Patient Safety & Quality Assurance Glossary

This glossary covers the core vocabulary for the Patient Safety and Quality Assurance domain, which makes up about 23.75% of the scored PTCE. This domain focuses on preventing errors and protecting both patients and pharmacy staff.

Adverse Event

Any undesirable experience associated with the use of a medical product in a patient, whether or not it is considered related to the product.

Ancillary Label

An auxiliary warning label affixed to a prescription container in addition to the main label, such as "May cause drowsiness" or "Take with food," used to communicate important safety information.

ASHP

The American Society of Health-System Pharmacists, an organization that publishes guidelines and standards related to pharmacy practice, safety, and hazardous drug handling.

Bar Code Medication Administration (BCMA)

A technology system that uses barcode scanning to verify the correct patient, drug, dose, route, and time before a medication is administered, reducing administration errors.

Beyond-Use Date (BUD)

The date after which a compounded or repackaged preparation should no longer be used, determined by factors such as ingredient stability and storage conditions, and distinct from a manufacturer's expiration date.

Chemotherapy Spill Kit

A specialized kit containing personal protective equipment and supplies used to safely clean up a spill of hazardous or cytotoxic medications.

Closed-System Transfer Device (CSTD)

A device used when compounding or administering hazardous drugs that mechanically prevents the transfer of environmental contaminants and the escape of hazardous drug or vapor outside the system.

Confidentiality

The ethical and legal obligation to protect a patient's personal and health information from unauthorized disclosure.

Contamination

The unintended introduction of impurities, microorganisms, or foreign material into a medication or sterile preparation.

Cross-Contamination

The unintended transfer of a substance, drug residue, or microorganism from one product, surface, or preparation to another.

Culture of Safety

An organizational environment that encourages open reporting of errors and near misses without fear of blame, with the goal of identifying system weaknesses and preventing future harm.

Engineering Control

A device or piece of equipment, such as a laminar airflow workbench or biological safety cabinet, used to reduce exposure to hazardous substances or contamination during compounding.

Error of Commission

A medication error that occurs when the wrong action is taken, such as dispensing the wrong drug or wrong dose.

Error of Omission

A medication error that occurs when a necessary action is not taken, such as failing to counsel a patient or failing to check for an interaction.

Extravasation

The unintended leakage of an intravenous drug into the surrounding tissue instead of the vein, which can cause tissue damage, particularly with vesicant medications.

Failure Mode and Effects Analysis (FMEA)

A proactive, systematic method used to identify and evaluate potential failure points in a process before an error occurs, so preventive steps can be put in place.

Hand Hygiene

The practice of cleaning hands, typically through handwashing or use of an alcohol-based sanitizer, to reduce the transmission of pathogens and prevent infection.

Hazardous Drug (HD)

A drug identified as posing a risk to healthcare workers who handle it due to properties such as carcinogenicity, teratogenicity, or reproductive toxicity, often referenced against a list such as NIOSH's.

High-Alert Medication

A drug that carries a heightened risk of causing significant patient harm if used in error, such as insulin, anticoagulants, opioids, and concentrated electrolytes.

Incident Report

An internal document used to record the details of a medication error, near miss, or adverse event for the purpose of investigation and quality improvement.

Infection Control

Practices and procedures implemented to prevent the spread of infectious agents within a healthcare setting.

ISMP

The Institute for Safe Medication Practices, a nonprofit organization dedicated to preventing medication errors, known for publishing lists of high-alert medications and error-prone abbreviations.

Look-Alike/Sound-Alike (LASA) Drug

Two or more medications with names, packaging, or appearances similar enough that they can be easily confused, increasing the risk of dispensing or administration errors.

MedWatch

The FDA's safety information and adverse event reporting program, used to report serious problems suspected to be associated with drugs and other medical products.

Medication Error

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of a healthcare professional, patient, or consumer.

Medication Reconciliation

The process of comparing a patient's current medication list with newly ordered medications to identify and resolve discrepancies, typically performed at transitions of care.

Near Miss

An error that was caught and corrected before it reached the patient, also called a "good catch."

NIOSH

The National Institute for Occupational Safety and Health, a federal agency that publishes a list of hazardous drugs and guidance for safe handling in healthcare settings.

Personal Protective Equipment (PPE)

Protective gear such as gloves, gowns, masks, and eye protection worn to reduce exposure to hazardous drugs, infectious agents, or other workplace hazards.

Quality Assurance (QA)

A systematic process of monitoring and evaluating pharmacy operations to ensure that established standards of quality and safety are consistently met.

Quality Improvement (QI)

An ongoing, systematic effort to identify, analyze, and improve processes in order to enhance patient outcomes and system performance.

Recall

An action taken by a manufacturer or the FDA to remove a defective, contaminated, or mislabeled drug product from the market. Recalls are typically classified as Class I, II, or III based on severity of risk.

Root Cause Analysis (RCA)

A structured, retrospective method used to investigate a serious error or adverse event to identify the underlying system-level causes rather than just individual blame.

Sentinel Event

An unexpected occurrence involving death or serious physical or psychological injury, unrelated to the natural course of the patient's illness, that signals the need for immediate investigation.

Sharps Container

A puncture-resistant container used for the safe disposal of needles, syringes, and other sharp medical instruments.

Spill Control

Procedures and equipment used to safely contain, clean up, and dispose of a hazardous material spill.

Standard Precautions

A set of infection control practices used to prevent transmission of pathogens, applied to all patients regardless of suspected infection status, including hand hygiene and use of PPE.

Sterile Compounding

The process of preparing a sterile pharmaceutical product, such as an IV admixture, under conditions designed to prevent microbial contamination.

Swing Bed

An error-prevention concept referring to a hospital bed that can transition between acute and skilled nursing care levels; understanding transitions of care helps prevent medication errors during handoffs.

Tall Man Lettering

A method of using uppercase letters within a portion of a drug name, such as "hydrOXYzine" and "hydrALAZINE," to help distinguish between look-alike drug names and prevent errors.

Teratogenic

Capable of causing developmental abnormalities in a fetus if a pregnant person is exposed to the substance.

USP General Chapter

A numbered standard published by the United States Pharmacopeia that establishes requirements for pharmacy practice, such as sterile and non-sterile compounding and handling of hazardous drugs.

Verification

The step in the dispensing process, typically performed by a pharmacist, in which a filled prescription is checked against the original order for accuracy before it is given to the patient.

Wrong Patient Error

A medication error in which a drug intended for one patient is dispensed or administered to a different patient, often prevented through use of at least two patient identifiers.