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MODULE 25: RISK MANAGEMENT, AUDITS, AND LEGAL SAFEGUARDS
Section 25.5: Governance and Policy Maintenance for Ongoing Safety
Explore the mechanisms for long-term risk management, including the role of a clinical governance committee and the process for regularly reviewing and updating all policies and procedures.
SECTION 25.5
Governance and Policy Maintenance for Ongoing Safety
Building a Living Framework for Durable, Proactive Risk Management.
25.5.1 The “Why”: From Static Rules to a Dynamic Safety System
In many organizations, policies and procedures are treated as static artifacts. They are created during the launch of a new service, approved by a committee, and then filed away in a shared drive, rarely to be seen again until an auditor asks for them. This “set it and forget it” mentality is one of the most significant latent threats to a clinical practice. A policy that is not actively maintained, reviewed, and adapted becomes a historical document, not a functional safety tool. Over time, it grows dangerously disconnected from the realities of current clinical practice, emerging evidence, new technologies, and evolving regulations.
As a CCPP, you are not just a user of policies; you are a steward of them. You are responsible for ensuring that the foundational documents that govern your practice—your CPA, your scope of practice, your clinical protocols—are not just compliant on paper, but are living, breathing frameworks that actively promote safety and quality. This requires a fundamental shift in perspective: from viewing policies as a bureaucratic hurdle to be cleared once, to seeing them as the central operating system for your clinical service, requiring regular updates, patches, and maintenance to function optimally.
This final section of our risk management module provides the blueprint for building this dynamic system of safety. We will explore the concept of clinical governance—the formal structure that provides oversight and accountability for your practice. You will learn how to establish a robust, scheduled process for policy review that goes far beyond a simple rubber stamp. We will dissect the dangers of “practical drift” and the normalization of deviance, where well-intentioned workarounds slowly erode the safety margins built into your protocols. Ultimately, this section is about ensuring the long-term viability and safety of your CCPP service. It is the work that happens “behind the scenes” that makes excellent, sustainable patient care possible on the front lines.
Pharmacist Analogy: The Annual Wellness Visit for Your Clinical Practice
Imagine a complex patient with diabetes, hypertension, and heart failure whom you have managed for years. When you first started seeing them, you created a comprehensive medication action plan. It was perfect—based on the guidelines, the patient’s labs, and their preferences at that time.
Now, imagine if you never reviewed that plan again. For five years, you simply kept refilling the same medications at the same doses. What would happen?
- Clinical Guidelines Would Change: New landmark trials would be published. SGLT2 inhibitors and GLP-1 agonists would emerge as the standard of care for cardiovascular risk reduction, but your patient would still be on an older, less effective regimen.
- The Patient’s Condition Would Evolve: Their renal function might decline, requiring dose adjustments or discontinuation of certain drugs. Their blood pressure might creep up, necessitating a new agent.
- New Risks Would Emerge: A new medication might be added by another specialist, creating a serious drug interaction with their existing regimen that you would never catch.
- “Practical Drift” Would Occur: The patient, on their own, might have started splitting their tablets to save money or taking a diuretic only on days they feel “puffy”—dangerous deviations from the plan that you would be unaware of.
Of course, no competent clinician would ever manage a patient this way. You instinctively know that you must conduct regular follow-up visits—an “annual wellness visit” at minimum—to reassess, re-evaluate, and update the plan based on new data and new evidence. Your Collaborative Practice Agreement and its associated policies are the “medication action plan” for your entire clinical service. Clinical governance and a formal policy review cycle are the “annual wellness visit” for your practice. It is the scheduled time to check the “vital signs” (quality metrics), review the “labs” (incident reports), screen for “new conditions” (regulatory changes), and ensure the treatment plan (your policies) is still the safest, most effective, and most evidence-based approach possible.
25.5.2 The Engine Room: Establishing a Clinical Governance Framework
Effective, ongoing safety management cannot be an ad-hoc process left to the initiative of a single dedicated individual. It requires a formal, recognized structure with defined authority, membership, and responsibilities. This structure is known as a Clinical Governance Committee. While the name may vary (e.g., “Ambulatory Pharmacy Oversight Committee,” “CCPP Quality Council”), its function is universal: to provide a multidisciplinary forum for the ongoing oversight of the advanced pharmacy practice services.
