Panel 1: Consumers and Purchasers
Testimony by Susan E. Sheridan, Consumer, Boise, ID
The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.
Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.
Disclaimer and Copyright Statements
I am relieved and delighted that this summit is taking place, and I thank you for the opportunity to share my story with you regarding medical errors and how my family has been affected. Quite honestly, it has consumed us emotionally, physically, and financially for the past 5 years.
According to the Institute of Medicine (IOM) report on medial errors, the health care system has failed thousands of patients. The system has failed my first born son, Cal, and my husband, Pat. In particular, we have had the unique opportunity to gain insight into the American health care system and its lenient oversight; the general disregard of the patient when a medical error occurs; the lack of quality-of-care standards; the lack of integrity and the code of silence, as the IOM puts it, present at hospitals; the absence of accountability and consequences when medical errors do occur; the legal system and its distortions; and the general complexity of the system whose responsibility it is to ensure patient safety.
Today is a big day for me. Not only because of this summit, but also because today is my son's first day of kindergarten, a day usually filled with thrill and excitement. But for Pat and me, it is a poignant reminder of the failures in our medical system. My 5-year-old son is starting kindergarten unable to walk or crawl. He is hearing and speech impaired, drools and has uncontrollable movements of his arms and legs. My son's condition was entirely preventable and was the result of a series of medical errors soon after his birth.
Cal was born on March 23rd, 1995, a beautiful healthy boy, a baby that we had hoped for for over 10 years. It was believed for several years that it was unlikely that we could conceive. Cal was called the miracle baby. Our joy, however, was short lived. Cal suffered brain damage while in the hospital when he was less than 1 week old, from jaundice, a condition known as Kernicterus, which is usually only found in underdeveloped countries.
The only recourse that we knew of was through the legal system. I was unfamiliar at the time with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Board of Medicine, the Idaho State Bureau of Facility Standards, or the Health Care Financing Administration (HCFA).
During the 2 1/2 years of litigation the following facts were discovered:
- St Luke's Regional Medical Center is a major regional hospital and obstetrical center in Boise, Idaho, that in 1999 delivered 4,705 babies. To put that in perspective, that is more deliveries than any hospital in the Washington DC
area and rivals some of the largest hospitals in California.) It was discovered that St Luke's Regional Medical Center did not have ANY policies or protocols on jaundice management or blood typing of neonates at the time of my son's birth in 1995 or even at the time of our trial in 1999. My son was discharged a "healthy baby" at 36 hours old with jaundice covering his entire body without a bilirubin test, blood typing or Coombes test. It appears that my son's jaundice was the result of an ABO blood incompatibility. (Our 3-year-old daughter had the same incompatibility, but was promptly treated and is fine.)
- Newborn nursery nurses did not understand even the most basic principles of jaundice management. A newborn nursery nurse of 18 years stated that she did not know the ramifications of the effects (of bilirubin) on the brain, and none of the three treating nurses understood the serious concern of jaundice appearing in the first 24 hours. A judge stated, "certainly these principles should be understood by the more highly skilled nurses in the newborn nursery, and that such should have been part of hospital policy and protocol." The nurses testified that they could not recall ever attending any in-service, skills lab or age-related competencies, or any other educational program at St. Luke's Regional Medical Center that specifically addressed jaundice management.
- When Cal was readmitted for hyperbilirubinemia, a family practice resident at the end of his shift erroneously documented that Cal's blood type was the same as mine. This ruled out a blood incompatibility; therefore, an exchange transfusion was never performed. Again, a blood type was never performed. No one ever confirmed the resident's conclusion. Three doctors, two other residents, and several shifts of nurses never questioned the absence of lab reports that would have revealed blood type. (For those of you familiar with bilirubin values, my son's TSB was 34.6mg/dL when it was finally tested. It was one of the highest bilirubin levels recorded at St Luke's Regional Medical Center.)
Although there were undeniable breaches in the standard of care, we lost the trial. In a 7-week medical malpractice trial, our counsel used nationally recognized expert witnesses in the area of hyperbilirubinemia and Kernicterus. They have all either published, lectured, or conducted research in the area of Kernicterus and hyperbilirubinemia or have extensive experience in diagnosing and treating Kernicterus. Doctors from UCLA, Stanford, University of Pennsylvania School of Medicine and University of Washington all diagnosed Cal with "classic" Kernicterus and testified that it was 100% preventable.
Cal has subsequently been diagnosed with Kernicterus by Dr. Joseph Volpe, Pediatric Neurologist in Chief at Boston Children's Hospital, and Bronson Crothers, Professor of Pediatric Neurology at Harvard Medical School, and author of Neurology of the Newborn.
