CPIA Module 16, Section 1: Readiness Assessments and Go-Live Planning
MODULE 16: IMPLEMENTATION & GO-LIVE STRATEGIES

Section 1: Readiness Assessments and Go-Live Planning

The masterclass in measurement, verification, and planning that separates a smooth launch from a chaotic failure.

SECTION 16.1

Readiness Assessments and Go-Live Planning

From Final Checks to Flawless Execution: Mastering the Art of the Launch.

16.1.1 The “Why”: The Pharmacist’s Oath of Prevention

In pharmacy, your entire professional ethos is built upon a foundation of prevention. You prevent medication errors through meticulous verification. You prevent adverse drug events through proactive counseling. You prevent disease progression through adherence monitoring. Every action is a calculated step to mitigate a future risk. The go-live readiness phase is the informatics equivalent of this sacred duty. It is the final, most critical stage of risk prevention for the entire project.

Months, or even years, of planning, building, and testing have led to this moment. The temptation can be immense to rush across the finish line, to declare victory and flip the switch. This is a catastrophic error in judgment. A premature go-live, launched without exhaustive readiness verification, is not a celebration; it is an act of institutional malpractice. It knowingly introduces unmitigated risks into the live patient care environment. It is the equivalent of dispensing a high-risk medication without a final check, but on a scale that can impact every patient in the hospital.

This section is dedicated to the systematic, evidence-based processes that ensure a project is truly ready for deployment. We will deconstruct the tools that transform the go-live decision from a hopeful gamble into a data-driven conclusion. We will cover the Go/No-Go Checklist, the non-negotiable list of criteria that must be met. We will perform a deep dive into Final Validation Testing, the last line of defense against system and workflow failures. And we will master the creation of a Cutover Plan, the minute-by-minute script that orchestrates one of the most complex operational events a hospital can undertake. Your diligence in this phase does not just ensure a smoother launch; it upholds your fundamental oath to protect patient safety above all else.

Retail Pharmacist Analogy: The Overnight System Conversion

Imagine your pharmacy chain has announced a massive, mandatory upgrade. You are moving from your old, familiar pharmacy management system to a brand-new, state-of-the-art platform. The conversion is scheduled to happen overnight, between closing at 9 PM on a Saturday and reopening at 9 AM on Sunday. This is your project’s go-live.

What does readiness look like? It is not simply showing up on Sunday morning hoping for the best. True readiness is a multi-week, systematic process that you, as the pharmacy manager, must lead.

  • Go/No-Go Checklist: Weeks before, you have a checklist from corporate. Has all staff completed the mandatory 8 hours of online training? (Training Completion). Have the new servers, scanners, and signature pads been installed and tested? (Hardware Deployment). Did the test data conversion of your patient profiles, sig codes, and doctor files complete with less than a 0.1% error rate? (Data Migration Validation). Has the new system been certified to connect to the state’s Prescription Drug Monitoring Program (PDMP)? (Interface Testing). You hold a meeting with your lead technicians a week before the launch. If any of these critical items are not checked off, you escalate a “No-Go” risk to your district manager.
  • Final Validation Testing: The week before, corporate provides a “sandbox” version of the new system with your pharmacy’s data. You and your team spend hours performing a “Day in the Life” test. You don’t just log in; you run through real-world scripts. You process a new C-II prescription, a third-party rejection, a partial fill, a return-to-stock, and a complex compounded prescription. You discover that the sig code for “take one tablet by mouth every 4 to 6 hours as needed for pain” doesn’t translate correctly and prints gibberish on the label. This is a critical finding that must be fixed before go-live.
  • Cutover Plan: You create a detailed, hour-by-hour plan for Saturday night.
    • 9 PM: Final patient-facing transaction.
    • 9:30 PM: Run final end-of-day reports on the old system.
    • 10 PM: Technician team confirms final backup of the old system is complete.
    • 10:30 PM: Corporate IT begins the final data migration.
    • 2 AM: IT confirms migration is complete. You and your team log into the new system. You perform a “smoke test”—can you pull up three specific test patients? Is their allergy information correct?
    • 2:30 AM: You process a test claim through the new system. Does it adjudicate?
    • 3 AM: You print a test label. Does it print to the correct printer with the correct formatting?
    • …and so on, until 9 AM.

