Monday Mornings

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For anyone who wants a peek behind the curtain of Morbidity and Mortality conferences–those secret peer review meetings where medical errors are discussed–there’s a book-turned TV series that offers an interesting glimpse.  Monday Mornings is a TNT series based on a book of the same name by medical journalist Sanjay Gupta.  As with most things worth watching, the series was cancelled after one season, but it remains readily available thanks to Amazon Instant Video!

As I’ve ranted before, the medical profession has an established tradition of meeting to discuss bad outcomes in patient care, and has prevailed upon legislatures in every state to pass laws allowing them to keep those discussions secret, even from the patients whose care is being discussed.  Monday Mornings offers a fictionalized description of what goes on behind those closed doors.

While the characters’ personalities–the pompous chief of staff, the emergency department doctor who shoots from the hip, the scruffily handsome neurosurgeon who is having an affair with his beautiful colleague– are rather stereotypical and obviously created to bolster the dramatic storyline, there is still plenty of focus on how hospitals react to medical mistakes.  For the most part, discussions in the Monday morning meetings are brutally honest in their criticism of surgeons who’ve made errors, both in technique and in reasoning.  Of course, when the chief of staff decides to terminate the privileges of a doctor who made an inexcusable error, it is clear that he will allow the physician to go practice at another facility–another dose of reality in a world where bad doctors move freely from hospital to hospital and state to state.

Most people outside the medical profession will never get a chance to see the inner workings of the peer review process up close and personal.  Gupta’s inside knowledge brings readers and viewers a unique look at how the medical profession handles errors.  The result is flattering and frightening in equal parts, as the providers genuinely seem to strive for improvement, yet at the same time are willing to conceal mistakes from public view.  Despite the dramatic embellishments, the book is worth a read for lawyers and patients who are interested in how the peer review system really works. The TV series faithfully tracks the book, and the cast makes a compelling drama.

Surgical Errors on the Rise?

mast-surgical-errorRecently released statistics from the Massachusetts Division of Health Care Quality  (DHCQ) show a projected increase in certain types of surgical errors in 2012 as compared to 2011.  According to the data, which comes directly from mandatory hospital reports, the number of surgeries performed on the wrong body part and the incidence of foreign objects left in patients both increased by 60% in the first half of 2012, as compared to the previous year.  Hospitals reported smaller increases in performance of the wrong surgery or procedures performed on the wrong patient.

The DHCQ calculated the statistics by doubling the the number of each type of incident reported by hospitals from January through June 2012 to estimate the number of adverse events for the full calendar year.  The data for the last half of the year is not yet available, and may not be directly comparable due to changes in some definitions that took effect in October 2012.

The statistics are based on Massachusetts hospitals’ self-reports of “serious reportable events (SREs),” a term intended to capture certain presumably preventable adverse events.  Under DHCQ regulations, hospitals must report events falling within the enumerated categories–and must notify patients that such an event has occurred.

A major weakness in the system is that it is dependent on the honesty of hospitals and the health care providers who may be involved in errors.  A surgeon who quickly finds a sponge left in a patient might not report it to the administration–or the administration might interpret the regulations so as not to require a report.  For example, recent statistics show that neither Children’s Hospital in Boston nor South Shore Hospital in Weymouth–two fairly busy hospitals– reported ANY surgical errors during the 18 months from January 2011 through June 2012.  Maybe, but I’m suspicious.

A more serious problem flows from the definitions used by the DHCQ, which exclude many otherwise serious reportable events.  For example, hospitals are required to report any death of a low-risk patient occurring within 24 hours of surgery.   Yet if the patient  is irreversibly brain damaged during surgery, yet remains on life support until the day after the surgery, no report is required.

Other gaps occur when patients are treated at multiple hospitals, none of which accepts responsibility for the report.  For example, in one case we handled, a mother suffered a hemorrhage during delivery and was transferred to a tertiary care hospital, where she later died (a reportable event).  The delivering hospital took the position that it was not required to report the death because the mother didn’t die at its facility–while the receiving hospital didn’t feel it had to report since the injury that caused the death occurred elsewhere.  In another case, a psychiatric patient being transferred from one hospital to another eloped  (another reportable event) during transport and committed suicide.  Neither hospital reported the elopement.

While the SRE program is well-intended, the tremendous individual variation in hospital reporting and the narrow definitions used by the DHCQ make the resulting statistics of limited use to consumers.  Unless more stringent reporting requirements are instituted, it is difficult to compare one hospital to another, or even to determine whether the quality of care is improving.  So far, there is little evidence to show that it is.

Read the DHCQ presentation of its statistics here.

Who and What Does HIPAA Protect?

HIPAA-COMPL monkeysThe HIPAA police are at it again.  A Massachusetts federal district court has dismissed a claim brought against Baystate Medical Center by a nurse who was fired for asking about a patient’s condition and expressing her concerns about the hospital’s care of the patient.  The hospital claimed that the nurse’s conduct was a violation of the patient’s privacy, in violation of HIPAA (the federal Health Insurance Portability and Accountability Act).

