The Patient Safety Act — Always One Day Closer to a Fatality?

“Good morning, ladies and gentlemen. Thank you for an outstanding safety performance yesterday. We are one day closer to our next fatal crash.” When I was in the Air Force, one colonel would start all of our safety briefings with this statement. To this day, his statement has stuck with me because it is so true about life. Focus is needed in many walks of life, but for patient safety it is needed every day. Every pharmacy across the country is always one day closer to dispensing a fatal dose of medication. Regrettably, over time people can become comfortable and complacent. When those two items are combined, it creates the perfect environment for an accident to occur. Pharmacists can fill hundreds of prescriptions a week, and unfortunately, in order to meet the demands of pharmacy life, they may overlook small steps and have a misfill occur.

To help improve patient safety and reduce misfills, everyone in the pharmacy must be involved in quality control; helping to identify missteps and errors, and being aware of sound-alike/look-alike drug fills, are ways to ensure you are taking proactive measures. Errors found behind the counter are quality control, errors going out the door are medication errors. Errors do happen, and it is important to understand what you need to protect yourself, as well as your patients. The Patient Safety and Quality Improvement Act (Patient Safety Act) requires that a continuous quality improvement (CQI) program be implemented. A CQI program is designed for detecting, documenting, analyzing, and preventing quality-related events (QREs), with the intent of preventing medication errors.

A CQI program creates an environment that makes quality the top priority and allows pharmacy staff to learn from past mistakes, while focusing on improving patient safety by decreasing errors and increasing quality. Pharmacy staff must be willing and open when discussing all failures of quality. Reporting errors should not lead to blame or punishment, but instead need to be seen as an opportunity to learn and improve. When an error occurs, your first question should be, “What in our system allowed this error to occur?”

A proper CQI program will:

  • Designate an individual or individuals to be responsible for monitoring CQI program compliance.
  • Identify and document QREs.
  • Minimize the impact of QREs on patients.
  • Analyze data collected in response to QREs to evaluate causes and discover contributing factors.
  • Incorporate findings to formulate an appropriate response and develop a corrective action plan.
  • Provide ongoing education, at least annually, on CQI related to pharmacy personnel systems and workflow processes designed to prevent QREs.

Pharmacies must recognize that problems exist — problems that unavoidably cause mistakes to happen. These are systems problems; to change the outcome and prevent the same error from occurring in the future, we must change the system. To start improving your quality of care, a few simple questions can help open the dialog with staff.

Do you:

  • Discuss medication errors and near misses that occur in your pharmacy?
  • Evaluate your workflow and look for areas for improvement?
  • Know which errors occur most often in your practice?
  • Meet to discuss ways to implement new processes to prevent errors in the future?

Traditionally, there has been resistance to open discussion and disclosure of patient safety events. Legitimate concerns over potential legal and financial liability would arise. To encourage a safe environment for discussion, patient safety organizations (PSOs) were created. PSOs serve as independent, external experts that can assist providers in developing insights on effective methods to improve quality and safety. The Patient Safety Act allows PSOs to offer federal protection of data collected, studied, and reported so healthcare providers can comply with regulations, work to decrease near misses and errors, and keep the work that they do confidential and safe.

A PSO will most likely assist you in designing your patient safety evaluation system (PSES), which is a system of procedures and policies for collecting, managing, and analyzing information for reporting to the PSO. A PSO provides the framework for safety data to be protected as a patient safety work product (PSWP). A PSWP is defined as any quality data and analysis and/or oral statement assembled or developed by a provider for reporting to a PSO and that constitutes the deliberation or analysis of a PSES. A PSWP is not subject to subpoena, discovery, or admission into evidence. According to the Patient Safety Act, federal privilege preempts state tort law, but not state reporting laws. However, federal privilege does not preempt state laws that are more stringent. The collected and reported quality and patient safety data that you report to a PSO are shielded by federal confidentiality and privilege protections. The protected information can include event reports, root cause/systems analyses, minutes of quality/safety meetings, related graphs, spreadsheets, reports, communications to and from the PSO, and related information listed in the act. In order to maximize the legal protections afforded by the act, pharmacies must enter into an agreement to join a PSO, develop and maintain a PSES, conduct all quality and safety activities within the PSES, maintain the PSWP as confidential, and protect the PSWP from disclosure outside the PSES. In turn, the PSO must remain in good standing with the Agency for Healthcare Research and Quality (AHRQ) and must meet operational and security requirements set forth by the Patient Safety Act regulations.

PSOs can make a positive impact on the pharmacy operation — providing feedback, recommendations, and support processes of root cause analysis. There are currently 84 PSOs supporting all healthcare providers, but only five are listed as focusing on pharmacy, and they are:

  • Alliance for Patient Medication Safety
  • Institute for Safe Medication Practices
  • The Patient Safety Research Foundation
  • The PSO Advisory
  • Quantros Patient Safety Center

Each PSO offers different services and contract fees. You need to find the best solution for your operation. Check with your PSAO, as they may already have a relationship with a PSO.

A PSO provides far more than just a framework to participate in a CQI program in a protected environment. Think about how much time and effort are spent identifying an error, reversing the prescription, re-dispensing the correct prescription, and making multiple contacts with the patient; the pharmacy has definitely lost money on the prescription. When pharmacists and staff start realizing the amount of time and money that are lost, the importance of reducing medication errors takes on a new meaning.

The pharmacist in charge is responsible for ensuring everyone understands the importance of patient safety and can use the PSO resources and recommendations to improve the quality of patient care within a culture of safety.

No one comes to work thinking he or she is going to dispense medications that will harm a patient, but look at the workload the pharmacy staff is required to handle: the number of calls and faxes to and from patients, insurance companies, and physician offices, often made while processing as many as 20 or more prescriptions on the counter at one time. With so many interruptions, plus patients at the counter, it is amazing that there are not more medication errors. Fortunately, the pharmacy continues to be one of the safest healthcare providers, but errors do occur. In a team-oriented environment, where safety is the priority, the staff can review breakdowns in the workflow processes and achieve the goals of increased patient safety. Efficiency is improved and misfills are reduced, resulting in better quality of care for patients. Maybe we should all consider starting our weekly patient safety discussions with, “Good morning, ladies and gentlemen. Thank you for an outstanding safety performance yesterday. We are one day closer to our next fatal medication error.” CT

Jeff Hedges is president and CEO of R.J. Hedges & Associates in New Florence, Pa. The company provides complete turnkey healthcare compliance programs for clients. The author can be reached at