Babies with Heart Problems – Problems of Corporate Healthcare

St. Mary’s Medical Center pediatric open heart surgery center was three times the national average for patient deaths from 2010-02013 (CNN Report).

Tenet Healthcare Corporation owns St. Mary’s Medical Center and an understanding of Tenet’s corporate history is helpful to an appreciation for what is currently happening there.

Tenet is no stranger to problems in healthcare; particularly in the area of cardiac surgery. Some of the allegations made against Tenet over the years involved individual patient lawsuits, some involved serious concerns by governmental oversight agencies and some involved hefty fines meted out against Tenet by the government.

Between 1997 and 2002, Palm Beach Gardens Medical Center (a Tenet Hospital) was experiencing uncontrolled, systemic infections in their open heart surgery patients. Some patients developed sepsis and died. Many more patients suffered painful infections, multiple surgeries and disfigurement. Cardiac surgery is a huge profit center for hospitals and so it was predictable that Tenet’s persistent approach to the problem was to bury their head in the sand and hope it went away. It did not and it cost them more than $31 million.

In 2000, in Redding Hospital (a Tenet hospital in Southern California), Chief of Cardiac Surgery Dr. Charles Rosen learned that he had been performing open heart surgeries on patients for months with surgical instruments not properly sterilized. He discovered the flash sterilizers, which were supposed to provide him with clean surgical instruments, had been malfunctioning and no one told him. It was later discovered that other healthcare workers were instructed not to tell the surgeons about positive spore samples found on surgical instruments. Dr. Rosen resigned with the parting statement that, Tenet focuses on “the bottom line, regardless of what is good for the patients.”

In December of 2004, Tenet Healthcare agreed to pay $395 million to 82 victims of unnecessary heart surgeries performed at their Redding Medical Center.

For many years, St. Mary’s Medical Center has focused its area of expertise on trauma medicine and it has always held itself out as one of the foremost trauma centers in this area of the country, often with good reason.

One must wonder why Tenet Healthcare would decide to insert a pediatric open heart center into a trauma medical center. A trauma center and its surgical component are there to handle sudden, usually severe, traumatic injuries. Heart surgery centers are typically housed in a facility performing planned, deliberate medical treatment. This is particularly true for pediatric congenital heart centers. It may be that Tenet was so interested in getting into the pediatric cardiac business; that they were willing to place it anywhere. Anywhere they could make a profit that is.

As a part of the privilege to practice, hospitals must comply with many Florida statutes and regulations. The most basic statute that really forms the foundation for all those relating to quality of care is Florida Statute 766.110:

“All health care facilities…have a duty to assure comprehensive risk management and the competence of their medical staff….and are liable for a failure to exercise due care in fulfilling these duties.”

Underlying the statute is the principle that profits should not be placed ahead of quality care, sufficient staffing and good risk management to protect patients.

In 2014, a team of physicians came to St. Mary’s to audit the open heart pediatric program. Some of the comments from these esteemed physician experts show a minimally staffed program.

Dr. James Fudge, the Director of the Congenital Cardiac Catheterization Program at the University of Florida, set forth these concerns among others:

“Dr. Chandar is currently the only pediatric interventional cardiologist with privileges to perform pediatric cardiac catheterizations at Palm Beach Children’s Hospital. This creates a void in coverage for both routine and emergent cardiac catheterization cases when he is not available. In addition, Dr. Chandar’s primary practice is located approximately sixty miles from Palm Beach Children’s Hospital; therefore, his immediate availability is somewhat limited by geographic distance. In order to provide comprehensive cardiovascular care to this complex patient population, it is important to provide continuous and readily available support from a pediatric catheterization team.” (emphasis added)

Dr. Ira Gessner, a distinguished Professor at the University of Florida’s Congenital Heart Center commented on the echocardiogram laboratory at St. Mary’s:

“Of further concern, the program did 20 transesophageal studies and these were reported by 5 physicians, two of whom, including Dr. Tsounias, reported only one. I think that quality control cannot be assured by this spread of reporting responsibility, and I do not think that this structure will allow the pediatric cardiology echocardiography laboratory to achieve societal approval.” (emphasis added)

In reviewing the practice of ALL patients receiving an echocardiogram if referred, whether they actually need it or not; Dr. Gessner went on to write:

I am quite aware that the large majority of pediatric cardiologists in Florida… accomplish echocardiograms on almost all new patients referred for any reason, including the most common, an asymptomatic heart murmur. I find this behavior unsupportable on scientific grounds and reprehensible in its costs. Those who reference studies that physicians’ skills in clinical diagnosis of a heart murmur are inadequate fail to mention that these studies do not involve pediatric cardiologists. A board certified pediatric cardiologist who cannot diagnose an innocent murmur as such by physical examination alone in over 90% of patients does not belong in clinical practice. (emphasis added)

Dr. Jorge McCormack, a prominent Cardiologist at Comprehensive Cardiology for Children of Florida, commented:

“Similarly, the institution does not currently have pediatric electrophysiology expertise nor a pediatric electrophysiology laboratory. Consequently, difficult postoperative arrhythmias or other arrhythmias that may present to the institution’s nursery or emergency room, can not be evaluated invasively at St Mary’s and are therefore referred to a different program. To my knowledge, there is not an agreement for a pediatric electrophysiologist to provide consultative services.”

