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healthysoch.com New Delhi, August 22, 2019 : A 63-year-old retired worker was referred to a cardiologist (Dr C) after his ECG showed atrial fibrillation, who believed the fibrillation to be of recent onset and put him on amiodarone. Over the next month, amiodarone was reduced as sinus rhythm had normalized. Six months later, the patient visited his PCP and Dr C with isolated complaint of a rapid heart rate and a full feeling in his chest. He continued to take amiodarone and daily aspirin. Six years later, the patient visited his hematologist for raised hemoglobin and complained of occasional epigastric pain with activity during one visit. The hematologist asked the patient to see Dr C thinking that the symptom could be related to the heart. A year later, the patient visited Dr C, who put the patient on a Holter monitor and the next day had him perform a stress test/ECG. Dr. Cs exercise echocardiographic report authored that second day stated that the patient was “being evaluated relative to the current status of his coronary anatomy, left ventricular function, and cardiac rhythm.” In that dictated report, Dr. Cs impressions were: no chest pain with exercise, no significant ST changes or arrhythmias, normal left ventricle systolic function and response to exercise, and no evidence of myocardial ischemia. The patient was considered stable and advised to return after 3 months by Dr C. But, the patient suffered an embolic stroke two months later leading to weakness in the left arm and leg and facial droop. The patient and his wife sued Dr C, alleging that he did not appropriately manage his atrial fibrillation. During his deposition by the plaintiffs attorney, Dr C testified that his focus on the patients return to his office after the long absence was to rule out coronary disease, not to follow up or rule out atrial fibrillation. During that deposition, however, the plaintiffs attorney showed Dr. C a history and physical report from the first day of that consultation. That H&P, an electronically generated record (with Dr Cs electronic signature), stated at the outset: “The patient is a 70-year-old male who presents for evaluation and management of atrial fibrillation.” The H&P also noted that the patient thought he was having a recurrence of the fibrillation twice or three times a week. Apparently, Dr Cs office was transitioning to electronic records at that time, and the first days H&P was the only record relating to the patients care by Dr C that was placed into the offices new electronic record. That electronic record was produced in the course of a copy-service request for the patients chart made by the plaintiffs attorney prior to litigation. Dr C resolved the litigation with the patient informally. (Source: Gordon T. Ownby. Malpractice case: dangers when transitioning to electronic records – Medscape – Jul 23, 2019) |
Electronic records offer several advantages such as quick and easy access to patient data as information is available at the touch of a finger or a click of mouse; improved efficiency and quality of care by minimizing risk of errors. They also save on storage space.
But, there are downsides to technology; most important being privacy and security violations, inaccurate or incomplete information, all of which pose potential risk of medical malpractice. But, most importantly, electronic records leave an audit trail i.e. a record of the changes that have been made to a database or file.
An audit trail can be defined as a “record that shows who has accessed a computer system, when it was accessed, and what operations were performed” (Brodnik, Melanie, et al., Fundamentals of Law for Health Informatics and Information Management. Chicago, IL: AHIMA, 2009, 215).
Like the paper records, electronic records too are subject to scrutiny; audit trails are asked for in malpractice litigations even though they are not part of the patient records.
The Electronic Health Record (EHR) Standards for India 2016 have outlined the principles of data change.
“The data once entered into a health record system must become immutable. The healthcare provider may have the option to re-insert/append any record in relation to the medical care of the patient as necessary with a complete audit trail of such change maintained by the system. Alteration of the previously saved data is not permitted. No update or update like command shall be accessible to user or administrator to store a medical record or part thereof. Any record requiring revision should create a new medical record containing the changed/appended/modified data of earlier record. This record shall then be stored and marked as ACTIVE while rendering the previous version(s) of the same record being marked INACTIVE. The data will thus in essence become immutable. A strict audit trail shall be maintained of all activities at all times that may be reviewed by an appropriate authority like auditor, legal representatives of the patient, the patient, healthcare provider, privacy officer, court appointed/authorized person, etc. as deemed necessary.”
Medical records are the best defense for the doctor. Poor records spell poor defense and no records mean no defense. World over, health care establishments are changing over to electronic health records from paper charts. But, the information has to be manually fed in the software and there is the risk of information being lost or missed out during the transition process.
Therefore, it is safer to also maintain paper records, as a safeguard, until the new EHR system is fully functional and/or until people get used to the new system.
Dr KK Aggarwal , Padma Shri Awardee
