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

SECTION C – PERFORMANCE WORK STATEMENT:

Great Plains Area Indian Health Service (GPAIHS) Pharmacy (Outpatient) Automated (Robotic) Packaging/Dispensing System – Multiple Locations

C-1 BACKGROUND:

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-2 PURPOSE/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:

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-3 SCOPE:

C-3.1 FUNCTIONAL 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 counseling

· Medication counseling message(s) should be locally configurable

· Third party insurance information

· Allows the pharmacy to record

· Who signed for a prescription

· When it was picked up

· Who it was dispensed by

· Supports HIPAA and Privacy Act form acknowledgement, along

The system shall be able to interface with a 3rd party interactive voice response refill system such as Audiocare and/or have, as an option, an organic (built-in or add-on) IVR:

· Number of lines to be determined by individual pharmacy/location need

· Offers automated prescription refill orders available to patients 24 hours a day, 7 days a week

· Provides detailed prescription status to the patient

· Including notification if the prescription has expired or has no refills

· Provides call routing to a live voice, if during normal pharmacy operating hours

The system shall have an inventory management module/application

· Capable of real-time inventory tracking and receiving within the system

· Interface with the prescription workflow of the system

· Capable of interfacing with various vendors for automated order management and electronic transmission

· Shall alert the user whenever a product is not available (e.g. temporarily out of stock).

· Carry over quantities of administered or dispensed drugs that did not reach package size levels to subsequent replenishment periods.

· Tracking and ordering of inventory for replenishment shall use electronically available information and not rely upon manual systems or reports

· Have fraud monitoring processes in place

· Return-to-stock and adjust electronic prescription dispensing history and drug inventory levels within seven (7) working days of prescription filling if the patient has not picked up the prescription within that time

· Be configurable by local sites to prompt users, per medication, to verify the inventory during transactions (e.g. loading, refilling, dispensing)

· Be capable of accurately incrementing and decrementing the inventory during user transactions (e.g. dispensing, returning, wasting, refilling).

The system shall allow physical access to the medications, via manual lock and key, during power failure and outages.

The system shall support the importing of external configuration data (e.g. drug files, user database, formulary data, equipment in clinical settings) from an external source file (e.g. database, spreadsheet, text file).

The system shall be configurable by local sites, per medication, to require verification via second authorized user during transactions.

The system shall be configurable by local sites, per user role access, to require a second authorized user during transactions.

The system shall be configurable by local sites to require a review of all medication orders by a pharmacist prior to dispensing.

The system shall utilize industry 1D and 2D barcode standards for transactions.

The system shall be configurable by local sites for safe medication usage by limiting the dispensing of medications due to predetermined conditions (e.g. expired medication, incorrectly stocked, user access level).

The system should possess the ability to track dispensed or administered drug by 11-digit NDC number

The system shall be capable of cross-referencing when performing medication searches within the system (i.e. user search using brand name, while the system displays the generic name for reference).

The system shall allow users to suspend inventory transaction or cancel all other in-progress transaction.

The system shall be capable of using and displaying multiple unique patient identifiers (e.g. patient name, medical record number, date of birth).

The system shall provide and maintain UPS for all deployed equipment supporting proper system shut down (e.g. workstations, equipment).

The system should provide an Enterprise Management Server (EMS) supporting all sites with capabilities including but not limited to patch management, security monitoring, and reporting functions

The system should have a method to notify patients when a medication is filled (notification board, text messaging, email, etc.) based on an ‘opt in’ registration by the individual patient, and in a manner that does not disclose personal, medical or confidential information.

C-3.2 REPORTING AND DATA ANALYSIS TOOL REQUIREMENTS

· The system shall be configurable by local sites to connect to a network printer (e.g. inkjet, laser, thermal) for printing reports (e.g. user report, inventory, system reports).

· The system shall maintain logs, including but not limited to activity logs, issue logs, technical logs.

