Quality assurance

This article will cover the following concepts:


 * Quality assurance practices for medication and inventory control systems (e.g., matching National Drug Code (NDC) number, bar code, data entry)
 * Infection control procedures and documentation (e.g., personal protective equipment [PPE], needle recapping)
 * Risk management guidelines and regulations (e.g., error prevention strategies)
 * Communication channels necessary to ensure appropriate follow-up and problem resolution (e.g., product recalls, shortages)
 * Productivity, efficiency, and customer satisfaction measures

Terminology
To get started in this article, there are some terms that should be defined.

risk management - Risk management is intended to identify errors, assess the root cause(s), and implement procedures to reduce medication errors. Risk management also involves measuring outcomes to determine if successful and then making additional process changes as necessary.

quality control (QC) - Quality control is the process of routinely checking/monitoring products to verify accuracy and/or appropriateness. Quality control typically looks at specific items at a given moment in time.

quality improvement - Quality improvement is the process of devising a method (quality assurance) to address concerns identified as potential sources of medication errors.

quality assurance (QA) - Quality assurance refers to the activities implemented so that requirements for a product or service will be fulfilled without error.

inventory - Inventory is simply the entire stock on hand for sale at a given time.

perpetual inventory - A perpetual inventory is a system that maintains a continuous count of every item in inventory so that it always shows the stock on hand. Some pharmacies maintain perpetual inventories on all products while others only do this with their schedule II medications.

reorder point - A reorder point provides minimum and maximum (a.k.a., par and max) stock levels which determine when a reorder is placed and for how much.

National Drug Code (NDC) - The National Drug Code is a unique product identifier used for medications intended for human use. It is a unique 10-digit, 3-segment numeric identifier assigned to each medication. The first segment identifies the manufacturer. The second segment identifies a specific strength, dosage form, and formulation for a particular manufacturer. The third segment identifies package forms and sizes.

lot number - A lot number is an identification number assigned to a particular quantity (or lot) of material from a single manufacturer made in a specific batch. Sometimes also called a batch number or control number.

The Joint Commission (TJC) - The Joint Commission, formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a nonprofit organization that accredits more than 20,000 healthcare organizations and programs in the United States.

hazardous drugs - Hazardous drugs are drugs that are known to cause genotoxicity, which is the ability to cause a change or mutation in genetic material; carcinogenicity, the ability to cause cancer in animal models, humans or both; teratogenicity, which is the ability to cause defects on fetal development or fetal malformation; and lastly hazardous drugs are known to have the potential to cause fertility impairment, which is a major concern for most clinicians. These drugs can be classified as antineoplastics, cytotoxic agents, biologic agents, antiviral agents and immunosuppressive agents.

nosocomial infection - A nosocomial infection is an infection acquired while in the hospital.

personal protective equipment (PPE) - Personal protective equipment is worn by an individual to provide both protection to the wearer from the environment or specific items they are manipulating, and to prevent exposing the environment or the items being manipulated directly to the wearer of the PPE.

communication - Communication is the activity of providing information through the exchange of thoughts, messages, or information, as by speech, visuals, signals, writing, electronic means, or by behavior. This information is exchanged between two or more people.

Risk management
The medical profession has a responsibility to provide safe, effective health care which includes reducing medication errors. Risk management is the process of identifying errors, assessing the root cause(s), and implementing procedures to reduce medication errors. These three aspects of risk management can be termed respectively as quality control (QC), quality improvement, and quality assurance (QA). These errors will typically be identified through quality controls (QC) and spontaneous error reporting. Quality improvement involves reviewing trends to verify consistency and identify/assess areas that require changes. Quality assurance is the plan for any processes that need to be implemented to reduce errors. Risk management should also seek a means of quantification to determine if the quality improvement plan actually achieves its desired goals, often through QC.

