A 57-year-old female presents for a laparoscopic cholecystectomy. Following the uneventful induction of general anesthesia, the patient is prepped and surgery begins.
Intraoperatively, the patient becomes acutely hypotensive and tachycardic. Despite intravenous fluids and phenylephrine, the hypotension persists. The patient is ultimately resuscitated but slow to awaken postoperatively. MRI of the head reveals an ischemic infarction. She regains consciousness on postoperative day 1, but has persistent right-sided weakness.
The spouse and surviving children bring suit against the anesthesiologist for failing to appropriately treat the hypotension resulting in a cerebrovascular accident. During discovery, the circulating nurse and scrub technician testify that the anesthesiologist was on her cell phone and checking e-mail immediately prior to the event. Plaintiff’s attorney subpoenaed the cell phone and hospital computer records validating the allegation.
Comments – Cell phone and hospital computer records are discoverable and may be admissible evidence at trial. In this case, the anesthesiologist’s defensible care is compromised by the proven allegation of electronic distraction during the anesthetic.
The medical community has historically approached new technologies with a reasonable degree of circumspection. In 1985, an Annals of Internal Medicine article addressed uncertainties surrounding the growing use of computer applications in health care.1 Specific concerns included ethics, confidentiality, regulatory measures, patient safety, and liability. Nearly 20 years later, these enduring issues remain topics of debate.
Benefits of Technology on Clinical Practice
Technology has changed the practice of medicine. Powerful handheld devices are serving escalating roles. These devices can seamlessly connect to information via the electronic medical record (EMR) and a host of other software applications. Benefits of this technology include improved communication, information access, and productivity.
Connectivity and Communication
Over a relatively brief period of time, physicians have grown accustomed to readily available connectivity and robust access to information. They now have the capacity to view critical information and prescribe therapy for anywhere in the world. The traditional location-centric approach to information acquisition has been replaced by a more user-centric model. For example, reviewing an echocardiogram no longer requires a walk to a specific department. Instead, the practitioner can view most studies from any computer inside or outside of the hospital.
Texting (including messages sent from mobile carrier websites, web-based paging applications, call centers, answering services, and hospital switchboards) can be a useful method of communication. In contrast to voice communication, text messaging is often more convenient for busy professionals’ schedules and expedites daily work flows. Additionally, the capacity to send attachments (such as pictures or other pertinent documents) augments communication efficiency.
Connectivity promotes better resource matching and supports evolving practice models. In anesthesiology or critical care medicine, electronic access to information has augmented the ability to centrally monitor multiple patient-care locations and can promote improved attending physician resource utilization. On a larger scale, telemedicine is rapidly expanding and becoming a vehicle for care in outlying communities.
Mobile solutions are evolving as a standard for information access and communication. Miniature devices now have computing power rivaling desktop tower workstations a few generations old. Many health care institutions are leveraging this technology and deploying fully mobile access solutions.
Beyond the provider-flexibility aspect, mobile solutions have other benefits for patient care. Radio-frequency identification (RFID) technology facilitates processes such as the efficient use of surgical equipment and pharmaceutical inventory management. RFID-labeled instruments and sponges yield prompt identification of retained surgical devices and improve patient safety.2-4
Anesthesia Information Management Systems
In many aspects, anesthesiology practice readily interfaces with automation. Anesthesia Information Management Systems (AIMS) can assist with escalating practice demands including immediate access to patient data, improved documentation legibility, contemporaneous documentation, and clinical decision support.5-7
Preoperatively, timely patient information enhances evaluation quality.8 Intraoperative functionality, such as automated electronic data acquisition, reduces clerical tasks and expedites data analysis.9 Throughout the perioperative period, clinical decision support (CDS) can potentially reduce errors and improve patient safety.10
Electronic medical records have the capacity to support large-scale data acquisition and analysis.11 Sophisticated data management and reporting facilitates compliance and safety initiatives such as the Surgical Care Improvement Project (SCIP), Patient Quality Reporting System (PQRS), and Anesthesia Quality Institute (AQI).
Technology and Patient Safety Concerns
In addition to the described benefits, technology has introduced new patient safety and ensuing medicolegal concerns. Medical staff and hospital leadership must establish guidelines, work flows, and processes to promote the rational use of these innovative tools. Table 1 lists common technology-related concerns and describes operational solutions.