· The system shall be configurable by local sites to generate scheduled pre-determined and ADHOC reports. The pre-determined reports shall include, but not limited to:

· User activity reports (e.g. load, refill, unload, remove, return, waste, override, log-in attempts)

· Inventory reports (e.g. load list, refill list, expired list, inventory list)

· System reports (e.g. user database, formulary, data dictionary, data schema, maintenance report, failed drawer/pocket, system status)

· The system shall be configurable by local sites to export reports into multiple file formats (e.g. spreadsheet, database, text file).

· The system should allow authorized users to connect Structured Query Language (SQL) based third party reporting and analytical tools (e.g. Business Objects, Statistical Analysis Software (SAS®), Tableau®, OpenRefine).

· The system shall be capable of providing descriptive statistical analysis reports including, but not limited to average usage, frequency distribution, and standard deviations.

· The system shall be capable of creating visual representation of descriptive statistical analysis reports including, but not limited to histograms, bar charts, and frequency tables.

· The system shall be capable of generating reports in real-time without affecting system performance.

· The system shall be capable of unarchiving and integrating archived data for reporting purposes.

C-3.3 BACKUP AND RECOVERY REQUIREMENTS

· The system shall maintain transaction data upon loss of network connectivity.

· The system shall automatically reconcile transaction data upon reestablishment of network connectivity.

· The system shall back-up and restore transaction data per site based on Government defined timeframe (e.g. 30 days, 45 days, or 60 days).

· The system shall be capable of rebuilding damage/lost files during data recovery process using database back-up data.

· The system shall be configurable by local sites to setup the parameters for incremental database back-up data.

· The system shall store, archive, and readily retrieve historical data for a minimum of five years.

C-3.4 MAINTENANCE AND SUPPORT

The contractor shall provide maintenance and support services through a maintenance license agreement that includes but not limited to, unlimited hardware and software support, hardware and software updates and upgrades/enhancements (i.e. Major and minor revisions). The maintenance and support shall include necessary hardware and software to ensure and maintain cybersecurity requirements

· Support Requirements

· The Contractor shall provide diagnostic and repair services, as well as preventive maintenance via on-site or remote support.

· The Contractor shall perform root cause analysis for issues and repairs involving hardware, software, or procedural problems that causes substantial operational difficulty, and prevents a system from dispensing medications, causing system downtime to include remote connectivity.

· The Contractor shall document a Field Service Report (FSR) with the following information about each service event:

· Name of Contractor;

· Contract Number;

· Name of Field Service Technician performing service;

· Contractor log/Control # (i.e. Work Order #);

· Date, time (beginning and ending), and hours on-site for service call;

· Description of problem reported by user;

· Equipment identification factors to include: original and replacement;

· Equipment

· Manufacturer

· Model

· Serial number

· Local Biomedical Equipment Control Number (BCN);

· Description of problem identified by the Contractor;

· Description of services and tests performed, parts used, corrective action taken;

· Problem resolution or pending actions; and Names;

· Field Service Technician signature; and

· Authorized local site personnel signature

· The Contractor shall provide FSRs to authorized local site personnel upon completion of each service event.

· The Contractor shall physically check-in and check-out with the authorized local site personnel (i.e. Security, Clinical Engineering, Facilities Management).

· The Contractor shall maintain a Hot Swappable List (HSL) of furnished/forward staged replacement parts required for all repairs performed by Contractor trained authorized local site personnel.

· The Contractor shall support the relocation of clinical equipment within the local sites.

· When the Government provides 30-days advance notice, the Contractor shall relocate and reconfigure clinical equipment from one facility to another facility within 100-miles.

Contractor shall provide a trackable means of submitting service requests that will be available 24 hours a day, 7 days a week, every day of the year. Including weekends and holidays.

C-3.4.1 MAINTENANCE REQUIREMENTS

· The Contractor shall coordinate on-site maintenance visits with authorized local site personnel (i.e. Clinical Engineering, Facilities Management, Pharmacy department).

· The Contractor shall provide authorized local site personnel an initial assessment of the operational condition of the system upon arrival for maintenance.

· The Contractor shall provide a FSR at the conclusion of the each maintenance visit.

· The Contractor shall affix a preventive maintenance sticker to each piece of equipment upon completion, which includes the date the work was performed, the next date due, and name of the technician performing the work.

