1 The Human Experiment- Electronic Medical/Health Records Patient safety is one of the primary stated intentions behind the push for computerized medical records. To the extent illegible handwriting leads to errors this specific problem would be eliminated by computerized medical records. However, the risks to patients when computerized record systems are used have caused a developing safety crisis. Companies market their software and hardware products as the solution to clinician induced medical errors including the elimination of illegible scribbled notes; unusual orders being met with an alert; and the standardization of medication dosages and names. In other words, computers are smarter than clinicians. However, these same companies fight regulation by promoting a lie. Namely, that computer induced patient injuries are extremely rare. The main fail safe mechanism in their system of checks and balances is the clinician. The logic is that the clinician is at the bedside and will catch a computer error before it causes a patient injury. Wait a minute-i thought this computer program was marketed as a means to prevent clinician errors? But when it causes errors, the same error producing clinicians are the safety net? It's an absurd and dangerous position that can only lead to an increase in preventable medical injuries. Definitions: Electronic Health Record (EHR) versus Electronic Medical Records (EMR) Both of these terms refer to automated systems that allow health care professionals to document patient specific information (allergies, medications, vital signs). Although these terms are used interchangeably, there is a difference. The main difference is that the EMR can only be accessed by one hospital or department whereas the EHR can be accessed by more than one facility. The National Alliance for Health Information Technology provided the following definitions: Electronic Medical Record: An individual s electronic record of health-related information that can be created, gathered, managed and consulted by authorized clinicians and staff within one health care organization. Electronic Health Record: An individual s electronic record of health-related information that conforms to nationally recognized interoperability standards and that can be created, managed and consulted by authorized clinicians and staff across more than one health care organization. Q: Why the rush to implement electronic health records? A: Money
2 On February 17, 2009 President Obama signed into law the American Recovery and Reinvestment Act (ARRA) which includes detailed provisions concerning health care technology. The health care information technology provisions of the ARRA are referred to as the Health Information Technology for Economic and Clinical Health (HITECH) Act and its provisions became effective in February With this law, billions of dollars in Medicare and Medicaid incentive payments became available to providers who demonstrate that they are meaningful users of electronic health records. Meaningful use by ARRA is defined as having three main components: 1. Use of a certified EHR in a meaningful manner, such as e-prescribing; 2. Use of certified EHR technology for electronic exchange of health information to improve quality of health care; and 3. Use of certified EHR technology to submit clinical quality and other measures. Examples of meaningful use include use of computerized provider order entry (CPOE) for medications; use of e-prescriptions; up to date problem lists; and documentation of patient information such as smoking, vital statistics and demographics. As if huge financial incentives were not enough to promote the transition from paper to computerized records the Centers for Medicare and Medicaid have also enacted penalties. Specifically, those who do not make the transition to computerized records could have their reimbursement rates cut by as much as 5%. Q: What are the potential benefits to EHR? A: It s a long list. Consult any list of the potential benefits that electronic records purportedly offer over paper records and you will find the following points being made. Electronic records allegedly: Allow access to patient information when and where it is needed Bring together all health information related to a patient in one place, thereby keeping it as current as possible; Improve privacy and security; Reduce costs through reduced paperwork, improved safety and reduced duplication of testing; Deliver more information in more directions while reducing the paperwork time for health care professionals; Support better follow-up with patients; Provide convenience for both patients and health care providers; and
3 Improve safety because entered information can provide alerts to health care providers when potential problems arise. Standardized Language Health and Human Services Final Rule regarding standards and certification criteria for EHR technology directs that ICD-9-CM [International Classification of Diseases, 9 th edition, Clinical Modification] or SNOMED CT [Systemized Nomenclature of Medicine-Clinical Terms] are the code sets which must be included in Certified EHR Technology. The ICD-9-CM is the official system of assigning codes to diagnoses and procedures in the United States. Most attorneys associate this system with billing codes for medical procedures. As of October 2, 2013, however, the ICD-10-CM and ICD-10-PCS should replace the ICD-9- CM in all Health Insurance Portability and Accountability Act transactions. Q: What measures are in place to regulate health care technology and promote patient safety? A: None There is always tension between the desire to provide a product quickly and the need for quality review to maximize safety. HIT does not receive any of the oversight afforded other medical devices. For example, currently, there are no regulatory requirements to evaluate HIT system safety. Many policy makers believe that the risks of HIT are minor and have fought against oversight. The FDA has and continues to promote a hands-off approach. In February of 2011 the FDA issued a final rule that provides a less burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards. Medical Device Data Systems are defined as off the shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use. Examples include: devices that store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed. The new Medical Device Data Systems Rule changes these devices from a Class III (or high risk) devices requiring premarket approval or accessories to an existing medical device or Class I.
