CCPP Module 21, Section 3: Policy and Procedure Implementation
MODULE 21: LAUNCHING YOUR FIRST COLLABORATIVE PRACTICE SITE

Section 21.3: Policy and Procedure Implementation

Transform your collaborative practice agreement into a set of clear, actionable, and compliant policies and procedures. This section will guide you through creating essential documents, including patient care protocols, documentation standards, and emergency procedures.

SECTION 21.3

Policy and Procedure Implementation

From High-Level Agreement to Ground-Level Action: Building Your Clinic’s Rulebook.

21.3.1 The “Why”: Policies as the DNA of a Safe and Scalable Practice

You have successfully navigated the complex processes of securing administrative buy-in and designing the physical logistics of your clinic. You have a signed Collaborative Practice Agreement (CPA) in hand—a document that grants you the authority to perform advanced clinical duties. It is easy to see this CPA as the finish line, but in reality, it is the starting gun. The CPA is the “what”—it defines in broad strokes what you are legally permitted to do. Now comes the essential work of defining the “how”: how, exactly, will you execute these duties, for which patients, under what circumstances, and with what safety checks in place? This is the domain of Policies and Procedures (P&Ps).

To a clinical purist, the process of writing P&Ps can feel like bureaucratic drudgery. It is anything but. Your clinic’s P&P manual is the single most important document you will create. It is the operational blueprint, the clinical playbook, the legal safeguard, and the training manual for your entire service, all rolled into one. It transforms your practice from a series of individual, ad-hoc decisions into a consistent, reliable, and high-quality system of care. For pharmacists, who are trained in the art of creating and following standard work to ensure accuracy and safety, building a robust P&P manual is a natural extension of our core professional identity.

Think of it this way: a well-written P&P manual provides the answer to every predictable question that might arise in your clinic’s daily operation. What happens when a patient’s blood pressure is dangerously high? The P&P has the answer. How is a new referral triaged? The P&P defines the process. What must be included in the clinical note for a follow-up visit? The P&P provides the template. This level of detail is not restrictive; it is liberating. It frees you from having to reinvent the wheel for every patient, allowing you to focus your cognitive energy where it matters most: on complex clinical decision-making. It ensures that every patient receives the same high standard of care, regardless of who is on duty. It is the foundation upon which a safe, effective, and scalable clinical practice is built.

Pharmacist Analogy: From Board License to USP <797> Compliance

Imagine you are the Pharmacist-in-Charge of a new hospital pharmacy that is going to perform sterile compounding. Your State Board of Pharmacy grants your pharmacy a license. This license is your Collaborative Practice Agreement (CPA). It is a high-level, legal document that grants you the authority to compound sterile products. It says *what* you can do, but it provides very little detail on *how* you must do it.

Now, think about USP General Chapter <797>. This is your Policy and Procedure Manual. USP <797> doesn’t grant you the legal authority to compound—the state board does that. Instead, it provides an exhaustive, detailed set of rules and procedures that you must follow to do it safely and effectively.

  • Your CPA might say: “The pharmacist is authorized to manage anticoagulation therapy.” Your Warfarin Dosing Protocol is the USP <797> that specifies the exact dosing nomogram to use, the required INR monitoring frequency, and the specific actions to take for a sub-therapeutic result.
  • Your CPA might say: “The pharmacist may order and interpret laboratory tests.” Your Monitoring Procedure for ACE Inhibitors is the USP <797> that dictates that a baseline serum creatinine and potassium must be drawn, and then repeated within 1-2 weeks of initiation.
  • Your CPA might say: “The pharmacist will document encounters in the medical record.” Your Documentation Policy is the USP <797> that provides the standardized SOAP note template that every pharmacist in your clinic must use for every visit.

You would never dream of opening a sterile compounding facility without a comprehensive P&P manual based on USP <797>. To do so would be reckless, unsafe, and a violation of professional standards. You must view your clinical practice through the exact same lens. The CPA is your license to practice at an advanced level. Your P&Ps are the evidence-based, peer-reviewed standards that ensure you do so with the utmost quality, consistency, and safety.

21.3.2 The P&P Hierarchy: Translating Broad Authority into Specific Action

A common point of confusion is the difference between a policy, a procedure, and a protocol. Understanding the hierarchy and the distinct purpose of each document type is the first step in building a useful and organized manual. These terms are not interchangeable. They form a cascade, moving from the general to the specific, that connects your legal authority to the actions you take at the patient’s bedside.

