NEWSLETTER Volume Twelve Number Three March 2016 What Constitutes the Medical Record? So how does your healthcare organization define the term medical record? Many may think that the response should be straightforward. But is it that easy to define the term? As the healthcare field hurdles forward into electronic medical records (EMR), electronic health records (EHR), and health information exchange (HIE) technology, there is apt to be a difference of opinion as to what is recognized content. The ongoing merger and acquisition activity throughout the healthcare industry may add further complexity. What one system has defined as the components of an EHR may be quite different than the content definitions in the acquiring organization. The Supreme Court of Ohio 1 recently weighed in on the issue in a case that focused on a legislative definition of what constitutes the medical record. While the ruling is specific to Ohio, the decision offers valuable insights to those responsible for medical record management, use, and litigation management. Further, the insights of the dissenting jurists serve to reinforce the importance of adopting an enterprise-wide information governance approach to defining the medical record. The Ohio Case. H.G. had been admitted to the defendant hospital A.H. for an operation to remove a part of his left lung. Subsequent to the operation, H.G. exhibited intermittent atrial fibrillation and he was put on continuous cardiac monitoring. He was assessed by a nurse on May 6, 2012 around 0400 hours. However, about RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 1
45 minutes later, H.G., an x-ray technician, found him unresponsive. The cardiac monitor leads had been detached from his chest. H.G. s hospital gown had been removed and his central line was found lying on the floor adjacent to his bed. Also, H.G. s chest tube had been disconnected. Most importantly, H.G. did not have a heartbeat. H.G. was resuscitated, put on life support and transferred to the intensive care unit. H.G. had sustained severe brain damage. On May 7, 2012 when he did not demonstrate neurological improvement, H.G. s family decided to remove him from life support. He died on May 8, 2012. 2 As the dissenting justice noted in his opinion, there was a retrospective review completed of H.G. s heart monitor at the nurse s station. It demonstrated that starting around 0400 hours there was no sign of cardiac rhythm from H.G. s electrocardiogram leads. This information was found in a discharge summary dated May 12, 2012. 3 The executor for H.G. s estate, his daughter, tried to obtain a complete copy of the decedent s medical record. In response, the defendant hospital furnished her with the medical record maintained by its medical records department. Thinking that it was not the complete medical record, the daughter made repeated requests for the request for the information. The hospital furnished data from May 2 through May 8, 2012 found in the medical records department. At one point she made an in-person request and she was shown what she was told was the complete medical record. Thereafter, she made another request for the medical record, and, once again, she received what was in the medical records department. 4 Thereafter, the daughter filed a legal action under Ohio law 5 to compel the defendant facility to produce the complete medical record. She claimed that the hospital had not produced any monitoring strips or nursing records from the patient s stay in the hospital. 6 Subsequent to filing the complaint, the daughter served the defendant hospital with requests for admissions and interrogatories. The hospital answered the interrogatories acknowledging that it had not produced the entire and complete medical record when the daughter had made her medical record requests. The director of medical records and transcription at the defendant hospital, J. R.-N., confirmed in her answer to the interrogatories that after the plaintiff had filed the legal action, the hospital produced the complete medical record. Along with the answer, the hospital provided hard copies of cardiac monitoring data from May 6, 2012, "as responsive documents from the visit that are not part of the medical RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 2
record." 7 Thereafter, Ms. J. R.-N. was deposed. In her first deposition in March 2013, J. R.- N. indicated that the hospital had produced the decedent s cardiac-rhythm strips recording made between 4:00 a.m. to 4:51 a.m. on May 6 in response to the request for documents. Ms. J. R.-N. testified in the deposition that While monitoring strips for a patient that are received by her department would be made part of the medical record, she explained that [the decedents] printouts were not part of his medical record because the nursing staff had not provided them to the medical-records department. She did not know who directed the nurses not to print [the decedent s] data. 8 Ms. J. R.-N. also testified that she did not know whether the strips met the legal definition of medical record. However, she did not have any reason to believe they did not meet the definition. 