In contrast, St Luke's chose to use as their witness neonatologist and close personal friend of the director of the family practice residency program at St. Luke's Regional Medical Center. He testified that he did not have any expertise in Kernicterus however, he offered testimony with reasonable medical certainty that Cal did not have Kernicterus. Instead, it was his opinion that Cal suffered from an unspecified viral inflammation of the brain. He offered scientifically unsound testimony and inaccurate statements that conflicted with St. Luke's medical charts and records and even with some of the American Academy of Pediatrics' (AAP) guidelines on neonatal issues, which he assisted in authoring as a consultant. According to jurors, his testimony was instrumental in the final outcome of the trial.
On July 19, 1999 (the day before my JCAHO Public Information Interview), the judge granted a new trial and issued a memorandum stating that, "the evidence was clear that the hospital nurses breached the
standard of care, and that the hospital did not have any protocols or policies on jaundice, and that St. Luke's failed to establish any policy with regard to the handling of cord blood."
Interestingly, he mentioned that "one defense witness offered an opinion to a reasonable medical certainty that the cause of Cal's cerebral palsy was a virus, a theory so thoroughly discredited in cross examination and in rebuttal that no one even brought it up in final argument. He then went on to say, "that under rule 702, expert testimony should be intellectually honest and candid ... and such testimony will not be offered for the mere purpose of obscuring the actual circumstances or misleading the court or jury." The judge stated that, "he has great difficulty when the expert appears to be straining an opinion to meet the requirements of advocacy." In short, no one is policing expert witness testimony. (The hospital has appealed the judge's decision to grant the new trial resulting in a several-year delay in any action.)
On the same day of the verdict, my husband, Pat, was diagnosed with a tumor in his cervical spine and was referred to one of the best neurosurgeons in the nation, in Phoenix, Arizona. He had the tumor removed from his cervical spine, and it was communicated to us that it was a benign schwannoma, a harmless tumor. However, Pat was never informed that the final pathology (signed and dated 22 days after his surgery) showed a malignant sarcoma, which 6 months later returned as a much larger, more aggressive tumor that was invasive in the spinal cord. The failure to treat the cancer resulted in a second surgery, 6 months of out-of-state chemotherapy, and clinical trials at M.D. Anderson, and it has undoubtedly reduced his chances to survive. A spinal cord cannot be removed.
After the second surgery and the confirmation of a malignant sarcoma, no one informed us of the initial failure to communicate its malignancy to us. We were under the impression that the initial benign tumor "became malignant." We discovered that the tumor had been malignant the first time only after having requested Pat's medical records on the day of discharge. He was discharged without any explanation or acknowledgment of the error. It was a very disturbing example of the "code of silence" and the challenges associated with accurate reporting.
It was later discovered in a phone call between the pathologist, the Chief Administrative Officer of Barrow's Neurological Institute, in Phoenix, Arizona, and myself that the pathologist knew that my husband had malignant cancer the second day after the initial surgery. Also, he could not offer any explanation as to the reason why it took 22 days to complete a pathology report. Apparently, the delayed report made it to Pat's file without having been seen by his surgeon.
I have been in touch with JCAHO, HCFA, the Office of the Inspector General (OIG), and state agencies regarding our experiences and concerns relating to both Cal and Pat.
QUESTIONS, CONCERNS AND AREAS OF RESEARCH
These experiences that I have just described, and the injuries that my son and my husband have suffered, are not only unacceptable, but highlight the clear, undeniable need for research in the implementation of policies and procedures to prevent injuries and deaths, the role of monitoring the competencies of nurses and other medical staff, and the protocols for double checking when clinical judgments are made in the absence of things like documented lab reports.
A potential area of research could be to identify which injuries or deaths could have been avoided by the simple implementation of a mandated standard. My son's condition, Kernicterus, is a perfect example of such an injury.
Kernicterus, a condition that had been virtually eradicated in the U.S. by the 1970's, is sadly reemerging in the United States. Dr. Lois Johnson, M.D., FAAP, stated, "that it should again be occurring in a medically advanced, sophisticated and wealthy country such as the United States during the 1990's is sobering and unacceptable Y and that it is a tragic turn of events." There are 89 reports of children (from only 23 states) that have suffered unnecessarily from Kernicterus in the past 14 years, a number undoubtedly understated. The cause and treatment of Kernicterus is widely known and supported by volumes of literature. The re-emergence is attributed to early discharge of newborns; the limitations of visual assessment of jaundice; the lack of concern about jaundice among pediatricians, neonatologists, and nurses; and the misinterpretations of the AAP Practice Parameters designed to protect newborns.
