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Medication Safety Toolkit

Claims lessons with medication focus

Outpatient monitored anesthesia care-beware of the “simple case”

The Case

When her dialysis access graft clotted, the patient’s nephrologist referred her to a free-standing radiology center for treatment. Providing her care were the center’s radiologist and a registered nurse. The patient’s history included morbid obesity, insulin-dependent diabetes, end-stage renal disease, syncope, sleep apnea, and hypertension.  The nurse administered Midazolam (Versed) 1 mg IV x 2 and Fentanyl 25 mcg IV x 2 at 3:05 pm.

Twenty minutes into the procedure, the patient could not be aroused with tactile stimuli. The records indicated the pulse oximeter had failed.  Narcan was administered without improvement.  At that point, the patient suffered a cardiac arrest and EMS was called. Mechanical maneuvers to open the airway were employed and atropine was administered. The physician began cardiac compressions, and intubated the patient.  EMS rushed the patient to a hospital emergency department (ED).  The ED physician’s impression was hypoxic-ischemic encephalopathy and post-hypoxic myoclonus. The patient was admitted to the ICU, and placed on a ventilator. She died five days post- procedure.

Allegations

In brief, the plaintiff alleged the patient was not a candidate for MAC/conscious sedation; that the physician and nurse ignored evidence of evolving hypoxia and impending cardiac arrest; the radiology center failed to ensure that the pulse oximeter was working; physician and nurse failed to take the appropriate actions to secure the patient’s airway, and summon timely assistance.

Disposition

This case settled for a very large amount on behalf of the radiologist and the radiology center.

Risk Management Commentary

When administering MAC/conscious sedation in the outpatient setting, it is important that potential problems are anticipated; that the staff and the setting are prepared to treat and monitor the patient effectively; and that the facility is prepared to handle emergencies.  Two key issues became apparent when developing a defense for this lawsuit:

        (1) Pre-sedation Protocol and Assessment

In this lawsuit, radiology experts opined that the patient would have been considered a Class III airway, and therefore was not a candidate for MAC/conscious sedation. The patient’s history of sleep apnea, coronary artery disease and morbid obesity, predisposed her to the development of airway complications, particularly after receiving sedating medications.

Patients being considered for sedation in an outpatient facility should meet American Society of Anesthesiology (ASA) selection criteria guidelines, and be appropriately cleared by a facility-credentialed physician.

        (2) Monitoring and Emergency Equipment

Experts opined that the facility departed from the standard of care by failing to ensure that all the equipment be inspected for proper working order prior to the procedure.

Risk Management Suggestions

Facilities administering MAC/conscious sedation are strongly encouraged to:

  • Utilize ASA guidelines for selecting patients who meet criteria for MAC/conscious sedation in an outpatient setting.
  • Work in conjunction with an anesthesiologist consultant to develop a quality assessment/improvement program.  Quality improvement programs include, but are not limited to, a closed evaluation of each patient who required transfer to a hospital or who had an unanticipated outcome. This type of review, tracking and analysis will help identify problem trends, and open up opportunities to improve patient safety.
  • Impose strict procedures for credentialing physicians and other licensed assistive staff.
  • Perform full assessments of patients' weights, allergies, and medical histories before administering anesthetics.
  • Make sure supplemental oxygen is routinely used and immediately available for sedated patients.
  • Have anesthesiologists check and document vital signs at least every 5 minutes for sedated patients, and
  • Run unscheduled drills periodically so that physicians and staff practice resuscitation protocols.

By establishing a quality improvement program, and implementing strongly suggested guidelines, outpatient facilities will be better able to provide safer, more effective care to patients undergoing procedures that require MAC/ conscious sedation in this setting.

Patient allegedly sustains anaphylactic reaction to Ancef in the operating room

The Case:

A middle-aged, obese male patient was scheduled for an elective surgical repair of an incisional hernia.

The patient’s allergies to codeine and penicillin were well-documented in his medical record. The surgeon ordered the antibiotic, Ancef, for pre-operative prophylactic infusion.