4 Q: Is an electronic medical record simply a neatly typed version of the traditional medical record? A: No. Most systems have taken the data categories of the paper systems and organized the computerized version around the categories. Physician s orders, progress notes, nurse s notes, radiology, laboratory reports and medication administration records are the computer folders. In a paper system you simply flip to the section of the chart that contains what you want and read the information. One of the biggest challenges in developing EHR is ready access to information. As one doctor recently testified in a case of mine, I never can find the consultants reports in the computer but they re working on it. In my experience, doctors frequently testify that they do not review nurses notes. But now with the EMR, they can t even find them. That testimony concerned the issue of communication between the nurse and the doctor. Essentially, what we have seen is that much of the medical chart is not even available to some health care providers. Q: Who enters the information into the computerized medical record? A: Nurses, secretaries, doctors and scribes. Scribes? A scribe is a worker who enters information into the computer as the physician examines the patient. The appeal is that the doctor can focus on the patient instead of the computer. Although this sounds reasonable, I wonder what the doctor does if he needs patient information only available in the computerized record. Is the doctor now unable to get the patient information without assistance? It is difficult to ascertain how popular this concept is but it is clearly growing. Loma Linda University Medical Center and Virginia Medical Center in Charlottesville, Virginia are using scribes in the emergency room. I have read estimates that about 200 emergency departments in community hospitals and academic medical centers are using scribes to enter information into the medical record. The doctors remain responsible for the accuracy of the medical record. Purportedly, they review the record and make appropriate additions and corrections and sign off. Perhaps this is no different than dictating a History and Physical in some ways. Certainly the doctor does not have to type it. However, if the information entered is time sensitive, such as an order, then what?
5 Litigation in the developing era of EMR. It s a systems issue. Many of the errors that result in catastrophe for the patient are systems errors. Whether an error is caused by inaccurate input, lack of checks and balances, software/hardware failure, lack of training or a failure to report and correct issues is now a critical area of discovery. The following is a broad outline of issues to be addressed by discovery. Issues to Cover in Discovery: Power Failure - frequency, problems, back up. System Failure - frequency, problems, back up. Software failures; interface problems; compatibility issues. Training. What constitutes the entire medical record? Do you have the entire medical record? Are there portions of the medical record that continue to be handwritten? Are any of the handwritten portions of the medical record entered electronically? What does the computer screen look like (many printed records do not appear the same on a screen)? What paper records do you have that the health care provider has no familiarity with? Medication Orders: How are medication orders communicated to the pharmacy? Who (secretary, nurse, doctor) enters the medication order? Who (secretary, nurse, doctor) verifies the medication order and how? Who (secretary, nurse, doctor) transmits the medication order? What does the pharmacy do to verify orders? How does the pharmacy handle IV orders?
6 If the CPOE system is directly linked to the pharmacy information system and that to the medication record, how are errors caught at each step? Do errors that occur early in the process have an increased chance of going undetected? Alerts/Alarms: Are there alerts or alarms that are part of the medication system? Review common alerts, allergies, drug interactions, dosage warning. What activates an alert? When in the process are alerts activated/reactivated? How do you silence the alarm/acknowledge the alert? Where are you when you silence the alarm? Is it at the bedside, nurses station, on-call room, or anywhere via a PDA alert? Anytime an alert/alarm is activated, ask why they thought it was activated. A sign or symptom is not a good enough answer. Ask what was done to investigate the sign or symptom that was significant enough to set off an alarm. Errors: What do you do when you make errors in a record? How do you change the electronic record? Wrong patient record. Wrong information. Incomplete information. What does the record show when you make a correction? Audit trails are not part of the patient s medical record that the clinician uses/accesses. Make sure to separately request an audit trail. Access: Who has access to the electronic record? How do you gain access (password, etc)? Do you have to sign out of the record?
7 Are you timed out of the record automatically if you forget to sign out or are distracted? Usefulness: What parts of the record do they routinely review? If a test (lab, radiology, etc.) is not available on the patient s individual chart, can it be accessed electronically? Who enters the information? (pre-med students, medical students, etc. frequently enter the info in the computer while physician examines). Medical care is a process by which you collect information and integrate it into an evolving differential diagnosis. Some of the technology requires that you complete one step before you can go onto the next step. It is designed to be linear whereas medical care is non-linear. Drop down menus and templates walk health care providers through a series of questions which may have no relevance to the patient and encourage rote thinking. Health care providers complain that they are being dumbed down. What departments communicate electronically? (Nursing to lab, pharmacy, ER to inpatient side)? Reporting Problems: How do you report a EMR problem? To whom do you report? Is there a centralized reporting mechanism? What do you do if the problem is not corrected? How do you work around the problem? Audit Trail: An audit trail is a mandatory log containing:
8 (a) the identity of the individual who accessed the record; (b) the time and date of record access; (c) which record or records were accessed; (d) the portion of the record accessed; (e) the modification made; and (f) where the person was when they accessed the record. See (FDA s) 21 CFR Part 11, (11.10e) The audit trail must be retained for six years from the date of its creation. 45 CFR section (e) (2) (i) Audit Trail Requests: Specify in your request for medical records that you want ALL handwritten medical records and ALL electronic medical records. When you request the audit trail depends upon your trial strategy. What you get will often reveal a difference between record times and display times. You may find conclusive proof that the records were composed defensively hours after the critical events. Tailor the request to relevant issues. OB cases get the fetal monitoring audit trail before depositions.