CASP Module 30, Section 5: Ongoing Internal Audit & Management Review
MODULE 30: YOUR GUIDE TO OPERATIONAL INTEGRITY AND MARKET VALIDATION

Section 30.5: Ongoing Internal Audit & Management Review Process

Maintaining compliance and driving improvement: Establishing sustainable processes for self-assessment and strategic quality oversight.

SECTION 30.5

Ongoing Internal Audit & Management Review Process

Closing the Loop: Building the Systems for Sustained Excellence.

30.5.1 The “Why”: Accreditation is a Marathon, Not a Sprint

You’ve done it. You survived the mock survey (Section 30.4), remediated the gaps, endured the official survey, and received your accreditation certificate. It’s tempting to breathe a sigh of relief, hang the certificate on the wall, and assume the hard part is over. This is perhaps the most dangerous mindset in the accreditation lifecycle.

Accreditation is not a one-time event; it is a continuous commitment. Your certificate is valid for three years, but your compliance is expected every single day. Accrediting bodies (URAC, ACHC) conduct surveillance audits, require annual data submissions, and expect you to maintain the high standards you demonstrated during the survey. More importantly, the healthcare landscape is constantly changing – new drugs, new regulations, new payer requirements. Your processes must evolve too.

How do you ensure you stay compliant? How do you prevent the dreaded “SOP drift” where practice slowly deviates from policy over time? How do you ensure your Quality Management Program (QMP) is actually driving meaningful improvement and not just generating paperwork?

The answer lies in two critical, interconnected processes mandated by all accrediting bodies:

  1. Ongoing Internal Audits: A systematic process of self-checking your own operations against your SOPs and the accreditation standards. This is your early warning system to catch compliance issues before they become major problems.
  2. Formal Management Review: An annual, high-level meeting where senior leadership reviews the entire performance of the QMP, analyzes trends, assesses effectiveness, and makes strategic decisions about quality goals and resource allocation for the upcoming year.

These are not optional activities; they are the essential mechanisms for sustaining your accreditation, ensuring continuous compliance, and embedding quality improvement into your organizational culture. This section provides the framework for building and documenting these vital processes.

Accreditation Mandate: Audits & Reviews are Required

Both URAC and ACHC explicitly require these processes:

  • Internal Audits: Standards require you to periodically evaluate your adherence to your own policies and procedures (e.g., URAC RM standards, ACHC QMI standards). While they don’t always dictate the *frequency*, best practice (and surveyor expectation) is an annual cycle covering key areas.
  • Management Review: Standards mandate an annual (at minimum) review of the QMP by leadership, covering specific inputs (data, feedback, audits) and producing documented outputs (assessment of effectiveness, action plans). Failure to produce minutes from an annual Management Review meeting is a significant deficiency.

Pharmacist Analogy: Owning vs. Maintaining a High-Performance Car

Getting accredited is like buying a brand-new, high-performance sports car. You passed the “test drive” (the survey) and got the keys (the certificate).

Driving it daily (Operations): You use the car every day, following the basic rules of the road (your SOPs).

Ignoring Maintenance (No Audits/Reviews): You love the car, but you skip the scheduled oil changes, ignore the tire pressure warnings, and never take it in for its annual inspection. Gradually, performance degrades. Small issues (minor non-compliance) go unnoticed. Eventually, you have a major breakdown on the highway (a failed surveillance audit or loss of a contract due to non-compliance). The car that was once your pride and joy is now a liability.

Following the Maintenance Schedule (Audits & Reviews): You diligently follow the manufacturer’s recommended maintenance schedule.

  • Regular Check-ups (Internal Audits): You periodically take it to your trusted mechanic (your internal audit team) who checks the brakes, fluids, tire tread, and engine diagnostics against the manufacturer’s specs (your SOPs and standards). They catch small leaks or worn parts before they cause a major failure.
  • Annual Performance Review (Management Review): Once a year, you sit down with your mechanic and review the car’s overall performance data (KPIs), maintenance logs (audit reports), any repair history (CAPAs), and decide on any upgrades or major services needed for the next year (strategic quality goals).

The internal audits are your regular check-ups, ensuring the day-to-day operations are running smoothly and according to spec. The Management Review is the annual deep dive, looking at the big picture, assessing overall health, and making strategic decisions to keep the car running optimally for years to come. Both are essential for long-term performance and reliability (sustained accreditation and operational excellence).