The anesthesiologist infused Ancef according to the surgeon’s orders and inducted the patient with Fentanyl and Propofol. At that point, she turned the case over to the CRNA. Five minutes later, the CRNA called the anesthesiologist for assistance when it turned into a difficult intubation. There were multiple attempts with success after use of a fiber optic scope.  Unfortunately, during the delay, the patient arrested. The anesthesiologist initiated CPR and administered Decadron, Benadryl, Epinephrine, and a Levophed drip to counter a possible anaphylactic reaction. The patient was eventually resuscitated and the procedure was terminated. He suffered a significant brain injury, resulting in an extended hospitalization, long-term rehabilitation, and permanent disability.

Allegation:  The plaintiff alleged the anesthesiologist failed to consider the patient’s allergies prior to administering Ancef and anesthesia.

Disposition:

Both the hospital and the anesthesiologist were named in this case, settling for a combined large amount of money.

Risk Management Commentary:

This case is not as simple as it seems on first presentation. It is an excellent example of one that might have been defensible as a difficult intubation, if it had not been for prescribing Ancef. The patient had a well-documented sensitivity/allergy to penicillin. The expert reviewers opined that, in hindsight, the patient may have suffered an allergic reaction to Ancef (Cefazolin).  Remember, Ancef is a first-generation cephalosporin antibiotic, falling into the category of beta-lactam antibiotics and related to penicillin.  Although the extent of allergic cross-reactivity between penicillin and cephalosporins is unknown and appears to be low, about 4% of patients with a proven penicillin allergy (by skin testing) also react to cephalosporins. 1 Since this patient had not been skin-tested, but had a positive history of penicillin sensitivity, the plaintiff argued that the selection of a non-beta lactam antibiotic probably would have been a better choice.

According to the case reviewers, the anesthesiologist’s overall approach to this patient’s care seemed careless. She should have documented an airway assessment, the strategy for dealing with a potentially difficult intubation, all allergies, and requested a medication change from Ancef before infusing it.

The American Society of Anesthesiology recommends an airway history be conducted, whenever feasible, before the initiation of anesthesia and airway management in all patients. The intent of the airway history is to detect medical, surgical and anesthesia factors that may indicate the presence of a difficult airway. 2 Examination of previous anesthesia records, which apparently did not occur in this case, may have yielded useful information about the airway management of this patient.

The patient had had three previous surgeries in recent years at the same hospital; a laparoscopic cholecystectomy, an appendectomy, and an umbilical hernia with mesh. Ancef was given prophylactically in all three of these procedures. There was no notation in his medical records as to whether he had exhibited any signs of prior sensitivity to Ancef. It is very important that any sign of patient medication sensitivity be documented in the patient’s medical record and noted in the allergy section, along with the documented reaction type.

Allergies can be present despite previous negative screening tests and no patient’s care can be taken for granted. In other words, the previous history of any allergic event should increase the clinician’s concern.

1 Administration of cephalosporins to a patient with a history of penicillin allergy.http://www.aaaai.org/ask-the-expert/administration-of-cephalosporins.aspx.; 9-24-2012

2 Practice Guidelines for Management of the Difficult Airway. An updated Report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology 2013: 188:XX-XX

Anesthesiologist innocently caught in a hospital employee's drug diversion scheme tells her story

By Kate O’Reilley, MD

The Story

It was a cold winter day in 2009 when my life changed forever; however, it would be months before I figured that out. On that fateful day, a drug-addicted surgical scrub tech assigned to my operating room allegedly stole syringes of fentanyl, a potent intravenous narcotic, from my anesthesia cart. According to news reports, investigative summaries, and the scrub tech’s confession, once she took the syringes, she used them on herself.

It’s hard to fathom, but that’s not even the really sick and twisted part to this tale. The scrub tech had hepatitis C, a blood-borne virus that attacks and, sometimes, destroys the liver. Based on her own testimony, she knew she was positive for the virus. Yet, after supposedly injecting herself with a drug intended for a vulnerable and innocent patient, she then allegedly chose to refill the syringe with saline. Theoretically, the syringe was contaminated with her infected blood. She then allegedly replaced the syringe in my cart. If these allegations are true, and there is no way of knowing, there was no way I could have known that she had tampered with my drugs. The syringes purportedly would have been in the same place where I left them, and both fentanyl and saline look identical. So, on that unfortunate day, it is alleged that I injected a mixture of saline and hepatitis C into my patient’s bloodstream, instead of a painkiller.

