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Tuesday, April 7, 2015

Health IT and patient safety: a JCAHO Sentinel Alert

From The Joint Commission comes this.
Safe use of health information technology
March 31, 2015

Health information technology (health IT) is rapidly evolving and its use is growing, presenting new challenges to health care organizations. This alert builds upon Sentinel Event Alert #42 on safely implementing health information and converging technologies (published in 2008) to take a broader look at health IT, particularly the socio-technical factors having an impact on its safe use. This alert’s suggested actions center on safety culture, process improvement and leadership.

Incorrect or miscommunicated information entered into health IT systems may result in adverse events. In some cases, interfaces built into the technology contribute to the events. The following examples obtained from ECRI Institute1 show a few ways adverse events may occur through the use of electronic health records (EHRs) and related technologies:

  • A chest X-ray was ordered for the wrong patient when the wrong patient room number was accidentally clicked. The orderer noticed the error right away and promptly discontinued the order, but not in time for the X-ray technician to see that the order was withdrawn. The technician performed the test on the wrong patient.
  • A drug was ordered as an intramuscular injection when it was supposed to be administered intravenously. The physician did not choose the appropriate delivery route from the drop-down menu.
  • A nurse noted that a patient had a new order for acetaminophen. After speaking with the pharmacist, the nurse determined that the order was placed for the wrong patient. The pharmacist had two patient records open, was interrupted, and subsequently entered the order for the wrong patient.
These examples show the risks inherent in health IT, and studies have documented mixed results in EHRs’ ability to detect and prevent errors. On the positive side, however, well-designed and appropriately used EHRs coupled with strong clinical processes can improve and monitor health care quality and safety through their ability to access important medical history data, provide clinical decision support tools, and facilitate communication among providers and between providers and patients. EHRs have demonstrated the ability to reduce adverse events, particularly EHRs with clinical data repository, clinical decision support, computerized provider order entry (CPOE) and provider documentation functionalities.
"Social factors?" Hmmm... "Talking Stick," anyone?

As I observed back in June 0f 2014,
My recent posts have ruminated on what I see as the underappreciated necessity for focusing on the "psychosocial health" of the healthcare workforce as much as focusing on policy reform (e.g., P4P, ACOs, PCMH), and process QI tactics (e.g., Lean/PDSA, 6 Sigma, Agile), including the clinical QI Health IT-borne "predictive analytics" fruits of ""Evidence Based Medicine" (EBM) and "Comparative Effectiveness Research" (CER). Evidence of psychosocially dysfunctional healthcare organizational cultures is not difficult to find (a bit of a sad irony, actually). From the patient safety-inimical "Bully Culture" down to the "merely" enervating emotionally toxic, I place it squarely within Dr. Toussaint's "8th Waste" (misused talent)...
See also my July 19th 2014 post "Medical Error, Interop, and the Patient Safety-Health IT nexus."

So, is this new Joint Commission Sentinel Event Alert 54 (pdf) giving us anything relating to improving the interpersonal psychosocial aspects of healthcare organizational culture, as a component of improving patient safety in general, and improving the effectiveness of health IT use specifically?

I'm not seeing much, beyond the usual vague (albeit necessary) exhortations.
Safety Culture
Create and maintain an organizational-wide culture of safety, high reliability and effective change management…

Process Improvement

Develop a proactive, methodical approach to health IT process improvement that includes assessing patient safety risks…


Within a culture of safety and process improvement described earlier in this alert, enlist multidisciplinary representation and support in providing leadership and oversight to health IT planning, implementation and evaluation...
Read the entire Alert, decide for yourselves.

