Section 19.2: Policy Development and Standardization
Translating Clinical Best Practices into Enforceable System Policies.
Policy Development and Standardization
From Clinical Consensus to Code: Engineering Consistency Across the Enterprise.
19.2.1 The “Why”: Policy as the Blueprint for Standardization
In the previous section, we established the critical governance structures—the committees—that make decisions. But what is the tangible output of those decisions? How does a consensus reached in a Clinical Advisory Group meeting transform from a line in the meeting minutes into a consistent, reliable, and enforceable practice for thousands of clinicians across an entire health system? The answer is through the deliberate development and implementation of policy.
In the context of health informatics, a policy is far more than a dusty binder on a shelf. It is the official, documented embodiment of the organization’s standard of care. It is the constitution that governs the digital medication-use process. A well-crafted policy serves as the definitive source of truth, eliminating ambiguity and clinical variation where it is unsafe or inefficient. It provides the necessary authority for building standardized tools—like order sets and alerts—and creates the framework for holding users accountable to best practices. Without a strong connection between governance decisions and documented policy, even the best ideas will fail to be implemented consistently, leading to the very chaos that governance is designed to prevent.
Consider the common challenge of managing verbal orders. If there is no clear, enterprise-wide policy, every unit may handle them differently. Some may allow them for any medication, while others restrict them. The documentation process may vary. This inconsistency is a massive patient safety risk. A strong policy, developed through governance, would clearly define the limited, emergent circumstances under which verbal orders are acceptable, specify the required read-back and documentation standards, and then—critically—this policy would be used as the blueprint to design the EHR’s verbal order functionality. The policy provides the “why” and the “what”; the informatics build provides the “how.” As an informatics pharmacist, you will be a central figure in this lifecycle, acting as the bridge between clinical intent and technical implementation, ensuring that every line of code is traceable back to a vetted, approved standard of care.
Retail Pharmacist Analogy: The Corporate Policy on Controlled Substance Dispensing
Think about the most high-stakes, highly regulated process in your retail pharmacy: dispensing controlled substances. A national pharmacy chain does not leave this to the discretion of individual pharmacists. They have a comprehensive, multi-page corporate policy that governs every single step. This is their policy for standardization.
- The “Why”: The policy exists to ensure patient safety, prevent diversion, and guarantee compliance with a complex web of federal and state laws (DEA, Board of Pharmacy).
- The Development (Governance): This policy wasn’t written by one person. It was developed by a corporate committee of legal experts, loss prevention specialists, clinical pharmacists, and operations managers (a governance body). They debated every clause, from what constitutes a “red flag” to the exact procedure for inventory reconciliation.
- The Content (The Policy Itself): The policy is incredibly detailed. It specifies the ID requirements for pickup, the time limits for filling C-II prescriptions, the mandatory use of the state’s Prescription Drug Monitoring Program (PDMP), the “corresponding responsibility” checks a pharmacist must perform, and the exact documentation required if a pharmacist refuses to fill a prescription.
- The Implementation (Informatics Build): How is this policy enforced? It’s hard-coded into your dispensing software. The system won’t let you complete the transaction without entering the patient’s driver’s license number. It automatically flags prescriptions that are too old. It may even have a mandatory hard stop that requires you to document your review of the PDMP. The software is built to make it easy to follow the policy and hard to deviate from it.
The corporate policy is the blueprint. The dispensing software is the tool built from that blueprint. As a hospital informatics pharmacist, you are now one of the architects, taking the decisions from your clinical “P&T” committees and creating the institutional policies that will serve as the blueprints for the EHR.
19.2.2 The Policy Lifecycle: A Framework for Durable Standards
Effective policies are not created in a single meeting. They evolve through a structured, iterative lifecycle designed to ensure they are evidence-based, practical, and maintainable. As an informatics pharmacist, you will shepherd medication-related informatics policies through this entire process. Understanding each phase is essential for your success.
Visualizing the Policy Lifecycle
The Continuous Cycle of Policy Management
1. Drafting
Identify need, gather evidence, and create the initial version.
2. Review & Approval
Vet through relevant CAGs and obtain final sign-off from senior governance.
3. Implementation
Build the required tools in the EHR and communicate the changes to end-users.
4. Education
Train staff on the new policy and the associated EHR workflows.
5. Monitoring & Maintenance
Audit compliance, measure outcomes, and review the policy on a set schedule.
Masterclass Deep Dive: Executing Each Phase of the Policy Lifecycle
Let’s use a tangible example to walk through the lifecycle: Developing a policy for the use of “Smart Pumps” with dose error reduction software (DERS).