Table 1. Technology Concerns and Solutions
|Excessive noise during critical periods||Control non-essential noise levels during all phases of each procedure allowing team members to effectively bi-directionally communicate|
|Eliminate all discretionary sources of noise during prescribed “sterile” periods and any unanticipated event requiring additional team communication|
|Reading, Phone Calls and Texting||Avoid discretionary internet-based activities during patient care Limit multitasking to brief, necessary events|
|Provide OR internet access only to patient-care related websites|
|Adhere to Professional Society guidelines addressing appropriate device use and minimizing distraction|
|Intraoperative nursing workflows||Maintain a culture of “patient first” for the entire surgical team|
|Avoid placing an expectation of managing mobile devices on the circulating RN or other team members|
|AIMS||Ubiquitous user involvement throughout the AIMS lifecycle|
|Reasonable, but consistent, education for all end users as a contingency of practicing in your facility|
|Encourage and expect only original documentation for all end users|
|Collaborate with IS and HIM departments regarding EMR data retention practices and policies|
|Alert Fatigue||Replace “informational” alerts with an “actionable” version|
|Implement an iterative process for evaluating individual alert effectiveness and modifying to effectively achieve the desired patient-safety goal|
|Compliance||Never send PHI of any variety over an unsecured texting platform|
|IS and clinical department collaboration regarding the security needs to protect patient information|
Intraoperative Noise Pollution
Numerous sources of noise pollution exist in the operating suite environment. Some sources of noise pollution, such as patient monitors and surgical equipment, are unavoidable. Discretionary sources, such as personal communication devices and digital music players, require consideration. Despite limited studies on this topic, available evidence supports concerns that intraoperative noise can adversely impact patient safety.12-14
Digital devices and widely available portable docking stations have introduced music into almost every operating suite. Music can promote a pleasant working environment, improve productivity, and reduce patient anxiety.15 Depending upon the timing and volume, however, music can also become noise and a distraction. A laboratory study by Stevenson et al. determined that visual attentional loads and auditory distractions additively reduced anesthesiology residents’ ability to detect changes in pulse oximeter tone.12 A subsequent study by Way et al. concluded that ambient noise (specifically music) similarly reduced auditory performance by surgical residents.16
Beyond medicine, other industries have identified occupational noise concerns as an important safety issue. The airline industry mandates that flight decks are free of distracting input during critical periods (a “sterile cockpit” in the vernacular).17 These critical periods include take off and landing. Critical intraoperative periods, such as anesthesia induction/emergence and unanticipated surgical events, should be treated with similar privilege. Ironically, Ginsberg et al. reported that ambient operating room noise volumes were consistently highest during critical anesthetic events.18
Other Operating Suite Distractions
Texting or talking on the phone negatively impacts the performance of common tasks such as operating a motor vehicle.19-21 The extent to which distracting activities influence anesthetic patient care is less clear. Slagle and Weinger evaluated the impact of reading during low-workload periods of the maintenance phase of anesthesia. The authors concluded that reading did not negatively impact objective vigilance measures.22 A second study by Wax et al. examined intraoperative electronic non-record keeping activities during anesthesia maintenance.23 Comparable to intraoperative reading, the authors did not observe a correlation between the potentially distracting activity and increased hemodynamic variability.
Despite the aforementioned studies, the topic of intraoperative distraction is complex and remains controversial. Elective multitasking may negatively impact previously unmeasured aspects of anesthetic care. Functional magnetic resonance imaging reveals that non-distracted information processing and storage involves the hippocampus. During multitasking, the striatum is activated and replaces hippocampal engagement. The latter condition may negatively impact creativity and adaptive problem solving.21
The ASA Closed claims database reports a relatively small (13 of 5822) number of adverse outcomes related to provider distraction.20 These included reading printed material, phone calls and loud music. Distraction-related events were more commonly judged as substandard care and were associated with payments in over 80% occurrences. As the vignette accompanying this article highlights, patients expect the full attention of each operative team member throughout surgery.
Intraoperative Nursing Workflows
Nursing workflows are designed to focus on patient care. Intraoperatively, the circulating nurse is often expected to answer cell phones, return calls, or read texts. These activities interrupt workflows and potentially detract from critical patient care events.