Quality control
Quality control provides regular intervals in which specific items may be measured as correct or incorrect (i.e., the medication refrigerator was within proper range when checked this morning or the vial of medication you filled was done correctly) to provide verification of the success of a particular quality assurance plan. This base line data is also necessary for future evaluations. Many healthcare facilities strongly encourage reporting of errors so they may gather information to improve or modify the process(es). To gather good information facilities need to remove the stigma associated with an individual making an error by emphasizing shared responsibility for the organization and promoting open discussion of errors at staff meetings.

Quality improvement
Quality improvement is the process of devising a method (quality assurance) to address concerns identified as potential sources of medication errors. There are many methods for quality improvement including: product improvement, process improvement, and people based improvement. Product improvement could be a redesign of the product or a labeling modification in such a way as to reduce the potential for misuse. Process improvement could involve removing potential sources of errors or adding additional safety processes such as barcode scanning. People based improvement could be improving or modifying the training procedures of staff, or increasing the knowledge base of the consumer.

Quality assurance
Quality assurance (QA) refers to the activities implemented, often as a result of a quality improvement plan, so that requirements for a product or service will be fulfilled without error. This can be contrasted with QC, which is focused on specific process outputs. QC and error reporting is necessary to help assess how well a particular QA plan works.

Evaluating process changes
Often, quality improvement plans will need additional modifications after they are implemented as the challenges of a complex work environment demonstrates the need for further changes. To achieve this, a mechanism will need to be included to obtain feedback. Feedback may come from QC statistics, error reporting, along with discussion involving staff and consumers. As the staff will have the majority of interactions with the processes, it is common for many institutions to adopt policies to regularly address medication and process errors at staff meetings.

Risk management is a continuous process that may require many incremental changes as you regularly measure, assess, evaluate, and manage your processes.

Inventory control
Inventory control can be used to provide quality assurance in a number of ways including: ensuring that the necessary medications are on hand to provide therapy, establishing methods to ensure the proper medications are being dispensed, removing expired and short-dated medications from stock, regularly checking for drug recalls and performing all appropriate follow-ups, and segregating/separating inventory to minimize the potential for miss-picks. Properly trained staff, careful attention to detail, and automation are important to proper and safe inventory control.

Inventory levels
Most pharmacies establish maximum and minimum inventory levels to try and assure an adequate, but not excessive, quantity of medicines are on the shelf. Often, max and min levels are monitored by computer systems that maintain perpetual inventories, but pharmacy staff will need to initially establish those levels and may occasionally need to intervene and adjust those levels. Furthermore, some pharmacies still do not have automated inventory systems. When you establish a max level, that is the most you want to have on the shelves and you should not exceed that quantity. When you establish a minimum level (or par level), that is the point when you order more (commonly called your reorder point), but not till you reach that minimum quantity. By controlling the inventory level it will help with both order fulfillment and minimize the potential for medications to sit around till they expire.

If your perpetual inventory is capable of tracking NDCs, lot numbers, and expiration dates, it can help you monitor not just for inventory levels, but also for expired medications, drug recalls, and can even make sure that your pharmacy management software is using available drugs (based on NDC) for orders that are being entered by the staff.

Order entry and barcode scanning
As technology in the pharmacy becomes increasingly prevalent, it provides additional safety checks within the dispensing process. The order entry process can be automatically linked to the NDCs stocked by a particular pharmacy, then when the medication label is printed it may have a barcode linking it to a patient profile and a particular medication. A barcode scanner can be used to verify that the correct drug is being used to fill the patient prescription. In many institutional settings, patients are also provided with barcodes on their hospital bracelets, and this further allows those providing direct patient care to ensure that it is the right drug, going to the right patient, at the right time.

Removing medication from stock
Pharmacies will often need to remove medications from stock whether it is due to the medications being expired, short-dated (near their expiration), or recalled.

