The file's text, extracted by GovTribe without its formatting.
Organization:
Date:
Site POC:
Quantity:
| Nomenclature: |
| Point of Use (POU) |
| ACN: |
| Clinical Application: |
| Medication Management, Processing, and Dispensing |
| Location/Region: |
| # |
| Systems Requirement Description |
| Minimum Requirement |
| 1 |
| Operating system |
| Win 10 |
| 2 |
| Interface and interoperability with pharmacy management system using the most current standardized language and protocols (i.e. RxNORM, SNOMED-CT, HL7, etc.) |
| Uni-directional interface |
| 3 |
| Modifiable drawer layout |
| Customizable drawer layout |
To accommodate unit medication needs
| 4 |
| Controlled Medication Management Workflow |
| Inventory validation via |
blind count method, Multi-user validation, Access restrictions, system Restricted access drawers/bins/ lids, etc.
| 5 |
| Automatic user activity tracking for audits |
| Required |
| 6 |
| Barcode driven interface |
| System enabled barcode |
scanning for restocking
| 7 |
| Real-time remote inventory management |
| Required |
| 8 |
| Support dynamic reporting and analytics |
| Required |
| 9 |
| Multiple storage configurations |
| Support bulk, unit dosed, |
IV, and refrigerated medications
| 10 |
| 24/7 Vendor Remote support and service |
| Required |
| 11 |
| Perpetual inventory management for inventory supply and expirations |
| System tracks inventory in real |
time and generates replenishment reports or expiration reports as defined locally
| 12 |
| Biometric enabled login |
| Required |
| 13 |
| System Monitored Refrigerator with Integrated Locking Mechanism |
| Required |
| 14 |
| Variable User Access Profiles |
| Required |
| 15 |
| Pharmacy Profiling feature |
| Pharmacy must profile |
for medication orders in Order to be pulled from system
| 16 |
| Real Time Notification of Critically Low Inventory |
| Required |
| 17 |
| Inventory discrepancy tracking |
| Required |
| 18 |
| System controlled and monitored return bin |
| Required |
| 19 |
| Dynamic Medication Profiles that enables local users to define POU tracked characteristics |
| Required |
| 20 |
| Large item storage capability |
| Integrated cabinet or |
Stand-alone cabinet controlled by system
| 21 |
| Automated safeguards to ensure right medication selection |
| Required |
| 22 |
| (Optional) Anesthesia Oriented Workstation |
| Optimized automation offering to |
Support surgery cases with necessary supplies in a small customizable configuration that can be moved and sterilized in a small foot print
| 23 |
| Clinical Decision Support System and Alerts |
| System provides alerts IAW |
locally managed settings and requirements
| 24 |
| Uninterruptible power supply for system for orderly shutdown of system in case of power loss |
| Required |
| 25 |
| On-Site Vendor Support |
| Required |
| 26 |
| Training for Pharmacy Staff |
| Required |
| 27 |
| Two sets of user manuals and two sets of service manuals |
| Required |
| 28 |
| Site prep: Provide all cost information for turn-key installation for the new system |
| Required |
| 29 |
| Must comply with U.S. Army Cybersecurity/Risk Management Framework (RMF) requirements (August 21, 2017) |
| Required |
| 31 |
| Warranty Coverage |
| 1 Year |
| 32 |
| Automation usable during network downtime |
| System may be placed in |
override mode to enable uninterrupted medical care
Information Assurance
| 1 |
| Authority to Operate (ATO) |
| Agree to comply with IA Terms |
and Conditions necessary to achieve a system
RMF ATO
| 2 |
| Joint Medical Device Risk Assessment Questionnaire (v1.1) and Nessus Scan |
| Provide a completed Joint |
Medical Device Risk Assessment Questionnaire for the offered system along with Nessus Scan of the system
| 3 |
| Operating System |
| OS with current commercial |
support
| 4 |
| Application Major Components |
| All major component software |
applications (SQL, IIS, .Net, etc.) have current commercial support
| 5 |
| Software Inventory |
| Provide full software inventory |
including associated ports, protocols, and support end dates
| 6 |
| Vulnerability Management |
| Established policies and |
procedures to distribute and install security updates within a documented timeframe
| 7 |
| Data At Rest Encryption |
| All PHI/PII on system is |
encrypted
| 8 |
| Auditing |
| System is capable of auditing |
System events to include:
1. login/logout information
2. The creation, modification and deletion of PHI/PII
3. The import and export of data to and from removable media.
4.Audit trail events include the logging of the execution of privileged functions.
| 9 |
| User Accounts |
| All general users of the system |
must have individual user IDs to log into the application.
All Admin accounts are separate from general user level access.
All accounts support DoD Password complexity requirements.
Site EC Team Members
| Print Name and Signature |
| Phone # |
| Date |
Clinician:
Maintenance:
IM/IT:
Facilities:
USAMMA TARA Approval Signature:
Turn Key:
The final quote must represent both the equipment and site preparation, construction, extended installation elements with line item pricing as well as a net selling price representing the turnkey.
Department of the Army Medical Command