Phase 1: Drafting – From Vague Idea to Concrete Proposal
The need is identified: The hospital is implementing new infusion pumps with advanced safety software, but there’s no institutional standard for how they must be used.
| Action Step | Informatics Pharmacist’s Responsibility |
|---|---|
| Literature Review & Evidence Gathering | You research best practices from organizations like the Institute for Safe Medication Practices (ISMP). You find clear evidence that requiring the use of DERS for all high-risk infusions significantly reduces harmful medication errors. You also gather internal data on past IV infusion errors. |
| Stakeholder Interviews | You meet with key stakeholders: the ICU nursing manager, the med-surg education specialist, the anesthesia technicians, and the clinical pharmacy manager. You ask them: “What are your biggest concerns about the new pumps? What parts of the workflow do we absolutely need to standardize?” |
| Drafting the Initial Policy | You synthesize all this information into a structured draft policy. You don’t start from scratch; you use the hospital’s standard policy template. The draft includes sections on Purpose, Scope (which units/meds it applies to), and specific procedural steps. |
Phase 2: Review & Approval – Forging Consensus
Your draft is just a starting point. Now it must be vetted by the collective wisdom of the clinical staff through the formal governance process.
| Action Step | Informatics Pharmacist’s Responsibility |
|---|---|
| Presentation to Pharmacy & Med Safety CAG | You present the draft policy to the P&M Safety CAG. You walk them through the evidence and the proposed procedures. A vigorous debate ensues. The ICU nurse points out a workflow conflict. The physician asks for an exception for emergencies. You facilitate this discussion. |
| Revision and Iteration | Based on the CAG’s feedback, you revise the policy. You add a clearly defined “emergency override” procedure and clarify the workflow for titratable drips. You bring the revised version back to the next CAG meeting. |
| Escalation for Final Approval | Once the P&M Safety CAG reaches consensus and formally approves the policy, it is submitted to the higher-level Clinical Governance Committee for final, official sign-off. Your Director of Pharmacy will likely present it, but you will be there as the subject matter expert to answer detailed questions. |
Phase 3, 4, & 5: Implementation, Education, and Monitoring
With an approved policy, your work shifts from consensus-building to execution.
| Phase | Action Step | Informatics Pharmacist’s Responsibility |
|---|---|---|
| Implementation | Drug Library Build | This is a massive informatics task. You work with your team to build the entire drug library for the smart pumps, ensuring every entry’s dosing limits, concentrations, and alerts directly reflect the approved policy. This is the technical enforcement of the standard. |
| EHR Integration Build | You work with IT analysts to ensure the EHR can wirelessly transmit infusion orders to the pump and receive documentation back, a process called interoperability. You design the EHR alerts that will prompt nurses to use the DERS library. | |
| Education | Develop Training Materials | You create tip sheets, newsletter articles, and presentation slides that explain not just *how* to use the pumps, but *why* the policy requires it. You frame it around patient safety. |
| Train the Trainers | You conduct training sessions for the nursing education department and the pharmacy super-users, equipping them to teach their colleagues the new policy and workflow. | |
| Monitoring & Maintenance | Audit & Compliance Tracking | After go-live, you use the pump’s data analytics software to track compliance rates with the DERS library. You create a monthly dashboard showing compliance by unit and identify areas that need re-education. You also track “good catches”—alerts that fired and prevented a potential error. |
| Scheduled Policy Review | Hospital policies are not static. Your Smart Pump policy should have a scheduled review date (e.g., every 2 years). When that date arrives, you are responsible for bringing the policy—along with all your compliance and outcome data—back to the P&M Safety CAG to determine if any updates are needed. |
The Golden Thread: Linking Policy, Practice, and Performance
A mature governance and policy management program creates a “golden thread” that is visible and defensible during an audit or survey (e.g., by The Joint Commission). An auditor might ask:
Auditor: “How do you ensure safe administration of IV insulin?”
Your Answer (following the golden thread):
“Our approach is governed by our (1) High-Risk Infusion Policy, which mandates the use of smart pumps with DERS for all insulin drips. This policy was developed and approved by our multidisciplinary Pharmacy and Medication Safety Committee. That policy provided the blueprint for our (2) EHR and Smart Pump build; as you can see, our standard insulin order set defaults to concentrations that match our pump library, and nurses are prompted to scan the patient and the pump before starting the infusion. Finally, we continuously monitor (3) performance and compliance with this policy. This dashboard shows our DERS compliance rate for insulin drips is 98.5% for the last quarter, and here are three documented cases where the pump’s hard limit prevented a tenfold overdose.”
This is the pinnacle of a high-reliability organization: a clear policy, translated into standardized practice through technology, and validated by performance data.