The following summer, the story made local and national headlines. At least 5,000 patients were at risk for having been exposed to the virus. Every anesthesiologist in my group secretly prayed that they weren’t involved. The hospital went into extreme damage-control mode. Tight restrictions and policies regarding the handling and securing of narcotics were strictly enforced. Panicked patients were tested en masse for the potentially lethal virus.

A few months later, I received notice that I was being sued, along with the hospital. Receiving the summons and the two-year ordeal that followed was, by far, the most painful, mortifying, demoralizing, and caustic event of my life. Of course I grieved for the patient, but I had to do so in silence because any discussion of the event was forbidden, on the advice of my attorneys. Never before would I have imagined the depths of shame, guilt, and self-doubt that I was capable of inflicting upon myself.

As the lawsuit evolved, the lawyers and the patient grew nastier and greedier. My initial feelings of compassion and empathy dissolved into rage and betrayal. I suffered through an eight-hour deposition with hostile attorneys where I was belittled, ridiculed, verbally abused, and intimidated. Months later, I was emotionally beaten down, and I made the painful decision to settle. At that point, it was no longer about right vs. wrong. I just wanted the nightmare to end. It was at that time, in the middle of settlement negotiations, that I was featured on the local television news station, only to be followed a week later by a front-page headline in the local paper. Statements I made during my deposition were taken out of context. The public commenters on the stories cried for my crucifixion. I will never know this for certain, but the timing of the stories and their prejudicial slant reeked of a couple of reporters on the take. I was made to look like a cold, heartless, reckless villain, whose patient was the innocent victim of my blatant negligence.

I never got my day in court or the opportunity to explain that I’m not a monster. I wish I could have explained that, before this happened I was a caring, compassionate, skilled, and highly qualified physician. The manner in which I secured and stored my narcotics was identical to the manner in which most of my colleagues handled theirs. We were all taught during residency that the operating room was a secure environment. Furthermore, we were taught to have our drugs drawn up in advance of our cases, so as to be able to handle emergent and unforeseen events more expeditiously.

Now I am a shadow of my former self. I’m bitter, defensive, cynical, and wounded. I want to stress that in no way is this article intended to take away from the fact that a patient was hurt. I was as much of a victim of the scrub tech’s crime as was my patient. We just endured different kinds of injuries. Mine were of the heart and soul and will never heal.

Addendum:

Once the news story broke, the hospital immediately released memos, and a new hospital policy, dictating that anesthesiologists could not draw up narcotics until the patient had physically entered the OR. There was zero tolerance for non-compliance, and audits were strictly enforced. This policy remains in effect today.

Within months, each operating room was equipped with its own Pyxis machine. Access to drugs is now controlled by biometrics. All drugs, even non-controlled substances, are locked and secured within the machines. Propofol, once as readily accessible as a local anesthetic, is now treated as a narcotic. Additionally, anesthesia providers are given prefilled, tamper-resistant 5 cc syringes of fentanyl. All other narcotics are still dispensed in vials and require the physician to draw up the drugs into syringes.

Hospital and surgery center rules vary at other facilities within my area. No other facility, other than mine, dictates exactly when narcotics can be drawn up prior to administration. However, most of the hospitals in my region have added individual Pyxis machines within each OR. Security is more tenuous at surgery centers. Although a number of surgery centers provide lock boxes within the anesthesia cart, it’s unclear as to how many keys exist for each box and who has access to those keys. Several of the surgery centers require anesthesiologists to check out an entire box of narcotics for the day. This leaves the physician with the responsibility of securing and protecting more drugs than he or she may require for their cases, thereby increasing their vulnerability.

Over the course of my lawsuit, the plaintiff’s attorneys found an expert witness who testified that narcotics should NEVER be left unattended and unsecured. Interestingly this “expert witness” was no longer practicing anesthesia, and was employed as a consultant in the private sector. In his deposition, he stated that he has never, not once, in his career ever turned his back on his narcotics. This includes times when he was starting lines and tending to critical matters with respect to patient care. Hmm, what do you think?

The fact remains, if some rogue individual wants access to drugs badly enough, he or she will achieve that goal. Today, I am hyper-vigilant with respect to my narcotics. Even so, I recognize that there still exist moments when my drugs could be diverted. The operating room is an intense, fast-paced and sometimes chaotic environment.

