The Need for Standards in Healthcare: For Improved Patient Safety and Quality of Care

by Christopher Jerry and Michael Wong

In his recent article, “A SEC for Health Care?”, Dr. Peter Pronovost, PhD, FCCM (Professor, Departments of Anesthesiology/Critical Care Medicine and Surgery, The Johns Hopkins University School of Medicine and Medical Director, Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality) discusses the tremendous variability in the quality and measures of healthcare provided across this country:

Depending where you look, you often get a different story about the quality of care at a given institution. For example, none of the 17 hospitals listed in U.S. News and World Report’s “Best Hospitals Honor Roll” were identified by the Joint Commission as top performers in its 2010 list of institutions that received a composite score of at least 95 percent on key process measures.

As an illustration of the variability of quality, the Emily Jerry Foundation recently released its “2013 National Pharmacy Technician Regulation Scorecard”. The development of this scorecard was prompted by the heartbreaking story of what happened to two year old Emily Jerry.

Emily had waged a successful battle against cancer. Her treatment had been so successful that her last MRI clearly showed that the tumor miraculously disappeared. In fact, three radiologists had to review her MRI films due to the fact that there wasn’t even any residual scar tissue left. Emily’s doctors said it was as if she never had cancer! Regardless she was scheduled to begin her last chemotherapy session on her second birthday, February 24, 2006. This last treatment was just to be sure that there were no traces of cancer left inside of her little body. Tragically, it was not cancer or the reoccurrence of cancer that ended Emily’s life. She was killed by an overdose of sodium chloride in the last chemotherapy IV bag she received.

Shortly after Emily’s tragic death, it was determined that a pharmacy technician, who did not have the proper training or core competency to be compounding IV chemotherapy, had made the deadly compounding error. The primary reason the pharmacy technician involved in Emily’s death lacked the core competency to be compounding IV medications safely, was due to the simple fact that in 2006, in the state of Ohio, there were absolutely no requirements to become a pharmacy technician, aside from having your high school diploma. No training requirements, no continuing education requirements, no oversight by the Ohio State Pharmacy Board, no licensing or registration requirements, etc.

What is even more disturbing, is the fact that The Emily Jerry Foundation has been receiving an outpouring of concern from most people in the general public, as well as, the caregivers themselves, who were previously completely unaware that in all of our nation’s world renowned medical facilities, including the leading pediatric facility where Emily was treated, pharmacy technicians are the individuals responsible for compounding virtually all IV medications in the clinical pharmacy. It was this type of variability in quality, in terms of pharmacy technician requirements, coupled with the fact that the pharmacy technician’s overall scope of responsibilities have expanded greatly in recent decades, that led to the passage of Emily’s Law in the state of Ohio in January of 2009. Even though Emily’s Law significantly helped to reduce much of this variability in quality in the state of Ohio, this inherent problem is still very evident in many other states across the nation.

The Emily Jerry Foundation’s 2013 National Pharmacy Technician Regulation Scorecard highlights the states that are doing a great job of protecting their patients through strict controls and educational requirements for pharmacy techs, as well as encourage those that are lagging behind to make improvements in their own standards in order to improve care and potentially save lives. States like North Dakota received a perfect score based on the Foundation’s grading criteria. However, it’s now 2013 and six states still have no oversight by their respective state boards of pharmacy and, subsequently, no regulation regarding their pharmacy technicians. Numerous studies have shown that overall pharmacy error rates are volume dependent. (reference: USA Today, “Speed, high volumes can trigger mistakes”). With that fact in mind, pharmacy technician oversight and regulation issues like these, become even more of a serious matter of public safety in states like New York, which currently has the second highest prescription volume in the United States (253,796,344 Rx filled in 2012). (reference: SDI Health, L.L.C.: Special Data Request, 2012)

How should this variability in quality be fixed and subsequently managed?