Audrey Dyjak had worked as a registered nurse at Baystate Medical Center in Springfield for some eighteen years, always garnering positive employment reviews.  She was commended at least fifteen times with “Baystate Best” awards giving excellent care.

In June of 2009, Dyjak was caring for a patient who became non-responsive.  As per hospital protocol, she paged a Rapid Response Team that was tasked with responding to such situations, and when the team did not arrive fast enough, she called a Code.  Dyjak was upset with what she viewed as a lack of a proper response, voiced her concerns loudly, and was told to leave the room by the radiology manager.

The next day, Dyjak saw the patient’s partner–who was also a Baystate employee–and mother in a restaurant at the hospital, and asked how the patient was doing.  The partner informed Dyjak that the patient had had a stroke.  Dyjak then related the events of the previous day, including the fact that she had been asked to leave the patient’s room.  She added that there was “some mismanagement” going on, and that she viewed the radiology director’s actions as “unprofessional.”  Few people were nearby at the time, and Dyjak spoke quietly.

A few days later, the partner complained to the hospital, saying she believed Dyjak had acted in violation of HIPAA.  The partner also told the hospital that Dyjak had  inappropriately expressed criticisms of the hospital staff.  The complaint resulted in Dyjak’s termination, the stated reason being her violation of the hospital’s Confidentiality Policy.  She sued Baystate for age discrimination, claiming that the hospital had used her supposed HIPAA violation as an excuse to get rid of her.

In Dyjak v. Baystate Health Systems, Inc., the federal court in Springfield ruled that the hospital was within its rights in firing Nurse Dyjak for her conduct, and that she had not proven that the hospital’s excuse was simply a pretext for age discrimination.

I don’t know whether Baystate was truly trying to get rid of older workers, but it does seem like the hospital’s termination of this long-time employee was motivated by her criticisms of its staff, rather than her rather benign inquiry about the condition of a patient she had cared for.  Most family members would be pleased by the nurse’s concern–not only for the health of their loved one, but for the quality of care that the patient was receiving.

It’s not clear from the court’s opinion exactly what, if any, medical information Dyjak disclosed to the patient’s partner and mother.  It’s difficult to believe that this was anything more than the kind of conversation that takes place in every hospital every day, when nurses update family members.  Perhaps technically, those are HIPAA violations, but at some point, the law must yield to common sense, courtesy and decency.  Most family members wouldn’t be pleased if their inquiries about a patient’s health were met with stony silence from nurses concerned with losing their jobs if they respond.

It really seems like what did Nurse Dyjak in was not her brief conversation with a patient’s family in a quiet  corner of a public place, but her airing of the hospital’s dirty laundry.  Most hospitals frown on their employees discussing mistakes with outsiders–and their internal discussions are strictly protected from disclosure by the peer review privilege,   In many facilities, written policies for “Resolution of Clinical Discord” or the like (what do to when providers don’t agree with each other), admonish providers not to express their disagreements in the medical records or in front of a patient’s family.

Dyjak may not have been fired because of her age, but rather for something much more dangerous for patient safety–speaking up about what she viewed as bad patient care.

Beyond the Boundaries of Ethics Research: the SUPPORT Study

premieA study designed to identify the safest oxygen levels for premature babies is under heavy fire for causing high levels of blindness, and perhaps even unnecessary deaths, among the 1316 very small infants who were enrolled.  Critics charge that 23 major research hospitals, including noted New England facilities Tufts Medical Center, Brown University, Women & Infants Hospital and Yale University, subjected babies to added risks, while failing to tell their parents about the potential dangers.

The SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial) study, conducted from 2004 to 2009, was designed to find out whether premature babies whose immature lungs required oxygen support were more likely to die or become blind if their oxygen levels were targeted to either a high or a low range.  As with any medical research study, the participants—or in this case, their parents—signed a consent form that was supposed to make sure they fully understood the risks and benefits of the study.  Yet in March of this year, the Office for Human Research Protections (OHRP), an arm of the federal Department of Health and Human Services (DHHS), charged the University of Alabama Birmingham (UAB), one of the lead participating hospitals, with failing to tell the parents that the amount of oxygen their baby received might affect whether the baby would develop blindness, a brain injury, or even die.  Instead, the only risk mentioned was that the device used to monitor the baby’s oxygen levels might cause skin breakdown.  While the consent form suggested to parents that babies who received lower levels of oxygen might have fewer eye problems, it failed to point out that the converse might also be true: babies assigned to receive more oxygen would be at higher risk for ROP.  And nowhere in the consent does it say that a baby might be at higher or lower risk of death, depending on the random assignment to one group or the other.

