Introduction & History (PA)

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Introduction

We all are familiar with Sully Sullenberger, the pilot who was the captain of the flight that successfully landed on the Hudson River – “The Miracle on the Hudson”. Captain Sullenberger has become involved in the conversations surrounding medical errors and made an observation that will forever stick in many of our minds. “ There are over 200,000 preventable deaths each year including medical errors, which are mostly system failures and health care associated conditions like hospital – acquired infections. That is the equivalent of 3 airliners crashing every day without survivors….that would not be tolerated in my (aviation) world.”

Just stop and think about that comment for a moment…. If each of us stopped and thought about the fact that even though there are thousands of flights every single day in the United States, how many of us would really get on a plane and fly if we gave considerable thought to the idea that there would be 3 planes that would crash that day and there would be no one that survived. I think most of us would be doing a tremendous amount of driving.

Another amazing fact is that across the United States, to become a certified cosmetologist, classes and training in excess of 1000 hours is required, although, to become a certified nurses aide, the required training is 75-100 hours. Again, just stop and think about that disparity for a moment.

So, why is it that as a nation, with such great controls in place for our aviation industry, and such high training requirements for cosmetologists, that we cannot establish better processes and controls to avert so many preventable deaths with so many of those deaths being due to medical errors/system failures? As we study medical errors throughout this course, we will provide information about the initial shock of the government and our citizens when we first learned of the significant number of preventable deaths and medical errors back in 1999, what actions the government and President Clinton immediately implemented to reduce these numbers, the effect of those actions, the most recent efforts to reduce medical errors, what errors specifically occur in physical therapy, and how to prevent errors in the practice of physical therapy. We will also cover root cause analysis and how to perform this process.

History of Medical Errors in the United States Health Care System

The history of medical errors is a rather short one as there was very little knowledge of medical errors until 1999. Through this course, we will start from the beginning and bring the events and progress right up to the present. To get started, let’s make sure we are all on the same page. What is the definition of a Medical Error? According to the Institute of Medicine, “Medical errors can be defined as the failure of a planned action to be completed as intended or the use of wrong plan to achieve an aim.”

Before we delve into the history of medical errors, let’s take a moment to look at factors that increase the risk of errors. J.T. Reason provided the following factors that we should keep in mind during the duration of this course. We have also added examples that might lead you to identify with one or more of these factors:

1) Fatigue – working double shifts and 12-hour shifts increase the fatigue level in humans. It has been documented that reducing work hours significantly reduces error rates.

2) Alcohol and/or other drugs – easy access and high stress levels have led to substance abuse among clinicians.

3) Illness – reporting to work when ill increases the chance of infecting patients.

4) Inattention/distraction – treating multiple patients can lead to lack of concentration.

5) Emotional status – everyone struggles to block out their own problems, which can lead to distraction and errors.

6) Unfamiliar situations or problems – clinicians covering for a co-worker may lead to issues in treatment.

7) Equipment design flaws

8) Inadequate labeling or instructions – without proper instructions on equipment, misuse can lead to errors. Medications can also have improper labeling that can lead to medical errors.

9) Communication problems – lack of communication, written, verbal or electronic between clinicians and/or patients can lead to problems.

10) Hard-to-read handwriting – Electronic medical records and electronic medication orders have already greatly reduced this issue.

The laser focused attention on medical errors/sentinel events in our healthcare system began in 1999, when the Institute of Medicine (IOM) released the first of two reports that were part of a series of reports known as the “Quality of Health Care in America” project. These two reports (IOM-1 and IOM-2) have changed the way the public, the government and healthcare systems think about patient safety and the quality of care. “To Err is Human: Building a Safer Health System” (IOM-1), was released in September of 1999 and was focused on the specific area of medical errors in the hospital based setting.

IOM – 1

The landmark report (IOM-1) revealed that 98,000 people die each year as a result of medical errors. The report estimated between $18 and $29 billion dollars were spent in medical care due to these errors. IOM-1 does not “point the finger” at any particular person or group, but rather refers to the faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.

IOM -1 brought with it’s staggering numbers of errors and expense, great controversy as to the reliability of the information. Two articles published in JAMA (Journal of American Medical Association) on July 5, 2000 represented polar opposite thoughts. McDonald and others suggested that the number of errors reported were grossly exaggerated. At the same time, Leape, a recognized leader in the field believed the numbers might be under-estimated and that the burden brought on by medical errors was far more staggering than suggested.

