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Note that page is still in development. The preliminary sharing of this information is | Note |
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Note that page is still in development. The preliminary sharing of this information is intended to benefit the ETOR initial implementers in preparation for their implementations, with the understanding that some information may change as our development evolves. |
To ensure a successful implementation, you will need to provide the required roles with the appropriate skill set and availability. When appropriate, auxiliary (i.e., additional) roles that may be engaged during the implementation to collaborate and/or provide insight into process(es) have been included for considerationand availability.
Below are details for role requirements on a standard APHL ETOR Implementation.
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Public Health Laboratory Roles and Responsibilities
The following roles and associated allocation will be necessary for an ETOR implementation. Depending on laboratory organization and staffing, some roles may be served by multiple individuals, or a single individual may serve in multiple roles. FTE requirements may vary based on the scope of your implementation and will be discussed. The success of the implementation and sustained ETOR solution is reliant on utilizing a team approach.
Role | FTE Implementation | FTE Sustaining | Responsibility | Recommended Skillset | Required Roles and Responsibilities |
Project Sponsor | 0.1 | < 0.1 | Implementation and Sustainability Identifies individuals to fill all required project roles. Commits to participating in implementation project as outlined in Project Charter. Advocate for ETOR with stakeholders. Provides leadership representation in discussions with healthcare organization. Approves milestones for progress (e.g., CLIA approval in Validation, approval to move into Production). Removes obstacles for the project team and negotiates escalated issues and risks related to the project and/or solution.
| Often a Lab Director Has access to and influence with stakeholders. Understands the value and benefits of ETOR. Authority to make commitments and decisions related the ETOR effort. Understands competing priorities and impacts to the ETOR implementation project. Ability to allocate resources to the project. Excellent communication and interpersonal skills.
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Project Manager | 0.5 | N/A | Implementation Works closely with APHL Project Manager to understand and commit to project scope, timeline, management approach. Directs the work assigned to the public health laboratory, monitoring and ensuring timely and quality completion, with assistance from APHL Project Manager. Works closely with healthcare organization team to align goals and tasks. Supports the APHL Project Manager in issue and risk management, escalating as necessary to the Project Sponsor. Creates and maintains the project communication plan for PHL internal and external communication. Coordinates APHL on-site visits. Coordinates all project approvals, including CLIA approval. Provides regular status updates to the Project Sponsor.
| Often a Bench Supervisor or Section Supervisor Knowledge of project management principles and practices. Previous project management experience. System implementation experience. Knowledge of laboratory workflow for receiving a test order and providing a test result. Ability to grasp technical information. Ability to work cooperatively with other organizational entities and engage 3rd parties as necessary. Excellent communication and organizational skills.
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Lab Subject Matter Expert (SME) | 0.5 | N/A | Implementation Provides insight into lab processes and workflow. Implements non-technical workflow changes. Creates lab process documentation that reflects updated workflows. Collaborates with HCO during validation. Works with APHL Terminologist and PHL Informatics/Technical Analyst to create test messages. Acts as the LIMS end user. In coordination with the Integration resource, creates formal document for CLIA approval that analyzes the integration, documents additional processes, and outlines any issues with mapping/vocabulary.
Sustaining Trains PHL staff on new ETOR workflow(s) and process(es). Updates standard operating procedures (SOPs) and accesses PHL staff competency in executing SOPs. Collaborates with auxiliary Additional Sustaining Support staff to manage the follow up needs of the new process. Supports additional ETOR test onboarding. Assist with ETOR quality assurance and troubleshooting.
| Often a Laboratorian Knowledge of lab processes and workflows (specifically for the tests being implemented during the implementation). Access to and experience with LIMS applications. Experience writing workflow procedures (SOPs) for business use. Experience implementing SOPs. Excellent communication and organizational skills. Team player.
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Informatics/Technical Analyst | 0.5 | 0.2-0.5
dependent on # of ETOR partners, test types, and volume | Implementation Collaborates with HCO to send/receive necessary artifacts and/or tests. Works with APHL Terminologist and PHL Lab SME to create test messages. Pulls reports/other artifacts or coordinates between PHL IT to do so. Reviews Service Level Agreements (SLAs) and coordinates updates as needed. Advocates for ETOR with stakeholders. Sets up connection to AIMS intermediary.
Sustaining Monitors ETOR feed and ensures data quality. Coordinates required updates and/or changes with test(s). Provides Help Desk support to PHL and HCO ETOR users (this may need to be covered by an additional resource). Troubleshoots issues and escalates as necessary with HCO and APHL counterparts. Documents ETOR troubleshooting processes and maintains technical SOPs. Reviews mapping updates in Symedical and coordinating with APHL as needed. Advocates for ETOR with stakeholders.
| Often a LIMS Administrator or IT Technical Architect Knowledge of laboratory standards preferred. Familiarity with HCO test data. Access to and experience with LIMS applications. Understanding of how to monitor data feeds (e.g., quality of data, quantity of data). Ability to maintain knowledge of NBS test updates and/or changes. Knowledge of integration engine a plus. Excellent communication and organizational skills. Team player.