  • Policy: A high-level statement of intent or a guiding principle. It answers the question “Why?” or “What is our rule?” Policies are typically broad and do not change often. Example: “It is the policy of this clinic that all patients on ACE Inhibitor or ARB therapy will have their renal function and potassium monitored in accordance with national guidelines.”
  • Protocol: A detailed, evidence-based plan of care for a specific disease state or clinical situation. It is a clinical algorithm that guides decision-making. It answers the question “What is the clinical plan?” Example: “The Hypertension Management Protocol,” which outlines which drug classes to use, titration schedules, and BP goals based on patient comorbidities.
  • Procedure: A step-by-step description of how to perform a specific task. It is a detailed “how-to” guide that ensures a task is performed the same way every time. It answers the question “How do I do it?” Example: “Procedure for Performing a Brown Bag Medication Review,” which lists the exact steps from greeting the patient to documenting the final reconciled list.
Masterclass Table: The Translation from CPA to P&P
Statement in Collaborative Practice Agreement (The “What”) Resulting Policy (The “Rule”) Resulting Protocol (The “Clinical Plan”) Resulting Procedures (The “How-To Steps”)
“Pharmacist is authorized to initiate, adjust, and discontinue medications for the management of Type 2 Diabetes.” “All clinical decisions made by the pharmacist will be based on the most current American Diabetes Association (ADA) Standards of Care.”
  • Basal Insulin Initiation and Titration Protocol
  • GLP-1 Receptor Agonist Selection Protocol
  • Hypoglycemia Treatment Protocol
  • Procedure for Patient Training on a New Glucometer
  • Procedure for Documenting a Diabetes Follow-Up Visit
  • Procedure for Reviewing Continuous Glucose Monitor (CGM) Data
“Pharmacist is authorized to order, interpret, and monitor laboratory tests relevant to the patient’s medication therapy.” “Pharmacists will adhere to established medication-specific monitoring protocols to ensure patient safety and therapeutic efficacy.”
  • Amiodarone Monitoring Protocol
  • Statin Therapy Monitoring Protocol
  • DOAC Monitoring Protocol
  • Procedure for Placing Laboratory Orders in the EHR
  • Procedure for Communicating Critical Lab Values to the Provider
  • Procedure for Patient Notification of Lab Results
“Pharmacist will maintain complete and timely documentation of all clinical encounters in the electronic health record.” “All pharmacist-patient encounters will be documented using the standardized clinic SOAP note template within 24 hours of the visit.” N/A – This is primarily an operational, not a clinical, function.
  • Procedure for Completing a New Patient Note
  • Procedure for Documenting a Telephonic Encounter
  • Procedure for Routing Notes to the Collaborating Provider for Co-Signature

21.3.3 Deep Dive: Crafting a Bulletproof Patient Care Protocol

The patient care protocol is the heart of your P&P manual. This is where you codify the clinical intelligence of your service. It is a document that must be rigorously evidence-based, unambiguous, and designed for rapid use in a busy clinical setting. It is not an academic treatise; it is an actionable algorithm. When developing your initial set of protocols, focus on the core disease states you defined in your pilot proposal. A hypertension protocol, a diabetes protocol, and an anticoagulation protocol are common starting points. Each protocol must be a self-contained guide that provides a clinician with all the necessary information to manage a patient from initial assessment to therapeutic goal.

Anatomy of a Clinical Protocol: The Essential Sections

Every clinical protocol you write should follow a standardized format for clarity and ease of use. This consistency ensures that anyone reading your protocols can find the information they need quickly. Your format should include:

  1. Protocol Title, Version Number, and Effective Date: For version control.
  2. Purpose/Objective: A one-sentence statement of the protocol’s goal.
  3. Scope: Clear inclusion and exclusion criteria defining the target patient population.
  4. Initial Assessment Requirements: A checklist of baseline data that must be collected before action is taken.
  5. Therapeutic Algorithm: The core of the protocol; often a flowchart or step-wise plan for treatment initiation and adjustment.
  6. Medication-Specific Details: Tables outlining starting doses, titration schedules, and key monitoring parameters for drugs used in the protocol.
  7. Safety Parameters & Hold Criteria: Explicit instructions on when to stop or reduce therapy and when to immediately consult the physician.
  8. References: A list of the clinical guidelines (e.g., ADA, AHA/ACC) upon which the protocol is based.
Masterclass Example: Hypertension Management Protocol

Protocol Title: Ambulatory Pharmacist Hypertension Management Protocol

Version: 1.0 | Effective Date: 01-Nov-2025 | Review Date: 01-Nov-2026

1.0 Purpose: To provide a standardized, evidence-based approach for the pharmacist-led management of essential hypertension in adult patients within the collaborative practice setting.