This meticulous, exhaustive preparation is the difference between opening on Sunday to a line of angry patients and a system that doesn’t work, versus a controlled, manageable first day on a powerful new platform. That is the essence of go-live planning.

16.1.2 The Go/No-Go Decision Framework: Your Shield Against Premature Launch

The Go/No-Go meeting is one of the most formal and crucial milestones in any project lifecycle. It is a high-stakes meeting where key stakeholders, led by the project manager and including clinical informatics leaders like yourself, formally review the project’s status against a pre-defined set of readiness criteria. The outcome is a binary decision: “Go” (we proceed with the launch as planned) or “No-Go” (we postpone the launch to remediate critical outstanding issues). This is not a meeting for subjective feelings or optimism; it is a court of evidence, and the Go/No-Go checklist is the primary exhibit.

As the pharmacy informatics lead, your voice in this meeting is paramount for medication-use systems. You are the clinical conscience, the patient safety advocate who must speak with authority on whether the system is truly safe and the staff is truly prepared. Your sign-off indicates that you are confident that the new system or workflow will function as intended and that the risks to patient care are identified and manageable.

The Purpose of the Go/No-Go Meeting

The Go/No-Go meeting is not for problem-solving. It is too late for that. The purpose is to:

  • Review Data, Not Opinions: Present metrics and statuses against the checklist. The question isn’t “Do we feel ready?” but “Does the data show we are ready?”
  • Formalize Accountability: Each functional lead (Pharmacy, Nursing, Lab, IT, etc.) must formally sign off on their area’s readiness. This ensures accountability.
  • Make a Conscious, Defensible Decision: The decision to proceed or delay is documented, along with the rationale. If an issue occurs post-launch, this documentation is critical for understanding the decision-making process.

Masterclass Table: The Comprehensive Go/No-Go Checklist for a CPOE/Pharmacy System Implementation

Below is an exhaustive example of a Go/No-Go checklist. For a real project, this would contain hundreds of items. Your responsibility is to own, verify, and report on every item within the “Pharmacy & Medication Management” domain.

