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Senate Bill 1301 (embodied in the Health and Safety Code at sections
1279.1, et seq.) requires hospitals to report adverse events to the
Department of Health Services within five days; the patient, or the
patient’s family or personal representative must also be told about
the occurrence of the adverse event before DHS is notified. If the
adverse event pertains to an “ongoing urgent or emergent threat,”
the notification period is “not later than 24 hours after the
adverse event has been detected.” This law goes into effect on July
1, 2007.
Though the Joint Commission adopted standards in 2001 for notifying
patients of “unanticipated outcomes,” the new law requires timely
reporting to the DHS and is modeled after the National Quality
Forum’s definitions of “Never 27” adverse events—those occurrences
which should “never” occur at a health care facility. It should be
noted that H&S section 1279.1 also contains what could be called the
“Never 28th” event which basically covers any adverse event that is
not specifically enumerated by the statute: “An adverse event or
series of adverse events that cause the death or serious disability
of a patient, personnel, or visitor.” (H&S 1279.1(7)).
The enumerated adverse events are grouped into the following
categories: Surgical events at section 1279.1(1); Product or device
events at section 1279.1(2); Patient protection events at section
1279.1(3); Care management events at section 1279.1(4);
Environmental events at section 1279.1(5); Criminal events at
section 1279.1(6); and, finally, the catch-all as described above at
section 1279.1(7).
If you are asked by a physician what role he or she should play in
disclosing the adverse event to a patient or a patient’s family, it
is important to consider the following:
1) Does the physician’s carrier have a policy on what role the
physician should play with respect to notifying the patient or the
patient’s family? The making of the report to DHS is the
responsibility of the hospital; however, hospitals may seek to
engage physicians in the process of notifying the family before the
DHS report is made. At least one carrier has put together a set of
guidelines for its insureds that includes a recommendation that
physicians educate themselves about how best to conduct a
physician-patient relationship in order to create a collaborative
platform for the discussion of adverse events or outcomes. The
appropriateness of an apology without an admission of liability is
also addressed.
2) Does the hospital where the event occurred have a policy in place
about who will give the notice to the patient or patient’s
representative? It is essential that physicians be familiar with
their hospital’s policy regarding this new law as it may include
requirements about who should be in attendance when the
patient/patient’s representative is given notice, or how the giving
of the notice is documented.
3) While it is the hospital’s duty to make a timely report and
notify the patient/patient’s representative before the report to DHS
is made, depending on the circumstances, it may be in the
physician’s best interest to have this discussion with the patient
him or herself. As a practical matter, most of the items listed
among the “Never 27” are adverse events so obvious that a patient or
his family will immediately know they’ve occurred (e.g. surgery
performed on the wrong patient or the wrong body part). A physician
will likely want to have the discussion with the patient about the
event in the context of his treatment of the patient. An apology
without an admission of guilt or wrongdoing may be appropriate and a
physician may seek your counsel on how to apologize in a meaningful
and sincere way, without making an admission of liability.
4) Consistent with its position that open and transparent
communications with patients are essential to a good
physician/patient relationship, the CMA has taken the position that
within the context of SB 1301 reporting, it is “essential that
physicians be involved in the discussion of these events with the
patients and families involved.” The CMA’s recommendations for
physicians can be found in the 2007 CPLH at Chapter 41.
5) Note that some of the events enumerated in H&S 1279.1 may not
involve the rendering of care by the physician (e.g. patient death
associated with a fall while being cared for in a health facility at
section 1279.1(5)(D)), so it will be important to discuss the type
of adverse event that occurred with the physician to help her
determine what, if any, role she should play in reporting the event
to the patient.
6) By January 1, 2015, the DHS must provide reported events on its
website, but the information made public must protect patient
confidentiality consistent with California law. Also, the law
prohibits the DHS from making the names of involved individual
health care professionals and workers available to the public.
Because the law has not yet gone into effect, it is hard to know how
or whether the new reporting requirements may affect peer review.
Also, the law does not define what a report should contain, so
hospitals will have some freedom to draft the reports as they see
fit. A physician whose care is implicated will likely want to take
part in notifying the patient/patient’s representative, and may want
to know whether he or his counsel can participate in the wording of
the report; however, given the fairly rapid turnaround time for
making reports, this could be challenging.
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