Regardless, I refuse to put my concerns for the integrity of my drugs over the care of my patients.

Note':' I would greatly appreciate any feedback. Also, if you have any questions or would like to schedule an interview regarding this or any other facet of life in the operating room, please contact me by email @ kateoreilley@gmail.com or visit my website@ www.kateoreilley.com.

Editor’s Risk Management Commentary:

Dr. O’Reilley so graciously and courageously allowed us to print her story for our readers, because despite her discomfort, it is her desire that none of her colleagues nor their patients and institutions endure similar experiences. As Dr. O’Reilley’s story depicts, the theft of drugs and controlled substances by health care professionals is a serious problem that can lead to patient harm and jeopardize patient safety. Numerous instances of hepatitis C transmission from an infected healthcare worker to a patient have been reported in the setting of narcotic diversion, as well as transmission of bacterial pathogens, with fentanyl being the most commonly implicated opioid.12

Current data reveals that rates of drug abuse among health care workers are comparable to the general population.3 The major difference between the general public and medical professionals is the accessibility of a large source of controlled substances, leading to illegal removal from the health system for the purposes of self-administration, selling, or supplying to others. Every health system should have in place a systematic, collaborative process to control the drug diversion problem.

When developing policies and procedures, Carlson and Corsaro suggest involving a multidisciplinary team from all affected departments, including pharmacy, security, human resources, employee health, EAP, and administration. An effective drug diversion policy/system:

  • Defines drug diversion
  • Defines the methods used in the investigation of suspected diversion
  • Appends a “Fitness-for-Duty” policy
  • Provides an appropriate chain of contact when diversion is suspected
  • Establishes a system that facilitates timely recognition of any diversion of controlled substances, as well as a procedure to quickly identify the individual responsible for diversion
  • Requires staff to report suspected drug diversion immediately to his or her department director or manager. All such information ,and the identity of the individual furnishing information, must be confidentiality protected to the extent allowed by law
  • Establishes a chain of command for reporting drug diversion, both within the institution and to the appropriate local and federal authorities, if necessary
  • Involves facility security and police, if necessary
  • Utilizes automated dispensing cabinets and software to analyze usage patterns for diversion.
  • Develops a well-defined process that identifies weekly counts and reviews all discrepancies, PCA and epidural usage, and OR processes.
  • Considers the placement of cameras in strategic locations

A number of states and hospital systems have been actively addressing drug diversion and effective prevention methods for hospitals and healthcare providers. Very good resources are available from the Minnesota Department of Health (MDH) originating from the work of a coalition of the MDH, Minnesota Hospital Association, area hospitals, providers, law enforcement, licensing and other stakeholders. The coalition issued its final report in April 2012, along with numerous resources for developing programs to effectively prevent and respond to drug diversions. For more information, contact the MDH Division of Health Policy at 651-201-5807.

1 Hellinger WC et Al., Healthcare-associated hepatitis C virus infections attributed to narcotic diversion. Ann Intern Med. 2012; 156:477- 482.

2 Berge KH et al., Diversion of drugs within healthcare facilities, a multiple-victim crime: Patterns of diversion, scope, consequences, detection, and prevention. Mayo Clin Proc 2012; 87 (7):674-682

3 Paulozzi LJ, Jones CM, Mack KA, Rudd RA, Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC. Morbidity and Mortality Weekly Report. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008 (November 4, 2011)

4 Steve Carlson, RPh, MHA , Andrew F. Corsaro , A Systematized Approach to Combat Drug Diversion, Pharmacy Purchasing Products, January 2012, Vol. 9 No.1

Summary

Drug abuse is a significant problem in the United States. With the comparable rates of addiction among health care workers, the potential of drug diversion occurring in our health systems is a constant issue. A vigilant approach is required to help prevent, monitor for, and investigate drug diversion. The ideal method is multidimensional, and includes explicit policies, detection methods, investigation processes, and an organizational culture of readiness. Without a systematized approach, hospitals and healthcare providers are vulnerable to major drug diversion and subsequent public and legal repercussions.

Amiodarone prescription and physician credentialing issues hamper the defense

The Case

This patient had been established with the cardiology practice for a number of years. His medical history included ischemic heart disease, morbid obesity, Type 2 Diabetes Mellitus, hypercholesterolemia, and hypertension. When he began experiencing episodes of atrial flutter, the patient’s cardiologist recommended evaluation by an electrophysiologist, a physician who was in the same practice. The electrophysiologist recommended the patient begin treatment with Coumadin and undergo an elective radiofrequency ablation.

