My family experienced a surgical error in 2007. We filed a complaint with the state Department of Public Health over this incident. In the single issue of exposing an IgE latex allergic patient to a medical device containing latex, it should have been very easy for DPH to find that the surgeon and hospital provided our daughter with negligent care. The device was clearly labeled as containing latex, the hospital and surgeon identified our daughter, Kelly, as a latex allergic patient before surgery, standard of care at the hospital was the strict avoidance of all latex products in an surgical/medical procedure for an identified latex allergic patient, and the Informed Consent for this procedure does not give the hospital or surgeon permission to treat our daughter with a medical device containing latex. DPH attempted to whitewash this preventable medical error since the pediatric medical center where this incident occurred is the home of a university residency program.
DPH allowed an “impartial” surgery consultant (reviewing the case for evidence of negligent or sub-standard care) to change the FDA approved latex warning on the device–negating latex as a cause of our daughter’s acute post-op reaction. Although the FDA and device manufacturer claim that the 9 foot long tube contained latex and was capable of causing a life-threatening reaction in any identified IgE latex allergic patient, the DPH consultant determined (without running any scientific tests) that the latex in the device used in our daughter’s surgery was specially coated making it less allergenic–DPH then decided that our daughter’s acute post surgical reaction was due to her disabilities, complex medical condition, or other allergies, but not the latex in the device. The surgery consultant even diagnosed our daughter with a neurological disorder that we didn’t know she had (and neither did her neurologists). DPH tried to dismiss the complaint against the surgeon and hospital in April 2008.
Our daughter’s allergists were outraged. Since they felt DPH was setting a precedent that endangered the lives of all patients with life threatening food, drug, and environmental allergies, they helped us file a challenge to DPH’s dismissal of the complaint against the surgeon and hospital. Our daughter’s allergists believed that DPH was violating our daughter’s civil rights (by applying a different standard of care to her surgery than they would to any “normal” IgE Latex allergic patient, and they believed that DPH violated federal law–only the FDA can alter safety determinations (including latex determinations) on an approved device. DPH ended up reopening the case against the surgeon, and it currently sits in the legal office while DPH tries to figure out a way to close the case without taking any action against the surgeon. In our daughter’s case there was no barrier between the regulators and regulated.
Our daughter’s complaint was filed with DPH on July 24, 2007–one week after surgery. My husband and I had to file the complaint with DPH in order to force the hospital to reveal the error and tell us why our daughter was having an acute post op reaction. Even though there was an open (valid) negligent care complaint against the surgeon and hospital, in September 2007, the DPH Commissioner and DPH worked very closely with my daughter’s surgeon and the hospital on a teen safe driving program. In November 2007 the Governor formed a Task Force to look into ways to reduce teen deaths due to motor vehicle accidents–she appointed the Commissioner of the Department of Public health a Co-Chair and our daughter’s surgeon to the Task Force; and the only hospital to sponsor the Task Force was the hospital where our daughter’s medical error occurred.
Although our state laws call for hospitals to report any incident that qualifies as a National Quality Forum “never event”, the hospital did not report this error as a preventable adverse event and DPH did not fine the hospital for their failure to report this incident. DPH entered into a secret agreement with the hospital and only asked the hospital to write a corrective action plan–the public was never informed of this serious 14 day breakdown in the hospital’s patient safety and quality system. The surgeon billed our insurer for part of the operation. We do not know if the hospital billed our health care insurer. We have not seen a bill but in December 2007 we received a “retroactive” certification from our health insurer Blue Cross of California. The only reason we received this document is that the local Blue Cross (Anthem) refused to deal with the hospital’s request for a retroactive certification and under California law we must be notified of any unusual requests from a hospital. According to Blue Cross the hospital asked our health insurer to retroactively certify this incident as the surgical placement of a jejunal feeding tube and a 21-day hospitalization due to an acute level (anaphylactic/life threatening) post-op allergic reaction–they did not report it to our insurer as a medical error.
Update:
Although Kelly has a neurological disorder and is unable to talk, she is aware and like many teenagers loves to watch TV/movies, shopping for pretty clothes, and boys.
We are currently working with our state Senator to change the way Connecticut handles medical error complaints filed by patients, and address the issue of correcting inaccurate or incomplete information in a patient’s medical records (especially from a medical error).
Currently in Connecticut (and many other states) it is almost impossible to correct information in the patient’s medical records if the hospital refuses. In Kelly’s case much of the information in her records from this incident is incomplete or inaccurate–and this has caused problems for the physicians in Boston who are trying to help us. There is a discrepancy between what we and Kelly’s pediatrician feel are her major problems after the July 2007 surgery and what the surgeon/hospital (where the error occurred) say is the problem. Kelly’s pediatrician, my husband, and I feel her feeding problems after the July 2007 jejunal surgery were caused by damage to her intestines from the use of a Baker Tube (suctioning hose) containing latex; while the surgeon and hospital (where this incident occurred) claim that Kelly’s post-op problems are due to her underlying condition or her disabilities.
It took us a year and a half to convince a surgeon (at Boston pediatric center) that Kelly’s feeding problems were due to the July 2007 surgery site. When the Boston surgeon finally operated on Kelly this past April (2009), he was embarrassed by what he found. Not only had the latex and the overly large tube caused scarring at the July 2007 surgery site; when hospital personnel (at the center where the error occurred) removed the jejunal tube from Kelly’s jejunum, they simply pulled it out, leaving Kelly with a gaping wound in her intestines/abdominal wall and an excessive number of non-absorbable stitches in her intestines. The Boston surgeon explained that non-absorbable stitches do cause small bowel obstruction (or pseudo-obstructions if they are not detected in radiology studies)–the stitches affect the ability of the intestinal muscles to move properly (peristalsis) and the ability of the intestine to stretch and move food. Apparently the hospital where this incident occurred, should have removed jejunal feeding tube surgically and removed the multiple sutures–or at least noted in Kelly’s record that they were leaving a number of “foreign bodies” in Kelly’s intestine (sutures are considered foreign bodies and they can cause a number of problems when left behind such as inflammation, intestinal irritation, or small bowel obstructions).