To better discuss issues related to medical errors, IOM- 1 report developed a category system for errors that is presented below:

1) Diagnostic errors

Error or delay in diagnosis

Failure to employ indicated tests

Use of outdated tests or therapy

Failure to act on results of monitoring or testing

2) Treatment

Error in the performance of an operation, procedure, or test

Error in administering the treatment

Error in the dose or method of using a drug

Avoidable delay in treatment or in responding to an abnormal test

Inappropriate (not indicated) care

3) Prevention

Failure to provide prophylactic treatment

Inadequate monitoring or follow-up treatment

4) Other

Failure of communication

Equipment failure

Other system failures

The greatest percentage of medical errors reported in IOM – 1, were medication errors. As can be expected, in 1999, when almost 100 percent of all prescriptions were handwritten, a significant number of errors occurred due to the inability of the pharmacy staff to correctly interpret the handwriting. Unfortunately, medication errors can occur at any stage of the administration of medication including ordering, transcribing, dispensing, administering, and monitoring. Another sad fact presented in 2000, revealed that 20% of patients were not literate enough to read, understand, and follow their prescription directions, which translated into more medication errors.

As a conclusion to the report, the committee recommended a four-part plan to include:

1) Create a “Center for patient safety within the Agency for Healthcare Research and Quality”.

2) Establish mandatory and voluntary reporting systems.

3) Raise standards and expectations for improvement in safety through the actions of oversight organizations, group purchasers, and professional groups.

4) Create safety systems inside healthcare organizations through the implementation of safe practices at delivery level.

During the period of 1999 – 2000, AHRQ (Agency for Healthcare Research and Quality) and Federal agencies of the Quality Interagency Coordination Task Force came together to strategize how to improve patient safety and improve working conditions in healthcare. The groups identified gaps in the knowledge that include:

1) The need for an evidence-based understanding of the impact of specific improvements in the healthcare workplace on quality of care.

2) The effect of staffing levels and organization of work on patient outcomes and health personnel.

3) The effect of incentives and alternative work organization strategies to promote healthcare worker retention and adoption of new methods to deliver high quality care.

As a result of this group strategy, in 2001, AHRQ received $10 million to support projects that specifically target healthcare workforce and quality improvements.

The government response to IOM – 1 was significant. Following are some of the immediate actions:

1) President Clinton signed the bill S.580 – “Healthcare and Research Quality Act of 1999. Bill S.580 expanded the mission of the AHRQ.

2) Clinton tasked QuIC with responding fully to the IOM – 1 report.

3) CQuIPS (Center for Quality Improvement and Patient Safety) was established within the AHRQ to coordinate public and private sector initiatives to improve patient safety. The purpose was to conduct aggressive research into medical errors and convert the errors into improved practices.

IOM – 2

The follow up to IOM-1, IOM-2 “Crossing the Quality Chasm: A New Health System for the 21st Century” was released in 2001. IOM-2 recommends a total redesign of the healthcare system in the United States. The report offers 4 points:

    • A set of performance expectations for the 21st century healthcare system.
    • A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality.
    • Key steps to promote evidence-based practice and strengthen clinical information systems, and
    • A set of ten new rules to guide patient-clinician relationships.

In addition, the ten guiding rules for patients and clinicians in the last point include:

1) Care based on continuous healing relationships – 24 hour a day response by additional means including the internet, phone and other additions to face-to-face meetings.

2) Customization based on patient needs and values – must meet common and uncommon needs or patient preferences.

3) The patient as the source of control – patient should be given information to help choose health care decisions that affect them.

4) Shared knowledge and the free flow of information – patients should have access to their medical information and communication with clinicians.

5) Evidence-based decision-making – patient care should be based on best scientific information and not vary among clinicians.

6) Safety as a system priority – patients should be safe from system errors.

7) The need for transparency – healthcare system should make information available for families to make informed decisions.

8) Anticipation of needs – needs of patients should be anticipated and not reacted to.

9) Continuous decrease in waste – there should be no waste of resources or patient time.

10) Cooperation among clinicians – clinicians acting collaboratively to coordinate care.

