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06-PWS - Pharmacy Dispensing System-R2.0-0.28.2022.docx

OVERVIEW

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Contract Opportunity
Date Originally Posted
Oct. 4, 2022, 6:03 p.m.
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SECTION C – PERFORMANCE WORK STATEMENT:

Great Plains Area Indian Health Service (GPAIHS)

Pharmacy (Outpatient) Automated (Robotic) Packaging/Dispensing System – Multiple Locations

C-1BACKGROUND:

The Indian Health Service (IHS), an agency within the Department of Health and Human Services, is responsible for providing federal health services to American and Alaska Natives. The IHS is the principal federal health care provider and health advocate for Indian people and its goal is to raise their health status to the highest possible level. The IHS provides a comprehensive health service delivery system for American Indian and Alaska Natives. IHS Services are administered through a system of 12 Area Offices and 170 IHS and tribally managed Service Units.

The mission of the Great Plains Area is to provide oversight to medical facilities within a four-state region (SD, ND, IA, NE), as well as to ensure timely and accurate medical care through providing, operating and maintaining safe patient care equipment within those hospitals, health centers, and various clinics. To this end, automated medication packaging and dispensing systems provide a method of providing prescription medications quickly and accurately to patients, and act as a ‘personnel multiplier’ allowing a few Pharmacy staff spend more time discussing prescriptions, drug interactions, cautions and warnings, and providing general medication counseling than physically filling bottles. By automating prescription fills/refills, tracking of inventory/medication stock, compiling regulatory reports and audit trails, the GPAIHS recognizes that these systems not only assist with accreditation, but leads to patient satisfaction and improved healthcare.

GPAIHS invites prospective offerors to provide information on a proposed approach to configure and implement site-specific solutions, including related functions, tools and services. All responses must conform to the requirements and instructions outlined in this document.

All proposals must include full pre-award documentation to include: key project personnel; quality control plan; draft quality assurance surveillance plan; a security management plan that includes logic/dataflow diagrams, communications protocols, and work flow diagrams; a NEMA/AAMI Manufacturer’s Disclosure Statement for Medical Device Security (MDS2); user/operator guides; and all information necessary for the technical evaluation team to create an accurate security assessment as well as a use/operation assessment of the system.

If the proposed solution, or portions thereof, will be cloud-based or cloud-hosted, offerors are required to have and provide FedRAMP certification of their solution and cloud service provider (CSP). The offors must provide either a Provisional Authority to Operate (P-ATO) or Joint Authorization Board (JAB) authorization documentation. It is unlikely that the IHS CIO will ‘assume’ any risk, or ‘sponsor’ any cloud solution that is not already FedRAMP certified.

The Office of Management and Budget (OMB) mandates that U.S. federal agencies use the Internet Protocol version 6 (IPv6). In November 2020, OMB issued memorandum M-21-07 "Completing the Transition to IPv6", which outlines the Federal government's strategic intent "to deliver its information services, operate its networks, and access the services of others using only IPv6". The IHS requires all new IT systems (hardware and software) to operate in a pure IPv6 network environment. This includes on-premises services or third-party hosted services that require network integration into the IHS network. The Offeror's solution shall comply with the IPv6 standards profile as defined by the NIST USGv6 Program: https://www.nist.gov/programs-projects/usgv6-program Any offered solution, or networked part thereof, that does not meet the requirement for IPv6 will not be considered.

The contractor shall provide all personnel, equipment, supplies, transportation, tools, materials, supervision, and other items necessary to perform the tasks outlined in this PWS.

C-2PURPOSE/OBJECTIVES:

The purpose and objectives of this contract is for the lease and/or purchase of commercial off-the-shelf (COTS) automated (robotic) medication packaging/dispensing systems offering amongst the features:

Storage – provides capability to store and manage different types of medications and pharmaceutical items.

Administration – provides automated system administration, tracking, and management of medications.

Interfacing – provides industry standard interface and integration capabilities and compatibilities.

Recovery – provides data recovery, data collection, and data retention capabilities.

Reporting – provides documentation, generation, and management of report functionalities.

