Legal Review & Commentary: Antiquated equipment, failure to provide trained technician resulted in infant's cerebral palsy and $78.5 million verdict
Legal Review & Commentary
Antiquated equipment, failure to provide trained technician resulted in infant's cerebral palsy and $78.5 million verdict
News: A 34-year-old woman, then 36 weeks pregnant, presented to Pottstown Memorial Medical Center in Philadelphia in August 2008 with signs of placental abruption. Fetal monitoring was inconclusive. A nurse and the obstetrician performed a bedside ultrasound examination and were unable to detect a fetal heartbeat. The obstetrician sought an ultrasound technician's confirmation of his diagnosis of fetal death; however, it took 75 minutes for the ultrasound technician to arrive. Upon arrival, the technician immediately identified the fetal heartbeat, but the placenta was completely disrupted and the fetus was not receiving any blood or oxygen from the mother. The child, now 3 years old, suffers from severe spastic quadriplegic cerebral palsy resulting from an 81-minute delay in performance of an emergency cesarean section delivery. A jury found the hospital 100% liable and awarded the plaintiff $78.5 million in damages.
Background: A 34-year-old woman, then 36 weeks pregnant, presented to Pottstown Memorial Medical Center in Philadelphia with complaints of abdominal pain. Fetal monitoring was inconclusive. A nurse and the obstetrician performed a bedside ultrasound examination and were unable to detect a fetal heartbeat. The obstetrician concluded that the fetus had died and informed the mother, who stated that she still felt the fetus kicking inside her. As such, the obstetrician sought an ultrasound technician's confirmation of his diagnosis, but it took 75 minutes for the technician to arrive at the hospital. Because it was a Sunday, the hospital did not have an ultrasound technician on the premises. The technician had to come from home to verify the obstetrician's findings. Upon arrival, the technician immediately identified the fetal heartbeat. However, the placenta was completely disrupted, and the fetus was not receiving any blood or oxygen from the mother. An emergency cesarean section was conducted.
The patient, individually and on behalf of her baby, brought a lawsuit against the hospital and obstetrician. Plaintiff alleged that she arrived at the hospital with signs of placental abruption that caused her unborn child to be deprived of oxygen and that a prompt delivery could have averted the problem, but the obstetrician initially concluded that the baby had died. Plaintiff further contended that the 81-minute delay in performing the cesarean section caused the condition of the fetus to deteriorate, which resulted in cerebral palsy. In addition, plaintiff asserted that had the hospital provided a trained ultrasound technician and not used antiquated equipment, the delay would have been averted.
Throughout discovery, deposition, and when first questioned during trial, the obstetrician testified that he performed the ultrasound properly and that the reason he could not identify the fetal heartbeat was because the fetus had died. He then insisted that the fetus's heart started again and that was why the ultrasound technician found the heartbeat. However, after experts testified that the ultrasound equipment was antiquated and that the wrong type of transducer was used (part of ultrasound equipment placed on a woman's belly), the obstetrician testified that he believed the equipment was to blame for his inability to detect the heartbeat. Defense experts also agreed that a more up-to-date ultrasound machine was required.
Significantly, the hospital's risk manager testified that there was no maintenance record for the subject ultrasound machine, nor was there any evidence that the equipment had been serviced in the last 10 years, despite the fact that the ultrasound's manual indicated annual maintenance was required.
The jury's $78.5 million award included $1.5 million in emotional distress; $10 million in past, present, and future pain and suffering to the infant plaintiff; $2 million in lost future earnings; and the remainder allocated for future medical expenses. The jury estimated that the infant, who requires around-the-clock nursing care due to quadriplegic cerebral palsy, will live until 2058.
What this means to you: The thread of patient safety runs through the fabric of this case. Most patients inherently trust their provider to render safe care, prudent opinions, and accurate decisions that affect their treatment plan and their ultimate outcome. In cases that involve an obstetrical patient, we might sometimes forget that we are caring for two patients, mother and baby, and the well-being of each must be considered in every treatment decision that is made.
This case presents several areas of vulnerability. The first area is the lack of preventative maintenance and service records on ultrasound equipment in use to provide patient care. Most equipment purchased within an institution is accompanied by a vendor contract or service agreement whereby the institution can require, as part of that agreement, the vendor to perform preventative maintenance and routine inspection of equipment at a predetermined time interval, usually every 6-12 months. This agreement also should outline the indications for replacement of either specific parts or provide for full replacement of the equipment. Careful crafting of such an agreement can transfer the responsibility, resources, and therefore, the risk from the institution to the vendor.
