Given recently developed new ways to track and maintain patient care data, more information is available than ever before as potential evidence in legal, regulatory, or administrative proceedings. This information is becoming highly sought after by plaintiff attorneys in medical professional liability lawsuits. The consequences of not maintaining the information, even if inadvertent, can be significant. The key for any healthcare provider is to understand what information it is, or is not, collecting and maintaining, and to understand what information is producible in response to a request for a patient’s “legal medical record” in the litigation context.
The term “legal medical record” is being used increasingly throughout the healthcare industry; however, the defined contents of a legal medical record are not uniform among (and even sometimes within) healthcare entities and provider practices. This leads to confusion about what information and things a provider should produce in response to a valid request for all, or part of, a patient’s legal medical record, and, consequently, what information and things a provider should maintain in order to be able to comply with a valid legal production request.
With the implementation of electronic health record systems to record and store patient health information and integration of systems across various healthcare providers and settings, more information is being gathered, and also tracked, in comparison with the traditional paper medical chart process. Much of this new information and data can be relevant to legal, regulatory, and administrative proceedings. Plaintiff attorneys are increasingly requesting production of this newly tracked and recorded electronic information in medical professional liability cases. Consequences for failing to maintain and produce discoverable information in legal proceedings can lead to sanctions against a healthcare provider defendant, pursuant to federal and state law as applicable.
This article provides an overview of relevant federal rules and procedures of significance to maintaining and producing patient care information in response to a request for production of a patient’s legal medical record; analyzes and defines the contents of the legal medical record; and presents a plan to ensure you are prepared to respond to a legal request for production of a patient’s legal medical record, or the relevant part of such record.
What is the Legal Medical Record?
First, your organization should have documented a uniform definition of the legal medical record and its contents. Some of the confusion involved with identifying the contents of the legal medical record is related to terminology and legal, regulatory, and accreditation requirements. For example, HIPAA permits a patient to access his or her own “Designated Record Set”; this is different from the patient’s medical record. Further, similar terms often are used interchangeably. Consider, for example: medical record, clinical record, legal medical record, and legal health record. Accordingly, before defining the components of the relevant record, identify the terminology you will use within your organization, and use that terminology consistently and uniformly throughout your organization.
This article suggests that the term “legal health record” should be used as the umbrella term, instead of the term “legal medical record.” It can be defined by two subsets: (1) all of a patient’s documented clinical record (i.e., medical record); and (2) any information discoverable or admissible in a legal, regulatory, or administrative proceeding; that is:
Clinical record (or medical record) + discoverable documents and things = legal health record
This definition can reduce confusion, enhance communication, and aid in compliance. The benefit of incorporating these two subsets under the umbrella of the legal health record also aids in identifying the components of each, with the clinical record generally governed by state and federal laws and regulations and accreditation standards, and the discoverable documents and things generally governed by federal and state rules of civil procedure and evidence on discovery and admissibility. Thus the next step is identifying the elements of each subset, so that you can identify the retention requirements, location, and methods of retrieval for each element of the subset.
What Are the Elements of the Clinical Record?
Notwithstanding the implementation of the electronic health record, the concept of the patient’s clinical record has not changed. The clinical record is intended to provide documentation of a patient’s course of treatment for posterity and to enhance communication among providers caring for a patient, establishing continuity of care. Therefore, the core elements of a patient’s clinical record have not changed.
No single specific resource identifies the elements of a patient’s clinical record, and due to varying state laws and regulations, applicable accreditation requirements, and organizational policy, what constitutes a patient’s clinical record may differ among healthcare entities and providers. However, as a general rule, a patient’s medical record is the documentation of healthcare services provided to a patient, documented in accordance with state and federal laws, rules, and regulations; payer requirements; and accrediting requirements. These resources can help an organization to define the components of its clinical record. (Because individual state laws vary, a detailed review of state law is beyond the scope of this article.)
The Joint Commission historically has been at the forefront of defining the clinical record, requiring that a hospital accredited by it define the parts of a complete medical record (see RC.01.01.01, EP 1). The Joint Commission’s requirements include RC.02.01.01 (content of medical record) and RC.02.01.03 (operative or other high-risk procedures and use of moderate or deep sedation or anesthesia).