Data Analysis – provides integrated data analysis functions and capabilities.

Maintenance and Support – Contractor to provide ongoing support and maintenance for optimal use and sustainment of solution

that will be used to upgrade and/or replace existing leased systems (see attached listing*) in pharmacies (primarily outpatient) at multiple Indian Health Service facilities throughout the Great Plains Area, including:

(45BLB)Quentin N. Burdick Memorial Healthcare Facility, Belcourt, ND

(45EBB)Cheyenne River Health Center, Eagle Butte, SD

(45FTB)Fort Thompson Health Center, Ft Thompson, SD

(45 FYB)Fort Yates (Standing Rock SU) Hospital, Ft Yates, ND

(45MLB)McLaughlin Health Center (Standing Rock SU), McLaughlin, SD

(45LBB)Lower Brule Health Center, Lower Brule, SD

(45PRB)Pine Ridge Hospital, Pine Ridge, SD

(45PRB)LaCreek District Clinic (Pine Ridge SU), Martin, SD

(45PRB)Kyle Health Center (Pine Ridge SU), Kyle, SD

(45PRB)Wanblee Health Center (Pine Ridge SU), Wanblee, SD

(45RBB)Rosebud Hospital, Rosebud, SD

(45SIB)Woodrow Wilson Keeble Memorial Health Care Center, Sisseton, SD

(45WGB)Wagner Health Center, Wagner, SD

The systems will be ‘turn-key’, fully implemented systems designed and aligned with healthcare and pharmacy best practices, meet all regulatory (FDA, DEA, CMS, etc.) requirements and accreditation standards.

(*Note: The presence of existing equipment does not imply any intent for ‘trade-in’. Currently leased equipment will be returned to the lessor as it is replaced.

C-3SCOPE:

C-3.1FUNCTIONAL REQUIREMENTS:

The system shall be configurable to support different clinical environments, including but not limited to hospital outpatient pharmacies, health centers, inpatient pharmacies, or other ambulatory health care facilities.

The system shall be configurable to support local sites’ capacity needs.

The system shall be able to store, package and properly label controlled and non-controlled medications and products in various sizes, and types.

The system must automatically select a prescription container of the proper size, fill the container with the proper medication, print and apply the correct prescription label, apply the correct auxiliary warning labels and apply the correct line drawings and description of the medication.

Auxiliary labels must be supplied and generated from the system’s medication database.

System must complete all labeling after filling the container.

System must deliver the filled and labeled container uncapped for final verification.

System must include a digital image of the medication to assist with final verification.

The system must have a quantity of cells sufficient to handle at least 100 NDC numbers, but be expandable enough to handle larger amounts based on the size, and throughput, of the particular pharmacy.

Cells must be a ‘universal’ dispensing cell

Each cell can accommodate any size or shaped tablet or capsule

Cells must be able to be fully calibrated on site.

Cells must be able to be fully cleaned on site.

System must fill containers directly from the cell preventing cross-contamination.

The system must support most prescription containers used in standard pharmacy practice.

System must be able to process at least three container sizes

System must be able to process prescription container from 12 dram to 60 dram.

System must be able to store at least 100 prescription containers per container dispenser.

System must fill at least 150 prescriptions per hour.

The system shall have workstations, in sufficient number for the particular pharmacy/location, that provide for:

Workflow management

Prescription verification, tracking and management for the entire dispensing process

Supervisor and Manager ability to access local and remote systems to view status of prescriptions in process

Workflow can be managed on-screen in real time

Ability of users to ‘toggle’ between RPMS/EHR GUI and dispensing system GUI

Prescription validation and filling

Prescription label generation and printing

Presents labels after verifying the correct medication has been scanned ensuring labeling accuracy

If label not accepted by user within a specified time period, the label is automatically disposed of

Up to five (5) auxiliary labels may be automatically printed directly on the prescription label

Medication image and/or description may be printed directly on the container label for an additional cross-check

Dispensed medication verification

Barcode scanner

Allows for prescription verification via access to a comprehensive medication database containing images and descriptions.

Electronic signature device

Captures a patient’s signature acknowledging

Medication counsel… Show All