any attempts at delivery. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company.

2.3.2 The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

2.3.3 The delivery of items identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays.

2.3.4 Delivery trucks will not be permitted to remain at the loading dock. Trucks shall be unloaded, moved from the dock, and then brought back to the dock if required to haul out any waste, tools, or excess materials.

2.3.5 Labeling of delivered items shall include the awarded contract number and VA purchase order number for identification and reference upon receipt of product.

2.4 Use of Warehouse

2.4.1 If the vendor requires the use of the Government’s activation contractor’s warehouse to meet the requirements of this contract the vendor must provide a certificate of insurance prior to the delivery and offloading of the item(s). This insurance certificate must be completed and presented to the activation contractor prior to delivery.

2.4.2 The vendor shall communicate through the VA POC any required coordination requirements.

2.5 Clean Up and Disposal

2.5.1 There are no dumpsters available for vendor use.

2.5.2 The removal of waste and/or excess material shall be conducted through the loading dock area. Delivery trucks and/or other vendor vehicles will not be permitted to remain at the loading dock. Vehicles will need to be brought back to the dock if required to remove any waste, tools, or excess materials.

2.6 Assembly and Installation [ ☒ is ☐ is not required]

2.6.1 The vendor is required to manage and coordinate installation at the VANTHCS with the

VA POC.

2.6.2 On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays.

2.6.3 The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

2.6.4 The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

2.6.5 The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage. The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces. Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor’s (or associated sub-contractors) installation.

2.6.6 During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and VANTHCS. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

2.7 Training [☒ is ☐ is not required]

2.7.1 The vendor shall coordinate through the VA POC to provide a hands-on training session to staff selected by the VA. Training shall be completed within 45 days after final installation of equipment. The vendor will record the training and provide an electronic copy of the training to the VA POC for VA to use to train additional personnel at a future date. In addition, the vendor shall provide additional training documents to the VA POC for training additional persons at a future date.

2.8 Standard Warranty

2.8.1 The products shall be covered by vendor’s standard warranty terms and provisions provided; however, the warranty coverage shall be no less than the following:

2.8.2 The Vendor shall provide a warranty certificate/form stating the warranty period, terms, and information required to initiate the warranty.

2.8.3 The warranty period set forth therein shall run for one year following the first day of use at

VANTHCS.

2.8.4 The vendor shall extend such warranty directly to the customer as if such customer had purchased the Products directly from the vendor.

2.8.5 The vendor shall warrant the products against defects in material and workmanship under normal use and service, repair or replace at vendor’s cost any defective Product (or issue a credit or refund, as the case may be, based on the purchase price paid therefor); and

2.8.6 The vendor shall pay (or refund the amount of) all freight and shipping charges for any defective Products returned under this paragraph.

2.9 Use of Premises

2.9.1 If during the performance of this contract, work will be carried out on VANTHCS premises, the vendor shall perform all work in such a manner that will cause a minimum interference with VANTHCS operations and the operations of other contractors on the premises.

2.9.2 The vendor shall communicate through the VA POC any required coordination requirements with the General Construction contractor prior to and during delivery and installation activities.

2.9.3 The project may be an active construction site during delivery and installation. The vendor shall take all necessary precautions to protect the premises and all persons and property therein from damage or injury. The vendor shall assume responsibility for taking precautions for the vendor's (and associated subcontractors’) employees, agents, licensees, and permittees. The vendor shall abide by any safety requirements imposed by the GC (e.g. hard hats, safety vests).

2.9.4 Salient Characteristics:

1. 115VAC, 60 Hz, 320VA

2. Must fit within a footprint of 60” x 48” (L x D)

a. Doorway into location is 32” x 48” (W x H) – Must be able to enter the doorway without the vault doorway being removed.

3. Unit dose pill packager system must be a stand-alone system with no network connectivity and no need for an interface

4. Must be able to perform the following operations:

a. Scan, read and input all drug information contained in the new Drug Supply Chain Security Act (DSCSA) barcode.

b. Capable of printing a DSCSA barcode on any unit dose label.

c. Capable of automatically inputting the NDC, GTIN, UPC, Manufacturer Expiration Date, Manufacturer Expiration Date, unique Manufacturer Bottle Serial number, and package quantity into the system to prevent errors.

d. Contain settings that allow default label templates.

e. Capable of automatically calculating the package “Beyond Use Date”.

f. Includes sensors that detect or prevent missed or empty unit dose packages.

g. Able to create and print a unique package serial number on every unit dose package.

h. Must be able to store a complete drug information database, including pill images, tallMAN lettering, and hazardous drug indicator within the device without continuous connection to local network.

i. Ability to package any size tablet or capsule to include flat, circular pills.

j. Ability to be connected to a direct thermal printer.

k. Capable of generating customizable data reports.

l. Bar Code Reader must be capable of reading both Linear and 2-D bar codes.

m. Unit dose pill packager system must be a stand-alone system with no network connectivity and no need for an interface.

n. The unit dose pill packaging system must include a complete starter supply kit. At minimum, this kit must contain labeling ribbon, amber cellulose material, and rolls of paper/foil sufficient for immediate operational use upon installation.