Table 1. . Description of initial Pharmacogenomic Testing for Veterans program resources evaluated as part of the first Plan-Do-Study-Act cycle.
Program phase and process step | Site-specific resources | National PHASER Program Office resources | Sanford Health resources | Resource user(s) |
---|---|---|---|---|
Preimplementation phase steps | ||||
1. Build buy-in from site leadership | Site leadership personnel | • PHASER program overview presentation • Available for discussion with site leadership • Sample test result report • Documentation of validation of laboratory testing, VA Ethics assessment, nonresearch determination by VA • Flow diagram for PGx samples and orders |
None | Site leadership |
2. Identify site champion | Site champion personnel | • Discussion with incumbent champion and/or site leadership • Description of roles and responsibilities |
None | Site leadership, site champion |
3. Identify optional site coordinator† | Site coordinator personnel | • Description of roles and responsibilities • Funding for site coordinator (12 months 0.5 full-time equivalent) |
None | Site coordinator |
4. Confirm site participation | Documentation of leadership commitment | • Draft site commitment letter | None | Site leadership, site champion |
5. Lab setup for PGx testing | Lab personnel, equipment and space | • Guides on setting up lab workflow with Sanford Health • End-to-end testing with dry run |
Personnel, equipment, space | Labs, Sanford Health |
6. EMR setup for PGx testing | LIM and CAC personnel, computer equipment | • Health informatics setup guides • Installation guides for clinical decision support tools • Workflow to store PGx reports within the health information system • End-to-end testing with dry run |
Personnel, equipment, space | LIM, CAC, Sanford Health |
7. Develop plan to engage providers and patients in program† | Develop roll-out plan | • Discussion with sites about their roll-out plan as needed | None | Site champions, site coordinators |
Implementation phase steps | ||||
1. Educate providers, provide support† | In-service meetings, tailor or create program materials | • PHASER listserv (for provider engagement) • Monthly news letter/off-cycle articles • Resources kept on an internal website • YouTube videos about program procedures • Executive medication summaries |
None | Providers |
2. Veterans receive optional preappointment mailings† | Tailor or create new materials | • Preappointment mailing introductory letter • Pretesting brochure • Sample PGx report • YouTube video • VA PHASER website |
None | Veterans |
3. Providers consent Veterans for PGx testing | None | • EMR tool to capture patient’s decision • Information sheet about the consent process |
None | Providers |
4. Patients submit blood sample | Blood sample collected | • Forms for blood sample submission | None | Labs |
5. Sites ship blood samples to Sanford Health for processing | Ship blood samples to Sanford Health | None | None | Labs |
6. Sanford Health processes blood samples and generates genetic test results | None | None | Personnel, PGx tests, reagents, equipment, PGx reports | Sanford Health |
7. Sanford Health distribute PGx results back to VA sites | Workflow to receive PGx results | None | Personnel to send PGx reports to sites | Site coordinator, site champion, Sanford Health |
8. Sites integrate PGx results into the EMR system for future use and mailed to patients | Personnel to enter PGx results in EMR and mail patients copy of report | • Quality control checks on PGx results entered into the EMR | None | Site coordinator, site champion |
Steps of the implementation process where sites have the flexibility to tailor proposed strategies from the national PHASER Program Office to ensure optimal adoption of the program occurs at the local level.
CAC: Clinical application coordinator; EMR: Electronic medical records; LIM: Laboratory information manager; PGx: Pharmacogenomic; PHASER: Pharmacogenomic Testing for Veterans; VA: Veterans Affairs.