30.5.3 Designing Your Internal Audit Program: The Proactive Compliance Engine

The goal of your internal audit program is simple: Find problems before the external auditors do. It’s a proactive, systematic process of examining specific areas of your operation to verify compliance with your written policies, procedures, and relevant accreditation standards.

Key Components of an Effective Internal Audit Program

  • Audit Policy/SOP: You need a formal SOP (e.g., SOP-QM-007: Internal Audits) that defines the purpose, scope, responsibilities, frequency, methodology, documentation, and follow-up process for internal audits.
  • Audit Schedule: A documented plan outlining which areas will be audited and when (e.g., quarterly, semi-annually, annually). High-risk areas (like dispensing, cold chain) or areas with known past issues should be audited more frequently.
  • Audit Tools/Checklists: Standardized checklists developed for each audit area. These checklists should be based *directly* on your internal SOPs and relevant accreditation standards.
  • Auditor(s): Who performs the audits?
    • Ideally, individuals who are knowledgeable about the area being audited but are *independent* of the day-to-day operations of that area (to maintain objectivity).
    • Often, members of the Quality department, compliance staff, or managers from different departments auditing each other’s areas.
    • Auditors need basic training on auditing techniques (sampling, interviewing, evidence gathering).
  • Audit Process: The SOP should define the steps: Planning (scheduling, preparing checklist), Conducting (reviewing records, observing processes, interviewing staff), Documenting Findings (using the checklist, noting evidence), Reporting (generating a formal audit report).
  • Reporting & Follow-Up: Audit reports (summarizing findings, non-conformities, and recommendations) must be submitted to the Quality Committee. Non-conformities must trigger the CAPA process (Section 30.3).

Masterclass Table: Sample Internal Audit Schedule & Focus Areas

Your schedule should ensure all key areas are covered over a defined cycle (typically 1 year).

Audit Area Frequency Example Checklist Items (Based on SOPs/Standards) Methodology
Patient Intake & BI/PA Quarterly – Was referral complete upon receipt? (SOP-INT-001)
– Was Welcome Call documented within X timeframe? (SOP-INT-003)
– Was BI comprehensive (Med & Rx)? (SOP-BI-001)
– Was PA status tracked and communicated? (SOP-BI-002)
– Was financial responsibility confirmed before shipping? (SOP-BI-004)		 – Record Review (Sample of N patient charts)
– Staff Interviews (Intake Specialists, BI Techs)
Clinical Management Quarterly – Was Pharmacist Initial Assessment documented per SOP-CLIN-001?
– Does chart contain an individualized Care Plan? (SOP-CLIN-002)
– Were scheduled follow-up calls completed and documented? (SOP-CLIN-003)
– Were reported side effects documented and addressed per SOP-CLIN-004?
– Is there evidence of prescriber communication/coordination? (URAC PM 8)		 – Record Review (Sample of N patient charts)
– Staff Interviews (Clinical Pharmacists)
Dispensing Accuracy & Operations Quarterly – Evidence of two verification steps? (Data Entry & Final RPh Check) (SOP-DISP-001/003)
– Are LASA drugs properly segregated?
– Are daily/monthly cleaning logs complete?
– Are staff competencies for dispensing tasks documented?		 – Record Review (Sample of N prescriptions)
– Observation (Watch dispensing workflow)
– Staff Interviews (Technicians, Pharmacists)
Shipping & Cold Chain Quarterly – Are temperature logs for refrigerators/freezers complete and within range? (SOP-SHIP-002)
– Was the correct validated pack-out used based on medication/season? (SOP-SHIP-001)
– Is there documentation of delivery confirmation?
– Is the process for handling temperature excursions followed? (SOP-SHIP-003)		 – Record Review (Shipping logs, Temp logs)
– Observation (Watch packing process)
– Staff Interviews (Shipping Clerks)
Quality Management Program Semi-Annually – Are QI Committee minutes complete and timely?
– Are QREs being reported per policy? (Review QRE Log vs. known events)
– Are RCAs performed for significant events?
– Are CAPAs being tracked, implemented, and checked for effectiveness? (Review CAPA Log)
– Are KPIs being collected and reported accurately?		 – Record Review (Minutes, Logs, Reports)
– Staff Interviews (Quality Director, Committee Members)
Training & Competency Annually – Do all employee files contain evidence of required initial/annual training (HIPAA, FWA, SOPs)?
– Are initial and annual competency assessments documented for all roles?
– Does training documentation match the Training Plan SOP?		 – Record Review (Sample of N employee files)
Complaint Management Semi-Annually – Is there a log of all complaints received?
– Is there documentation of investigation and resolution for each complaint?
– Was resolution communicated back to the complainant?
– Are complaint trends analyzed by the QI Committee?		 – Record Review (Complaint Log, QI Minutes)
Tutorial: Developing an Internal Audit Checklist