Proper rotation of inventory and periodic checking of expirations (pulling both expired and short-dated medications) help to reduce the potential for dispensing expired drugs. It also maximizes the utilization of inventory before medications become outdated. When looking at expirations on medication vials it is important to note that if a medication only mentions the month and year but not the day, then you are to treat it as expiring at the end of the month. As an example, if a medication is marked as expiring on 02/2020, then you would treat it as expiring on February 29, 2020.

Sometimes, medications may need to be recalled for a variety of reasons. There are three drug recall classifications, class I, class II, and class III.


 * Class I drug recalls have reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. An example would include the diet aid Fen-Phen (fenfluramine/phentermine) which caused irreparable heart valve damage and pulmonary hypertension.
 * Class II drug recalls involve the use of, or exposure to, a violative product that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. An example would include a medication that is under-strength but that is not used to treat life-threatening situations.
 * Class III drug recalls involve medications that the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Examples might be a container defect (plastic material delaminating or a lid that does not seal), off-taste or incorrect color, and simple text errors such as the incorrect expiration date on the manufacturer's bottle.

Pharmacies will regularly be notified about drug recalls through both the FDA and the pharmacy's wholesale supplier. Often recalls effect just specific batches or runs of medications. If this is the case the recall will include the specific lot number(s) being recalled. Depending on the seriousness of the recall, the pharmacy may even be required to contact patients that potentially received these recalled drugs.

Medications removed from stock should be carefully stored to avoid accidentally dispensing these medications. Some medications may be able to be returned to the wholesaler or manufacturer for credit, controlled substances may need to be disposed of through DEA approved means (contact your local DEA office for specific advice), and other medication it may be left to the pharmacy to find an appropriate means for drug disposal.

Separating inventory
Segregating inventory by drug categories helps to prevent potentially harmful errors. Examples include internal versus external products, hazardous drugs, and volatile or flammable substances.

The Joint Commission (TJC), formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), requires that internal and external medications must be stored separately. This reduces the potential that someone will dispense or administer an external product for internal use. The Joint Commission also has requirements for separate storage of oncology drugs and volatile or flammable substances.

Hazardous drugs (i.e., oncology drugs) should have a separate space on the shelves and be labeled in such a way that it will alert staff of the hazardous potential of these medications. Oncology drugs are often cytotoxic themselves and must be handled with extreme care. They should be received in a sealed protective outer bag that restricts dissemination of the drug if the container leaks or is broken. When potential exists for exposure to hazardous drugs, all personnel involved must wear appropriate personal protective equipment while following a hazardous materials cleanup procedure. All exposed materials must be properly disposed of in hazardous waste containers.

Volatile or flammable substances (including tax free alcohol) require careful storage. They must have a cool location that is properly ventilated. Their storage area must be designed to reduce fire and explosion potential.

Infection control
Infection control is concerned with preventing nosocomial or healthcare-associated infection. Infection control addresses factors related to the spread of infections within the healthcare setting (whether patient-to-patient, from patients to staff and from staff to patients, or among-staff), including prevention via hand hygiene and through the use of personal protective equipment (PPE). Also, with the rise in pharmacies providing injections, there is also an increased concern of infection from contaminated needles.

When assembling compounded sterile preparations, preparers should don personal protective equipment (PPE) to further minimize the likelihood that they will contaminate the final product. USP 797 provides requirements for how personnel should wash and garb including the order that they should don their PPE, from dirtiest to cleanest. First, personnel should remove unnecessary outer garments and visible jewelry (scarves, rings, ear rings, etc.). Next, they should don shoe covers, facial hair and hair covers, and masks (optionally they may include a face shield). Next, they must perform appropriate hand hygiene.

USP 797 states:

"...personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds with either nonantimicrobial or antimicrobial soap and water."

After hand washing, a nonshedding gown with sleeves that fit snugly around the wrists should be put on. Once inside the buffer area an antiseptic hand cleansing using a waterless alcohol-based hand scrub should be performed. Sterile gloves are the last item donned prior to compounding.

