Electronic Health Records and Patient Safety: Lessons Learned from Law-Medicine Conference: Part II

Documenting challenges with EHR usage.

Last week, I started telling you about a Law-Medicine combined conference I attended through Case Western Reserve University School of Medicine about EHRs and Safety concerns. I am going to continue with the speakers and review the assigned readings.

The speakers referred to, and the conference supplied as a reference article, Death by a Thousand Clicks: Where Electronic Health Records Went Wrong by Ericka Fry and Fred Schulte, published in Fortune March 2019 (http://fortune.com/longform/medical-records/). If you haven’t read this, you should!

It says the federal government has sunk $36 billion into supporting the process of bringing medical records into the digital world, but the state of the nation’s EHRs remains “a sprawling, disconnected patchwork,” and “has handcuffed health providers to a technology they mostly can’t stand”. Almost all hospitals have an EHR, but the technology is quite flawed. The “physicians complain about clumsy, unintuitive systems,” and how they spend more time with the computer than with patients. EHRs do not interface and cooperate with one another. Not all patients can access their own records.

The government has taken on improving this situation. Next up was Rachel Nelson, JD, MHA from the Office of the National Coordinator for HIT. Her disclaimer was that all the views were her own and not official from the ONC. She informed us that the ONC Health IT Certification Program Proposed Rule (84 FT 7424) is up for comments until May 3. That date, however, has since been extended for an additional 30 days.

There are many aspects up for revision, addition, and elimination regarding topics like innovation, reducing provider burden, advancing interoperability, and promoting patient access. I strongly recommend that if you have knowledge and interest in the area of HIT, you should participate: https://www.healthit.gov/topic/laws-regulation-and-policy/notice-proposed-rulemaking-improve-interoperability-health.

I do agree with improving interoperability and eliminating information blocking. If you get your medical care in System A and get taken to the ED at a hospital in System B for an emergent condition, it is in the patient’s best interest for the systems to share the patient’s information and medical records.

This article and the conference highlighted that there are reports of patient deaths, serious injuries, and near misses tied to software glitches, user errors, or other user-technology misalignments. Ross Koppel, Ph.D., who spoke on EHR Certification, elicited a “WOW!” notation next to my handwritten notes during his presentation. He taught me that EHR vendors impose non-disclosure, or gag, clauses where buyers/users are prohibited to speak out about safety issues and technologically-related medical errors. If you find an issue while working in one of those protected EHRs, you are forbidden to take a screenshot to share.

The other big eye-opener from Dr. Koppel was that the foxes are guarding the henhouse. There are a few approved testing organizations for EHR certification, but the criteria were lowered by vendor request. The questions are known in advance and the testing has no time limit. If you were to fail certification by one testing organization, you could try another (although it looks like they very rarely fail anyone).

For certification, he believes the most important factors are data standards, interoperability, and usability. One of his premises is that without data standards, you can’t achieve interoperability.

His suggested solutions were the following:

• Change the mission from selling EHRs to requiring they be usable and effective
• Prohibit non-disclosure and hold harmless clauses in contracts
• Remove barriers to reporting EHR problems.

The penultimate speaker was James Willig, a physician at the University of Alabama at Birmingham. His fascinating talk was about the story of an HIV/AIDS clinic where he works and how he set up a homegrown EHR early on to be able to collect data. This gave them the ability to improve patient care and do cutting-edge research because they were able to see trends and relationships that no one else had ever picked up on.

Their philosophy was that we have a shared responsibility for accurate documentation and decisions are only as good as the data they are based on. High-quality data that helps you help your patients. They “established and maintained a culture of data quality.” Finally, it is key to separate the data the institution wants from that data that is needed.

Dr. Willig shared their experience with trying to get patients to fill out questionnaires and how monitoring it in real time, giving them the insight that many of the patients were illiterate. Can’t get the data if the subjects can’t give it to you.

