How Should HHS Promote HIT Safety?

Does health information technology (HIT) pose risks to patients? Probably, but no one knows the extent of the risk.  The Institute of Medicine (IOM) released a report analyzing the risks to patient safety posed by electronic health records (EHR) and other HIT. Appendix C to the report estimates that perhaps 1 percent of medical errors involve HIT.

Advocates for a quick national adoption  of health information exchanges emphasize the benefits of consolidated data available to everyone who interacts with a patient. Quality of care will improve because analysis of the data will help physicians determine which actions lead to better (or worse) outcomes, resulting in the adoption of best practices. A recent white paper described an error in a hospital dermatology department in which an imaging report was  misfiled by the department’s separate record system. An AIDS patient’s physician saw the report in the hospital’s EHR and told the patient he didn’t have long to live because of skin cancer. Fortunately, the error was discovered and both the physician and the staff from the dermatology department met with the patient to explain the mistake.

Overall, however, the IOM decided that the scientific evidence  of the effects of HIT usage on patient safety was inconclusive. Some systems, such as medication tracking reduced errors. However, design of an EHR system can make it harder to use, increasing the chance of mistakes. For example, a counter-intuitive user interface, or the need to click through multiple screens or scroll to find needed information, all can interfere with the work flow.

Therefore, the IOM recommended to the Office of the National Coordinator  that systems must:

  • be  designed around the user’s work flow, perhaps by streamlining work or automating mundane tasks
  • allow easy retrieval of complete, accurate information
  • enable smooth transfer of information from one entity to another
  • provide needed information at the point of care.

A draft report of the National Institute of Science and Technology discussed design issues in detail, describing a protocol for evaluating the design of a system to minimize error. The researchers classified potential errors and considered how the design affected the likelihood of different classes of errors. They linked adverse events with the “root cause”, that is, the mistake that caused the adverse event and the factors that contributed to the mistake. Examples included “mode error,” where the program is not in the mode required for the action the user was trying to perform, inaccurate or incomplete data, or “recall error”, where the system required the user to remember data from a previous screen. A conflict between the method to determine a dose in the system and that used by the provider (relevance of the weight of the patient or conflict between the imperial and metric measures of volume.

The Second HHS Strategic Plan and the stage 1 meaningful use requirements focus on the data to be used and certain functionality, such as warning about drug-allergy and drug-drug interactions, generating lists of patients with a particular condition, interoperability and secure exchange of information. Encryption of transmitted data is required, each user must have an identifier, authentication must be required to access the records.  Verification that data has not been altered in transit is required.  But the standards do not specifically address usability.

The regulation requires eligible professionals to implement one clinical decision support rule during stage 1.  Use of programs to support clinical decisions is sometimes controversial, and the risk of errors is higher than with requirements to obtain data on smoking, body mass or medications.  It may be worth noting that the strategic plan lists widespread adoption of EHRs as Goal I. Inspiring confidence and trust in the system is Goal III.

The IOM report stated that one reason problems with HIT aren’t discussed widely is that the vendors’ contracts contain nondisclosure clauses, preventing providers and practitioners from sharing information to promote safety. Because of these clauses, physicians have been prevented from sharing reviews of their EHR systems the way other users of IT do. These contractual restrictions should be abolished. In fact, adverse events involving the use of HIT should be reported to a new federal agency created specifically to monitor and address HIT’s effects on patient safety.