Unsecured Texting and the New HIPAA Rule
Patient privacy is a compliance mandate and a periodically neglected aspect of patient care. Privacy violations often occur insidiously, such as through texting. Unsecured texting of protected health information (PHI) can result in potentially significant liability risks, federal compliance investigations, and civil monetary penalties.24 The final HIPAA omnibus rule creates a presumption in favor of notification of any breach of unsecured PHI. The HIPAA Privacy and Security Rules generally require covered entities and their business associates to implement appropriate physical, administrative, and technical safeguards to ensure confidentiality, integrity, and availability of all electronic PHI it creates, receives, maintains, or transmits.25 Secure passwords and encryption are common technical safeguards. PHI should neither be transmitted via an unsecured platform nor stored on public “cloud” archives.
Anesthesia Information Management Systems
Increasing AIMS implementations have introduced new concerns for patient safety. AIMS applications and workstations are highly configurable. Robust and mandatory training is critical. From an organizational perspective, case law has supported health care facility requirements to uphold adequate end-users training.26
Despite overwhelming concerns of technology-related safety issues, the most common sources of errors are user driven. While aberrant readings can occur, these can be corrected and updated by the vigilant provider. Prevalent intraoperative errors include incorrect medications, inaccurate timing, or even charting on the wrong patient. Copying and pasting within, and sometimes across, patient records is an undesirable but common occurrence and potential source of errors.27
End user notifications, sometimes called clinical decision support (CDS), are intended to mitigate critical user errors. Misguided overuse of this technology can result in end user alert fatigue and compromise the tool’s effectiveness. Alert fatigue results in end users disregarding up to 9 out of 10 notifications at some facilities.28 Strategies for effective CDS include the judicious deployment of actionable alerts and recurring institutional evaluation regarding individual alert effectiveness.
The New Medical Record
Long after the patient’s surgical procedure is complete, the medical record preserves critical event details. The emergence of the EMR has eliminated what traditionalists would call the “patient chart.” Instead, vast amounts of data are electronically acquired and stored throughout the patient’s hospitalization. This electronic warehouse can include the patient’s medical history, billing information, consents, imaging studies, medication administration, computer-generated advisories, risk management data, research data, race data, religion data, and almost certainly a whole host of other “fields” that most of us may never even suspect exist. Elements of these data are then extracted and placed into reports creating a facsimile of the traditional record.
One of the selling points of the EMR is that it becomes a clearinghouse for patient care considerations and to support the business aspect of medical care. For example, an anesthesia provider may manually or automatically enter procedure start and end times into the EMR for patient care reasons. Following the procedure, members within other hospital departments will almost certainly access this information for related services. A common scenario could involve the hospital’s coding and billing department. However, an activity as benign as a hospital coder’s entering the database to review start and end times for billing purposes could be used by creative plaintiff’s lawyers to argue a potential opportunity for falsification or alteration of the medical record.
More troubling still is the reality that draft versions of electronic documentation, prior to “sign-off,” may remain buried in the electronic data. For example, if a provider begins charting a narrative, then decides to change the word choice or provide additional information, the provider may be under the assumption that only the “final” version is saved in the EMR when the provider hits “save” or “sign-off” on the entry. For any serious and aggressive plaintiff attorney years later, the prior edits may still be available and regarded as valuable information. The concept is similar to those who were trained not to chart in pencil because it can be erased. The mere imprint of erasure makes what was previously written look potentially damaging.
The message from this reality is that when a health care provider does chart, one must choose their words carefully. Always assume that drafts of the entry can potentially be reconstructed with enough effort somewhere down the road. Physician administrators, health information management departments and information system professionals should prospectively collaborate and establish policies regarding mutually agreed upon data retention practices. This approach will promote reasonable documentation practices and information sharing.
Technology has improved multiple facets of medical practice. Predictably, technology has also been accompanied by new challenges requiring active management. Practitioners must have an understanding of technology-related topics ranging from the impact of distraction to compliance. Anesthesiology, surgery, perioperative, and information technology departments should cooperatively establish policies and procedures governing the acceptable use of technology in the operating suite. Multiple professional medical organizations have either created, or are in the process of creating, similar guidelines.
The authors acknowledge and appreciate the assistance of James Goodwin, Esq., with the Phoenix, Arizona, law firm of Sanders & Parks, P.C., in preparing this article.
Dr. Cammarata is a Clinical Assistant Professor in the Department of Anesthesiology at the University of Arizona, a Partner in Old Pueblo Anesthesia where he serves as Director of Quality Assurance, and Chief Medical Information Office at the Tucson Medical Center.