For a CCPP service, this committee is the engine room. It is where data is turned into information, information into insight, and insight into action. It is the body that holds the practice accountable to the standards set by regulators, the institution, and the profession itself. Establishing or integrating into such a committee is a hallmark of a mature and sophisticated CCPP program.
Masterclass Table: Core Functions of a CCPP Governance Committee
| Core Function | Description | Key Activities & Agenda Items |
|---|---|---|
| Policy & Protocol Oversight | The committee is the official owner and approver of all CPAs, scope of practice documents, and clinical protocols governing the CCPP service. | – Annual (or biennial) review and re-approval of all active CPAs. – Review and approval of any new proposed CCPP services or protocols. – Analysis of new state legislation or BOP regulations to ensure all policies remain compliant. |
| Quality & Safety Monitoring | The committee systematically reviews data to assess the performance and safety of the CCPP service. It is the primary forum for translating data into QI projects. | – Quarterly review of key performance indicators (KPIs), such as A1c reduction rates, percentage of patients at BP goal, or anticoagulation time-in-therapeutic-range (TTR). – Review of all event reports (complaints, near misses, ADEs) related to the CCPP service. – Commissioning and oversight of formal quality improvement projects (e.g., PDSA cycles). |
| Credentialing & Privileging | The committee is responsible for verifying the qualifications of pharmacists and recommending the granting of clinical privileges to practice under a CPA. | – Reviewing the credentials (licensure, training, certifications like CCPP) of any new pharmacist joining the service. – Establishing a process for Ongoing Professional Practice Evaluation (OPPE) and Focused Professional Practice Evaluation (FPPE) for all privileged pharmacists. – Recommending renewal of privileges on a regular cycle (e.g., every two years). |
| Peer Review & Event Analysis | When a significant event or concern arises, this committee serves as the formal, non-punitive body for conducting peer review and overseeing the Root Cause Analysis process. | – Convening a subcommittee to perform an RCA for any significant adverse event. – Reviewing the findings of the RCA and approving the final Corrective and Preventive Action (CAPA) plan. – Tracking the implementation and effectiveness of all CAPA plans. |
Building the Team: Ideal Composition of the Governance Committee
The strength of a governance committee lies in its multidisciplinary perspective. It should never be a committee of only pharmacists. Bringing together clinical, administrative, and safety leaders ensures that decisions are well-rounded and have the broad-based support needed for successful implementation.
Physician Champion (Co-Chair)
A key collaborating physician who is a respected leader and advocate for the CCPP service.
Lead CCPP / Pharmacy Manager (Co-Chair)
The operational leader of the CCPP service, responsible for day-to-day management and performance.
Service Line Administrator
A non-clinical leader who can provide financial and operational context and remove administrative barriers.
Quality & Patient Safety Officer
An expert in safety science, event investigation, and quality improvement methodologies.
Frontline CCPP Staff Member
A rotating position to ensure the voice and practical experience of the clinicians doing the work are represented.
Clinical Informatics/IT Liaison
An essential member to provide expertise on EMR functionality, data extraction, and clinical decision support tools.
25.5.3 The Policy Lifecycle: A Playbook for Continuous Readiness
A policy is not a static document. It has a life cycle that requires active management. Establishing a formal, predictable process for this cycle ensures that your governing documents never become obsolete. This process transforms policy maintenance from a dreaded, chaotic scramble into a routine, value-added activity.
The Six Phases of Policy Management
1. Creation/Revision: A new policy is drafted, or an existing one is revised, in response to a specific need (a new service, a regulatory change, findings from an event review).
2. Review: The draft is circulated to key stakeholders (frontline staff, physicians, administrators) for feedback on clinical accuracy, operational feasibility, and clarity.
3. Approval: The final draft is presented to the formal Clinical Governance Committee for discussion, potential amendment, and official approval.
4. Implementation & Education: The newly approved policy is published to a central repository. All affected staff are formally educated on the changes, and any necessary workflow or EMR adjustments are made.
5. Monitoring & Auditing: The organization actively monitors for adherence to the new policy through data analysis and the internal audit process (as described in Section 25.2).
6. Scheduled Re-evaluation: The policy is automatically added to the Governance Committee’s agenda for a full re-review at a pre-determined interval (e.g., annually for high-risk policies, every two years for others), at which point the cycle begins again.