· The Contractor shall immediately notify authorized local site personnel when the Contractor is unable to locate equipment within the maintenance window specified for assisting with locating the equipment, and shall escalate to the COR when the authorized personnel are unavailable or unresponsive.

· The Contractor shall provide maintenance and repair visits that include preventive and corrective maintenance, inspections, replacement of defective and worn parts, and testing services in accordance with Contractor Original Equipment Manufacturer (OEM) specifications.

· The Contractor shall be specifically excluded from coverage related to external causes (e.g. abuse, misuse, vandalism, unauthorized repairs), environmental hazards such as fires, floods, acts of nature (e.g. earthquakes, hurricanes, tornados), unregulated power, gas/atmosphere contamination, and physical damage that is not in the normal course of instrument operation.

· The Contractor shall perform all preparations to necessitate hardware replacement, including packing and transportation of the asset at no additional cost to the government.

· The Contractor shall only use OEM-approved replacement parts for maintenance and repairs.

· The contractor shall upgrade the Operating System 180-calendar days prior to end-of-lifecycle.

· Contractor shall be responsible for ensuring that the contractor's staff has the necessary tools and test equipment to perform work under this contract.

C-3.5 INTERFACE REQUIREMENTS

The system shall support interface connections to external systems. The Contractor shall create, maintain, and update the Interface Control Document (ICD) for each connection.

C-3.5.1 RESOURCE AND PATIENT MANAGEMENT SYSTEM (RPMS) / APDS INTERFACE

Resource and Patient Management System (RPMS) is a medical/pharmacy information system that automates and integrates clinical and demographic data and facilitates access to and delivery of, health care services from an IHS medical/pharmacy or dental treatment facility. There are RPMS hosts at each IHS medical/pharmacy or dental treatment facility. The RPMS supports HL7 messaging either natively or through 3rd party middleware provided by the IHS through a separate HL7 programming contract.

· The Contractor shall implement, maintain, and update an interface between the system and each RPMS host, either directly or utilizing a 3rd party vendor (i.e. Cimarron).

C-3.6 REMOTE CONNECTION SUPPORT

The Contractor shall complete all necessary tasks related to the documentation and implementation of any required LAN-to-LAN Virtual Private Networking, or other IHS approved secure communication means. Tasks include:

· Completion of an IHS Business Associates Interconnection Security Agreement.

· Virtual Private Network (VPN) or related equipment procurement and configuration

· Initiation and completion of all testing and implementation activities

C-3.7 TRAINING REQUIREMENTS

The Contractor shall develop a training plan to specify training approaches, methods, schedules, tools, and curricula.

The Contractor shall plan, schedule, and conduct formal training for all levels of users (e.g. system administrators, pharmacy, and nursing).

The Contractor shall train authorized local site personnel (i.e. Clinical Engineering) to perform minor maintenance and repair services, including but not limited to the following:

· Drawer recoveries

· Light bulb replacement

· Button bar replacement

· Drawer solenoid replacement

· Bio-ID reset/replacement

· Shelf reconfigurations

· Keyboard replacement

· CPU fan replacement

· Ribbon cable replacement

The Contractor shall develop mutually agreed upon training materials, to include course objectives, teacher guides, student guides, course materials, training manuals, distance learning tools, and computer- based tools.

· The Contractor shall deliver training materials in reproducible electronic format (e.g. Adobe© Acrobat®, Microsoft® Office™).

The Contractor shall make available to local site users training and implementation materials to include user guides with answers to frequently asked questions (FAQs) via public-facing and/or internal IHS hosted websites.

C-3.8 RESERVED

C-3.9 CONTRACTOR TRAVEL

Travel is incidental to the primary tasks identified in this PWS. Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the contractor.

C-4 PERIODS OF PERFORMANCE

The base-year performance period will be from PO issuance through 12/31/2023. There will be four (4) option year periods as follows:

· Option Year 1 – 1/1/2024 – 12/31/2024

· Option Year 2 – 1/1/2025 – 12/31/2025

· Option Year 3 – 1/1/2026 – 12/31/2026

· Option Year 4 – 1/1/2027 – 12/31/2027

C-5 GENERAL INFORMATION:

C-5-1 QUALITY CONTROL:

The Contractor shall develop and maintain an effective quality control program to ensure the performance of equipment and services in accordance with this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective equipment and services. The Contractor’s quality control program is the means to ensure that work complies with the requirement of the contract

The Contractor shall prepare and adhere to a Quality Control Plan (QCP). The QCP shall document how the Contractor will meet and comply with the quality standards established in this statement of work. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation.