Category Checklist Item Success Criteria (Definition of “Done”) Status Owner Critical Notes & Red Flags
Technical Readiness System Build Complete & Frozen All configuration and build activities for the go-live scope are 100% complete. A “code freeze” is in effect; no further changes are permitted without emergency change control approval. GO IT Lead Red Flag: Any outstanding build items or late-breaking change requests. An unstable build is a guaranteed No-Go.
Integrated Interface Testing All critical interfaces (ADT, Billing, Labs, MAR, ADC) have passed end-to-end testing with a 99.5%+ success rate. All identified showstopper defects are resolved. GO Integration Lead Your job is to ensure pharmacy-specific messages (e.g., order messages to ADCs, dispense messages to the carousel) were explicitly tested. A “general” pass is not sufficient.
Data Migration Validation Final, full-load data migration test completed in the production-like environment. Key data elements (formulary file, patient allergies, clinical alerts) have been manually audited by subject matter experts and signed off as accurate. Error rate is <0.1%. GO Pharmacy Informatics This is your domain. You must personally verify that high-risk drug files (e.g., heparin protocols, TPN compounder definitions) migrated perfectly. One wrong decimal can be catastrophic.
Hardware & Device Deployment All end-user hardware (workstations, printers, barcode scanners) are physically installed, configured, and have passed unit testing in their go-live location. 100% of devices are accounted for. GO (With Risk) Desktop Support Risk: 3 scanners in the ICU are still pending installation. Mitigation plan in place to use backup devices for 24 hours. You must assess if this risk is acceptable.
Backup & Recovery Test A full backup of the new production system has been completed and a successful restore has been demonstrated in a test environment. The downtime procedure has been documented and timed. GO System Admin Non-negotiable. Without a proven ability to recover the system, a go-live is reckless.
Operational & Clinical Readiness End-User Training Completion >95% of all impacted clinical staff (pharmacists, technicians, nurses) have completed all required training modules and competency assessments. GO Training Lead Dig into the numbers. Is the 5% who haven’t completed training all in one critical department? That’s a bigger risk than 5% spread evenly.
Super-User Identification & Readiness All departments have identified super-users for 24/7 go-live support coverage. Super-users have completed advanced training and participated in support readiness drills. The support schedule is published. GO Clinical Leadership You must confirm the pharmacy has designated, trained, and scheduled super-users for every shift, including overnight.
“Day in the Life” (DITL) Workflow Validation All high-risk, high-volume pharmacy workflows have been successfully demonstrated in the test environment by end-users. Scenarios include IV batch, cart fill, new order verification, controlled substance handling, and stat order processing. All critical issues resolved. GO Pharmacy Informatics This is your final clinical sign-off. If you are not comfortable with the performance of these core workflows, you must advocate for a No-Go.
Policy & Procedure Updates All supporting policies and procedures (e.g., Downtime Procedures, Med Rec Policy) have been updated, approved by committee, and published for staff access. GO Pharmacy Leadership Policies must be ready before go-live, not after. Staff need this documentation as a reference from hour one.
Go-Live Support Plan Finalized The Command Center is physically set up, the issue tracking process is defined, and the 24/7 support schedule for at-the-elbow support is fully staffed and published. GO Project Manager Confirm that pharmacy has dedicated informatics support scheduled for the Command Center for the first 72 hours.
Project Management Readiness Vendor Confirmation The primary software vendor has formally confirmed their go-live support staffing, including on-site resources and remote technical support escalation paths. The vendor PM has signed off on readiness. GO Project Manager Get this in writing. Vague promises of support are not enough.
Go/No-Go Decision All stakeholders have reviewed the checklist and formally agree to proceed. Decision is documented in meeting minutes. PENDING Project Sponsor This is the final item, checked off at the conclusion of the Go/No-Go meeting itself.

16.1.3 Final Validation Testing: The Pharmacist’s Masterclass in Verification

In your pharmacy practice, verification is an active, cognitive process, not a passive checkmark. You don’t just confirm a prescription is present; you confirm it’s the right drug, right dose, right patient, right time, and right route. Final validation testing requires this same level of deep, clinical scrutiny. It’s not about re-doing all the testing from the past year; it’s about a final, integrated confirmation that all the pieces work together in a way that is safe and effective for real-world clinical practice.

Your role shifts from builder and tester to the ultimate quality assurance auditor. You will design, witness, and evaluate testing scenarios that mirror the complexity and chaos of a real hospital day. This is the final opportunity to catch critical errors before they have the chance to cause patient harm.

Integrated System Testing (IST): The End-to-End Journey

IST is where we confirm that the digital dominoes fall correctly. A single action by a physician should trigger a cascade of accurate data flow across multiple, independent systems. As a pharmacist, your focus is on the entire medication use lifecycle. You must champion test scripts that follow a single medication order from its conception to its administration and billing.

Consider the journey of a single order for “Vancomycin 1g IV Q12H”:

1. Order Entry (CPOE)

Provider enters order. Does the system correctly trigger the “renal dosing required” alert? Is the order associated with the correct diagnosis (e.g., Pneumonia)?

2. Pharmacy Verification

Does the order appear in the correct pharmacy queue? When the pharmacist verifies it, does it correctly decrement from the virtual inventory?

3. ADC Dispense

Does the verification message transmit to the Automated Dispensing Cabinet on the patient’s floor? Can the nurse select the correct patient and access the medication?

4. eMAR Administration

Does the order appear correctly on the patient’s electronic Medication Administration Record? Does barcode scanning of the patient wristband and the medication work as expected?

5. Billing & Labs

Upon administration, does a charge drop to the billing system? When the trough level is drawn, does the lab result interface back into the patient’s chart and display correctly?

A failure at any one of these steps is a critical system failure. A successful IST script validates the entire chain, proving that the technical integrations are sound.

