I now see a stunning story of the results of EHR iconoclasty and patient advocacy:
CNO claims hospital forced her out after she raised concerns about EMR
Becker's Hospital Review
June 14, 2016
A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.
Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.
Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.
If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.
Bad health IT:
Bad Health IT is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.
Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.
A wrongful termination lawsuit was apparently filed:
... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.
These types of gross defects, if true, represent an on its face menace to patient safety.
Further, these issues (and the harm that may result) are well known. In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).
CEO Ray Hino had the usual refrain seen in so many postings here (under the blog query "Patient care has not been compromised" - http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):
Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.
Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems. His bio is at https://www.linkedin.com/in/raymondhino.
As to whether patients were harmed, that is irrelevant if the EHR has such defects. Sooner or later, they will be. The issue is risk, not body counts (yet).
There's also this. The EHR in question is not the product of the major EHR vendors but the work of apparent insider. See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:
... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.
Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors.
I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.
Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.
My expertise is available should the parties so desire.
The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)). (Lim, 1990)
As defined by HHS regulations:
"Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R. 46.102(f)]
"Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R. 46.102(f)])
"Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R. 46.102(f)] )]
"Identifiable information"- specific information that can be used to identify an individual
Human subject rights
In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
- Voluntary, informed consent
- Respect for persons: treated as autonomous agents
- The right to end participation in research at any time
- Right to safeguard integrity
- Benefits should outweigh cost
- Protection from physical, mental and emotional harm
- Access to information regarding research
- Protection of privacy and well-being