C-5-2 QUALITY ASSURANCE:

The Contractor shall prepare and adhere to a Quality Assurance Surveillance Plan (QASP) that the government shall use to evaluate the Contractor’s performance under this contract. The QASP focuses on what the Government must do to ensure that the Contractor performs in accordance with the performance standards throughout the contract term. The QASP defines the application of the performance standards, the frequency of surveillance, and the minimum acceptable quality levels.

The Government will review monthly performance and status reports and will attend regular performance review meetings with the Contractor to survey quality of products and services.

Further, the QASP provides the Contacting Officers Representative (COR) with a proactive way to avoid unacceptable or deficient performance. The QASP will be finalized following award. The QASP is a living document and may be updated through negotiations and discussions when necessary

C-6 HOURS/DAYS OF PERFORMANCE / HOLIDAYS:

Unless otherwise stated within a purchase order or agreed upon with the Contracting Officer or Contracting Officer's Representative (in writing), initial installation, configuration, and training, as well as routine scheduled maintenance shall be performed Monday through Friday, 8am to 5 pm (IHS facility local time) excluding weekends and federally recognized holidays. State, local, and other non-federally recognized holidays will not be recognized for any award under this PWS.

Corrective maintenance and other non-routine services will be available/performed 24 hours a day, 7 days a week, every day of the year, including weekends and holidays. This availability may be determined by the severity of the failure/problem in accordance with any ‘service level agreement’ and timelines stated in either the contract award documents and/or explicitly accepted ‘terms and conditions’.

C-7 PLACE OF PERFORMANCE:

The work to be performed under this PWS will be at the contractor’s facility and the government facilities shown in C-2 of this PWS. The specific equipment amounts, types, and configurations will be determined on a location by location basis following consultation with the Pharmacist and other facility representatives. Contractor is expected to provide a detailed quote by location (see section L).

Any servers, such as configuration control, patch management, central reporting, data archiving/back-up, that are intended to be, or will be, shared across the installed systems/locations, will be located in the IHS Data Center in Sioux Falls, SD. The IHS prefers that any such common/shared servers be virtual machines that can be provisioned/built within the GPAIHS existing VMWare and HyperV hosting systems.

C-8 TYPE OF CONTRACT:

Contract award(s) shall consist of one or more:

· Firm Fixed-Price for lease, service & support, billed in either monthly or quarterly intervals for the performance period(s) noted in Section C-4

· Note: The Government reserves the right to ‘buy out’ the lease at any point in the contract, either base year or any one of the option years, for remaining ‘fair market value’ of the equipment, software, peripherals, etc. exclusive of any service and maintenance agreement (SMA). Exercising any ‘buy out’ does not obligate the Government to obtain a SMA.

· Firm Fixed-Price for purchase, installation and configuration. With the option of entering a separate service and maintenance agreement (SMA) for the performance period(s) noted in Section C-4

Although there may be multiple contracts (purchase or lease and the associated service & maintenance agreements) awarded under this solicitation, award will be made to one (1) and only one (1) vendor on an all or none basis. With option periods that may be exercised to meet IHS patient care requirements during the designated renewal periods at the IHS discretion and when funding is available.

The Government reserves the right not to include any one, or more, of the locations listed in this solicitation in any award/contract without affecting any one, or more, of the remaining locations.

C-9 CHANGE ORDERS / EQUIPMENT/SERVICE MODIFICATIONS::

Only the Contracting Officer can make material changes to any award/contract for this solicitation/PWS. If, after award, any requests to make alterations, adjustments, or changes to equipment, software, services or anything else related to this PWS, are brought forward to the Contractor or Contractor’s employees, said requests must be forwarded to the Contracting Officer and/or Contracting Officer’s Representative for review. At no time will changes be made without a fully executed contract modification or other written direction by the Contracting Officer.