“In closing, a new program should always consider having all the necessary elements of a complete pediatric cardiologyIcardiac surgical program in place before performing cardiac procedures so that risks and complications, both foreseen and unforeseen, can be adequately managed internally. This type of comprehensive pre-planning is fundamentally important to achieve the best and safest patient care.” (emphasis added)

Dr. Jeffrey Jacobs, a noted authority in Cardiac Surgery at Johns Hopkins Medical Center was called in by St. Mary’s to investigate the state of their pediatric open heart surgery center. His advice was blunt:

“Stop doing complex heart surgeries on children” and

“Stop doing any heart surgeries on babies younger than six months old.”

Indeed, Dr. Jeffrey Jacobs went on to warn:

“It is common knowledge that multiple pediatric cardiac surgeons (at CMS providing institutions across the state of Florida) have expressed serious concern about babies having complex pediatric cardiac surgery at by St. Mary’s Medical Center and Palm Beach Children’s Hospital and subsequently being transferred to other facilities in Florida for the management of major complications. Several of these children have died at the receiving hospital after having undergone complex pediatric cardiac surgery at St. Mary’s Medical Center and Palm Beach Children’s Hospital.” (emphasis added)

“Concern exists across the State of Florida about the above described mortality and morbidity and also about the extremely low volume of pediatric cardiac surgery being performed at St. Mary’s Medical Center and Palm Beach Children’s Hospital.”

“When the Certificate of Need (CON) was granted to perform pediatric cardiac surgery at St. Mary’s Medical Center and Palm Beach Children’s Hospital, one of the stipulations was that the program at St. Mary’s Medical Center and Palm Beach Children’s Hospital would form a formalized collaborative program with another pediatric center in South Florida. This collaborative relationship never developed.” (emphasis added)

All of the comments and recommendations expressed by experts examining St. Mary’s pediatric open heart surgery center have a common thread running through them and it is to stop trying to run a highly complex treatment center on a shoe string. Tenet must put patient care above profits, purely and simply.

In 2006, Tenet Healthcare Corporation, the owner of St. Mary’s Medical Center, paid $900 million to the United States for a release from liability under the False Claims Act, and other administrative penalties. As a part of their agreement (that expired in 2012), Tenet agreed to establish and maintain a Corporate Compliance agreement to include the following:

• Appointment and maintenance of a Chief Compliance Officer.
• Appointment and maintenance of Regional and hospital Compliance Officers.
• Create and maintain an Ethics and Compliance Department.
• Create and maintain a Clinical Quality Department.
• Create and maintain Regional and Hospital Compliance Committees.

These are all committees or positions to insure that Tenet and its hospitals complied with and stayed in compliance with quality care, legal compliance and ethical adherence.

Tenet also agreed to a “Code of Conduct” and its use in evaluating “the performance of all employees”; which included a code covering the following areas:

• Tenet’s commitment to full compliance with all Federal health care program requirements, including its commitment to prepare and submit accurate claims consistent with such requirements;
• Tenet’s requirement that all of its Covered Persons shall be expected to comply with all Federal health care program requirements and with Tenet’s own Policies and Procedures; and
• Tenet’s employees will be expected to report to the Chief Compliance Officer, or other appropriate individual designated by Tenet, suspected violations of any Federal health care program requirements or of Tenet’s own Policies and Procedures.

Besides striking an agreement relating to Tenet’s honesty and ethical compliance with Medicare, the United Sates also required agreements that reflected quality clinical care of patients by:

• Measuring, analyzing, and tracking quality indicators, including adverse patient events…;
• Incorporating quality indicator data, including patient care data and other relevant data to monitor the effectiveness and safety of services and quality of care…;
• Tracking medical errors and adverse patient events, analyzing their causes, and implementing preventive actions;
• Conducting quality assessment and performance improvement projects, including periodic clinical quality audits of Tenet hospitals;
• Periodically reporting quality assessment and performance improvement data to the Board Committee;
• Monitoring practitioners with current privileges by the review of clinical practice patterns, ongoing case review, proctoring, and discussion with other individuals involved in the care of patients;
• Incorporating clinical quality metrics on the balanced scorecard for senior management and implementing effective responses when clinical quality problems are discovered.

We have reviewed only a few of the several questionable occurrences in Tenet Hospitals in the past. They all stem from a corporation which seems intent on maximizing profits, even if it requires providing marginal or minimal quality of patient care; even after having been sued and settled or found guilty on multiple occasions. The agreement the United States forced upon Tenet is clearly to mandate improvement in the corporate delivery of improved health care to patients.

Tenet’s approach to business might be understandable if they were selling widgets. They might well manufacture and sell widgets, while only hiring the bare minimum of employees and equipment to do the job. With a bare minimum, one might make errors along the way, but the savings would provide a higher contribution to profit.

Tenet, however, is dealing in human life. In the case of the new St. Mary’s open heart pediatric center, they are gambling with the lives of children and we, the citizens of Florida, are the losers of that gamble.