Dr. Pronovost, together with his colleagues, in their paper, “Achieving the Potential of Health Care Performance Measures” propose seven recommendations:

1. Decisively move from measuring processes to outcomes;
2. Use quality measures strategically, adopting other quality improvement approaches where measures fall short;
3. Measure quality at the level of the organization, rather than the clinician;
4. Measure patient experience with care and patient-reported outcomes as ends in themselves;
5. Use measurement to promote the concept of the rapid-learning health care system;
6. Invest in the “basic science” of measurement development and applications, including an emphasis on anticipating and preventing unintended adverse consequences; and
7. Task a single entity with defining standards for measuring and reporting quality and cost data, similar to the role the Securities and Exchange Commission (SEC) serves for the reporting of corporate financial data, to improve the validity, comparability, and transparency of publicly-reported health care quality data. Many in the healthcare industry use this likes of this service to help them in their data management and transparency reports.

Dr. Pronovost says the last proposal would bring about the most change:

Of the proposals, perhaps the biggest game-changer would be the creation of an entity to serve as the health care equivalent of the U.S. Securities and Exchange Commission. Rather than wading through a bevy of competing and often contradictory measures, patients and others would have one source of quality data that has national consensus behind it.

While the merits and demerits of a SEC for healthcare can be debated, one thing is clear from the comments posted in reply to Dr. Pronovost’s article – experts in specific areas should build consensus and determine what the ideal system should look like.

An example of the development of consensus is in checklists. The checklist developed by the Physician-Patient Alliance for Health & Safety reminds caregivers of the essential steps needed to be taken to initiate Patient-Controlled Analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA.

Monitoring patients receiving opioids by patient-controlled analgesia (PCA) is a critical patient safety issue. In its Sentinel Event Alert, “Safe Use of Opioids in Hospitals”, The Joint Commission recently stated:

While opioid use is generally safe for most patients, opioid analgesics may be associated with adverse effects, the most serious effect being respiratory depression, which is generally preceded by sedation.

More than 56,000 adverse events and 700 patient deaths were linked to PCA pumps in reports to the Food and Drug Administration (FDA) between 2005 and 2009. One out of 378 post-surgical patients are harmed or die from errors related to the patient-controlled pumps that help relieve pain after surgical procedures, such as knee or abdominal surgery. This is a startling amount. People who are wrongfully treated whilst feeling they are in the hands of a person in a trustful position, can get in touch with lawyers from firms like the Atlanta Law Firm to see if they can claim for medical malpractice.

More recently, Pennsylvania Patient Safety Authority released its analysis of medication errors and adverse drug reactions involving intravenous fentaNYL that were reported to them. Researchers found 2,319 events between June 2004 to March 2012 – that’s almost 25 events per month or about one every day. Although one error a day may seem high, their analysis is confined to reports made to the Pennsylvania Patient Safety Authority and only include fentaNYL, a potent, synthetic narcotic analgesic with a rapid onset and short duration of action. This drug is now being used by many drug addicts as an alternative to heroin, although fentanyl can be anywhere from 25 to 50 times stronger than heroin. This is causing many heroin addicts to overdose and die due to using the same doses as they once did while injecting heroin. How can a drug that once used for its medicinal and pain-relieving properties now require a fentanyl drug test to be readily available in efforts to try and decrease opioid use?

Consequently, to provide greater patient safety, one of the recommended steps of the PCA Safety Checklist therefore provides:

Patient is electronically monitored with both:
pulse oximetry, and
capnography

The relentless push for quality and better patient safety must continue. To do otherwise will mean more Emily Jerrys and Amanda Abbiehls (who died after unmonitored use of a PCA).

For those of us who might think that death in a healthcare facility cannot happen to us or someone we know, Dr. Pronovost reminds us that preventable deaths is a leading cause of death. As he recently stated on The Katie Couric Show:

Frame the size of your problem. I suspect that all of your viewers either have been touched by or a family member has been harmed by mistakes. It is the third leading cause of death in this country. More people die from medical mistakes each year than died per year in the civil war.

So, make sure adequate training is provided for all those involved in healthcare delivery, like pharmacy technicians, and use checklists as a reminder of essential steps, such as the PCA Safety Checklist. It just may save a life.