A month later, Public Citizen, a private non-profit group that advocates for patient safety, fired off a letter to DHHS Secretary Kathleen Sebelius, claiming that the violations occurred at all of the participating hospitals, not just UAB, and calling for OHRP to go further by requiring the facilities to apologize to parents for what they had done, and to institute corrective measures to prevent similar lapses in the future.

Several parents whose babies died have already filed lawsuits against UAB.  As the deficiencies in the consent form, and the adverse effects on some of the babies become more well-known, it is likely that there will be more, including here in Massachusetts and Rhode Island.

The cause of the controversy focuses on the researchers’ decision to assign babies randomly to receive either a higher (91-95%) or lower (85-89%) oxygen concentration.  Normally, the amount of oxygen a premature baby receives is carefully individualized depending on the infant’s medical condition and other treatments he is receiving.  Neonatologists attempt to keep the oxygen levels as low as possible to avoid the complication known as retinopathy of prematurity (ROP), where an abnormal growth of blood vessels in the eye can lead to blindness and other vision problems. The results from the study showed a statistically significant (unlikely to be due to chance or coincidence) increase in blindness for the babies who received higher oxygen levels, and in death for babies who received lower levels.

Not surprisingly, the researchers have their defenders.  They claim that all of the oxygen levels received by babies in the study were within the standard range of treatment, and pointed out that, in fact, the babies in the study had a lower death rate than a supposedly similar group of premature infants.

The treatment of the patients and parents in the SUPPORT study is particularly disturbing, because it involves very vulnerable babies and parents who most likely would go to the ends of the earth to improve the outcome for their children.  Understandably, the researchers wanted to increase participation in their study–for which they needed the parents’ consent.  But however well intentioned the doctors were, there is no justification for making decisions based on random assignments rather than the best interests of each individual baby.  In this case, it is likely that the lack of information induced many parents to enroll their babies in the study when they would not otherwise have done so.

There is no question that medical research can lead to tremendous improvements in patient care and outcome.  But particularly in studies like SUPPORT, where the subjects are tiny premature babies, the institutions conducting such research must be vigilant to insure that their patients’ rights are protected.  It is likely that many of the study participants’ parents are still unaware of the harm their babies faced—or even actually suffered—as a result of their decision to participate.   It is never too late for the hospitals to explain to these parents what actually happened, and to try to atone for the breach of trust and, in some cases, physical damage, they have caused.

Read the letter to the UAB from OHRS here

Read Public Citizen’s letter to DHHS Secretary Kathleen Sebelius here

Read the original published report of the SUPPORT trial here

Bereaved Family Makes Other Patients Safer

ambulanceCrowe & Mulvey, LLP recently helped a Connecticut family  who lost their son to participate in changing transport procedures for psychiatric patients to help prevent future tragedies.

The firm represented the family of Gregory Hillman, a college student from Darien, Connecticut, who had been brought to Berkshire Medical Center  in Pittsfield by the staff at Gould Farm, in Monterey, where he had been a resident for the previous week.  On June 29, 2009, Gregory left Gould Farm in the middle of the night, leaving behind a goodbye message on his Facebook page and a note indicating his intention to end his life. Within hours, the Monterey police located Gregory and returned him to Gould Farm, where the staff determined that he should be brought to Berkshire Medical Center for psychiatric evaluation and treatment.

Gregory was evaluated at Berkshire Medical Center and found to be suicidal and in need of hospitalization.  The Crisis Team at Berkshire Medical Center made a decision to transfer Gregory to the Greylock Pavilion at North Adams Regional Medical Center, nearly an hour away.  County Ambulance of Pittsfield was called to provide transportation for Gregory, but was not informed by the staff at Berkshire Medical Center that Gregory was a flight risk.

When the ambulance carrying Gregory arrived at North Adams Regional Hospital, the attendants removed Gregory’s restraints and allowed him to walk into the facility.  While he was being escorted inside, Gregory began to run away, and the attendants were unable to catch up with him.

The North Adams police were alerted, and an intensive search for Gregory occurred over the next several days.  During the search, Peter and Lisa Hillman made multiple public appeals for information regarding their son’s whereabouts.  Gregory’s body was recovered from the Hoosic River on July 9, 2009.

The Hillmans reached an agreement with County Ambulance that involved the parties’ joint input in creating new protocols to make the transport of patients like Gregory safer.  The agreement included a meeting between the Hillmans and County representatives, which both sides felt was productive and helpful.  The Hillmans felt that they had been able to honor Gregory by using the tragedy of his death to help other patients and families in similar situations.

The lawsuit continues against the providers at Berkshire Medical Center, whom the Hillmans charge with failing to give information about Gregory’s flight risk to the EMTs to help them understand the measures needed to transport Gregory safely.  The Hillmans hope that BMC will some day be willing to follow County Ambulance’s lead in making care safer, but so far, their efforts to elicit a response form BMC have not been fruitful.

Read the joint press release from the Hillman family and County Ambulance here.

Read the North Adams Transcript coverage of the case here.