Removal: At no time shall the contractor remove, or cause to be removed, any device, operation option, or accessory from the healthcare clinic, hospital, or health station without express written consent from the Contracting Officer, Contracting Officer Representative or the GPIHS HTM (Clinical Engineering) Division

C-10 NETWORK/IT/CYBERSECURITY/USER ACCESS:

Only currently supported operating system, database, and other software may be used throughout the proposed system. The contractor shall provide a Security Management Plan that will, at a minimum:

· Identify as security-critical those core items (hardware, software, or business process) whose failure could lead to a breach of system security

· Identify the OS and other software proposed as part of the system

· Shall have a minimum underlying Operating System (OS) of Microsoft® Windows™ 10 and Windows™ Server 2018

· Describe patch management and vulnerability mitigation

· Identify virus/malware prevention software/methods

· Describe user and servicer access to the system and required ‘privilege’ levels including

· User management/access

· Password management

· Be configurable to automatically prompt user to change password on a locally defined interval

· Preferred to utilize HHS/IHS “PIV” card for authentication/access

· Be configurable by local sites to provide temporary access (e.g. user name/password) for on-call or floating users.

· Be configurable by local sites to log users out of the system automatically (e.g. the session times out after five minutes of inactivity)

· Be configurable by local sites to suspend user credentials due to system access inactivity (e.g., user has not logged-in within the 30 days)

· Active Directory integration, including

· AD requirements

· AD credentials

· Preferred to utilize HHS/IHS “PIV” card for authentication/access

· OU requirements

· GPO requirements

· Networking/system diagram

As well as an up to date and detailed HIMSS/NEMA Manufacturer’s Disclosure Statement for Medical Device Security (MDS2) and VA Directive 6550 worksheet for each component of the proposed system.

C-11 PERSONNEL SECURITY/CONTRACTOR IDENTIFICATION:

Unless otherwise stated in the award documents, subsequent regulations, or changes in the Indian Health Service policies and procedures, all contractor staff shall have the appropriate full background investigation and clearance prior to working within any Indian Health Service facility. Contractor staff will also be required to complete any security awareness or safety training (i.e. Information Systems Security Awareness, Protecting Children from Sexual Abuse, etc.) required by the Indian Health Service.

When on-site, Contractor staff will:

· Check in/out with the Security desk at each location

· Check in/out with the Facility Manager and/or Clinical Engineering at each location

· Wear Contractor issued photo identification

· Wear IHS issued visitor/contractor badges (as applicable)

C-12 POST AWARD CONFERENCE/PERIODIC PROGRESS MEETINGS:

The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office. The Contractor shall also plan and conduct regular, routine meetings (via teleconference) with a bi-weekly (every 2 week) minimum frequency with the Government to review progress and status of activities under this contract. Each review shall provide insight into staffing, progress, risks, and status.

The Contractor shall provide project briefings addressing schedule, performance, and status of this contract, noting any problems or risks and alternative and recommended solutions. These meetings shall be at no additional cost to the Government. The Contractor shall provide meeting agendas and meeting materials to Government participants prior to the meeting and that data presented at program reviews is current within not more than ten (10) days.

C-13 CONTRACING OFFICER REPRESENTATIVE (COR):

The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

· Assure that the Contractor performs the technical requirements of the contract;

· Perform inspections necessary in connection with contract performance;

· Maintain written and oral communications with the Contractor concerning technical aspects of the contract;

· Issue written interpretations of technical requirements, including Government drawings, designs, and specifications;

· Monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies;

· Coordinate availability of government furnished property; and

· Coordinate site entry of Contractor personnel.

A letter of designation will be issued to the COR with a copy sent to the Contractor, stating the responsibilities and limitations of the COR. The COR is not authorized to change any of the terms and conditions of the resulting Contract.

