Thursday, November 14, 2019

Electronic Health Records and medical mistakes

Electronic Health Record systems (EHRs) have been broadly implemented by hospitals and health systems around the country as a way of increasing the accuracy, availability, and timeliness of patient health status and treatment information. (These systems are also sometimes called "Digital Medical Records" (DMRs).) They are generally regarded as an important forward step in improving the quality of healthcare. Here is a description of the advantages of Electronic Health Record systems, according to Athena Health:

The advantages of electronic health records in the clinical setting are numerous and important. In the 2012 edition of the Physician Sentiment IndexTM, published by athenahealth and Sermo, 81% of physicians said they believe EHRs improve access to clinical data. More than two-thirds said an EHR can actually improve patient care.

The use of an electronic health records system offers these clinical advantages:
  • No bulky paper records to store, manage and retrieve
  • Easier access to clinical data
  • The ability to establish and maintain effective clinical workflows
  • Fewer medical errors, improved patient safety and stronger support for clinical decision-making
  • Easier participation in Meaningful Use, Patient-Centered Medical Home (PCMH) and other quality programs, with electronic prompts ensuring that required data is recorded at the point of care
  • The ability to gather and analyze patient data that enables outreach to discreet populations
  • The opportunity to interact seamlessly with affiliated hospitals, clinics, labs and pharmacies
Considering all the advantages of electronic health records, and the rapidly growing electronic interconnectedness of the health care world, even if EHRs had not been mandated by health care reform, their development and eventual ubiquity in the health care industry was inevitable.

And yet, like any software system, EHR systems are capable of creating new errors; and some of those errors can be harmful to patients.

Nancy Leveson is an important expert on software system safety who has written extensively on the challenges of writing highly reliable software in safety-critical applications. Here are a few apt observations from her book Safeware: System Safety and Computers (1995).
Although it might seem that automation would decrease the risk of operator error, the truth is that automation does not remove people from systems -- it merely moves them to maintenance and repair functions and to higher-level supervisory control and decision making. The effects of human decisions and actions can then be extremely serious. At the same time, the increased system complexity makes the decision-making process more difficult. (10)
The increased pace of change lessens opportunity to learn from experience. Small-scale and relatively nonhazardous systems can evolve gradually by trial and error. But learning by trial and error is not possible for many modern products and processes because the pace of change is too fast and the penalties of failure are too great. Design and operating procedures must be right the first time when there is potential for a major fire, explosion, or release of toxic materials. (12)
(To the last statement we might add "or harm to hospital patients through incorrect prescriptions or failed transmission of lab results".)
The safety implications of computers exercising direct control over potentially dangerous processes are obvious. Less obvious are the dangers when ... software generated data is used to make safety-critical decisions, ... software is used in design analysis, ... safety-critical data (such as blood bank data) is stored in computer databases. The FDA has received reports of software errors in medical instruments that led to mixing up patient names and data, as well as reports of incorrect outputs from laboratory and diagnostic instruments (such as patient monitors, electrocardiogram analyzers, and imaging devices". (23)
Automatic control systems [like aircraft autopilots] are designed to cope with the immediate effects of a deviation in the process -- they are feedback loops that attempt to maintain a constant system state, and as such, they mask the occurrence of a problem in its early stages. An operator will be aware of such problems only if adequate information to detect them is provided. That such information is often not provided may be the result of the different mental models of the designers and experienced operators, or it may merely reflect financial pressures on designers due to the cost of providing operators with independent information. (117)
One of the cases examined in detail in Safeware is the Therac-25 radiation-therapy device, which due to a minor software flaw in the treatment-entry plan module began seriously injuring patients with excessive doses of radiation in 1985-87 (515 ff.). It had operated without incident thousands of times before the first accident.

So Leveson gives ample reason to be cautious about the safety implications of DMRs and the "fault pathways" through which their normal functioning might harm patients. What has been the experience so far, now that the healthcare industry has witnessed widespread adoption of DMR systems?

Two specific issues involving EHR errors affecting patient care have been identified in the past several years. The first is in the area of errors in the administration of prescription drugs, and the second is in the area of the handling and routing of medical test results. Both errors have the potential for harming the patient.