2.0 Scope:

2.1 Inclusion Criteria:

  • Adults aged 18 years or older.
  • Established diagnosis of essential hypertension.
  • Patient referred by a collaborating provider for pharmacist management.
  • Average home or in-clinic BP reading consistently above goal as defined by current ACC/AHA guidelines.

2.2 Exclusion Criteria:

  • Pregnant patients.
  • Patients with hypertensive urgency/emergency (SBP >180 or DBP >120 with end-organ damage).
  • Patients with suspected secondary hypertension requiring specialist workup.
  • Patients with end-stage renal disease (eGFR < 15 mL/min) on dialysis.

3.0 Initial Assessment: Prior to initiating or adjusting therapy, the pharmacist must document the following:

  • Average of at least two BP readings.
  • Complete medication history, including adherence assessment.
  • Baseline laboratory values (within last 3 months): Serum Creatinine (SCr), eGFR, Serum Potassium (K+), Hemoglobin A1c.
  • Calculation of 10-year ASCVD risk score.
  • Assessment for comorbid conditions (Diabetes, CKD, Heart Failure, Ischemic Heart Disease).

4.0 Therapeutic Algorithm (based on 2017 ACC/AHA Guideline):

Step 1: Determine BP Goal

BP Goal is <130/80 mmHg for nearly all patients, including those with clinical CVD, ASCVD risk >10%, CKD, or Diabetes.

Step 2: Initiate First-Line Agent
  • General Population: Initiate Thiazide diuretic, ACE Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), or Calcium Channel Blocker (CCB).
  • Compelling Indication (CKD or Diabetes w/ Albuminuria): Initiate ACEi or ARB.
  • Black Patients (without CKD/HF): Initiate Thiazide or CCB.
Step 3: Follow-Up & Titrate

Schedule follow-up visit in 4 weeks. If BP is not at goal, titrate first agent to maximum tolerated dose OR add a second agent from a different first-line class.

Step 4: Reassess & Add Therapy

Continue to reassess monthly until BP goal is met. Most patients will require at least two agents. Consider addition of agents such as spironolactone for resistant hypertension.

5.0 Medication-Specific Details:

6.0 Safety Parameters & Hold Criteria: The collaborating physician must be notified immediately if any of the following occur:

  • Symptomatic hypotension (dizziness, lightheadedness).
  • Acute rise in SCr by >30% from baseline after initiating ACEi/ARB.
  • Serum Potassium (K+) > 5.5 mEq/L.
  • Development of angioedema.

7.0 References: 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.

21.3.4 Establishing Documentation Standards: Your Clinical and Legal Armor

In the world of healthcare, the mantra is absolute: if it was not documented, it was not done. For a pharmacist practicing under a collaborative agreement, this principle takes on an even greater level of importance. Your clinical note is more than just a record of the visit; it is the primary legal evidence of your clinical judgment, the main communication tool with the rest of the healthcare team, and the foundation for any potential billing for your services. Sloppy, incomplete, or inconsistent documentation undermines your professionalism and creates significant clinical and legal risks.

Therefore, a core policy for your new clinic must be the adoption of a standardized documentation template and a set of clear expectations for its completion. The SOAP (Subjective, Objective, Assessment, Plan) note format is the universal standard in ambulatory care and should be the framework for your documentation policy. Creating a pre-built template within your EHR is one of the most powerful things you can do to improve your efficiency and ensure the quality of your documentation from day one.

