Waking Providers from Alarm Fatigue

heart monitorThe Joint Commission, an independent accrediting body for health care organizations, has just released a “Sentinel Event Alert” related to the on-going problem of hospital staff failing to respond to alarms on patient monitors.  Entitled “Medical Device Alarm Safety in Hospitals,” the bulletin is aimed at helping hospitals to institute safety procedures for the use of medical devices with alarms.

Monitoring technology has become ubiquitous in hospitals, starting with the fetal monitoring machines that monitor unborn babies’ heart rates during labor through heart and oxygen monitors that keep track of critically ill patients.  While these machines provide important information to health care providers, their widespread use has created a number of problems.

The most widely reported problem is so-called “alarm fatigue”–the phenomenon where busy providers, bombarded with multiple alarms, are slow to respond to the sound.  The reasons for this are many, ranging from understaffing, to a high number of false positives, where the machine alarm sounds when there is really no danger to the patient, to providers simply tuning out a sound that is a part of the normal environment.  Virtually anyone who has ever sat in an intensive care unit with a family member has witnessed delays or even failures in responding to machine alarms.  It can be terrifying to patients and families, and as the Joint Commission points out, it can even be life-threatening.

Because alarms are so frequent, particularly in intensive care settings, the Joint Commission notes that “clinicians may turn down the volume of the alarm, turn it off, or adjust the alarm settings outside the limits that are safe and appropriate for the patient – all of which can have serious, often fatal, consequences.”  The Commission suggests a series of steps that hospitals can use to insure that patient alarms are properly set so as to minimize false readings, and that providers are able to hear the alarms and respond in a timely fashion.

When a patient suffers injury or death in a hospital, alarm errors can be very difficult for families to identify, as medical records often do not record what monitors are being used, what parameters are set, whether and when an alarm sounded, and whether and when a provider responded to the alarm.  Some cases come to light when the hospital admits to the patient or family–usually following some sort of adverse event–that there was a problem with the monitoring, while others are uncovered during discovery in a lawsuit, when a health care provider admits in response to specific questions that a monitor was ignored or turned off.

The ability of patients to obtain data from malfunctioning or ignored monitors varies greatly.  Some monitors have no internal storage of data, while others save information only for a relatively short time.  Some types of monitoring records are saved by hospitals, but not considered part of a patient’s record, and must be specifically requested–often only after a lawsuit is filed.  This data, if available, often provides important insights into what happened during crucial times in a patient’s care.

Read more: The Boston Globe recently published an article discussing the risks to patients from “alarm fatigue.”

All in the Family?

DNA chainA Massachusetts Superior Court judge has ruled that he will review the school records for the sibling of a young man who suffered lead poisoning to see if they contain information that might tend to show a familial or genetic cause for the plaintiff’s cognitive and learning disabilities.  If the records contain pertinent information, the defense will be allowed access to the records, even though the sibling is not a party to the case.

The claim that a plaintiff’s medical condition has a hereditary basis is often raised by defendants in medical malpractice and other personal injury actions.  As yet, no Massachusetts appellate court has addressed the question of when or how the defendant may obtain copies of medical and other personal information related to another family member in order to support its contention.  However, defense lawyers commonly issue subpoenas for this type of material, ignoring the rights of the non-party family member.

The defendants in Sapienza v. Beaulieu sought an order requiring production of the plaintiff’s 10-year-old sibling’s school records, in order to determine whether there is evidence to support a genetic or familial cause for the plaintiff’s cognitive disabilities.  In support of their motion, the defendants submitted an affidavit from a neuropsychologist, who stated that review of the medical and educational records for other family members would be important to her conclusions about the cause of the plaintiff’s disability.

Last month, Superior Court Associate Justice Jeffrey Winik ruled on the defense motion, issuing a sensible order that is roughly modeled on procedures for obtaining non-party records in criminal cases.   The school has been directed to produce the records in a sealed envelope, which will be opened and reviewed by the judge.  If the judge determines that there is information pertaining to “attention deficit disorder, specific learning disabilities, such as speech delay, and mental illness,” he will appoint a guardian ad litem for the minor sibling, who will have an opportunity to argue why the records should not be produced to the defense.   If the judge then determines that the records should be produced, he will allow defense counsel and the expert to see them under strict safeguards.

Normally, someone who files a lawsuit alleging personal injury is considered to have waived any privilege or privacy rights to medical and other information related to that injury.  There is no automatic waiver, however, for family members or others who are not parties to the case.  Judge Winik’s opinion strikes a reasonable balance between the privacy rights of non-party family members, whose medical condition may arguably be relevant to the causation issues being litigated, and the defendants’ need for information to contest the claim of causation.  The detailed procedures instituted by the court recognize that other family members’ rights must be protected, and cannot be waived simply by a relative’s act of bringing a lawsuit.