What of the above-cited antecedent JCAHO Sentinel Event Alert #42? (pdf)
Issue 42, December 11, 2008
Safely implementing health information and converging technologies

As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT— are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate. Technology-related adverse events can be associated with all components of a comprehensive technology system and may involve errors of either commission or omission. These unintended adverse events typically stem from human-machine interfaces or organization/system design. The overall safety and effectiveness of technology in health care ultimately depend on its human users, ideally working in close concert with properly designed and installed electronic systems. Any form of technology may adversely affect the quality and safety of care if it is designed or implemented improperly or is misinterpreted. Not only must the technology or device be designed to be safe, it must also be operated safely within a safe workflow process…

Contributing factors
Inadequate technology planning can result in poor product selection, a solution that does not adapt well to the local clinical environment, or insufficient testing or training. Inadequacies include failing to include front-line clinicians in the planning process, to consider best practices, to consider the costs and resources needed for ongoing maintenance, or to consult product safety reviews or alerts or the previous experience of others. Implementing new clinical information systems can expose latent problems or flawed processes with existing manual systems; these problems should be identified and resolved before implementing the new system. An over-reliance on vendor advice, without the oversight of an objective third party (whether internal or external), also can lead to problems. “There’s often an expectation that technology will reduce the need for resources, but that’s not always true,” says Bona Benjamin, BS Pharm, director of Medication-Use Quality Improvement, American Society of Health-System Pharmacists. Instead, technologies often shift staffing allocations, so there is not typically a decrease in staff.

Technology-related adverse events also happen when health care providers and leaders do not carefully consider the impact technology can have on care processes, workflow and safety. “You have to understand what the worker is going through – whether that worker is a nurse, a doctor, a pharmacist or whoever is using the technology. The science of the interplay between technology and humans or ‘human factors’ is important and often gets short shrift,” says Ronald A. Paulus, M.D., chief technology and innovation officer, Geisinger Health System.

If not carefully planned and integrated into workflow processes, new technology systems can create new work, complicate workflow, or slow the speed at which clinicians carry out clinical documentation and ordering processes. Learning to use new technologies takes time and attention, sometimes placing strain on demanding schedules. Th resulting change to clinical practices and workflows can trigger uncertainty, resentment or other emotions that can affect the worker’s ability to carry out complex physical and cognitive tasks. For example, through the use of clinical, role-based authorizations, CPOE systems also exert control over who may do what and when. While these constraints may lead to much needed role standardizations that reduce unnecessary clinical practice overlaps, they may also redistribute work in unexpected ways, causing confusion or frustration. Physicians may resent the need to enter orders into a computer. Nurses may insist that the physician enter orders into the CPOE system before an order will be carried out, or nurses may take over the task on behalf of the physician, increasing the potential for communication-related errors. Physicians have reported a sense of loss of professional autonomy when CPOE systems prevent them from ordering the types of tests or medications they prefer, or force them to comply with clinical guidelines they may not embrace, or limit their narrative flexibility through structured rather than free-text clinical documentation. Furthermore, clinicians may suffer “alert fatigue” from poorly implemented CPOE systems that generate excessive numbers of drug safety alerts. This may cause clinicians to ignore even important alerts and to override them, potentially impairing patient safety…
apropos of that last paragraph, this THCB post (to which I referred in my prior post) comes to mind.
An Epic Struggle for the Soul of Medicine

This week I attended an all day “training” session in a new medical record system.  I thought it was interesting that the experience was called “training”...

The experience transported me back to the Northwood Elementary School when my parents decided to enroll me in clarinet lessons. They rented a metal clarinet. The teacher, Mrs. Strickland, traveled among the elementary schools in the district, spending a half day in each, introducing kids to music. The emotional memory remains vivid.  I just couldn’t make a sound with the thing; not even a squeak!  I also didn’t know where to put my hands and, of course, could not read the music.  It was a horrifying experience. Now, at the age of 69 I was back in the same situation; infantilized in a windowless room with 16 computers, behind each of which was a doctor who should have been seeing patients. There were only two differences between then and now. One, I now have many more things that I should be doing than I did then.Two, at least the end product of what I was doing then was inherently meritorious; namely making music. Now I was playing a video game, and what was even more horrifying was that some of the people around me were actually enjoying it.

I know all the rationales for an electronic medical record, such as bringing our supposedly chaotic medical system into line, reducing medication errors and improving communication; all meritorious goals. There is nothing inherently good or evil about an electronic record. After all it is just a computer program; basically a machine.  The fact is that a machine has no soul. It has no feelings and no commitment to the practice of medicine. To allow the machine to dictate the rules reminds one of HAL from Stanley Kubrick’s film, 2001: The Space Odyssey. “Just what do you think you’re doing, Dave.”

The electronic medical record does not adhere to any natural laws, such as the laws of biology. The rules are arbitrary. They are created by people. Playing with the machine is nothing more than a video game.  In fact, at the end of my day in “training” I was told to go home a use the “playground”; a simulated electronic medical record that would help me to become more facile at following the unnatural rules of what is really a billing machine. But this is not play for me. It is tedium which distracts me from the job for which I am educated; namely reducing suffering in human beings. I only have a finite number of days when I can utilize my skills. One day in the windowless room is one fewer that I have left. If we are not very careful, we might even convince society that the electronic medical record, and what it represents, is an end in itself; more important than taking care of the sick, training our successors and finding cures for human disease. Or, is it already too late? Has the door already closed behind us?…
You don't have to look far at all to come upon cascades of HIT scorn. Dr. Samuels never utters the name "Epic," but, IMO it's a pretty safe bet as to which EHR platform he's referring.

Back to JCAHO. What did these good folks proffer a good six years ago, back in 2008?
Joint Commission suggested actions

Below are suggested actions to help prevent patient harm related to the implementation and use of HIT and converging technologies.

  • Examine workflow processes and procedures for risks and inefficiencies and resolve these issues prior to any technology implementation. Involving representatives of all disciplines—whether they be clinical, clerical or technical—will help in the examination and resolution of these issues.
  • Actively involve clinicians and staff who will ultimately use or be affected by the technology, along with IT staff with strong clinical experience, in the planning, selection, design, reassessment and ongoing quality improvement of technology solutions, including the system selection process. Involve a pharmacist in the planning and implementation of any technology that involves medication.
  • Assess your organization’s technology needs beforehand (e.g., supporting infrastructure; communication of admissions, discharges, transfers, etc.). Investigate how best to meet those needs by requiring IT staff to interact with users outside their own facility to learn about real world capabilities of potential systems, including those of various vendors; conduct field trips; and look at integrated systems (to minimize reliance on interfaces between various vendor systems).
  • During the introduction of new technology, continuously monitor for problems and address any issues as quickly as possible, particularly problems obscured by workarounds or incomplete error reporting.
  • During the early post-live phase, consider implementing an emergent issues desk staffed with project experts and champions to help rapidly resolve critical problems. Use interdisciplinary brainstorming methods for improving system quality and giving feedback to vendors.
  • Establish a training program for all types of clinicians and operations staff who will be using the technology and provide frequent refresher courses. Training should be appropriately designed for the local staff. Focus training on how the technology will benefit patients and staff, i.e. less inefficiency, fewer delays and less repeated work. Do not allow long delays between orientation and system implementation.
  • Develop and communicate policies delineating staff authorized and responsible for technology implementation, use, oversight, and safety review.
  • Prior to taking a technology live, ensure that all standardized order sets and guidelines are developed, tested on paper,and approved by the Pharmacy and Therapeutics Committee (or institutional equivalent).
  • Develop a graduated system of safety alerts in the new technology that helps clinicians determine urgency and relevancy. Carefully review skipped or rejected alerts as important insight into clinical practice. Decide which alerts need to be hard stops when using the technology and provide appropriate supporting documentation.
  • Develop a system that mitigates potential harmful CPOE drug orders by requiring departmental or pharmacy review and sign off on orders that are created outside the usual parameters. Use the Pharmacy and Therapeutics Committee (or institutional equivalent) for oversight and approval of all electronic order sets and clinical decision support alerts.
  • Assure proper nomenclature and printed label design, eliminate dangerous abbreviations and dose designations, and ensure MAR acceptance by nurses.
  • To improve safety, provide an environment that protects staff involved in data entry from undue distractions when using the technology.
  • After implementation, continually reassess and enhance safety effectiveness and error-detection capability, including the use of error tracking tools and the evaluation of near-miss events. Maximize the potential of the technology in order to maximize the safety benefits.
  • After implementation, continually monitor and report errors and near misses or close calls caused by technology through manual or automated surveillance techniques.
  • Pursue system errors and multiple causations through the root cause analysis process or other forms of failure-mode analysis. Consider reporting significant issues to well recognized external reporting systems.
  • Re-evaluate the applicability of security and confidentiality protocols as more medical devices interface with the IT network. Reassess HIPAA compliance on a periodic basis to ensure that the addition of medical devices to your IT network and the growing responsibilities of the IT department haven’t introduced new security and compliance risks.
Again, all important and necessary. But, all process and technology oriented (and, stuff we were all talking about back during the MU-antecedent "DOQIT" era) -- two legs of a stable 3-legged stool. All assuming the continuation of a transactional / instrumental view of those toiling within healthcare organizations.