Mr. Thomas is Senior Claims Attorney and Director of Risk Management with the Preferred Physicians Medical Risk Retention Group.
- Miller RA, Schaffner KF, Meisel A. Ethical and legal issues related to the use of computer programs in clinical medicine. Ann Intern Med 1985;102:529-37.
- Catalano K, Fickenscher K. Emerging technologies in the OR and their effect on perioperative professionals. AORN J 2007;86:958-69.
- Greenberg CC, Diaz-Flores R, Lipsitz SR, et al. Bar coding surgical sponges to improve safety. Ann Surg 2008;247:612-16.
- Ellner SJ, Joyner PW. Technologies and patient safety. Surg Clin N Am 2012;92:79-87.
- Jones SC, McMenamin J, Kibbe DC. The intraopeative health record: preserving its promise by recognizing and limiting physician liability. Food Drug Law J 2008;63:75-87.
- Hodge JG Jr, Gostin LO, Jacobson PD. Legal issues concerning electronic health information: privacy, quality and liability. JAMA 1999;282:1466-71.
- van Rosse F, Maat B, Rademaker CMA, et. al. The effect of computerized order entry on medication prescription errors in pediatric and intensive care: a systematic review. Pediatrics 2009;123:1184-90.
- Vigoda M, Dennis JC, Dougherty M. E-record, E-liability: addressing medico-legal issues in electronic records. Journal of AHIMA 2008;79:48-52.
- Maile MD, Patel RA, Blum JM, Tremper KK. A case of malignant hyperthermia captured by an anesthesia information management system. J Clin Monit Comput 2011;25:109-11.
- Sittig DF, Singh H. Legal, ethical, and financial dilemmas in electronic health record adoption and use. Pediatrics 2011;127:1042-7.
- Dixon-Woods M, Redwood S, Leslie M, et. al. Improving quality and safety of care through “Technovigilence”: an ethnographical case study of secondary use of data from an electronic prescribing and decision support system. The Milbank Quarterly 2013;91:424-54.
- Stevenson RA, Schlesinger JJ, Wallace MT. Effects of divided attention and operating room noise on perception of pulse oximeter pitch changes: a laboratory study. Anesthesiology 2013;118:376-81.
- Brammer AJ, Laroche C. Noise and communication: a three-year update. Noise Health 2012;14:281-6.
- Lee JY, Lantz AG, McDougall EM, et. al. Evaluation of potential distractors in the urology operating room. J Endourol 2013;27:1161-5.
- Moris DN, Linos D. Music meets surgery: two sides to the art of “healing.” Surg Endosc 2013;27:719-23.
- Way TJ, Long A, Weihing J, et. al. Effect of noise on auditory processing in the operating room. J Am Coll Surg 2013;216:933-8.
- Clark GJ. Distractions and interruptions in the OR. AORN J 2013;97:702-7.
- Ginsberg SH, Pantin E, Kraidin J, et. al. Noise levels in modern operating rooms during surgery. J Cardiothorac Vasc Anesth 2013;27:529-530.
- Collet C, Guillot A, Petit C: Phoning while driving I: A review of epidemiological, psychological, behavioural and physiological studies. Ergonomics 2010;53:589-601.
- Domino KB, Sessler DI. Internet use during anesthesia care: does it matter? Anesthesiology 2012;117:1156-8.
- Jorm CM, O’Sullivan G. Laptops and smartphones in the operating theatre – how does our knowledge of vigilance, multi-tasking and anaesthetist performance help us in our approach to this new distraction? Anaesth Intensive Care 2012;40:71-8.
- Slagle JM, Weinger MB. Effects of intraoperative reading on vigilance and workload during anesthesia care in an academic medical center. Anesthesiology 2009;110:275-83.
- Wax DB, Lin H-M, Reich DL. Intraoperative non-record-keeping usage of anesthesia information management system workstations and associated hemodynamic variability and aberrancies. Anesthesiology 2012;117:1184-9.
- Department of Health and Human Services. Federal Register. 2013;78:5583.
- 45 CFR 164.306 (a)
- Mangalmurti SS, Murtagh L, Mello MM. Medical malpractice liability in the age of electronic health records. N Engl J Med 2010;363:2060-7.
- Safety risks of electronic medical records. Health Devices 2013;42:134-5.