During the radiofrequency ablation, the electrophysiologist experienced technical difficulties due to the rotation of the patient’s heart, an enlarged right atrium, and difficulty accessing the coronary sinus.  The ablation attempt was incomplete, but the electrophysiologist performed a successful cardioversion. The patient converted to NSR, and was placed on Amiodarone 200 mg BID and magnesium to help him maintain a normal rhythm.

Three months later the patient complained of problems with his eyesight. He was seen by an ophthalmologist who diagnosed optic neuritis, thought to be due to the Amiodarone. The patient was instructed to discontinue the Amiodarone immediately. Neuro-ophthalmology testing showed severe diffuse visual field impairment in both eyes. The neuro-ophthalmologist opined that the most likely etiology for the bilateral ischemic optic neuropathies was secondary to the Amiodarone therapy. He recommended treatment with corticosteroids to decrease any optic disc swelling. In addition the ophthalmologist suggested the patient have a temporal artery biopsy to fully rule out giant cell arteritis. The patient decided against both of these recommendations. Several months later, the patient’s eye examination remained unchanged; the neuro-ophthalmologist informed him that he was legally blind.

Allegations: The plaintiffs alleged there was no indication for treatment with Amiodarone. In addition, once this medication was prescribed, the patient should have been closely monitored. No information with regard to potential side effects was provided to the patient.  The plaintiffs also alleged the other doctors in the practice were vicariously liable for the electrophysiologist because they had failed to properly credential him to practice the subspecialty of cardiac electrophysiology.

Disposition: the case was settled for a large amount of money.

Risk Management Commentary

Several clinical experts reviewed the cardiac- electrophysiologist’s medical records and expressed concerns about his care.

  • Each reviewer individually opined that the physician could have considered a more conservative approach. Amiodarone has the highest risk for side effects compared to other medications that could have been prescribed. One expert criticized the decision-making process that led the physician to prescribe Amiodarone.
  •  From a medical record review, it could not be determined whether the patient had been advised of the risks and alternatives of taking Amiodarone
  • The physician had not completed all ACGME Program Requirements for Graduate Medical Education in Clinical Cardiac Electrophysiology, as required by his contract with his cardiology group.
  • Most importantly, the electrophysiologist not truthful in his discovery responses about his actual credentials. This fact created a credibility issue for the physician, and added to problems for his defense.

About Amiodarone

Amiodarone is a complex antiarrhythmic agent with multiple electrophysiological effects, unusual pharmacokinetics, and numerous potentially harmful drug interactions and adverse effects. Although the U.S. Food and Drug Administration (FDA) has labeled Amiodarone only for the treatment of life-threatening ventricular arrhythmias, the drug also is used to treat atrial fibrillation. Because of the complexity and widespread use of this agent, other treatment decisions often are affected.[1]

According to the literature [2] patients treated with Amiodarone should be followed regularly to assess ongoing need for Amiodarone, efficacy of the drug, appropriateness of dosage, adverse effects, and potential drug interactions.

Consensus follow-up recommendations from the North American Society of Pacing and Electrophysiology (NASPE) have been summarized by the Practice Guidelines Subcommittee of the NASPE. [3]

In the article [4]Amiodarone: Guidelines for Use and Monitoring, Dr. Lyle Siddoway shares a form to help guide the monitoring of adult patients taking Amiodarone. A downloadable checklist is available online at: http://www.aafp.org/afp.

[1] American Family Physician, Amiodarone: Guidelines for Use and Monitoring  LYLE A. SIDDOWAY, M.D., York Hospital, York, PennsylvaniaAm Fam Physician.2003 Dec; 68(11):2189-2197. dol: http://www.aafp.org/afp/2003/1201/p2189.html

[2] IBID

[3] Goldschlager N, Epstein AE, Naccarelli G, Olshansky B, Singh B. Practical guidelines for clinicians who treat patients with Amiodarone. Practice Guidelines Subcommittee, North American Society of Pacing and Electrophysiology. Arch Intern Med. 2000;160:1741–8.

