Kenneth Maxik

Four Fast USP <800> Facts Every Healthcare Leader Should Know

August 31, 2017 by Kenneth Maxik Leave a Comment

In February 2016, the United States Pharmacopeia (USP) released General Chapter <800> to “provide standards for safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment.” The rule provided much-needed codification around the handling of hazardous drugs, following research that found improper employee exposure may lead to both acute and long-term health effects. The chapter was released twice for public comment, and has now been finalized with the feedback of hundreds of stakeholders. As USP <800> will soon take effect, it’s critical health care facilities and organizations understand the following about the chapter:

It applies to many different types of facilities. Even if they don’t frequently use drugs they consider “hazardous,” facilities shouldn’t assume USP <800> doesn’t apply to them. Per USP, the chapter is broadly applicable to “all healthcare personnel who handle HD preparations and all entities that store, prepare, transport, or administer HDs,” which could include “pharmacy and nursing personnel, physicians, operating room personnel, environmental services workers, workers in research laboratories, veterinary care workers, and shipping and receiving personnel.” And for some facilities, the definition of a hazardous drug may be surprising. For example, per the National Institute for Occupational Safety and Health (NIOSH), many drugs not normally associated as being hazardous can require additional safeguards when in certain forms (e.g., crushed in a suspension) – facilities must be sure they know which ones.
The deadline is less than a year away. USP <800> goes into effect on July 1, 2018, and many facilities have yet to conduct a risk assessment to determine what’s needed for compliance. As soon as possible, health care facilities must develop a list of the NIOSH-classified “hazardous” drugs they use and conduct a gap analysis for each – what are the likely risks the drug poses to patients and employees, what policies are currently in place to minimize those risks, and how must those policies be updated in accordance with USP <800> standards? This is a good exercise anyway to be sure facilities are embracing industry best practices, but it’s also critical for Joint Commission accreditation, and in some cases, to meet CMS’s “conditions for participation.” Boards of pharmacy in some states, such as California, are currently considering rules related to USP <800> compliance.
Implementation might be expensive. While some facilities may find they’re ahead of the curve when it comes to USP <800> compliance, others may have a long road ahead. Once a facility conducts its gap analysis, it should prioritize necessary actions based on the expense and resources required. For example, some facilities may need to upgrade their HVAC systems to ensure proper air handling, or even change their layout to meet storage guidelines (for example, hazardous drugs used for nonsterile compounding may no longer be stored in sterile compounding areas). For some facilities, these changes may cost up to $500,000, and if they haven’t already accounted for this expense in their annual capital improvement plan, they’ll need to do so quickly to avoid potential financial hardship.
Compliance will be an ongoing process. Once a facility has conducted its USP <800> gap analysis, and rewritten policies and procedures to ensure compliance, it must train employees on the new guidelines and ensure their ongoing adherence to the rules. It may be helpful to consult with a third party to conduct the initial risk assessment and gap analysis (as, through no fault of their own, facility workers may be “too close” to the subject matter to approach these processes objectively). This person can also provide guidance on the best way to engage employees to understand and enforce the changes. As a final step, facilities may identify a USP <800> “champion” (either as a new role or as a new responsibility for an existing role) to communicate the importance of the new rules to employees and address any questions or concerns.

While for some facilities, USP <800> compliance may seem overwhelming, it may comfort them to know that, in addition to the primary goal of improving worker health and safety, implementation of these best practices may also improve their long-term operational efficiency. For additional information, facilities may review free resources on USP’s website, including the organization’s overview and FAQ sections for the chapter.

Kenneth Maxik is director of patient safety and compliance for CompleteRx. He has more than 20 years of pharmacy operations and management experience and works closely with health organizations across the country to help them stay ahead of current and imminent regulatory standards.

Moving Plans to Action: Implementing a Winning Strategic Plan

May 1, 2017 by Kenneth Maxik Leave a Comment

In the fast-paced, ever-changing healthcare industry, it is a common occurrence for organizations to become weighed down in day-to-day tasks and priorities, leaving strategic planning to fall by the wayside.