Dr. Vinod Bhutani, M.D., and Lois Johnson, M.D. both fellows of the AAP, Apropose that a universal screening of bilirubin be mandated concurrent to the routine predischarge metabolic screening. Universal bilirubin screening in the term and near-term newborns when plotted on the AHour-specific Bilirubin NomoGram will predict the high risk and the low risk groups and facilitate cost effective and individualized follow up to those babies at risk. (See "Prospective Management of Newborn Jaundice")
Cost-cutting efforts have eliminated many needed laboratory tests. A bilirubin test is a $27 test at St. Luke's Regional Medical Center. It could be combined with the mandatory PKU and be even less expensive. My son's life care plan reflects that his medical costs will be between $4 million and $7 million. That translates to a cost of roughly $500 million dollars in medical costs based on the reported population of children with Kernicterus who are listed in the Pilot Registry. What costs are being saved?
An area of research specific to Kernicterus could include looking at a proposed collaboration between consumers, the AAP, and JCAHO (or some regulatory body) to implement minimum mandatory standards to protect some of the most vulnerable patients from Kernicterus. Kernicterus is preventable. Let's prevent it!
The Role of the Consumer/Role of the Regulatory Agencies
My family's experiences also point out the need to look carefully at the role of regulatory agencies, how they work, and the role of the consumer once errors or problems are reported.
How are consumers informed of the process to report medical errors? Are consumer's complaints taken seriously? Is there a formal process? Consumers need to be more empowered, involved, informed, and must receive feedback when reporting a medical error. In fact, what are the independent responsibilities of JCAHO, HCFA, and state licensing entities to ensure patient safety? Have adequate studies been done that analyze these functions, and has it been determined that the appropriate organization is doing the appropriate job? In other words, has the oversight function of these organizations been properly designed? Do the agencies, themselves, understand their jurisdiction and their responsibilities? And, how is the public informed of those responsibilities?
In July 1999, I participated in a JCAHO Public Information Interview regarding my son's brain injury. I took my responsibility very seriously and spent hours preparing the documentation, referring to medical charts and testimony to ensure accuracy. I was living in Michigan at the time so that Cal could attend a summer program for kids with cerebral palsy. I flew back to Idaho for the JCAHO interview. I was given 15 minutes, and my complaint and documents were not given to the survey team prior to my interview. I was told that there would be no dialog and that their investigation into my complaint would be very limited. Near the conclusion of my 15 minutes I was given a 1-minute warning although I indicated that my complaint was not close to being complete. (I also provided JCAHO with the judge's memorandum).
After the interview, there was no follow up or communication by JCAHO. After the performance report was issued in January, 2000, I requested information on the effect of my interview, and whether it had any impact on the final report. I was only told that it was Aconsidered and helped them look closer at some of the issues that were brought up in their report. JCAHO, however, would not share any information with the media despite calls to the Communications Department from a local newspaper and TV station. St. Luke's overall JCAHO evaluation score went up in 1999 and provided little information to the consumer.
In July 1999, I provided the same documentation (JCAHO complaint and judge's memorandum) to the Idaho State Bureau of Facility Standards. In September 1999, they investigated only four components of my complaint and issued a report saying that my complaint was unsubstantiated, since by that time policies on blood typing and jaundice management were in place. I expressed concern about the limited scope of the investigation, and they responded that their investigation was limited by HCFA mandate. I then requested (through FOIA) the dates of implementation of the policies on jaundice and blood typing.
That request was denied. When the concern of competency of the nurses and doctors was reported to the Idaho Bureau of Facility Standards, their response was that they are responsible "only to see if they had a system, not to see if the system adequately trained them in jaundice management" Who, then, is responsible for monitoring the competency of nurses and doctors? What happens when the current systems in place to monitor the performance of nurses and other hospital personnel fail to work? Is there an ongoing analysis taking place of how to hold personnel and the facilities, themselves, accountable for the care that they provide?
In February 2000, I sent a personal letter via registered mail to Dr. Dennis O'Leary, president of JCAHO, regarding my concerns and requested a reply. There was no response. I later copied the letter to June Gibbs-Brown at OIG, and Nancy Ann Min deParle at HCFA. I did not receive a response from HCFA; however, OIG did contact me.
Regarding the failure to communicate a malignant pathology, do hospitals have a system to prevent such oversights? Is there a minimum time that a pathology must be completed, dictated, transcribed, and urgently reported to the doctor and patient? When I reported the above-mentioned failure to the Division of Assurance and Licensure, in Phoenix, Arizona, they replied that this did not fall within their jurisdiction and forwarded my complaint to the Board of Medical Examiners(BOMEX). BOMEX responded that the average complaint took 9 months to a year to investigate, and that they had a backlog of 3 years. It is, however, under investigation. Why isn't the failure to report a malignant pathology for 22 days within the jurisdiction of the Division of Assurance and Licensure? The system not only failed Pat, but also failed the neurosurgeon, as well. Undoubtedly, the surgeon should have been more vigilant about the report and did not fulfill his responsibility to my husband, but the failure to recognize a Asystem failure by the Division of Assurance and Licensure automatically assigns all culpability to the doctor. It appears that the system, itself, is party to the plight of doctors being identified as defendants in medical malpractice lawsuits. When the same complaint was sent to JCAHO, they said that the hospital would be "monitored."