9 A few days after the deposition, the defendant hospital filed a motion for summary judgment. It asserted that the plaintiff had been furnished with a complete copy of the decedent s medical record. To support the argument for summary judgment, the hospital supplied sworn answers to interrogatories from J. R.-N. 10 Also in March 2013, Ms. J. R.-N. filed an errata sheet in order that she could correct some of part of her deposition testimony. Ms. J. R.-N said that the May 6 rhythm strips did not meet the legal definition of medical records. She also stated that the rhythm strips "were printed from electronic monitoring equipment after the discharge of the patient at the direction of hospital risk management. The data in this equipment is not part of the medical record." 11 After Ms. J. R.-N. presented the errata sheet, the trial court ordered her to take part in a second deposition. Ms. J. R.-N. stated that to make certain that the information was correct in her first deposition, she had conferred with both the hospital risk manager and a registered nurse on the cardiac unit. She learned that the rhythm strips from May 6, 2012 had been printed from a cardiac monitor by a registered nurse. The print-out took place after the patient died and at the direction of the hospital s risk management department. She could not say whether the print out included all data that was on the decedent s cardiac monitor. 12 RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 3
As Ms. J. R.-N. explained, the cardiac monitor was set up to store electronically a patient s data for 24 hours after a patient had been discharged. Thereafter, unless a physician ordered that the data be saved, it was deleted from the monitor. However, she was uncertain how long such data would be saved. Subsequent to the second deposition, a cardiac rhythm strip for the decedent was produced for the plaintiff. It was from 2:51 am on May 3, 2012. 13 The trial court granted a defense motion for summary judgment. The court determined that the hospital had satisfied the obligation to procedure the decedent s medical record. The determination was based on the definition of medical record found in Ohio legislation data in any form that pertains to a patient's medical history, diagnosis, prognosis, or medical condition and that is generated and maintained by a health care provider in the process of the patient's health care treatment. 14 The appellate court affirmed the trial court decision. Like the trial court, the appellate court focused on the word maintained in the statutory definition. Both courts took the position that the word pertains only to records that "'a hospital determines needs to be maintained by a health care provider in the process of a patient's health care. 15 The courts rejected the idea that it refers to "everything having to do with the patient.'" 16 Further, the term does not refer to what a medical malpractice plaintiff believes should be maintained. On this point, it was made clear that Documents kept by any other department, including risk management, do not meet the definition of a medical record because they were not 'maintained' by the medical records department." 17 Since the hospital had certified that it had provided the decedent s medical records as defined in the state statute, the appellate court ruled that the trial court did not err in granting the defense motion for summary judgment. 18 In a split decision, The Supreme Court of Ohio agreed with the appellate court that the term medical record as used in Ohio legislation does not include all RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 4
patient data. Instead, it refers to data that a healthcare provider has decided to keep or preserve in the process of treatment. 19 At the same time, the Supreme Court of Ohio ruled that the appellate court had erred when it held that the medical record includes only that information maintained by the medical records department. 20 In other words, the physical location of patient data is not determinative of whether it meets the statutory definition of what constitutes the medical record. 21 Turning to the case in question, the cardiac monitoring strips were not kept in the medical records department. If saved at the direction of a healthcare provider, that information would be part of what is defined under applicable state legislation as the medical record. As such, the court remanded the case to the trial court to use the statutory definition as discussed in the decision to order further proceedings if needed to develop the evidentiary record, and to make a determination whether the hospital has met its burden. 22 There were two dissenting opinions in the Ohio case. 23 One judge asserted that the hospital had in fact provided the plaintiff with the complete medical record as defined under statutory law. The judge pointed out that the cardiac monitoring strips were generated and maintained not by a healthcare provider in the course of the patient s care, but rather, at the request of the hospital risk management department. 24 The other dissenting judge noted that the plaintiff was able to obtain the information she wanted through interrogatories and that the parties had already reached a settlement. 25 He questioned why the case should be remanded since there were no material facts left in dispute. He also went further, reminding the majority that the language of the statute suggested that it was within a hospital s discretion through its employees, to select, preserve, and store records relevant to the health care of a particular patient in the manner it sees fit. 26 Risk Management Observations on the Ohio Case. Aside from state law, perhaps the most authoritative resource for what constitutes the medical record is the American Health Information Association or AHIMA. It defines the legal health record as: RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 5