Masterclass Tool: The Annual CPA & Protocol Review Checklist
Use this comprehensive checklist during your scheduled policy re-evaluation to conduct a thorough and effective review. The goal is to challenge every assumption and ensure the document is still fit for its purpose.
| Category | Review Question | Findings & Recommended Action |
|---|---|---|
| Part 1: Regulatory & Legal Alignment | ||
| State Law & BOP Rules | Have there been any changes to the state’s Pharmacy Practice Act or BOP regulations in the past year that affect our scope of practice, CPA requirements, or supervision rules? | |
| Federal Regulations | Have there been any changes in CMS or other federal rules (e.g., related to billing, privacy) that impact our documentation or practice? | |
| Part 2: Clinical Evidence & Best Practices | ||
| Guideline Congruence | Are the clinical recommendations in our protocol (e.g., target A1c, first-line antihypertensive) still aligned with the latest major national guidelines (e.g., from ADA, ACC/AHA)? | Action: Update BP target from <140/90 to <130/80 per new guidelines. |
| Formulary Alignment | Does our protocol recommend agents that are still on our health system’s formulary? Have there been changes to preferred agents that should be reflected? | |
| New Safety Information | Have any new black box warnings, major drug interactions, or safety advisories been issued for medications included in our protocol? | |
| Part 3: Internal Data & Performance Review | ||
| Event Reports | Have any patient complaints, near misses, or adverse events from the past year revealed a weakness, ambiguity, or gap in our current policy? | Action: Add specific guidance on sick day management for SGLT2i users based on recent euglycemic DKA event. |
| Internal Audits | Did our internal documentation audits reveal consistent misunderstandings or deviations from the policy that suggest the policy needs to be clarified or simplified? | |
| Clinician Feedback | What is the feedback from the frontline CCPPs and collaborating physicians? Are there parts of the protocol that are consistently confusing, inefficient, or difficult to follow in practice? | |
25.5.4 The Silent Danger: Identifying and Correcting “Practical Drift”
One of the greatest challenges in maintaining a safe practice is a phenomenon known as “practical drift” or the “normalization of deviance.” This is the slow, often invisible, and usually well-intentioned erosion of formal policy in the face of real-world pressures. It starts with a small, seemingly harmless workaround to save time or solve a minor inefficiency. Over time, as nothing bad happens, that workaround is adopted by others and becomes the new, unwritten “normal” way of doing things. The gap between the “work-as-imagined” (what the policy says) and the “work-as-done” (what actually happens) grows wider and wider, silently eroding safety margins until a unique combination of circumstances leads to a catastrophic failure.
Anatomy of Drift: The Shortcut Becomes the Standard
Let’s see how this can happen in a CCPP clinic.
- Policy (Work-as-Imagined): “The CCPP will obtain verbal confirmation from the collaborating physician before initiating any high-risk medication, such as an SGLT2 inhibitor, and will document this confirmation in the EMR.”
- The Pressure: Dr. Smith is incredibly busy and often hard to reach by phone. Waiting for a callback can delay therapy for a patient by a day or more.
- The First Deviation: A CCPP, knowing Dr. Smith trusts their judgment, decides to just send an EMR message: “Plan to start empagliflozin, please co-sign if you agree.” This seems more efficient. Nothing bad happens.
- The Drift: Other CCPPs see this works well and adopt the practice. It becomes the new team norm.
- The Normalization of Deviance: New CCPPs joining the team are taught, “We just send an EMR message; the policy about a phone call is outdated.” The unsafe shortcut is now the accepted standard.
- The Latent Failure: The system now relies entirely on the physician seeing and responding to an EMR message in a timely manner. The interactive safety check of a real-time verbal conversation has been eliminated.
- The Accident: Dr. Smith is on vacation, and his EMR messages are being covered by a partner who is unfamiliar with the clinic’s unofficial workflow. The CCPP starts an SGLT2i on a patient with borderline renal function, sending the standard EMR message. The covering partner doesn’t see the message for three days. The patient develops an AKI. In the subsequent investigation, the CCPP will be found to have violated the written policy, despite following the “normal” team practice.
Clinical governance is the primary antidote to practical drift. Regular audits, direct observation of workflows, and open, blameless conversations in committee meetings are how you uncover the gap between “work-as-imagined” and “work-as-done” and realign them before an accident occurs.