“Day in the Life” (DITL) Testing: Simulating Reality

While IST validates the data flow, DITL testing validates the human workflow. This is arguably more important and is where your clinical expertise is irreplaceable. You must assemble real clinicians—pharmacists, technicians, nurses—in a room and have them run through their most common and most complex daily tasks in the new system. This is not a training session; it’s a dress rehearsal for the go-live. You are looking for awkward workflows, missing information, and points of confusion that could lead to errors under pressure.

The Critical Flaw of “Happy Path” Testing

A common failure in testing is to only test the “happy path”—where everything goes perfectly. A new order is entered correctly, the drug is in stock, the patient has no allergies. This is useless. DITL testing must embrace chaos. You must design scenarios that test the exceptions and the workarounds. What happens when the scanner breaks? What happens when a physician enters an ambiguous order? What is the workflow for a patient’s home medication that is not on formulary? These “unhappy paths” are where the real safety risks lie.

Masterclass Table: Pharmacy DITL Scenarios
Scenario ID Scenario Title Actors High-Level Steps Key Verification Points
PHARM-DITL-01 STAT First Dose Verification & Dispense ED Physician, Pharmacist, ED Nurse 1. MD enters STAT order for ceftriaxone in CPOE.
2. Pharmacist receives and verifies order from STAT queue.
3. Pharmacist sends dispense message to ED ADC.
4. Nurse removes med from ADC and administers on eMAR.		 – Does the order generate an audible/visual alert in the pharmacy system?
– Is the turnaround time from order to verification measurable?
– Does the barcode on the ADC-dispensed dose match the eMAR?
PHARM-DITL-02 Heparin Drip Protocol Order & Titration ICU Physician, Pharmacist, Lab Tech, ICU Nurse 1. MD orders the “Heparin Drip for VTE” protocol.
2. Pharmacist verifies the order, including the initial bolus and infusion rate.
3. Lab tech results a 6-hour PTT.
4. Nurse accesses the protocol on the eMAR, finds the new rate based on the PTT result, and titrates the infusion.		 – Does the protocol order set contain all the necessary components (bolus, infusion, labs)?
– Does the PTT result display clearly for the nurse in the eMAR?
– Does the system allow the nurse to correctly document the rate change?
PHARM-DITL-03 Controlled Substance Discrepancy Resolution Floor Nurse, Pharmacy Technician, Pharmacist 1. Nurse performs a cycle count on an ADC and finds a discrepancy for morphine.
2. Nurse documents the discrepancy in the ADC.
3. The discrepancy report is generated and reviewed by the pharmacy tech.
4. Pharmacist investigates and resolves the discrepancy in the pharmacy system.		 – Does the ADC system force the nurse to document a reason for the discrepancy?
– Are the reports from the ADC and the pharmacy system clear and easy to reconcile?
– Is there a clear audit trail of who resolved the issue and when?
PHARM-DITL-04 Medication Reconciliation on Admission Admitting Nurse, Hospitalist Physician, Pharmacist 1. Nurse takes a home medication list from the patient.
2. MD reviews the list, makes decisions to continue/hold/discontinue, and signs the admission med rec.
3. Pharmacist reviews the completed med rec, verifies the inpatient orders, and clarifies any ambiguities.		 – Can the system pull in data from a retail PBM?
– Is the user interface for the physician clear on which medications are being ordered?
– Is there a dedicated queue or task list for pharmacists to review completed reconciliations?

16.1.4 Crafting the Cutover Plan: The Go-Live Execution Script

The cutover plan is the single most important document for the go-live event itself. It is a highly detailed, time-sequenced script of every single task that must be performed to transition from the old system(s) to the new one. This is not a high-level summary; it is a granular, checklist-style document that can have hundreds or even thousands of lines. It choreographs the actions of dozens of people across technical and operational teams, often during a high-pressure overnight downtime window.

As a pharmacy informaticist, you will be a key contributor and a primary executor of this plan. You will be responsible for defining, sequencing, and performing all tasks related to the pharmacy system shutdown, data validation, and startup. A well-crafted cutover plan minimizes downtime, reduces the risk of missed steps, and provides a clear framework for communication and decision-making during the event.