a formally defined legal business record for a healthcare organization. It includes documentation of healthcare services provided to an individual in any aspect of healthcare delivery by a healthcare organization. The health record is individually identifiable data in any medium, collected and directly used in documenting healthcare or health status. The term also includes records of care in any health-related setting used by healthcare professionals while providing patient care services, reviewing patient data, or documenting observations, actions, or instructions. 27 But there are also other influence drivers for what constitutes the medical record. Contracts with payers may also set forth criteria on the subject. Research protocols may also be a source of influence, especially if sponsored research includes retrospective and longitudinal data abstracting of crucial clinical data elements. In an era in which comparative effective research is seen as a foundation for clinical practical guidelines, there is a need for agreed upon definitions of data from which information can be gleaned to shape appropriate levels of healthcare delivery. It is hard to compare apples with oranges, particularly if one facility at its discretion decides to eliminate certain data components. The judicial discussion is troubling for other reasons. Imagine the impact on the level of care provided to a patient with a history of chronic heart disease if at the discretion of one healthcare provider, a box is checked on a form that excludes cardiac monitoring data from the medical record. The next time the patient presents, the previous information will not be available. Such information could be particularly useful, especially if the patient s history included cardiac monitoring of certain rhythms, the influence of a new type of cardiac medication, or significant tracings of an unusual pacing issue. The statutory definition may also present problems in terms of utilization review. Absent such information subsequent to the patient s discharge from observation services at a hospital, the physician may be hard pressed to establish that the 28-hour observation stay was medically necessary such that such a service was covered by Medicare. 28 The result may be an unwelcome out-of-pocket expense for the patient. Lawyers and judges are obliged to get into the weeds of defining or interpreting legislative terms. The derivative consequences of such determinations can have RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 6
repercussions that extend well beyond discovery proceedings in a medical malpractice claim. Strategies for Defining the Medical Record. The foundation for what constitutes the medical record is applicable law and regulations. Beyond these fundamental requirements are other sources that shape the definition of the medical record, including contractual requirements for a specific purpose, national position statements, and policy materials. Taken together, this information can guide the development and use of an agreed upon definition of the medical record. Strategies for this purpose include the following: 1. Review Applicable Legislative and Regulatory Requirements for the Medical Record. Carefully research applicable state law and regulations for what constitutes the medical record in the jurisdictions in which the healthcare organization or professional provide care-giving services. Think about specific legislative-regulatory requirements that may pertain to telemedicine and telehealth medical record documentation. Consider too, any federal Medicare or Medicaid standards for this purpose. 2. Identify Contractual and Accreditation Standards for the Medical Record. Review any health plan, health insurance, or research trial agreements relevant to defining the medical record. Factor in as well accreditation standards on the medical record that are applicable to the healthcare organization. 3. Review Medical Record Requirements Arising from Merger and Acquisition. Work with the legal team to identify any medical record content or definition requirements that may be identified during the due diligence phase of a merger and acquisition. Think about relevant contractual or accreditation requirements applicable to the entities being merged or acquired with a view to reconciliation this information into the definition and use of the medical record. 4. Factor in Guidance from AHIMA and Other Reputable Sources. Take into consideration recognized authorities on the definition of the medical record, including the American Health Information Management RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 7
