Standard Operating Procedures (SOPs) are established or prescribed methods to be followed routinely for the performance of designated operations or in designated situations (Merriam-Webster Dictionary). In healthcare, the aim of SOPs is to achieve efficient, quality, safe, and uniform performance in compliance with state and federal regulations and in accordance with established best practices. They serve all employees as a reference for clear performance of processes and procedures, especially those used infrequently, and a defined standard of expectations. Documentation of training employees in facility SOPs acts as a safety guideline, performance review standard, and legal grounds in case of accident or violation.
Examples of SOPs from multiple sites and states, including various forms, are included in the Appendices\Standard Operating Procedures.
Procedures and processes should be reviewed and updated regularly, adjusting to changes in regulations, technology, efficiency, therapeutic guidelines, and best practices. Updates can reflect feedback on quality improvement, safety, cost savings, improved productivity, and reduction in error rate. Use of flowcharts and examples in process explanation act as visual aids to add clarity. See Flowchart for external referral for an example.
Types of Standard Operating Procedures
Policies are established for federal and state licensing of the facility (pharmacy), and staff (pharmacist, technician, other). They may include frequency of renewal, methods of documentation, and consequences of non-compliance. Policies may include regulations including signage, language, or notifications to patients. E.g. state phone number to call to report an error, dispensing prescription in patient language, etc.
Security and safety procedures and policies protect employees, patients, and products. They include:
- Environmental: fire, disaster, hazmat, etc.
- Technologyaccess and privacy
- Patient confidentiality and privacy, HIPAA
- Media Release
Retention and destruction of records including:
- Pharmacy and patient-related; regulations may vary by state – See Record Keeping
- Governance, Tax, Intellectual Property (copyrights, etc.)
- Pension and benefits
- Government Relations (lobbying, etc.)
See Appendices\Standard Operating Procedures\2009RecordRetentionPolicy.doc.
Employee policies may include:
- Compliance with Core Values and Mission of organization
- Education or certifications needed for positions – See Appendices\Human Resources for job description
- Procedure documentation including orientation to position, training in new or changed procedures, and ongoing compliance – See Appendices\Standard Operating Procedures\Competencies and Competency
- Employee standards for attire, attendance, behavior, etc.
- Steps for leadership or career advancement
Pharmacists, and in some states technicians, are required to complete annual or bi-annual continuing education. Some states differentiate between certified and non-certified technicians.
An employee handbook serves as a record for the employee of applicable policies and documentation for the employer of employee education. Examples of employee handbooks may be found in Appendices\Standard Operating Procedures.
Example layout of pharmacy: STH River Park Plaza Pharmacy
Financial policies relate to business practices (bribes/collusion, etc.). Patient financial policies relate to prescription payment (no charge, safety-net, etc.) Topics include:
- Conflict of interest
- Financial planning and reporting
- Budgeting Process
- Recording and Audits
A sample financial SOPs is in Appendices\Standard Operating Procedures\2017 Financial Policy and ProcedureOCP.docx.
Policies, procedures and processes covering medication from acquisition to destruction ensure compliance with government regulations, safety for patients and handlers, and established best practices. See Appendices\Standard Operating Procedures and Appendices\Inventory Management. Formulary\Forms for examples of policies and forms.
- Formulary management: restrictions (no controlled substances, birth control, pain medication, other therapeutic classes, devices); use of therapeutic interchange and restrictions.
- Medication ordering and receiving procedure, especially if vary by vendor
- Medication storage: temperature-sensitive products, logs, procedure when storage temperature is violated (alternative storage arrangement, shortening of expiration/beyond use date, disposal).
- Medication segregation: by vendor, therapeutic class (oncology, inhalers, topical, etc.).
- SampleMedications – See Donations from Prescribers and Practices
- Returns and recall procedures, usually vary by vendor
- Inspection for expiration: who (volunteer, tech, pharmacist) and frequency (monthly, quarterly)
- Medication destruction procedures – See Medication Destruction
Policies, procedures, and processes covering prescriptions ensure uniformity, safety, and compliance with government and vendor regulations. Regular review of processes adjusts for changes in technology, efficiency, therapeutic guidelines, and best practices.
- Prescription processing: information needed for processing, system for waiting/returning/next day/provider call back
- Day supply and incentives for adherence
- Medication information resources for pharmacist and for patients
- Labeling: multiple languages, samples, eligibility, counseling or other alerts
- Dispensing: patient counseling, use of interpreter
- Return to stock: frequency, process for specific vendors
- Adverse Event and Quality Complaints Reporting
Patient enrollment may be paper, electronic, or both. Processes may vary if enrolling for medication available at charitable pharmacy or through a manufacturer patient assistance program. Types of acceptable documentation for identification, lack of insurance, residency, income, and other requirements need to be made clear to staff and patients.
See chapter on Eligibility and Enrollment for more details.
Vendors and bulk assistance programs require practices that meet with their established policies and procedures. These include, but are not restricted to, patient eligibility, acceptable forms of documentation, refill requirements, and prescriber and prescription documentation. SOPs may be required regarding:
- Manufacturer Patient Assistance Programs
- Manufacturer Bulk Assistance Programs
- Facility Audits
- Notification of Regulatory Inspections
See chapter on Inventory Management for more details.
With new staff orientation, implementation of a new process or procedure, and at regular intervals, usually annually, competencies are administered to review and measure employee compliance and maintenance of understanding. For annual review, topics such as safety, financial and privacy compliance, and core values are sometimes offered with a pre-test. A pre-test score of 100% accuracy allows the employee to skip the review.
Clinical and technical skills usually require a proficiency exam annually and at implementation of a change.
- A math test may be used to demonstrate calculations of day-supply, units/volume as in an insulinpen or drops in eye dropper, pediatric dosing, and conversion of measures (pounds to kilograms, milliliters to ounces). See example Appendices\Standard Operating Procedures\Competencies\Math Competency 10.15.docx.
- Equipment: cleaning and use, e.g. a counting machine or robot
- Therapeutic Interchanges: insulins, inhalers, within classes – See Appendices\Standard Operating Procedures\Competencies and Appendices\Collaborative Practice
- Collaborative Practice