C-14 KEY PERSONNEL:

The following Contractor personnel are considered key personnel by the Government:

· Project Manager

· Field Service Engineer/Technician

· Clinical Applications Specialist

C-14.1 PROJECT MANAGER:

The Contractor shall provide a Project Manager who shall be responsible for daily operations to include performance of work. The name of this person who shall act for the Contractor shall be designated in writing to the Contracting Officer. The Project Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Project Manager shall possess the following experience:

· Progressive experience (minimum 5 years) in Program Management of projects requiring integration, implementation, and training

· Experience in schedule management, quality assurance, and cost management accounting

· Project Management Professional (PMP) Certification preferred

C-14.2 FIELD SERVICE ENGINEER/TECHNICIAN:

The Contractor shall provide at least one Field Service Engineer/Technician who shall be responsible for the on-site set up, installation, configuration, and initial validation testing of the equipment/system, as well as other duties typically performed by Contractor’s field service personnel. The name(s) of this person, or persons, shall be designated in writing to the Contracting Officer. The Field Service Engineer/Technician shall possess the following:

· Progressive experience (minimum of 5 years) in deploying, configuring and servicing the Contractor’s equipment/system(s)

· Statement of competency by the Contractor attesting to the FSE’s training and competency

C-14.3 CLINICAL APPLICATIONS SPECIALIST:

The Contractor shall provide at least one Clinical Applications Specialist who shall be responsible for coordinating workflow processes with the individual pharmacies, and training Pharmacy staff on the use of the equipment/system. The name(s) of this person, or persons, shall be designated in writing to the Contracting Officer.

C-14.4 SUBSTITUTION OF KEY PERSONNEL:

The Contractor shall provide complete resumes for proposed substitutes of Key Personnel and any additional information requested by the Contracting Officer. Proposed substitutes should have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 days after receipt of all required information of the consent on substitutes. No change in fixed unit prices may occur as a result of Key Personnel substitution.

C-15 TRANSITION:

C-15.1 INCOMING TRANSITION PLAN:

The vendor shall provide an Incoming Transition Plan including, but not limited to the following:

· No more than 180 calendar-days, that is achievable, of incoming transition from the existing leased Automated Pharmacy Dispensing System(s) to the Contractor’s ADPS that includes:

· Equipment delivery and installation timelines for each facility/location

· End user training

· HTM (Clinical Engineering) training

· Implementation of warranties, support agreements, and licenses.

· Coordination with Government representatives

· Orientation phase and program to introduce Government personnel, programs, and users to the Contractor’s team, tools, methodologies, and processes

· When applicable, de-installation of existing leased Automated Pharmacy Dispensing System(s)

C-15.2 SITE SURVEYS/INFORMATION COLLECTION:

The Contractor shall coordinate with the designated COR and other Government representatives to plan and schedule site surveys, information collection to support the configuration, and deployment of solution materials, (e.g. equipment, software, systems) to the designated sites. The Contractor shall compare existing site capabilities (e.g. server rack size, wired or wireless capability, floor space) and features with site requirements for system, software, and equipment. The Contractor shall compile a list of site modifications/additions required to support deployment.

C-15.3 SOLUTION DEPLOYMENT:

The Contractor shall coordinate with the designated COR and other Government representatives to plan and schedule solution deployments. This shall include the development of detailed, Integrated Deployment Schedules. Schedules shall identify all elements of the planning, preparation, shipping, installation, integration, checkout, and operational capability to include post deployment evaluation and modification.

The system shall be deployed utilizing a decentralized configuration (e.g. local facility), and where applicable a regional (e.g. Service Unit*) configuration.

(*locations designated by the Indian Health Service as a ‘Service Unit’ where a main hospital exists in one physical location with outlying health centers and clinics that fall under that main hospital’s management)

C-15.4 ON-SITE TRAINING:

The Contractor shall plan, schedule, and conduct mutually agreed upon on-site training to each local site during initial implementation.

C-15.5 SHIPMENT, RECEIPT AND INSTALLATION:

The Contractor shall coordinate with designated commercial shipping organizations to plan the shipment of materials and equipment to designated deployment sites. The Contractor shall use industry best practices to ensure the most efficient and effective shipping means are utilized. This shall include ensuring appropriate packaging and packing, providing for necessary insurance, ensuring ability to track shipments, coordinating delivery and unloading at facilities that do not have loading docks, and coordinating to accommodate international customs processing (as applicable). The Contractor shall receive, unpack, dispose of packing materials, configure, setup, and ensure the system is functioning properly to comply with planned and approved configurations.