Jennifer Bresnick (link) summarizes the results of a report by the Pennsylvania Patient Safety Authority concerning medication errors caused by DMR systems. Medication errors (wrong medication, wrong dose, wrong patient, wrong frequency) can occur at several stages of the clinical process, including prescribing, transcribing, dispensing, and administration. The digital medical record is intended to dramatically reduce all these sources of error, the Pennsylvania study shows that the DMR can also contribute to errors at each of these stages.
While EHRs and other technologies are intended to reduce errors and improve the safe, standardized, and well-documented delivery of care, some stakeholders believe that digital tools can simply serve to swap one set of mistakes for another. Poor implementation and lackluster user training can leave patients just as vulnerable to medication errors as they were when providers used paper charts, commented Staley Lawes, PharmD, BCPS, Patient Safety Analyst, and Matthew Grissinger, RPh, FISMP, FASCP, Manager of Medication Safety Analysis in the brief. (link)
Part of the blame, according to the Pennsylvania report, belongs to the design of the user interface:
For this reason, it is important to design a system with an intuitive user interface to minimize the risk for human error. Users should be able to easily enter and retrieve data and share information with other healthcare professionals.  When systems are designed without these considerations in mind, patients are subject to undue risk. (link)
The report contains several specific design standards that would improve the safety of the DMR system:
The interaction between clinician and software is a key component that is to be taken into consideration when trying to improve the safety of health IT,” the report says. “Incident reports can provide valuable information about the types of HIT-related issues that can cause patient harm, and ongoing HIT system surveillance can help in developing medication safety interventions. (link)
It is clear that ongoing health IT system surveillance and remedial interventions are needed. Efforts to improve health IT safety should include attention to software interoperability, usability, and workflow. The relationship between clinician and software includes complex interactions that must be considered to optimize health IT’s contribution to medication safety.
Yackel and Embi (link) treat the problem of test result management errors in "Unintended errors with EHR-based result management: a case series". Here is their abstract:
Test result management is an integral aspect of quality clinical care and a crucial part of the ambulatory medicine workflow. Correct and timely communication of results to a provider is the necessary first step in ambulatory result management and has been identified as a weakness in many paper-based systems. While electronic health records (EHRs) hold promise for improving the reliability of result management, the complexities involved make this a challenging task. Experience with test result management is reported, four new categories of result management errors identified are outlined, and solutions developed during a 2-year deployment of a commercial EHR are described. Recommendations for improving test result management with EHRs are then given.
They identify test management errors at four stages of the clinical process:
  • results not correctly communicated to provider;
  • results communicated but never received or reviewed by the provider;
  • results reviewed, but appropriate action not recommended by provider;
  • appropriate recommendation made by provider, but action not carried out.
They make several key recommendations for improving the performance of DMR systems in managing test results: Develop fault-tolerant systems that automatically report delivery failures; use robust testing to find rare errors that occur both within and between systems; implement tracking mechanisms for critical tests, such as cancer screening and diagnostics; and deliver results directly to patients.

These are just two types of errors that can arise in digital medical record management systems. It is evident that the designers and implementers of DMRs need to take the systems-safety approach described by Nancy Leveson and implement comprehensive safety failure analysis, both in terms of "safety case analysis" (discovery of failure scenarios) and after-event investigation to identify the source of the failure in the software and its human interface.

These examples are not intended to suggest that DMRs are hazardous and should be avoided. On the contrary, the consolidation and convenient presentation of patient information for the provider is clearly an important step forward. But it is crucial that designers and implementers keep safety at the center of their attention, and to have a healthy respect for the ways in which automated systems can incorporate incorrect assumptions, can produce unintended interactions among components, and can be presented in such a confusing way to the human provider that patient care is harmed.

(Here is a case of treatment involving several different errors conveyed through the digital medical record system that involved attaching biopsy and test results to the wrong patient, leading to the wrong treatment for the patient. It is interesting to read because it reflects some of the complexity identified by Leveson in other system failures.) 

No comments: