Quality assurance and medication error prevention



Quality assurance and medication error prevention



Learning objectives



1. Identify training and competency requirements for personnel who are compounding sterile preparations.


2. Discuss causes of medications errors and the technician’s role in a prevention plan.


3. Define quality assurance, and list the major components of a quality assurance program.


4. Describe the compounded sterile preparation risk levels, including examples, quality assurance, and media fill test procedures.




Terms & definitions


Beyond use date (BUD) 


The date or time when a compounded sterile preparation (CSP) should no longer be stored or transported; it begins at the time of the preparation of the compound


International Organization for Standardization (ISO) 


Organization whose goal is to make products and services safe, reliable, and of good quality


Media fill test 


A test designed to access the quality of compounding processes or aseptic technique of personnel by using a microbiological growth medium


Process validation 


A systematic testing of aseptic technique and processes used in preparing CSPs to ensure sterility


Standard operating procedures (SOPs) 


Set of procedures, including environmental controls, personnel training, and validation of technique, to ensure sterility of all CSPs



Introduction


The roles of pharmacy technicians have changed greatly over the years. In addition to performing aseptic technique and routine prescription processing, the roles have expanded to more innovative responsibilities, such as administration in some states. Participating in medication error prevention and quality assurance (QA) programs have expanded the level of education and training as well as opened specialty areas. In this chapter, we will discuss the components of a QA plan and ways to prevent errors, the USP 797 guidelines for aseptic preparation, and the requirements for technicians and other personnel who prepare intravenous admixtures.



USP 797 guidelines concerning risk levels


Compounding sterile preparations requires proper techniques, equipment, and training. The Unites States Pharmacopoeia Chapter 797 (USP 797) as well as the American Society of Health-System Pharmacists (ASHP) technical assistance bulletin describes conditions and practices that will prevent harm, and even death, to a patient. Patient safety, accuracy, and the prevention of errors should be priorities in every aspect of the sterile preparation of compounded sterile preparations (CSPs). There should be standard operating procedures (SOPs) in place as well as a QA program to ensure that personnel involved in the preparation of CSPs are trained and that the environment and processes meet established criteria for accuracy. USP 797 states, “All personnel who prepare CSPs are responsible for understanding these fundamental practices and precautions, for developing and implementing appropriate procedures, and for continually evaluating these procedures and the quality of final CSPs to prevent harm.” (USP)



Medication errors


During preparation of CSPs, there are several types of errors that may occur. The most common error is microbacterial contamination, or nonsterility. This may be due to microbial, physical, or chemical contamination, such as improper handwashing, improper compounding environment, or incorrect manipulations or procedures. For instance, if handwashing is not done properly, contamination may occur due to physical contact.


If critical areas are compromised through either touch or interruption of first air in the laminar airflow workbench (LAFW), contamination may occur. If the LAFW is not cleaned properly or is not turned on for the required 30 minutes prior to manipulations, contamination may occur.


Any direct or physical contact with critical site areas poses the greatest threat of risk to the patient, and compounding personnel must always be conscientious of this fact. A technician must have a responsible attitude when performing aseptic compounding. Some errors may occur that would not be recognized by a pharmacist checking a final IV, such as the occurrence of a touch contamination (without being seen by the pharmacist), a wrong strength of an ingredient, or a syringe pulled back to the correct amount but not actually added to the admixture (Figure 11-1). Preparation usually occurs in the International Organization for Standardization (ISO) Class 5 area with minimal supervision of a pharmacist who is often staged in the order entry area or ante area. Final check of a retail prescription can easily include verification of the amount of tablets found in the bottle. How does a pharmacist measure the amount of additive in the admixture respectively?


image
FIGURE 11-1  A syringe being held properly in the hood. (From Hopper T: Mosby’s pharmacy technician principles & practice, ed 3, St Louis, 2012, Elsevier Saunders.)


imageTECH NOTE!


Remember: CSPs are potentially the most hazardous to patients because they bypass the digestive tract (oral route of administration) and are administered parenterally (into the bloodstream), which is one of the fastest routes of administration (Figure 11-2).


image
FIGURE 11-2  Routes of administration through the bloodstream. (From McKenry LM, Tessier E, Hogan MA: Mosby’s pharmacology in nursing, ed 22, St Louis, 2005, Mosby.)


Environmental conditions where compounding takes place must also meet certain standards to ensure sterility. Proper cleaning, placement, and environmental sampling should be incorporated to provide the cleanest environment for aseptic compounding. This is why the USP 797 provides environmental quality specifications and monitoring standards. Tasks, such as proper garbing and handwashing, air quality, and equipment calibrations, should be incorporated as standard procedures to prevent contamination and subsequent harm to the patient. USP 797 guidelines provide a sampling plan for air and surface compounding areas. These include areas within the ISO Class 5 area and surrounding surfaces, as well as the ISO Class 7 and 8 areas, which should be collected and reviewed on a periodic basis. Equipment should be kept in operating condition according to manufacturers’ specifications. Accuracy of automated compounding devices, such as that used in total parenteral nutrition (TPN) preparation, and balances should also be tested to prevent errors in measurements.


Incorrect dosages and strength and quality of correct ingredients are also types of errors. Labels for CSPs should include correct amounts and names of all ingredients, total volume, appropriate route of administration, and storage conditions. Patient names should be double-checked, as well as all calculations, additives, and fluids used. All finished CSPs should be inspected for cloudiness or any particulate matter that may be present. Proper storage instructions and beyond use dates (BUDs) should also be included.



imageTECH NOTE!


Use reference guides (e.g., Trissel’s Handbook on Injectable Drugs,5 Drug Facts & Comparisons,3 and package inserts) for compatibility, dilution, and preparation and storage information.



Medication errors can occur due to poor handwriting that is difficult to read, confusion about drugs with similar names, or a lack of training and knowledge of sterile technique and best practices. In the institutional setting, there are several ways to prevent medication errors. Some of them include:



• Recheck calculations and interpretations of orders. This may be accomplished by simply allowing another technician or pharmacist to read the same order.


• Reconfirm confusing or specialty orders. This may be done by reviewing websites (such as the Institute for Safe Medical Practices (ISMP) at http://ismp.org/) for high-risk drug information and sound-alike/look-alike drugs, or printed pharmacy references, such as Drug Facts and Comparisons or Mosby’s Drug Guide for Nursing Students.


• Always check reference materials for unusual doses, and consult the pharmacist—especially for TPN or chemotherapy orders—before preparing the compounded product.


• Check for drug incompatibilities. Use reference sources, such as the Handbook on Injectable Drugs by Trissel or 2013 Intravenous Medications by Gahart and Nazareno, to verify proper diluents, stability, and any special storage or preparation information.


• Do not store sound-alike drugs or look-alike drugs on the same shelf. Follow standards of practice and procedures to verify these drugs, and ask someone to check with you. For a complete listing of sound-alike/look-alike drugs, see the ISMP website (http://ismp.org/).


• Always work as a team to ensure the best patient care and continue to gain knowledge in the field. The IV technician is part of a team that should continuously look for ways to improve and expand knowledge about the quality of sterile preparations.


• Always continue to gain knowledge about new medications through continuing education and by staying current in the practice to ensure that the most up-to-date information and practices are used.



imageTECH NOTE!


When in doubt, check it out. If the order seems unusual or the interpretation is not clear, ask a colleague to read it, or discuss it with them.




Patient rights of administration


Patient safety should always be the most important aspect of any health care worker’s job, and patients are guaranteed certain rights when it comes to medication, including infusion therapy. They are as follows:


Related posts:

  1. Administration of intravenous products
  2. The basics of aseptic preparations
  3. Chemotherapy nutrition
  4. Techniques for preparing intravenous admixtures

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Aug 9, 2016 | Posted by in PHARMACY | Comments Off on Quality assurance and medication error prevention

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