In addition, standards from The Joint Commission require that an institution inspect, test, and maintain life support and non-life support equipment as articulated in Environment of Care (EC) standards 02.04.01 and 02.04.03. Notably, documentation of this activity is required to prove compliance during the survey process. Typically, the facility's biomedical engineering department "owns" the chapter and the requirements therein; however, risk management needs to be kept apprised of any deviations. The use of maintenance checklists, electronic or otherwise, is a helpful "tickler" tool to ensure compliance with thorough and timely inspections. Moreover, ongoing status reports regarding the maintenance of equipment should be reported to the facility's EC or safety committee on a quarterly basis.
Moreover, accreditation by professional organizations bolsters the institution's reputation for ensuring quality care and patient safety by complying with rigorous requirements. The American College of Radiology, which is the accrediting body for facilities with radiological services, including ultrasound, surveys these facilities every three years for compliance with standards. Specifically, the standards require that each facility institute a continuous quality control program that ensures equipment is inspected and maintained on a semi-annual or annual basis. Compliance with this standard is required to maintain accreditation.
By instituting the above-mentioned risk reduction strategies, the likelihood of using outdated, equipment that has not been maintained diminishes significantly. However, there still must be a mechanism in place, within the institution's hierarchy, whereby clinicians can request and ultimately obtain equipment that would provide the standard of care to patients. Usually the administrator or director of a department can make a capital expense request to replace or repair any outdated or defective equipment. Each manufacturer has varying models of the same equipment based on cost. As such, each model will perform the same function, although some might have more sophisticated features than others. As a result, there is usually a model to suit every budget, so the notion of not providing the community standard of care based on cost is not an option. A facility can create a product value analysis committee to serve as a forum for the initial presentation and discussion of such issues.
Another area of concern in this case is the apparent delay in the arrival of the ultrasound technician. In general, for those facilities that provide on-call ultrasound technologists, the standard response time from initial contact to arrival to the facility is 60 minutes. In this case, it took the ultrasound technician 75 minutes to arrive at the hospital to confirm the physician's diagnosis. Whether the delay in the arrival of the technologist contributed to the ultimate outcome is difficult to determine; however, it is certainly enough to introduce some speculation into the minds of the jurors.
Lastly, this case raises concerns regarding the competency of the ultrasound "operator." Ultrasound is a subjective study and is highly "operator-dependent." The skill and expertise of the operator definitely will impact the findings and outcome of the study, ultimately affecting the diagnosis and treatment plan. Because there were discrepant findings between the obstetrician and ultrasound technician, the competency of the obstetrician in performing the ultrasound study is called into question. Each physician that performs ultrasonography must produce evidence of ongoing competency when requesting privileges through the institution's medical staff office. Additionally, CME credits and, in some cases, proctored observations are required to fulfill this requirement and ensure continued competency. For ultrasonographers, the American Registry for Diagnostic Medical Sonography (http://www.ardms.org) requires that each sonographer renew their registration every three years and provide supporting documentation of CE credits to ensure their competency.
In this case, the jury ultimately found the hospital 100% negligent and absolved the obstetrician of any wrongdoing. The focus of the case quickly turned to the hospital as the target when experts testified that the equipment was antiquated and the risk manager testified that there was no evidence the equipment had been serviced for more than 10 years. Indeed, if the hospital had implemented some or all of the risk management strategies discussed above, it might not have shouldered all of the responsibility in this case.
Nicholson-Upsey v. Touey, et al. Court of Common Pleas of Philadelphia County, Pennsylvania. Case No. 2001-20863. 2010 WL 1841777.News: A 34-year-old woman, then 36 weeks pregnant, presented to Pottstown Memorial Medical Center in Philadelphia in August 2008 with signs of placental abruption. Fetal monitoring was inconclusive. A nurse and the obstetrician performed a bedside ultrasound examination and were unable to detect a fetal heartbeat. The obstetrician sought an ultrasound technician's confirmation of his diagnosis of fetal death; however, it took 75 minutes for the ultrasound technician to arrive.
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