Medical Records Gone Digital

EMRVisitNoteNew regulations passed under the Health Insurance Portability and Accountability Act (HIPAA) will soon permit patients to request and receive their medical records electronically.  These regulations have the potential to help patients by reducing the cost of obtaining records, providing the records in a form that is more accessible, and perhaps even by allowing access to hidden information that patients don’t generally get without a fight.

45 CFR §164.524 will be effective as of March 25, 2013, but health care providers have until September 25, 2013 to comply.  The regulation requires that providers who maintain their patient records in electronic form must, on request by the patient, provide the records in an electronic format acceptable to the patient if the record is “readily producible” in that format, or, if not, in a different electronic format agreed to by the covered entity and the individual.  Instead of the usual per-page copying charges, the provider may charge a reasonable, cost-based fee, which may include the cost of the data device (CD-ROM or USB device), actual labor costs and postage.  However, the published interpretation from the U.S. Department of Health & Human Services states that that charge does not include non-labor-based retrieval fees or overhead costs for creating or maintaining electronic systems and equipment.

The regulatory comments suggest that in many cases, the patient will request records in Portable Document Format (pdf).  In most cases, the patient should request and the provider must provide, a searchable pdf file.  This will make record review much faster and easier.  In the alternative, patients may want to request a copy of the file in its “native” state, just as it is used in the hospital or office, although the software necessary to read this format may be proprietary and not readily available.

Although the issue of metadata is not specifically addressed in either the regulations or the comments, an argument can be made that the patient is entitled to receive the entire contents of the facility’s electronic file, including often invisible information about when and by whom entries were made, changed or even accessed.  If the timing of entries or who reviewed them will be an issue in a medical malpractice case, this information can be invaluable.  While it is usually obtainable through discovery, in many cases it would be advantageous to have it sooner rather than later.

Finally, the new regulations establish a fixed time limit of 30 days for the health care provider’s response to the patient’s request.  Unlike the old regulations, this period is not extended if the data is stored off-site.  Time spent negotiating with the patient about the format of the electronic response is chargeable against the 30 days.  The provider may request a one-time extension of 30 days, with written notice to the patient or other requestor about the reason for the delay and the expected date of completion.

Read the full text of the regulations and comments here.

Getting Your Medical Records

medical records wide viewIn Massachusetts and most other states, you have the right to get copies of your medical and hospital records.  In theory, the process is simple: just make a written request to your doctor, hospital, or other health care provider.  Include your name, address, date of birth, and a description of the records you want to receive.  A hospital is required to respond to your request within thirty days if the records are kept in the hospital, or sixty days if they are stored in an off-site location.  Many hospital websites provide specific information and authorization forms for use in requesting records from the facility.  It’s usually a good idea to call the provider before submitting your request to make sure you’re sending the right form to the right address.

If you are the parent of a minor child, you may request your child’s records.  If you are the administrator or executor of the estate of a deceased person, you may request records for the decedent.  Sometimes the provider will release the records of a deceased person to the surviving husband or wife, or to the person named in the will as executor, but many institutions require a formal probate court appointment.

In Massachusetts, the provider is permitted to charge you a reasonable fee, set by a statute, General Laws, Chapter 111, Section 70, for retrieving and copying the records, unless the records are for use in a Social Security claim, or for a federal or state needs-based program.  The provider may not withhold the records because you have not paid a bill for medical services.  A hospital is required to keep records for 20 years from the date the patient is last seen.  A doctor must keep records for seven years, or until the patient reaches age 18.

When requesting records, it is important to be specific about which records you are requesting.  Particularly where the records are voluminous, or cover a long period of time, a hospital may provide only a summary or abstract of the records.  Depending on the purpose of the request, this may or may not be sufficient.  You are also entitled to receive copies of x-rays, CT or MRI scans, and other imaging studies.   Many labs and hospitals will not release pathology slides directly to the patient or an attorney, but will send them to another health care provider.

Georgetown University has a website that attempts to track requirements and time limits for requesting medical records in each state.  This site includes specific information for Massachusetts, New Hampshire and Rhode Island.  The Massachusetts Board of Registration in Medicine also publishes a brochure to help patients understand their rights in this area.

If you’re considering a medical malpractice claim, you may want to consult a lawyer before requesting your medical records.  A lawyer will be able to help you determine which records are necessary to evaluate a potential case, and most lawyers will handle the requests for you.  Health care providers  tend to interpret medical record requests quite narrowly, and will normally respond only with copies of records they created, omitting information received from other providers, administrative and billing documents and similar material.  If the purpose of a request is to investigate a medical malpractice case, there may be other important documents in the provider’s file that must be specifically requested.  These may include correspondence, records from other health care providers, billing records, history or information forms completed by the patient, and phone messages.

Most patients–and even many lawyers–do not realize that there may be important information that a hospital will not include even in response to a request for the complete record.  An often overlooked category of records includes certain anesthesia and surgical monitoring documentation.  For some reason, many hospitals do not consider these documents to be part of the patient’s record, and will not include them even in response to a request for the complete hospital record.  In a case involving surgical or anesthesia negligence, this documentation may be critical, as it contains detailed information not found in any other record.