C-16 CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM:

The Contractor Performance Assessment Reporting System (CPARS) has been adopted by the Indian Health Service to electronically capture assessment data and manage the evaluation process. CPARS is used to assess a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured in the CPARS form and together make a complete assessment. Once the Assessing Official completes the proposed assessment for the period of performance, the assessment is released to the appropriate Government Contractor Representative for their review and comments. User ID and Password will be provided to the designated Government Contractor Representative upon issuance of a contract. The Contractor has 30 days after the Government's assessment is completed to comment on the assessment. The Government Contractor Representative must either concur or non-concur to each assessment. When the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the assessment, the Assessing Official may close out the assessment. Otherwise, the Assessing Official must forward the assessment to the Reviewing Official for review, enter comments when appropriate, and close out. The Reviewing Official may direct the Assessing Official to forward previous assessment for review.

C-17 CONTRACTOR PAYMENT PROCESSING:

The Contractor is responsible for properly preparing and forwarding invoices to the payment office shown on the contract and concurrently submit a copy to the COR.

All payments are due and payable upon receipt of complete and accurate invoices and in accordance with the Prompt Payment Act. Invoices shall be submitted with all information and supporting documentation as required. The Prompt Payment Act Clause will be provided by the Contracting Officer at the time of award and will further clarify the requirements. Finance charges for late payment of charges due to problems not of the Contractor’s making shall be paid according to the regulations and amount determined by the Great Plains Area Indian Health Service Financial Management Branch. If the Government fails to pay an amount when properly due, the Contractor has the option of suspending all services provided by this contract after providing a detailed explanation to the Contracting Officer. The Contracting Officer is responsible for assuring that direct patient care is not compromised by frivolous or unlawful suspension of services. Disputes will be handled according to the Disputes Clause and shall not violate any rule or regulation or law.

C-17.1 INVOICE REVIEW

The COR may reject or require correction of any deficiencies found in the invoice. In the event of a rejected invoice, the Contractor must be notified in writing by the COR of the specific reasons for rejection.

A complete and accurate invoice is substantially correct in that all aspects of the required information are clearly evident on the invoice. If items such as invoice number, date, dates of service, contract/purchase order number, etc., are not on the invoice, it will be returned to the Contractor for resubmission.

C-17.2 INSPECTION AND ACCEPTANCE:

The COR specified in the COR appointment letter is responsible for inspection and acceptance of all incoming shipments, documents, and services.

C-18 GOVERNMENT ACCEPTANCE PERIOD:

The COR will have fifteen (15) workdays to review system installation and validate function and configuration. Should the Government fail to complete the review within the review period the system installation and configuration will become accepted by default, unless prior to the expiration of the fifteen (15) workdays the Government notifies the Contractor in writing to the contrary. The COR will have the right to reject or require correction of any deficiencies found that are contrary to the information contained in the Contractor’s accepted quote. In the event of a rejection, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to make corrections.

C-19 RESERVED

C-20 WARRANTY:

Contractor shall state warranty periods for any and all items installed under this contract, as well as provide a statement of warranty for any subsequent maintenance/repair work performed following system installation.

C-21 CONTRACTOR’S TERMS & CONDITIONS:

The contractor’s terms and conditions shall be incorporated into the contract by reference. Where conflicts arise, the Federal Acquisition Regulations, and other Federal Regulations, Laws and Rules shall take precedence.

C-22 LIABILITY/INSURANCE:

The contractor shall be properly insured, and shall provide evidence of insurance.

In no event shall the Government release the Contractor from liability arising from acts of omission, improper repair, negligence, or deliberate or non-deliberate acts that jeopardize the health and safety of patients and/or Government employees. The rules of law governing such incidents or actions shall prevail.

C-23 RELEASES:

No information, findings, or determinations generated in pursuit of this contract may be released outside of the contractors’ immediate possession without the concurrence of the Contracting Officer.