[4] American Family Physician, Amiodarone: Guidelines for Use and Monitoring

Incorrect ear drops result in deafness

The Case

This claim involves a 10 ½ month old child who was inadvertently given the incorrect ear drops during tympanostomy tube placement, resulting in erosion of both ear drums and deafness.

A newly employed nurse arrived to the surgical center early to check the list of four surgeries scheduled for the day. She prepared the medications to be used during each of these four procedures. She drew up Ciprodex, a combination of ciprofloxacin and dexamethasone used to treat ear infections, in three one cc syringes; labeled them correctly; and placed them on a surgical tray. She drew up a fourth syringe from a vial containing trichloroacetic acid (TCA) 50% for the last procedure. She correctly labeled it and placed this syringe apart from the other three on the same tray. It looked identical to the three syringes containing the Ciprodex.

This nurse, said to be experienced, had only been working with the surgical practice for two days. She was unaware of a standard setup of the tray where only Ciprodex was placed in the syringes on the tray. In addition, she was unaware of the practice’s policy to prepare TCA only on request by the surgeon. The nurse, who usually prepared the surgical set-up, arrived late to work. She noticed that the tray setup was different from the way she normally did it, but didn’t change anything. She went to the pre-op area to prepare the four patients for surgery. During the procedure on patient #1, the 10 ½ month old, the scrub tech provided the physician with the syringe containing TCA. The physician used it in both of the child’s ears. The recovery room nurse discovered the problem within minutes; the physician attempted to flush the child’s ears with copious amounts of saline, and irrigated both ears with Ciprodex. He explained the error to the child’s parents. The child eventually sustained profound hearing loss, and was speech impaired.

Risk Management Commentary

The surgeon remains responsible for all aspects of the procedure, and was held liable in this case. From the sequencing of events preceding the patient’s injury, one can surmise the root cause of the error, and the opportunities not taken before and during the tympanostomy tube placement, any of which could have prevented the error and the subsequent major, life-altering patient injury occurring:

  • Orient and mentor all new employees, regardless of experience, particularly reviewing all surgery suite policies and procedures, prior to any interaction with patients.
  • Stop and take the time to question set-ups that are not within the norm.
  • Make no assumptions about the medication content of syringes. Had the scrub tech read the TCA labeling, he would have known not to provide that syringe to the physician, or at least would have mentioned it to him.
  • If there had been a two-person verification process[1] in place, the physician and the scrub tech would have taken the few seconds necessary to verify the correct agent was placed in this little patient’s ears.

The case report presented is a composite drawn from MagMutual’s case files. Any similarity to a specific case is both coincidental and unintended. The risk management advice presented in the Claim Lesson is intended as general information of interest to physicians and other healthcare professionals. The recommendations and advice published herein do not reflect a legal opinion, establish a standard of care, and do not establish rules for the practice of medicine. Successful outcomes are not guaranteed. The publication of this information is not intended as an offer to insure such conditions or exposures, or to indicate that MagMutual Insurance Company will underwrite risks for the reader. Our liability is limited to the specific written terms and conditions of the actual insurance policies issued.

  [1]National Patient Safety Goals Effective January 1, 2015, Office-Based Surgery Accreditation Program, Goal 1- Improve the accuracy of patient identification. Elements of Performance for NPSG.01.01.01 doi:http://www.jointcommission.org/assets/1/6/2015_NPSG_OBS.pdf

Defective hand-off communication forces defendant physician & hospital to settle lawsuit

The Case:

The patient complained to her primary care physician (PCP) of itching and hives. She denied exposure to new foods, medications, or other products. Her PCP diagnosed idiopathic urticaria; administered Decadron; and ordered oral prednisone, Benadryl, and Pepcid.

Six days later, the patient’s husband called 911. Her condition had worsened; she felt her throat closing. The Emergency Department (ED) physician ordered Solu-MedroI IV 125 mg, Pepcid IV, and hydroxyzine HCL. Only minutes later the patient became unresponsive and had a cardiac arrest. Resuscitation was successful. She was admitted to the ICU, placed on a ventilator via tracheostomy, and had multiple clinical consults, including one with an allergist.