RC.01.01.01 EP 4-8 requires that the record contain patient identifiers (e.g., name, address) and information needed to support the diagnosis and condition of a patient, to justify the patient’s care and treatment, to document the course of care and results of care, and to promote continuity of care.
A copy of a patient’s medical chart may be requested by a payer as part of quality or other reviews.
RC.02.01.01 requires that the medical record contain information that reflects the patient’s care, treatment, and services provided, including the following:
Element of Performance (EP) 1: Documentation of demographic information in the medical record;
EP 2: Certain clinical information required to be in the medical record;
EP 4: An advance directive, informed consent, patient generated information, records of communication with the patient including telephone calls or email;
EP 21: Documentation requirements for the emergency department medical record; and
EP 28: Collection of race and ethnicity information and language data.
RC.02.01.03 requirements include:
EP 1: Documentation of surgery or high-risk procedure and/or the administration of moderate or deep sedation;
EP 2: Documentation of provisional diagnosis prior to surgery;
EP 3: History and physical examination;
EP 5: Operative or high-risk procedure report;
EP 8: Postoperative record documentation requirements;
EP 9: Documentation of post-anesthesia care unit discharge; and
EP 10: Documentation of discharge criteria.
In addition to these, RC.02.01.07 requires that the record include a summary list for each patient receiving ambulatory services; RC.02.03.07 addresses documentation of verbal orders; and RC.02.04.01 addresses hospital documentation of a patient’s discharge.
The Joint Commission is just one example of an accrediting entity; other accrediting entities or organizations may have requirements for medical record content relevant to your individual organization.
Federal regulations that define CMS’ Condition of Participation include requirements for medical record content. Not only is the required documentation essential for reimbursement, but a copy of a patient’s medical chart may be requested by a payer as part of quality or other reviews.
CMS requires that the medical record “must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services” (42 C.F.R. §482.24(c). ) This is quite broad, although the regulations provide additional guidance. In paragraph (c)(4), they state that the medical record must include evidence of:
A medical history and a history and physical;
An updated patient examination;
Documentation of complications, hospital-acquired infections, and unfavorable reactions to drugs and anesthesia;
Completed informed consent forms, as required by law;
All healthcare provider orders, nurses’ notes, reports of treatment, medication records, radiology, laboratory reports, and vital signs and “other information necessary to monitor the patient’s condition”;
Discharge summary; and
Final diagnosis. (42 C.F.R. §482.24(c)(4)(i)(A),(B) and (ii)-(viii)).
Interpretive guidelines issued by CMS provide further guidance, defining the term “medical records” as follows (emphasis added): “ . . . includes at least written documents, computerized electronic information, radiology film and scans, laboratory reports and pathology slides, videos, audio recordings, and other forms of information regarding the condition of a patient” (42 C.F.R. §482.24 Interpretive Guidelines). Required content for discharge summaries and a discharge planning memo is also addressed (see 42 C.F.R. §482.24(c)(2)(vii) Interpretive Guidelines). Although not the law, the Interpretive Guidelines identify documented parts of a patient’s care that an organization should address in any policies and procedures related to defining the clinical record, maintaining the clinical record, and producing the clinical record.
CMS is only one reimbursement entity; a provider should determine whether additional requirements for medical record content are mandated by its other payer health plans.
It can be useful also to identify what items are not part of your clinical record, such as clinical research documents, draft reports, privileged information, event reports, and workers’ compensation records. Other organizational policies likely apply to the retention and production of those documents. These same documents and things also should be evaluated to determine whether they could be discoverable in any relevant, future litigation proceeding.
What Are Discoverable Documents and Things?
After identifying the elements of your clinical record, identify the discoverable documents and things that are part of patient care. Discovery is a formal, legal process where parties to a lawsuit exchange information that is relevant to a case and that may later be used as evidence at trial. Federal and state court civil procedure and evidentiary rules address the information and things that are discoverable and/or admissible in their respective forums. The scope of discoverable information is broad. In federal courts, subject to certain exceptions, any information that is not privileged and is relevant to a party’s claim or defense generally is discoverable (F.R.E. 26(b)(1)).