Post IOM 1&2

In 2001, AHRQ funded 4 new CERTs (Center for Evaluation and Research in Therapeutics) to begin to resolve problems of therapeutic error more generally. The research of the CERTs had 3 goals: 1) to increase awareness of the uses and risks of new drug combinations, biological products, and devices; 2) to provide clinical information to patients and consumers; health care providers; pharmacists and pharmacy benefit managers; HMOs and health care delivery systems; insurers; and government agencies, and 3) to improve quality while reducing costs of care.

As time passed, more and more groups began research and studies to look at why medical errors were occurring in such large quantities and how to correct the issues. In 2002, AHRQ began to follow and support many such projects, including studies on: the impact of nurses’ workload and working conditions; effects of fatigue and stress; working conditions in nursing homes; reducing adverse events; organizational climate and culture; and many others.

Also in 2002, the Patient Safety and Quality Improvement Act provided a means for healthcare facilities to report and investigate errors to help develop strategies for improvement without being used as the basis of a lawsuit. Unfortunately, many healthcare providers and systems have been hesitant to use this system due to the litigious nature of the US culture. University of Pennsylvania law professor, Tom Baker, stated, “we have an epidemic of medical malpractice, not of malpractice lawsuits.” In other words, there are a much greater number of medical errors than lawsuits. Michael Gibbons was dead on when he wrote that, “The war on medical errors will be hard to win due to data suppression concerning adverse events”.

In 2005 AHRQ released a statement that the reason adverse events and medical errors occur is that evidence-based information about what works to prevent them, or to reduce the harm they cause, does not exist. As a result of this statement, the National Quality forum, which includes representatives of 260 of the nation’s leading healthcare providers, purchasers, and consumer organizations, identified “30 Safe Practices for Better Health Care”. The organizations involved strongly urged that the 30 Safe Practices be universally implemented to reduce risk of harm to patients. The “30 Safe Practices” can be found at http://www.ahrq.gov/research/findings/factsheet/errors-safety/30safe/index.html

The last historic information presented here for 2005 was the move by the Denver Health and Hospital Authority to use a Toyota car company practice in a program called “Lean Healthcare”. In the National Journal, Chief Medical Officer, Philip Mahler reported that the hospital was able to rearrange lab workspaces to reduce errors in labeling and to decrease duplications. This is just another example of how other industries have surpassed the health system in becoming more efficient and therefore, encountering less mistakes/errors.

Financial Burdens

In 2006, it is estimated that 187,135 deaths and 6.1 million injuries costing between $393 billion and $958 billion were attributed to medical mistakes according to John Goodman and Pamela Villarreal of the National Center for Policy Analysis. Villarreal stated, “For every dollar spent in the health care system, about 18 to 45 cents of that dollar went to hurting someone.”

There were no significant accomplishments or initiatives leading up to the report in the Journal of Health Care Finance in 2008. According to a study sponsored by the Society for Actuaries, medical errors cost the US $19.5 billion with 87% of that cost being associated with additional medical costs. An even higher economic impact of nearly $1 trillion dollars annual cost is realized when quality adjusted life years is added for those who died due to medical errors. The financial impact of lost time due to death adds a staggering impact to the overall financial impact of medical errors.

CMS Actions

Other significant actions and studies came to light in 2008. CMS (Center for Medicare and Medicaid Services) instituted new rules to try and push hospitals to put into place processes to avoid reasonably preventable hospital acquired conditions. These new rules stopped the payment by CMS for hospital and clinician preventable errors. CMS also released 10 reasonably preventable conditions that they would not reimburse for and that could not be billed back to the patient.

CMS 10 Hospital Acquired Conditions Not to Be Reimbursed:

1) Object left in surgery (Serious Preventable Event – SPE)

2) Air embolism (SPE)

3) Blood incompatibility (SPE)

4) Stage III and IV pressure ulcers

5) Falls and trauma

6) Manifestations of poor glycemic control

7) Catheter-associated urinary tract infections (UTIs)

8) Vascular catheter-associated infection

9) Surgical site infection following

a) Coronary Artery Bypass Graf

b) Bariatric Surgery

c) Orthopedic Procedures

10) Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

The creation of Medicare Compare in 2008 was significant as it created a public database for hospitals to share performance. Compare was designed to send participating hospitals a private report of how its performance compared to other hospitals through a secure website. Again, many health systems were reluctant to send information for fear of legal sanctions. As Carolyn Clancy, MD, and head of AHRQ stated, “it’s really hard to know how much harm and avoidable harm really happens because hospitals hide it.”

 

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