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LIMS Vendor Representative - 3rd party | Dependent on LIMS capability | Dependent on LIMS capability | Implementation and Sustaining | |
Auxiliary and/or Additional Roles and Responsibilities |
Sample Receiving Staff – Responsibilities include focusing on test sample receiving and data entry (complementary to the required Lab SME role).
Quality Assurance Specialist – Responsibilities include determining a validation plan, ensuring its completion, and overseeing compliance of any regulatory requirements.
Legal Representation – Responsibilities include ensuring the legal documentation between project partners meets PHL needs.
Additional Sustaining Support – Responsibilities include managing the follow up needs of the new process, providing training to other ETOR support staff, and updating documentation as needed.
Test Courier – Responsibilities include representing and providing insight into the needs of test courier(s) in the ETOR process.
ProcurementStaff – Responsibilities include guidance and management of timely procurement of new systems and/or services to meet project needs and timelineapproach. Directs the work assigned to the public health laboratory, monitoring and ensuring timely and quality completion, with assistance from APHL Project Manager. Works closely with healthcare organization team to align goals and tasks. Supports the APHL Project Manager in issue and risk management, escalating as necessary to the Project Sponsor. Creates and maintains the project communication plan for PHL internal and external communication. Coordinates APHL on-site visits. Coordinates all project approvals, including CLIA approval. Provides regular status updates to the Project Sponsor.
| Often a Bench Supervisor or Section Supervisor Knowledge of project management principles and practices. Previous project management experience. System implementation experience. Knowledge of laboratory workflow for receiving a test order and providing a test result. Ability to grasp technical information. Ability to work cooperatively with other organizational entities and engage 3rd parties as necessary. Excellent communication and organizational skills.
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Lab Subject Matter Expert (SME) | 0.5 | 0.1 | Implementation Provides insight into lab processes and workflow. Implements non-technical workflow changes. Creates lab process documentation that reflects updated workflows. Collaborates with HCO during validation. Works with APHL Terminologist and PHL Informatics/Technical Analyst to create test messages. Acts as the LIMS end user. In coordination with the Integration resource, creates formal document for CLIA approval that analyzes the integration, documents additional processes, and outlines any issues with mapping/vocabulary.
Sustaining Trains PHL staff on new ETOR workflow(s) and process(es). Updates standard operating procedures (SOPs) and accesses PHL staff competency in executing SOPs. Collaborates with support staff to manage the follow up needs of the new process. Supports additional ETOR test onboarding. Assist with ETOR quality assurance and troubleshooting.
| Often a Laboratorian Knowledge of lab processes and workflows (specifically for the tests being implemented during the implementation). Access to and experience with LIMS applications. Experience writing workflow procedures (SOPs) for business use. Experience implementing SOPs. Excellent communication and organizational skills. Team player.
|
Informatics/Technical Analyst | 0.5 | 0.2-0.5
dependent on # of ETOR partners, test types, and volume | Implementation Collaborates with HCO to send/receive necessary artifacts and/or tests. Works with APHL Terminologist and PHL Lab SME to create test messages. Pulls reports/other artifacts or coordinates between PHL IT to do so. Reviews Service Level Agreements (SLAs) and coordinates updates as needed. Advocates for ETOR with stakeholders. Sets up connection to AIMS intermediary.
Sustaining Monitors ETOR feed and ensures data quality. Coordinates required updates and/or changes with test(s). Provides Help Desk support to PHL and HCO ETOR users (this may need to be covered by an additional resource). Troubleshoots issues and escalates as necessary with HCO and APHL counterparts. Documents ETOR troubleshooting processes and maintains technical SOPs. Reviews mapping updates in Symedical and coordinating with APHL as needed. Advocates for ETOR with stakeholders.
| Often a LIMS Administrator or IT Technical Architect Knowledge of laboratory standards preferred. Familiarity with HCO test data. Access to and experience with LIMS applications. Understanding of how to monitor data feeds (e.g., quality of data, quantity of data). Ability to maintain knowledge of NBS test updates and/or changes. Knowledge of integration engine a plus. Excellent communication and organizational skills. Team player.
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LIMS Vendor Representative - 3rd party | Dependent on LIMS capability | Dependent on LIMS capability | Implementation and Sustaining | |
In addition to the project roles defined above, the following personnel may be minimally be involved and/or impacted by the ETOR implementation: legal representation sample receiving staff/test courier, quality assurance specialist, procurement staff, and/or additional sustaining support.
Please provide contact information for the required Public Health Laboratory Roles Here: Profile Page
Healthcare Organization Roles and Responsibilities
The following roles and associated allocation will be necessary for an ETOR implementation. Depending on healthcare organization and staffing, some roles may be served by multiple individuals, or a single individual may serve in multiple roles. FTE requirements may vary based on the scope of your implementation and will be discussed.
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Please provide contact information for the required Healthcare Organization Roles Here: Profile Page
APHL Roles and Responsibilities
The assigned APHL Technical Assistance (TA) Team will be supported by a centralized team that includes architects, terminologists and engineers. The centralized team will be responsible for the intermediary configuration, while the public health laboratory focused team will be responsible for addressing public health laboratory (PHL) and healthcare organization (HCO) unique requirements, and supporting the design, documentation and updates of local systems and processes. The below includes a description of the roles that will be a part of the public health laboratory focused team.
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