Federal and many state courts have amended their rules of evidence to address discovery of electronically stored information.
The introduction of electronic health records and increased technology in healthcare has led to an abundance of new information and data. Much of the confusion in responding to a request for a patient’s legal medical record arises because of this newly accessible information and data. What should a provider track? What should a provider maintain? What should be produced in response to a request?
Federal and many state courts have amended their rules of evidence to address discovery of electronically stored information. In the relevant part, the federal rule states (emphasis added) that “any designated documents or electronically stored information – including writings, drawings, graphs, charts, photographs, sound recordings, images, and other data or data compilations – stored in any medium from which information can be obtained either directly or, if necessary, after translation by the responding party into a reasonably usable form” is discoverable within the confines of Rule 26(b) (F.R.Civ.P. 34). The rule also addresses the process for production of ESI and format.
Many are familiar with the concept that electronic systems now track who accesses a patient’s medical record, when, and where. This is the type of information, for example, that was not available during the age of the paper medical chart. Plaintiff attorneys are requesting, and receiving, audit logs that track this information, and they are using the logs in cases to cross-examine provider-defendants and witnesses. Depending on the case, this may be good for the defendant; in some cases, however, it can be used against the defendant. We cannot go backwards the information is here, and if a healthcare provider fails to maintain certain electronic data and information, such that it cannot produce it in response to a legal request for the electronic information, it can prove to be a significant detriment for the provider in litigation.
The legal concept of “spoliation of evidence” is implicated. Spoliation of evidence is the failure to preserve or the destruction/alteration of information that may be relevant to a pending or future legal proceeding. Spoliation of evidence can result in minor to severe sanctions against a party in litigation. In 2006, the Federal Rules of Evidence were amended to address electronic data spoliation. See F.R.C.P. 37(e):
If electronically stored information that should have been preserved in the anticipation or conduct of litigation is lost because a party failed to take reasonable steps to preserve it, and it cannot be restored or replaced through additional discovery, the court:
upon finding prejudice to another party from loss of the information, may order measures no greater than necessary to cure the prejudice; or
only upon finding that the party acted with the intent to deprive another party of the information’s use in the litigation may:
presume that the lost information was unfavorable to the party;
instruct the jury that it may or must presume the information was unfavorable to the party; or
dismiss the action or enter a default judgment.
Reducing the risk of spoliation of evidence, particularly the newly implicated electronically stored information, necessitates planning—identifying the type of information that would be discoverable in a future legal proceeding, and ensuring that such information is appropriately maintained and producible.
In anticipation of one day needing to retrieve all or part of a legal health record, implement relevant policies and procedures, or revisit existing policies and procedures. Update them to identify and define relevant terminology for a uniform standard throughout your organization, identify relevant parts of the legal health record to be retained, and define processes for retrieving the information and producing it in response to a valid legal request for the information. In addition, scrutinize your electronically stored information. The following steps may be helpful in guiding your process:
Define what your organization means by the “legal health record.”
Identify the elements of your clinical record (medical record).
Identify the elements of your evidentiary record. (Note: some identified items may be relevant to both the clinical record and also your evidentiary record.)
Define retention requirements for the elements of both the clinical record and the evidentiary record.
Identify the locations and formats of the elements of both the clinical record and the evidentiary record, and the locations and formats of the elements in their retained state.
Identify the methods for retrieval of the elements, and select the primary method of retrieval to be used by your organization for each of the elements.
Document the elements and their retention requirements, locations, formats, and retrieval method in your policy.
Educate your relevant staff and providers on these topics and particularly on any changes to existing policies and procedures.
By clearly defining your legal health record and its components and maintaining the clinical record and potentially discoverable information, you can enhance your process for responding to requests for patient care information; reduce confusion; enhance efficiency; ensure compliance with relevant laws, regulations, and rules; and reduce the risk of spoliation of evidence in any future legal proceeding.
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