Masterclass Table: The Pharmacist’s SOAP Note Template
Section Purpose Essential Elements to Include in Your Template
Subjective (S) To capture the patient’s story in their own words and your interview with them.
  • Chief Complaint: Reason for today’s visit (e.g., “Follow-up for hypertension management.”).
  • History of Present Illness (HPI): Details about the chief complaint.
  • Medication Review: A line-by-line review of each medication, assessing adherence, side effects, and patient-reported efficacy.
  • Home Monitoring Data: Patient-reported blood pressure or blood glucose logs.
  • Review of Systems (ROS): Focused questions to screen for adverse drug effects (e.g., “Any cough with the lisinopril? Any dizziness?”).
Objective (O) To record all the measurable, verifiable data for the visit.
  • Vital Signs: BP, HR, Weight (as measured by MA).
  • Point-of-Care Tests: Today’s POC A1c or INR result.
  • Recent Laboratory Results: Pull in relevant labs from the EHR (e.g., SCr, K+, A1c, Lipids).
  • Current Medication List: The official, verified medication list from the EHR after your reconciliation is complete.
Assessment (A) This is the synthesis of the S and O. It’s where you state your clinical conclusions and justify your plan. This is the most important section.
  • Organized by problem/disease state (e.g., #1. Hypertension, #2. Type 2 Diabetes).
  • For each problem, state your assessment of control (e.g., “Hypertension, uncontrolled based on home BP log and in-clinic readings.”).
  • CRITICAL: Justify your planned actions by explicitly referencing your CPA and protocol (e.g., “Patient remains above goal. Per Hypertension Protocol, will add second agent.”).
  • Identify and assess any new drug therapy problems (e.g., “Adverse Effect: Patient reports persistent dry cough, likely secondary to lisinopril.”).
Plan (P) This details the specific actions you will take, organized by the same problem list from the Assessment.
  • Medication Changes: Be explicit. “Discontinue Lisinopril 10mg daily. Initiate Losartan 50mg daily.”
  • Labs Ordered: List any labs you ordered today.
  • Patient Education: Briefly summarize key counseling points (“Educated patient on s/sx of hypotension and importance of daily BP monitoring.”).
  • Referrals: Note any referrals made (e.g., to Diabetes Education, Ophthalmology).
  • Follow-Up: State the specific timeframe for the next visit (“Return to pharmacist clinic in 4 weeks for follow-up BP check.”).

21.3.5 Building Your Safety Net: Operational and Emergency Procedures

While clinical protocols define how you care for patients, operational and emergency procedures define how your clinic runs and how you respond when things go wrong. These are the logistical and safety backbones of your practice. Neglecting them is not an option. A clear no-show policy, a standardized communication plan, and a well-rehearsed emergency response procedure are just as important to the health of your clinic as your clinical algorithms are to the health of your patients. These procedures ensure your clinic is efficient, professional, and, above all, safe.

The Unspoken Responsibility of Direct Patient Care

When you move into a direct patient care role, you inherit a profound responsibility. The patient in your exam room is under your direct care. You are no longer separated from the patient by a counter or a phone line. If that patient experiences a medical emergency while in your clinic, you are the first responder. You must be prepared for this reality. Having a clear, written, and practiced emergency procedure is not a suggestion; it is a professional and ethical obligation. You must know who to call, what to do, and where the emergency equipment is located before you see your first patient.

Masterclass Table: Essential Operational & Emergency Procedures
Procedure Key Questions to Answer in Your Written Procedure Why It’s Critical
Patient No-Show & Late Cancellation Policy
  • How is a “no-show” defined (e.g., no call, no arrival within 15 minutes of appointment time)?
  • What is the process for documenting a no-show in the EHR?
  • What is the follow-up action? (e.g., Staff attempts to call patient once; if no answer, a letter is sent).
  • After how many no-shows is a patient discharged from the service (e.g., after 2 consecutive or 3 in a 12-month period)? Who makes this decision?
 Protects your schedule from being wasted, ensures access for other patients, and creates a clear documentation trail for patient non-compliance.
Provider Communication Protocol
  • What is the primary method for routine communication (e.g., EHR staff message)?
  • What is the expected turnaround time for a response?
  • What defines an “urgent” communication that requires a direct page or phone call?
  • How are “curbside” consults documented?
 Ensures clear, reliable, and documented communication, which is the cornerstone of a safe collaborative practice. Prevents messages from being lost and clarifies expectations for the entire team.
Emergency Medical Response Procedure
  • What is the phone number to call for the internal medical response team or “code blue” team?
  • Where is the nearest crash cart and AED located?
  • Where is the clinic’s emergency medication kit (containing oral glucose, aspirin, diphenhydramine, epinephrine auto-injector)?
  • What is the pharmacist’s role versus the MA’s role while waiting for the response team to arrive? (e.g., Pharmacist stays with patient, MA calls and gets equipment).
 This is a critical patient safety procedure. In an emergency, you will not have time to look up a phone number. This must be a memorized, drilled procedure for everyone in the clinic.