Another suggested reading was A Decade of Health Information Technology Usability Challenges and the Path Forward, by Raj Ratwani, et. al., from JAMA, 2/26/19, Vol321, Number 8, pp 743-744

I will tell you what I gleaned from reading this article, but it seems to me that some of the suggestions “to achieve progress” would have been good to implement before they rolled out the technology in the first place. Their recommendations:

1. Create a national database of usability and safety issues and set up resources to investigate issues. This would override the non-disclosure clause prohibition.
2. Establish evidence-based basic design standards. Discounting the recent Boeing 737 Max 8 catastrophes, this article and several of the speakers held up the aviation industry as a paradigm for establishing safety standards and procedures.
3. Unintended harms must be addressed by having shared responsibility and collaboration. Vendors are presently shielded from liability by “hold harmless” clauses. These would also have to be eliminated.
4. Federally mandated documentation requirements affecting usability need to be adjusted to decrease provider busy work. The Patients Over Paperwork initiative has started to address some of this.
5. Develop standard usability and safety measures so progress and improvement can be tracked. Comparing EHRs right now is like comparing Honeycrisp apples and Honeybell oranges. The recommendation is that the ONC’s certification program could include standardized scenarios which could prompt iterative product improvement.

Sharona Hoffman, JD, LLM, Professor of Law and Bioethics, and Co-Director of the Law-Medicine Center of CWRU School of Law, was the Co-Course Director. She wrote and spoke on the topic of burnout, her area of interest. We often talk about physician burnout on Talk Ten Tuesdays.

The article is: Healing the Healers: Legal Remedies for Physician Burnout; (download here: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3244831)

Burnout is a syndrome that is characterized by emotional exhaustion, depersonalization, and dissatisfaction with one’s work accomplishments, and over fifty percent of physicians report burnout.

[There is a tool to measure burnout called the Maslach Burnout Inventory (MBI) which is not publicly available, but I found a non-validated, generic burnout scoring tool online.]

One of the primary factors in burnout for physicians is dissatisfaction with the EHR, including documentation requirements, an extension of work into home life (to complete charting), and EMR functionality. Current-day physicians spend as much as 50% of their work time on documentation and a study was referenced which determined that an ED provider in a community hospital may perform 400 mouse clicks per hour!

Professor Hoffman’s article has many suggestions and recommendations regarding improving EHR technology to address physician burnout. Efforts to increase time with patients seems to be empowering and partially successful. A few approaches are scribes and allowing ancillary personnel to work at top of scope (especially now that HPI need only be verified, not repeated in full), and direct primary care (DPC).

DPC is a model of healthcare delivery where clinicians provide all of their patients’ primary care for a monthly fee, like a subscription. The patient has unlimited access, 24/7. They do not bill third-party payers and have significantly fewer patients in their practice than a traditional practice model. Concierge medicine (CM) is a variation on the same theme – higher monthly fees, fewer patients, but concierge practices continue to bill insurance companies for covered services. It was interesting to me that Ms. Hoffman did not point out that DPC and CM still have to adhere to CMS documentation guidelines.

Besides decreasing regulatory burden on the providers, she recommends improving the technology with more extensive usability testing and national usability standards. Whittling down drop-down lists to a more reasonable number of choices would be welcome. The technology may advance to the point that natural language processing might eliminate the need for structured fields altogether. Customization must be done with caution and thoughtfully.

One of the suggestions floated in the article was permitting acceptance testing of the EHR. This is reminiscent of 30-day money back guarantee. If the device doesn’t perform as expected and the vendor can’t remedy the problem, you can return the product, no questions asked. If the EHR “doesn’t have the functionality to do that,” but your facility must have that capability, or there is a serious safety concern that can’t be fixed, you shouldn’t be required to continue to utilize a fatally flawed EHR system.

 A final thought. The 21^st Century Cures Act, December 2016, was designed to accelerate medical product development and bring new innovations to patients, combat the nationwide opioid epidemic, and mandated the Department of Health and Human Services develop a plan to reduce administrative burdens imposed by EHR usage. This has led to the initiative to overhaul the evaluation and management coding guidelines. I personally do not believe the government should eliminate guidelines for history and physical examination and move exclusively to medical decision making or time.

Good doctors and good documenters probably don’t need guidelines as to what is important to record to take excellent care of your patients; bad doctors and bad documenters definitely do. I personally do not subscribe to “Patient Without Any Paperwork at All.”

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