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Protocol Development and Quality Improvement Jaime Robenolt Gray, Pharm.D., FCCM, BCCCP Temple University Health System Department of Pharmacy Philadelphia, Pennsylvania…

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Protocol Development and Quality Improvement Protocol Development and Quality Improvement Jaime Robenolt Gray, Pharm.D., FCCM, BCCCP Temple University Health System Department of Pharmacy Philadelph…

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Learning Objectives 3 min

Protocol Development and Quality Improvement Learning Objectives 1. Determine the steps involved in the development of a guideline and/or policy. 2. Design a medication use evaluation (MUE) with…

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Protocol Development and Quality Improvement 4. Which medication use process is best suited for an MUE? A. Pharmacist verification times for routine orders in the ICU. B. Management of warfarin-i…

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Exam Content Outline 1 min

Protocol Development and Quality Improvement BPS Critical Care Pharmacy Examination Content Outline This chapter covers the following sections of the Critical Care Pharmacy Examination Content Outline…

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Protocol Development and Quality Improvement I.  POLICY AND GUIDELINE DEVELOPMENT Objective: Critical care pharmacists should participate in developing ICU and institutional policies, procedures, gui…

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Protocol Development and Quality Improvement 4. Interdisciplinary team effort: Patient, physician/prescriber, nurse, respiratory therapist, pharmacist, clinical dietitian, physical therapist, social…

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Protocol Development and Quality Improvement e. Write the final draft. f. Document the date that the policy was ratified and then subsequent review dates. g. Committee review and approval. h. Inco…

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Protocol Development and Quality Improvement (d) Makes the decision-making process transparent to colleagues and patients (e) Leads to greater appreciation of the evidence for our practice as well a…

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Protocol Development and Quality Improvement c. Strengths and limitations of evidence are described. d. Health benefits, adverse effects, and risks are considered when developing recommendations. e.…

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Protocol Development and Quality Improvement B. Goals of a Gap Analysis – To provide the project team with an understanding of the differences between current and best practices. An assessment must…

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Protocol Development and Quality Improvement E. Examples of a Gap Analysis Include: 1. Centers for Disease Control and Prevention (CDC): The Core Elements of Hospital Antibiotic Stewardship Program…

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Protocol Development and Quality Improvement III.  QUALITY ASSURANCE, QUALITY/PERFORMANCE IMPROVEMENT A. Overview 1. Quality improvement (QI) consists of systematic and continuous actions that lead…

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Protocol Development and Quality Improvement B. Critical Care Pharmacist’s Role in QI – Metrics for evaluating the quality of critical care pharmacy services 1. ICU and hospital LOS 2. ICU readmiss…

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Protocol Development and Quality Improvement b. Patient safety–endorsed measures notable for ICU care (2015) i. ADEs ii. Catheter-associated urinary tract infections iii. Central line–associated b…

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Protocol Development and Quality Improvement (1) Unless an authorized staff member prepares a medication, takes it directly to the patient, and administers it without a break in the process, the med…

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Protocol Development and Quality Improvement (e) Comprehensive stroke - CSTK-08 Thrombolysis in cerebral infarction (TICI) post- treatment reperfusion grade (f) Emergency department - ED-1a - Median…

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Data Tables 3 min

Protocol Development and Quality Improvement Table 1. Selected CMS Hospital IQR Program Measures for FY 2026 Payment Update Topic Measure Stroke Measure (STK) Set • Discharged on antithrombotic thera…

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Protocol Development and Quality Improvement 12. The Choosing Wisely initiative of the American Board of Internal Medicine Foundation was a collaboration of critical care societies including the Ame…

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Protocol Development and Quality Improvement PRACTICE-FOCUSED RECOMMENDATIONS A1. Pharmacists should collaborate with patients, families, and caregivers to ensure that treatment plans respect patie…

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Protocol Development and Quality Improvement ORGANIZATION-FOCUSED RECOMMENDATIONS A7. The pharmacy workforce, in all care settings, must have access to complete patient medical records and related…

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Protocol Development and Quality Improvement PROFESSION-FOCUSED RECOMMENDATIONS D6. A scope of practice including core competencies should be developed and defined for pharmacy technicians in acut…