The allergist was unable to find a specific allergy trigger for the patient’s condition. The patient was transferred to another hospital where she markedly improved over eleven days. At that facility, the patient was seen by a neurologist for the evaluation of her generalized weakness. The neurologist ordered Solu-Medrol IV to be given over the weekend. When the patient’s evening shift nurse attempted to administer the Solu-Medrol, the patient’s husband instructed her that his wife was allergic to steroids, and not to administer it. The nurse noted the reported allergy in the EHR. However, the next morning, the day shift nurse started the 100 mg bag of IV Solu-Medrol. The patient’s husband, who had gone downstairs for breakfast, returned to the room, finding his wife unresponsive with agonal breathing. The patient was transferred to the ICU, and placed on a ventilator. She was eventually transferred to a nursing home where she remained in a persistent vegetative state.

Allegations:

It was alleged the allergist failed to consider the possibility that the anaphylactic reaction the patient sustained in the first hospital’s ED could have been caused by the IV administration of Solu-Medrol succinate.

It was also alleged that the allergist failed to notify subsequent treating physicians in the form of a medical record documentation of the possible allergy to Solu-Medrol.

Disposition:

The case was mediated and settled for a large amount of money on behalf of the allergist, although defense experts were supportive of the allergist’s medical treatment. The hospital settled their claim separately, on behalf of its nurses.

Risk Management Commentary:

Our case files are replete with serious medical errors caused by miscommunications during hand-offs between medical providers. A review of MagMutual closed claims (2010-2014) revealed that 4% or more of claims were specifically due to provider communication problems.

From a risk management perspective, this patient’s injury may have been prevented by clearer handoff communications by all providers involved in the care of this patient.

Subsequent providers should have had the ability to read the allergist workup, the observations of the patient’s experiences, and concern with regards to the Solu-Medrol. Although no allergy test exists for Solu-Medrol or its component, succinate, the allergist did testify he suspected the patient was having a problem with Solu-Medrol, but didn’t document this suspicion for the benefit of the patient and other providers.

Likewise, the admitting nurse at the second hospital only partially completed the first part of communicating the patient’s husband’s allergy concerns. She did document the allergy in the section provided within the medical record, but was found negligent in not completely communicating this allergy report to the nurse who took over the patient’s care at shift change. Consequently, neither she nor her nurse colleague followed-up the allergy concern with the prescribing physician, or the hospital pharmacy, concerning the existing Solu-Medrol order.

The Joint Commission requires all health care providers to "implement a standardized approach to handoff communications, including an opportunity to ask and respond to questions" (2006 National Patient Safety Goal 2E.) The Joint Commission National Patient Safety Goal also contains specific guidelines for the handoff process, many drawn from other high-risk industries:

  • interactive communications
  • up-to-date and accurate information
  • limited interruptions
  • a process for verification
  • an opportunity to review any relevant historical data

The Accreditation Council for Graduate Medical Education also requires that residency programs maintain formal educational programs in handoffs and care transitions.[i]

In 2009, The Joint Commission Center for Transforming Healthcare developed the Targeted Solutions Tool® (TST®) for Hand-off Communications. The TST reports that by fully implementing solutions targeted to the specific cause of an inadequate hand-off, participating and pilot organizations achieved an average of over 50 percent reduction in defective hand-offs. Using the tool and the solutions from the Center’s Hand-off Communications project, health care organizations reported an increase in patient and family satisfaction; staff satisfaction; and successful transfers of patients (reduced bounce backs). [ii]

We encourage both our hospital and physician policyholders to take a close look at the tools provided by the TST®, and/or other tools, designed to help providers deliver effective handoffs [iii] [iv] [v], and to adapt these tools to their individual situations, as necessary.

[i] AHRQ PSNet, Patient safety network, National Patient Safety Goals, Oakbrook Terrace, IL: The Joint Commission; 2015

[ii] The Joint Commission Center for Transforming Healthcare, http://www.centerfortransforminghealthcare.org/projects/detail.aspx?Project=1

[iii] SBAR Toolkit-Institute for Health care Improvement; http://www.ihi.org/resources/Pages/Tools/sbartoolkit.aspx

[iv] TeamSTEPPS®: Strategies and Tools to Enhance Performance and Patient Safety

[v] 10 Patient Handoff Communications Tools, Becker’s Infection Control & Clinical Quality, http://www.beckersasc.com/asc-quality-infection-control/10-patient-handoff-communications-tools-2014.html

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.