While organizations agree on the importance of a strategic plan to secure success, many don’t dedicate the necessary time and resources to developing, deploying and implementing an effective plan. In my previous article Eye on the prize: Leveraging the Baldrige Excellence Framework to Develop a Winning Strategic Plan, I discussed in detail the framework for developing a winning strategic plan along with the inputs organizations should consider to ensure its success.

The basis for this framework that many organizations used was the Baldridge Excellence Framework – a systems approach to improving organizational performance, developed by the Baldrige Performance Excellence Program (established by the Malcolm Baldrige National Quality Improvement Act of 1987).

Establishing a strategic plan from this framework is, naturally, followed by a detailed process to implement the plan. It has been found, though, that many organizations fail to allocate the necessary resources required to put such a plan into action. The results of a recent CompleteRx poll revealed that 79 percent of the healthcare professionals surveyed said they implemented only slightly more than half (51 percent) of their strategic objectives in 2016.

This would indicate a tendency of healthcare organizations to bite off more than they can chew, resulting in a failure to fully put a strategic plan in place. To avoid this potential pitfall, there are a number of steps organizations can take to implement their strategic plan, easily broken down into two phases: action plan development and deployment, and action plan modification.

Action Plan Development Phase

Eye On the Prize: Leveraging the Baldrige Excellence Framework to Develop a Winning Strategic Plan

April 13, 2017 by Kenneth Maxik Leave a Comment

For any organization, strategic planning is a mission critical function, which helps prioritize resources and ensure employees and stakeholders are “moving as one” to meet primary objectives. Arguably, this activity is especially vital in the healthcare industry, which, in recent years, has faced devastating budget cuts in addition to the ever-present challenge of synchronizing employees across different disciplines to achieve uniquely high standards of reliability.

Despite how beneficial comprehensive strategic planning can be to healthcare organizations, however, it too often falls to the wayside as they feel compelled to focus on more short-term, “survival” activities. In fact, in a recent CompleteRx poll, more than half (60 percent) of those healthcare professionals surveyed said they consider their organization’s strategic plan to be only “somewhat effective.” While developing a winning strategic plan is admittedly a significant undertaking, it’s also the most surefire way to set an organization on a path toward consistent success.

Many organizations have leveraged the Baldrige Excellence Framework – a systems approach to improving organizational performance, developed by the Baldrige Performance Excellence Program (established by the Malcolm Baldrige National Quality Improvement Act of 1987) – to achieve this task. The framework is built upon core values and concepts within the boundaries of an organization’s “profile” (a snapshot of the organization, the key influences on how it operates, and its competitive environment), and consists of seven categories, including strategic planning, which in turn, features the inputs outlined below. Healthcare organizations should consider these inputs as they develop and evaluate their strategic plans to ensure the highest chance of success:

Four Ways to Reduce Hospital Medication Errors Today

February 28, 2017 by Kenneth Maxik Leave a Comment

While it may shock those outside of the healthcare industry to hear it, at most hospitals, medication errors are an ever-present reality. Many medication errors are relatively minor (e.g., a doctor prescribes the wrong medication, but a nurse catches the error before the drug is administered to the patient), and don’t affect patient care; but systemic issues that produce minor medication errors can also produce major ones, and all it takes is one of these to destroy a health care provider or a hospital’s reputation – or worse, a patient’s life – forever.

While all hospitals should strive for zero medication errors, even small improvements can have a material impact on patient safety. Healthcare executives should consider simple tactics, such as those below, to protect staff and patients alike:

Work together: Many medication errors occur due to ineffective or insufficient communication between hospital departments. One obvious way to counteract this risk – at least between nursing and pharmacy – is to virtually house those departments together. Hospitals are beginning to decentralize their pharmacies, transferring one or two pharmacists from the “basement” to the patient floor where they may work face-to-face with nurses, doctors, and patients. Here, pharmacists may serve as a second set of ears or eyes, cover some of the duties of a short-staffed nursing department, and counsel patients on the appropriate use of a medication. While this may seem like a significant undertaking, many of these hospitals have achieved a decentralized pharmacy without hiring additional staff by analyzing pharmacy workflows for operational efficiencies. What’s more, the benefits to decentralizing the pharmacy go far beyond patient safety – hospitals that have done so have also realized increased job satisfaction among the pharmacy team who feel they’re having a more direct impact on patient outcomes.
Target low-hanging fruit: For hospitals with short staffs and budgets, enacting system changes to reduce medication errors (particularly if they’re relatively minor) may seem like an uphill battle. One tried and true method to pick up some momentum is to collect medication error data, perform root cause analyses, and target low-hanging fruit. For example, hospitals may utilize simple data analytics including segmentation to identify the top 10 most common medication errors (note: this will bring you to the common type of error, not the common cause), conduct visual observations to identify the behaviors that cause those errors, and discuss (ideally, on an interdisciplinary team) ways to eliminate them. Sometimes, hospitals may find the same behavior or misconception is causing multiple errors, and a single change (e.g., physically separating “look alike, sound alike” drugs or eliminating unnecessary steps in the medication administration process) can have a dramatic impact. With the small issues tackled, the team may feel more empowered to put together a long-term action plan to enact mid-size and large changes.
Upgrade reporting systems: While federal regulations require hospitals to track all errors and adverse events that harm patients, CMS predicts only 14 percent of medical errors are ever reported (SafePatientProject.org). There are many potential reasons – despite the fact that many staff members believe it is a function of their job to catch errors – for this trend. As mentioned previously, most errors cause minimal to no harm to patients, and as such, staff may not find these events significant enough to report. In this case, hospitals need to educate their staff on how critical each piece of data – no matter how seemingly insignificant – is to improving patient safety. In other cases, hospitals have arduous reporting processes, and staff may feel they don’t have time to complete them. To solve for this, hospitals may consider streamlining their processes – removing unnecessary questions, offering digital reporting options, or even hiring additional staff to support this task. Finally, some staff perceive a “punishment culture” at their hospital, and are hesitant to report errors lest they get themselves or colleagues into trouble. Healthcare executives can rectify this by making sure to correct behaviors rather than punish actors.
Get patients on board: Many healthcare professionals feel their hospital should take 100 percent of the responsibility for ensuring patients’ safety while admitted (and, sometimes, beyond). While this is understandable, teams who don’t engage their patients in their care are missing out on a critical opportunity for safety improvement. Hospital staff should study up on the most common medication errors and identify ways to partner with patients and caregivers to prevent them. For example, 16 percent of medication errors involve using the wrong route of administration (FDA.gov), such as when a patient orally ingests a suppository. Pre-discharge counseling and thorough instruction by a pharmacist on the correct use of prescribed drugs can greatly reduce or eliminate this error. Even short-staffed hospitals can minimize medication errors by targeting particularly vulnerable populations – including older people, who are likely to be taking multiple medications, patients for whom English is a second language, and patients who are isolated within the hospital – and making special efforts to ensure medication is administered properly to them within the hospital, and they’re educated enough to continue safe practices at home.

Medical errors are nothing new, but recently, following a BMJ study identifying them as the potentially third-leading cause of death in the U.S., there has been a brighter spotlight on them. Public and private entities have been hard at work on macro solutions to the problem, such as new technology – including computerized physician order entry, barcode medication administration, and electronic medication reconciliation.

Such fixes are expensive, however, and in some cases, can cause an initial spike in medication errors due to the learning curve associated with implementation. Thus, it’s critical healthcare executives, hospital staff, and patients themselves are invested in reducing medication errors, and make a concerted effort – including through the actions above – to do so.

Kenneth Maxik has worked with interdisciplinary hospital teams for more than 20 years on quality, patient safety and compliance. In his role as director of patient safety at CompleteRx—a hospital pharmacy management and patient care company—he develops and annually updates a proprietary 250-point patient safety checklist for clients, including medical error measures, leveraging the data he collects to recommend protocols that improve patient safety at client facilities.