Recapping needles at appropriate times can decrease opportunities for unintended needle sticks. Any time a syringe is being drawn up it should be recapped if it is not going to be used immediately. Also, the old practice of breaking used needles prior to discarding them into a sharps container is strongly discouraged as the process of breaking the needle is another opportunity which someone could incur an accidental needle stick.

Communications
Communication channels are necessary within the pharmacy, interprofessionally, and between the pharmacy and its patients to help assure good therapeutic outcomes.

Within the pharmacy itself, pharmacy staff should be sharing information about drug recalls, drug shortages and back orders, along with important patient specific information. Quality assurance plans should address all these situations to reduce potential for frustration and errors. This information may be disseminated throughout the staff in several ways including emails, printed memos, bulletin boards and white boards for posting information, and even setting up information within the pharmacy management software to help flag critical items (be careful about sharing sensitive information by means that may allow to much public access to the information). It is also advisable to discuss these situations at staff meetings to ensure everyone is aware of the potential challenges what circumventions may be necessary to handle these situations.

Interprofessionally, pharmacists and pharmacy technicians will often need to contact physicians, nurses, third-party payors, and other professional groups and individuals in order to provide quality care. These communications may include attempting to get approval for a medication, needing a prescription clarification, concerns over potential interactions, to deal with third-party payor claim rejections or just making sure that your patient profile is complete and accurate. Some of the processes may be automated, or scripted, but other items that require more clinical judgment may need to be reserved for pharmacists.

Communications between the pharmacy staff and the patients is a critical point as pharmacies have the ability to both gather and disseminate information for the patient. During the in-take process the pharmacy should gather information from all the various care-providers that the patient may see, ailments the patient is being treated for, allergies, and the pharmacy also has the ability to include information about dietary supplements and over the counter medications the patient may use. The collection of this data should be a routine process within the pharmacy in order to screen for interactions and contraindications. The pharmacy should disseminate information by offering counseling, providing medication guides, and assuring that all appropriate auxiliary labels are attached to prescriptions. Also, patients should informed when their are problems with or changes to their medication therapies so they can be compliant with their therapy.

As an example of communication within the pharmacy, interprofessionally, and between the pharmacy and patients, in early 2009 the FDA posted a recall on metoprolol succinate from a specific manufacturer. The FDA alert would have gone out to anyone that had signed up for it at http://www.fda.gov/Safety/Recalls%20 and the next pharmacy delivery would have included the appropriate recall information. Upon receipt of the recall information the pharmacy staff should have pulled any offending bottles from the shelves, and if deemed appropriate contacted patients at home about the significant medication problem. The pharmacy should have then posted the recall information for the staff to be aware of this important information. Also due to the widespread nature of this particular recall that pharmacy needed to make all the staff aware of the drug shortage caused by this. In the short term any patients that needed metoprolol succinate needed to either be switched to a different medication, by their physician (which often occurred after the pharmacy contacted the physician about the shortage), and find a substitution that was covered by the patient's insurance coverage when applicable. Also, the pharmacy had a responsibility to inform the patient about their medication change.

Productivity
Through the use of automation and by establishing routines for how procedures should be done can offer quicker turn around times for patients with fewer errors, which has the potential to improve customer satisfaction. Automation to aid these processes may include items like barcode scanners, electronic pill counters, and automated filling cabinets (i.e., ScriptPro). These products allow for some steps to be made easier and free up the technicians to work on other tasks. Also by establishing routines it is easier to keep track of where you are at in a particular process when the inevitable work flow interruptions occur. This allows the staff to more quickly determine where it is at in its process when they return to it and minimizes the potential of either skipping or repeating a step. Some pharmacy management software systems on the market today even offer assistance with this by requiring a barcode scan as each part of the filling process is completed. The desire of this increased productivity is not just intended to provide improved abilities to handle larger workloads with fewer errors but also to help free up pharmacy staff to spend more time assisting the patients with their questions, concerns, and needs.