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Protocol Development and Quality Improvement F. ASHP Standardize 4 Safety Initiative 1. ASHP received funding from the FDA on this interprofessional effort. 2. Goal is to standardize medication co…

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Protocol Development and Quality Improvement c. What changes can we make that will result in improvement? i. Broad, general ideas and thoughts about change (“change concepts”) ii. Select the change…

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Protocol Development and Quality Improvement I. Analysis Tool Kit 1. Affinity diagrams 2. Cause-and-effect diagrams 3. Decision matrixes 4. Root-cause analysis 5. Apparent cause analysis 6. Pro…

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Protocol Development and Quality Improvement IV.  MEDICATION USE EVALUATION A. TJC requires medication use evaluations (MUEs) to be completed to monitor the safety of medications. ASHP published gui…

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Protocol Development and Quality Improvement 5. Assess value of innovative practices 6. Meet quality or regulatory standards 7. Minimize costs a. These should be considered together with the impac…

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Protocol Development and Quality Improvement Box 1. Examples of High-Risk Medication-Related Processes Suited for an MUE in Critically Ill Patients PADIS (ABCDEF bundle) protocols Use of neuromuscula…

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Protocol Development and Quality Improvement T. Policies and educational initiatives should be developed to improve opportunities identified from the MUE, such as: 1. In-service lectures 2. Newsle…

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Protocol Development and Quality Improvement 4. Additionally, critical care pharmacist interventions may identify opportunities for protocol or guideline development or may identify opportunities fo…

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Protocol Development and Quality Improvement 5. Both methods should be available for documenting pharmacotherapeutic interventions, and criteria should be established to determine which method is mo…

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Protocol Development and Quality Improvement C. Evaluation of CPS 1. Continuous QI should include quality indicators and periodic reviews of pharmacist-written documentation and consultations. 2.…

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Protocol Development and Quality Improvement e. Provide data for QA or research initiatives. f. Accreditation purposes g. Promotional reasons h. Financial impact can be analyzed and used to justif…

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Protocol Development and Quality Improvement Box 2. Examples of Pharmacotherapeutic Interventions 1.  Discontinue drug 2.  Switch drug 3.  Switch drug for less expensive but equally safe and effectiv…

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Protocol Development and Quality Improvement Intervention Type Consult Pharmacy Dosing Order Clarification Allergy Drug Interaction Non-Formulary Duplicate Therapy IV to PO Emergency Response Medicati…

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Protocol Development and Quality Improvement Total No. of Clinical Interventions 50000 40000 30000 20000 10000 $0 2020 2021 2022 2023 2024 Clinical Interventions 20945 24500 23452 35459 38496 Total An…

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Protocol Development and Quality Improvement REFERENCES Policy, Procedure, and Guidelines American Society of Health-System Pharmacists (ASHP). ASHP guidelines on medication use evaluation. Am J Hea…

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Protocol Development and Quality Improvement Sciences; January 5–8, 2009; Washington DC. Accessed May 1, 2025. https://orchid.cs.illinois.edu/publications/ HICSS-idea-generation-2009.pdf Institute fo…

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Answers & Explanations 4 min

Protocol Development and Quality Improvement ANSWERS AND EXPLANATIONS TO PATIENT CASES 1. Answer: B Using evidence-based practice helps provide support in creating a clinical pathway with support an…

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Protocol Development and Quality Improvement added without interventions and cost savings metrics associated with it (Answer c is incorrect). While renal dose adjustments and intravenous to oral con…

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Self-Assessment 4 min

Protocol Development and Quality Improvement ANSWERS AND EXPLANATIONS TO SELF-ASSESSMENT QUESTIONS 1. Answer: D Financial justification for a critical care pharmacist has been shown by the impact of…

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Protocol Development and Quality Improvement 6. Answer: D Because the data have already been collected, they must be analyzed to determine the baseline time to antibiotics (Answer D is correct). Th…

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Protocol Development and Quality Improvement Exert from Source: Centers for Disease Control and Prevention (CDC). The Core Elements of Hospital Antibiotic Stewardship Programs: Antibiotic Stewardship…

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Protocol Development and Quality Improvement Appendix 2. Example of Interventions and Clinical Pharmacy Services Cost Savings Pharmacy Department Data for 2024 Measure Benchmark 1st Quarter 2nd Quarte…

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