A good checklist is the foundation of a consistent audit.

  1. Identify the Scope: What specific process or SOP are you auditing? (e.g., SOP-INT-003: Welcome Call Process).
  2. Break Down the SOP/Standard: List the key requirements or steps described in the SOP or accreditation standard. (e.g., “Call within 24h,” “Verify demographics,” “Explain services,” “Review Rights & Responsibilities,” “Document call content”).
  3. Formulate Yes/No Questions: Turn each requirement into a clear, objective yes/no question that can be answered by reviewing records or observing practice. (e.g., “Was the Welcome Call documented within 24 hours of intake completion?” “Does the documentation include confirmation that Patient Rights were reviewed?”).
  4. Add Space for Evidence/Comments: Include columns for the auditor to note “Yes/No/NA,” the specific evidence reviewed (e.g., “Patient Chart #12345, Note dated 10/25”), and any comments or observations.
  5. Include Reference: Note the specific SOP number or Standard number each question relates to.
  6. Pilot and Refine: Test the checklist on a small sample to ensure the questions are clear and capture the necessary information.

30.5.4 Designing Your Management Review Process: Strategic Oversight

While the Quality Committee focuses on the operational details and tactical improvements, the Management Review is the annual, strategic “State of the Union” address for your entire Quality Management Program. It’s where senior leadership steps back, looks at the big picture, and determines if the QMP is effectively meeting its goals and supporting the organization’s strategic objectives.

Purpose and Goals

  • Assess the overall suitability, adequacy, and effectiveness of the QMP.
  • Ensure the QMP remains aligned with the organization’s strategic direction.
  • Review performance against quality objectives and KPIs.
  • Identify opportunities for improvement and make decisions on resource allocation.
  • Fulfill accreditation requirements for annual leadership review.

Key Components

  • Frequency: Must occur at least annually.
  • Participants: Senior leadership (CEO, COO, CFO, CCO), the designated Quality Leader, and potentially other key department heads.
  • Input Data (Crucial): This meeting is driven by data compiled throughout the year. The Quality Leader prepares a comprehensive report including:
    • Results of internal and external audits.
    • Analysis of KPI trends (performance against targets).
    • Summary of QREs, complaints, and patient satisfaction data (including trends).
    • Status of CAPAs (open, closed, effectiveness results).
    • Feedback from customers, staff, and other stakeholders.
    • Assessment of previous Management Review action items.
    • Changes in the external environment (new regulations, standards, market conditions).
    • Adequacy of resources for the QMP.
  • Formal Agenda: A structured agenda covering all required input topics.
  • Documented Minutes: Formal minutes capturing attendees, discussion points, data reviewed, decisions made regarding the QMP’s effectiveness, and specific action items for improvement with assigned responsibilities and deadlines.
  • Output Actions: Decisions and actions related to:
    • Improving the effectiveness of the QMP and its processes.
    • Improving services related to customer requirements.
    • Resource needs (staffing, technology, training).
    • Updates to the Quality Plan or quality objectives for the coming year.
Tutorial: Structuring Your Annual Management Review Meeting & Report

This is a formal, high-level meeting. Preparation is key.

Pre-Meeting (Quality Leader’s Role):

  1. Compile all required input data into a comprehensive “Annual Quality Report.” Use charts, graphs, and concise summaries.
  2. Develop a formal meeting agenda based on the required inputs.
  3. Distribute the report and agenda to attendees well in advance.