Association. 29 Consider as well reliable content experts who offer direction on the electronic health record, electronic medical record, and health information exchanges as they may have offer insights that drive the definition of the medical record beyond state legislation and regulations. 5. Work with IT on Data Mapping Medical Record Elements Stored in a Cloud or Server. Use the definition to craft a data map for components of the medical record. Recognize that parts of the medical record may be stored in onsite serves or, alternatively, in off-site locations and in a cloud. Make certain that there is clarity whether or not fetal monitoring strips, event monitoring strips, EEG, and ECGs, are considered part of the medical record. Data map the location if this information is considered part of the medical record. 6. Review and Revise as Necessary Retention Plans to Accommodate the Updated Definition of the Medical Record. At the outset and then on at least an annual basis, evaluate medical record documentation retention plans to make certain that the timeframes are consistent with the anticipated uses of the medical record. 7. Work with Legal Counsel and IT to Develop a Data Map for Clinical and Administrative Access as well as e-discovery and Legal Hold. Implement a practical matrix schedule that identifies who will have access to the updated definition of the medical record, the extent to which someone may have access, and if there are any restrictions such as reading on-line only. Collaborate with legal counsel, IT, and other key stakeholders to transform the data map into an operational framework for such issues and e-discovery and legal hold. Conclusion. Defining what constitutes the medical record may not be as simple and straightforward as some might think. As the Ohio ruling suggests, the precise meaning of the medical record in enabling legislation is important. Statutory and regulatory requirements set the foundation for what constitutes the medical record. Taken together with accreditation standards and private contractual terms, it can be challenging to define the medical record. RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 8
Adopting an enterprise risk management approach can help facilitate development of an appropriate definition of the medical record. Built using a scalable approach, care providers can put the tools in place to accommodate revisions in the definition of the medical record. Adopting such a process can help facilitate the inclusion of clinical data into a health information exchange (HIE), intra-facility electronic medical record, a patient-centered medical home, or an accountable care organization. The key is to design a process that meets the clinical continuity needs of the organization while supporting ongoing utilization review, billing, coding and peer review activities. Seen from this perspective, defining the medical record is not as simple as if may first appear. If you would like assistance in developing enterprise risk management based policies and procedures, please contact The Rozovsky Group. www.therozovskygroup.com or (860) 242-1302 1 G. v. A.H., 2016 Ohio LEXIS 759 (Sup. Ct. Ohio, Case No. 2014-1055, December March 23, 2016). 2 Id. from factual information in the majority decision [at p.763] and the dissenting opinion of O Donnell [at p. 775-776]. 3 Id. at 776. 4 Id. at 773. 5 Ohio Revised Code 3701.74 and 2317.48, referenced in G. v. A.H., supra note 1 at 763. 6 G. v. A.H., supra note 1 at 764. 7 Id. at 764. 8 Id. at 765. 9 Id. 10 Id. 11 Id. 12 Id. at 766. 13 Id. at 766-767. 14 Ohio Revised Code 3701.74(A)(8), referenced in G. v. A.H. at 768. 15 G. v. A.H. at 768. 16 Id. 17 Id. 18 Id. 19 Id. 20 Id. RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 9
21 Id. 22 Id. at 775. 23 Id. at 775-786. 24 Id. at 775-782. 25 Id. at 782-786. 26 Id. at 786. 27 AHIMA e-him Work Group on the Legal Health Record. "Update: Guidelines for Defining the Legal Health Record for Disclosure Purposes," referenced in AHIMA. "Fundamentals of the Legal Health Record and Designated Record Set." Journal of AHIMA 82, no.2 (February 2011): expanded online version. 28 See, Notice of Observation Treatment and Implication for Care Eligibility Act or the NOTICE Act Pub. Law 114 42 (2015). A Proposed rule has been published for the implementation of the NOTICE Act that will include a new type of beneficiary notice called MOON, an acronym that stands for Medicare Outpatient Observation Notice. See, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports, Proposed Rule, Fed Register, 81(81): 24945-25322, April 27, 2016. See also, F.A. Rozovsky, The Miranda Warnings of Observational Status, Dialogues in Healthcare, Vol. 9, No. 8, August 2015. 29 AHIMA e-him Work Group on the Legal Health Record. "Update: Guidelines for Defining the Legal Health Record for Disclosure Purposes," referenced in AHIMA. "Fundamentals of the Legal Health Record and Designated Record Set, supra note 27. RMS NEWSLETTER ALL RIGHTS RESERVED 2016 PAGE 10