From the perspective of my hospital gurney last week:
Q: "So, what do you think of Epic?”
A:  "It's a great tool -- for tracking our every move."
Ouch. Yeah, I know this quite well from another context. As I posted last August,
There are 3 fundamental aspects of workflow in the digital era: physical tasks, IT (EHR) tasks, and cognitive tasks. Every certified EHR has to have an audit trail to comply with HIPAA, given that every time ePHI is created, viewed, updated, transmitted, or deleted the transaction must be “date-time/who/what/about whom” captured in the audit trail log.

The ePHI audit log, to me, is a workflow record component. It can’t tell me WHY front desk Susie or Dr. Simmons took so long to get from one transaction element to the next — i.e., physical movements or cognitive efforts — but it can tell me a lot, adroitly analyzed.

I worked for number of years as a credit risk and portfolio management analyst in a credit card bank. We had an in-house collections department that took up an entire football field sized building, housing about 1,000 call center employees. I had free run of the internal network and data warehouse. One day I just happened upon the call center database and the source code modules (written by an IT employee in FoxPro, which I already knew at an expert level). I could open up the collections call log and watch calls get completed in real time. We were doing maybe a million outbound calls a month (a small Visa/MC bank).

(My fav in the Comments field was “CH used fowl language,” LOL)

It was, in essence, an ongoing workflow record of collections activity.

I pulled these data over into SAS and ground them up. I could track and analyze all activity sorted by any criteria I wished, all the way down to the individual collector level. I could see what you did all day, and what we got (or didn’t) for your trouble.

I was [able to] rather quickly show upper management “Seriously? You dudes are spending $1,000 to collect $50, every day, every hour” etc. The misalignment was stunning. I started issuing a snarky monthly summary called “The Don Quixote Report” with a monthly “winner.” …Yeah, we called this hapless deadbeat 143 times this month trying to get 15 bucks out of him…

Well, it didn’t take long to squelch all that. We saved the bank 6 million dollars in Collections Department Ops costs that year via call center reforms. Didn’t exactly endear me to the VP of Collections, whose bonus was tied to his budget.

Gimme a SAS or Stata install and SQL access to the HIT audit logs, and I will tell you some pretty interesting (Wafts-of-Taylorism 2.0) workflow stories.
In this regard, see my cite of Simon Head's book "Mindless."


I'm deep into Dr. Bob Wachter's fine new book.

While I will have plenty to say about it, Matthew Holt of Health 2.0 has a review of it up on THCB. Worth your time.
The Digital Doctor -- The Review
...There are by and large three camps of opinions about what’s happened [within Health IT]. One is that the EMR is a pox visited on physicians that costs a fortune, has worsened quality, heightened medical errors, blown up successful processes, and ruined the lives of doctors–unless they were given scribes. The second is that because of the “rush to judgement” caused by the HITECH Act and Meaningful Use, we put in EMRs that were based on 1990s client-server technology but they were the only ones mature enough for the job. Most of this camp thinks that they were way better than paper, will slowly improve, and that doctors and patients will find that these technologies will soon integrate with easy to use iPhone-like apps as their APIs open up–and that if we hadn’t mandated EMRs when the great recession gave us the chance, nothing would have happened. The third camp agrees that EMRs are better than paper but felt that the way HITECH was rolled out kept a bunch of dinosaurs in business, and is preventing the health IT equivalent of Salesforce displacing Siebel (or Slack displacing email).
I'm finding the book an excellent read thus far. Reading it carefully in linear fashion.

More to come...

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