Meeting Agenda Example:

  1. Call to Order & Review of Previous Action Items
  2. Review of Quality Policy & Objectives (Are they still relevant?)
  3. Summary of QMP Performance:
    • KPI Dashboard Review (Trends vs. Targets)
    • Internal/External Audit Results Summary
    • QRE/Incident Trend Analysis
    • Complaint/Patient Satisfaction Trend Analysis
    • CAPA Program Summary (Status, Effectiveness)
  4. Assessment of QMP Effectiveness (Discussion: Is the system working? Meeting goals?)
  5. Review of Resource Adequacy (Staffing, Budget, Technology)
  6. Review of External Changes (Regulations, Standards)
  7. Identification of Opportunities for Improvement
  8. Setting Quality Objectives for the Upcoming Year
  9. Assignment of Action Items
  10. Adjournment

Post-Meeting:

  1. Draft formal minutes detailing discussions, decisions, and action items.
  2. Distribute minutes for review and approval.
  3. Track action items through the Quality Committee.

Surveyor Focus: Surveyors *will* ask for your last 1-2 years of Management Review minutes. They scrutinize these documents to ensure leadership is actively engaged in overseeing the QMP and using data to make strategic quality decisions.

30.5.5 Closing the Loop: The Continuous Improvement Cycle

Internal Audits and Management Reviews are not isolated events. They are integral parts of the continuous Plan-Do-Check-Act (PDCA) cycle that powers your entire QMP.

The QMP Continuous Improvement Cycle

How the Pieces Connect:

  • Internal Audits (“Check”): Provide objective data on process compliance. Findings feed directly into the Quality Committee.
  • Quality Committee (“Check” & “Act”): Reviews audit findings, analyzes KPI/QRE trends, triggers RCAs, and develops/oversees CAPAs.
  • CAPA Process (“Act”): Implements changes to address identified problems.
  • KPI Monitoring (“Check”): Tracks the effectiveness of CAPAs and overall process performance.
  • Management Review (“Check” & “Plan”): Reviews all the data from the year (audits, KPIs, CAPAs), assesses overall QMP effectiveness (“Check”), and sets strategic quality objectives for the next cycle (“Plan”).

This continuous loop ensures that your pharmacy is constantly evaluating its performance, learning from deviations, and strategically improving its processes and outcomes.

30.5.6 Documentation: Maintaining the Proof of Sustainability

As with all aspects of accreditation, meticulous documentation is non-negotiable. Surveyors will specifically ask for evidence of your ongoing audit and review processes.

Essential Records to Maintain:

  • Internal Audit SOP & Schedule: The plan itself.
  • Completed Audit Checklists/Tools: Evidence of audits performed.
  • Formal Internal Audit Reports: Summaries provided to the QI Committee.
  • CAPAs Resulting from Audits: Proof that you acted on findings.
  • Management Review SOP/Policy: Defines the process.
  • Annual Quality Reports: The data package presented at Management Review.
  • Management Review Agendas & Signed Minutes: Proof the meeting occurred and covered required topics, including decisions and action items.
  • Tracking of Management Review Action Items: Evidence of follow-through.

These records demonstrate to accreditors that your QMP is a living, breathing system, not just a binder created for the initial survey.

30.5.7 Conclusion: Embedding Quality into Your Pharmacy’s DNA

Passing your initial accreditation survey is a significant achievement, but it is merely the starting line. The true mark of a high-performing specialty pharmacy lies in its ability to sustain compliance and continuously improve over time. Ongoing Internal Audits and the annual Management Review are the cornerstones of this sustainability.

Internal audits provide the routine “health checks,” proactively identifying deviations and ensuring your daily practices align with your documented standards. The Management Review provides the strategic “annual physical,” allowing leadership to assess the overall health of the Quality Management Program and chart the course for future improvements.

By implementing these processes rigorously and documenting them meticulously, you create a powerful feedback loop. You move beyond reactive problem-solving to proactive compliance assurance. You transform your QMP from a set of requirements into a dynamic engine for operational excellence. Most importantly, you embed a culture of continuous quality improvement into the very DNA of your organization, ensuring you not only maintain your accreditation but also consistently deliver the safest, most effective care possible to your patients for years to come.

This concludes Module 30, providing you with a comprehensive guide to selecting accreditation, building your operational framework through SOPs, designing your quality engine (QMP), pressure-testing it with mock surveys, and establishing the systems for ongoing compliance and improvement.