Key Principles of a Great Cutover Plan
  • No Ambiguity: Each task must have a clear description, a single owner, and a specific start/end time. “Check pharmacy system” is a bad task. “Pharmacist Jane Doe to log into production, search for test patient ZZZ_TEST, and confirm allergy field populates” is a good task.
  • Dependencies Mapped: The plan must show dependencies. Task B cannot start until Task A is complete. This is crucial for managing the critical path.
  • Verification is Everything: Every major technical task should be followed by a validation task. “Start ADT interface” must be followed by “Verify patient admission message flows from registration to pharmacy system.”
  • Includes Communication Steps: The plan should explicitly state when and what to communicate. “1:00 AM: Email ‘Downtime Has Begun’ to All Staff DL.” “4:30 AM: Announce ‘System is Available for Super-User Validation’ on conference bridge.”
  • Defines the Rollback Point: The plan must have a pre-defined “point of no return” and clear triggers for a rollback decision.

Masterclass Template: The Go-Live Cutover Plan

This table represents a snippet of a full cutover plan, focusing on the pharmacy-centric tasks. Note the level of detail required for each entry.

ID Time Block Task Description Owner Dependencies Verification / Completion Criteria Status
100 Phase 1: Pre-Downtime (Friday 21:00 – Saturday 01:00)
101 Fri 21:00 Send final “Go-Live Downtime Begins in 4 Hours” communication page to all staff. Project Manager – Page is confirmed as sent by communications operator. Done
102 Fri 23:00 Pharmacy staff completes final cart fill from legacy system for the morning medication pass. Pharmacy AM Lead – Lead tech signs off on paper form that fill is complete. Done
200 Phase 2: System Downtime & Cutover (Saturday 01:00 – 05:00)
201 Sat 01:00 LEGACY SYSTEM SHUTDOWN. Disable all user access to the old pharmacy system. IT System Admin 102 Admin confirms login attempts are rejected. Done
202 Sat 01:15 Perform final backup of legacy pharmacy database. DBA Team 201 Backup job completes successfully with checksum verification. Done
203 Sat 02:00 BEGIN FINAL DATA MIGRATION. Execute scripts to migrate all patient, order, and formulary data to the new system. IT Data Team 202 Migration script runs to completion. Error log generated. Done
204 Sat 03:30 PHARMACY DATA VALIDATION. Pharmacy Informatics team performs spot-checks on migrated data. Pharm Informatics (John) 203 Checklist of 20 critical drugs, 5 complex order sets, and 10 test patients is verified as 100% accurate. Sign-off provided to PM. In Progress
205 Sat 04:00 NEW SYSTEM STARTUP. Bring all production servers and application services online. IT System Admin 204 All system services show as “Running” in monitoring dashboard. Not Started
300 Phase 3: Validation & Go-Live (Saturday 05:00 – 07:00)
301 Sat 05:00 TECHNICAL SMOKE TEST. IT team logs into the new system to confirm basic functionality. IT Lead 205 Able to log in, search for a patient, and access system admin menus. Not Started
302 Sat 05:15 INTERFACE STARTUP & VALIDATION. Enable ADT, Pharmacy, and Lab interfaces. Integration Lead 301 Test patient admitted in registration system appears in the new pharmacy system within 60 seconds. Not Started
303 Sat 05:45 CLINICAL VALIDATION. Super-user teams begin running test scripts in the live production environment on test patients. Super-User Leads 302 All P1 (Priority 1) validation scripts must pass. Pharmacy team must successfully process a test STAT order from CPOE to ADC dispense. Not Started
304 Sat 06:45 GO DECISION FOR USER ACCESS. Command Center Lead confirms successful validation and gives the “GO” to open system for all users. Project Sponsor 303 Verbal GO given on the command center bridge. Not Started
305 Sat 07:00 GO-LIVE. All users are notified that the new system is live and available for patient care. Downtime is officially over. Project Manager 304 “Go-Live is Complete” communication sent. Not Started