My experience with JCAHO and other similar bodies raises questions many of us consumers have. How can a state-licensed, JCAHO-accredited, highly ranked hospital (top 100 hospitals by HCIA) fail to have basic policies such as blood typing and jaundice management in place?
Why does JCAHO have a standard (PI.4.3) that requires an intensive analysis of sentinel events such as ABO incompatibility resulting in adverse outcomes (attached), no specific standards to prevent it (blood typing, bilirubin tests, or competency requirements for nurses)? Could some of the JCAHO standards become more proactive, rather than reactive?
Are there national standards that require stringent supervision of residents and medical students? Are there shift limits? What safety net is there for the patient when a Adoctor in training is working under the direction of a bad doctor?
What are the responsibilities of hospitals and healthcare organizations to a patient who is the victim of a medical error? Do hospitals have a financial responsibility to an injured patient? Are there standards to protect patients?
Our biggest disappointment in the healthcare system has been the intolerable lack of integrity and blatant dishonesty which appears to be an accepted practice throughout the industryranging from individual doctors up to the level of top executive officers of hospitals.
George Grob, Deputy Inspector General, stated, "if a hospital had something it didn't want you to find, it could keep you from finding it." Covering up medical errors is not uncommon. Are there penalties or consequences? If not, how will the self-reporting of sentinel events to JCAHO be effective? The consumers must be engaged.
Who monitors medical malpractice expert witness testimony? What authoritative body should be notified if expert witnesses offer improper testimony? Are there consequences? I called the AAN, AAP, the American College of Physicians, the Ada County Prosecutor, the Washington State Board of Medical Examiners, JCAHO, HCFA, the Bureau of Facility Standards, and finally the OIG. All agree that something must be done, but that it didn't fall within their jurisdiction. (The AAN did, however, mention their grievance procedure.) Dishonest medical expert witness testimony distorts the reporting of the medical errors, disciplinary action and mandatory reporting to the National Practitioner Data Bank. Dr. Sidney Weintraub, M.D., stated, "Junk science produces junk justice and a new standard of care." Would the establishment of a National Peer Review Board help reduce the improper testimony?
In 1996, St. Luke's was made aware that my son suffered brain damage from jaundice, but St. Luke's Regional Medical Center did not implement any policies regarding jaundice management or blood typing for neonates until after litigation was completed in 1999, endangering neonates for 2 2 years while the litigation process took place. Is this ethical? This was reported to JCAHO and HCFA and to the State Facilities Standards. To my knowledge, no action was taken. Is this acceptable?
In closing, from a consumer's point of view, the "system" is confusing, and very hard to navigate. It appears that the agencies responsible for patient safety lack coordination and have a potentially dangerous "hands off" policy toward hospitals even in the event of blatant misconduct and breaches in the standard of care. How can the system become more "user friendly" and engage the consumers, physicians, media and agencies in improving the health care system?
In comparing the health care industry to the automotive and airline industries, it can only appear that the Federal government is more concerned about consumers being injured in SUVs and airplanes than they are in the hospitals. 88 people were killed in the Alaska Airlines crash in California. The FAA launched a massive investigation, and even the Federal Bureau of Investigation (FBI) is involved. There appear to be 68 deaths and 100+ injuries from defective Firestone tires, and a massive Federal investigation and recall of tires is currently underway. It doesn't appear that the Federal government is concerned with Firestone's, Ford's, or Alaska Airline's images, or the risk of potential lawsuits. There have been 89 babies who have suffered brain damage from Kernicterus, and potentially 90,000+ deaths this year from medical errors. Why no massive investigation?
Undoubtedly, the attempt to reduce medical errors is an enormous undertaking. I hope that we walk away from this summit recognizing that we all have the responsibility to reduce medical errors, including the consumer. Consumers need to be more empowered, and more informed about how to help prevent and report medical errors. On the flip side, the health care agencies responsible for patient safety need to be responsive and respectful of the consumer. This would undoubtedly raise consumer confidence.
I can't change what has happened to my son or my husband, but I do hope that by telling our story, I can make a difference and help prevent it from happening to other babies and daddies.
Current as of September 2000
Return to Testimony Directory
National Summit on Medical Errors and Patient Safety
QuIC Home Page
Department of Health and Human Services