PATIENT SAFETY AUTHORITY
Draft Guidance for Healthcare Facility Determinations of Serious Events under Act 13 of 2002
[39 Pa.B. 1178]
[Saturday, February 28, 2009]
This document outlines draft guidance to Pennsylvania healthcare facilities in making determinations about whether specific occurrences meet the statutory definition of a Serious Event as defined in Chapter 3 of the Medical Care Availability and Reduction of Error Act of 2002. This draft guidance was developed by the Patient Safety Authority (Authority) and the Department of Health (DOH) staff to provide more consistent and clearer standards against which determinations about Serious Events may be evaluated. It is being disseminated by the Authority to solicit comments.
This document, approved by the Patient Safety Authority Board of Directors for purposes of public comment, identifies draft interpretations for the terms used in the Serious Event definition. The Authority and DOH are seeking comments regarding this draft guidance. Comments will be accepted for 30 days following the publication of this document. Comments may be submitted in the following manner.
By email to: email@example.com
By fax to: Attention Bulletin Response (717) 346-1090
By regular mail to: Patient Safety Authority
Attention Bulletin Response
P. O. Box 8410
Harrisburg, PA 17105-8410
Upon review of the comments, this document may be subject to revision. Revisions will be published jointly by the Authority and DOH in the Pennsylvania Bulletin as final guidance. Healthcare facilities may rely upon the final guidance as a standard to which they will be held by their DOH surveyors. Final guidance will require approval from the Authority Board of Directors and the Secretary of the DOH.
It is not possible to define and establish unambiguous criteria for every conceivable Serious Event that may occur during the delivery of healthcare. This document does not attempt to do so, and the cases discussed in this document are for illustration purposes only and serve as examples to which the principles outlined in this document may be applied.
Since implementation of Act 13 and initiation of the Pennsylvania Patient Safety Reporting Program (PA-PSRS), representatives of healthcare facilities have held different interpretations of the definition of Serious Events.
Differences in interpretations among facilities of the Serious Event definition have resulted in an over 100-fold variation in the level of reporting, which has not been sufficiently reduced by previously issued guidance.
Even after adjusting for differences in the volume of care delivered in different hospitals, there are substantial differences in the number of reports submitted by each hospital. Table 1 shows the range of Serious Event report volumes from hospitals by quartile. A small number of hospitals submitted no reports in 2007.
Table 1. Serious Event Reports from Hospitals per 1,000 Patient Days, Quartiles (2007)
Quartile Serious Event Reports
1,000 Patient Days
Fourth (Top 25%) 1.0 to 9.9 Third 0.5 to 0.9 Second 0.3 to 0.4 First (Lowest 24%) 0.0 to .02
Differences among types of hospitals do not explain the variation in reporting rates. For example, while one large, urban, teaching hospital reports over 5 Serious Events per 1,000 patient days, another similar hospital reports only 0.08. Two 100--200 bed rehabilitation hospitals report 7.9 versus 0.2 Serious Events per 1,000 patient days. There are similar disparities in reporting among other types of specialty hospitals.
The Authority and DOH are concerned with the reporting variation for several reasons:
* There is the potential patients and their families will not be notified when a Serious Event has occurred.
* Unequal reporting creates a distorted picture of patient safety issues in Pennsylvania and detracts from the Authority's ability to assess data and issue accurate reports.
* It can create the false impression that problems don't exist when in fact they are just not reported.
* The variation leaves healthcare facilities open to financial penalties from the DOH for failure to report a Serious Event.
Patient Safety Officers have asked the Authority for additional guidance about whether certain types of events are reportable as Serious Events, and facilities have expressed concern about conflicting advice they have received from the Authority and DOH staff.
Definition of Serious Event
The statutory definition of a Serious Event is: ''An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.''
The following principles are being considered as guidance for facilities regarding reporting of serious events.
Event, occurrence or situation
Principle 1: For a death or unanticipated injury to be a Serious Event, it must result in part from an event, occurrence or situation involving the clinical care of a patient. Deaths or injuries that are solely the result of the patient's disease, in the absence of any contributing event, occurrence or situation, are not Serious Events.
* Example: A patient presents to the Emergency Department (ED) with a ruptured abdominal aortic aneurism, a condition that gives the patient only 50% odds of survival. The patient is on the operating room or table in less than 30 minutes after presentation, and appropriate clinical care is provided, but the bleeding cannot be controlled quickly enough, and the patient dies on the table. This is not a Serious Event because there is no contributing event, occurrence or situation that resulted in the patient's death.
* Example: A patient presents to the ED with a ruptured abdominal aortic aneurysm, a condition that gives the patient only 50% odds of survival. There is a delay in getting an operarting room, and the patient remains in the ED for an extended period before being transferred to the OR. The bleeding cannot be controlled, and the patient dies on the table. This is a Serious Event because the delay in getting to the operating room may have contributed to the patient's death.
* Example: After induction of labor for a planned vaginal delivery, the fetus is found to be in breech presentation. The fetal monitor shows signs of fetal distress, which are not timely recognized, leading to a delay in converting to a Cesarean section. The infant suffers hypoxic complications as a result. This is a Serious Event because the failure to timely identify the fetal distress represents the event, occurrence or situation resulting in the unanticipated injury.
* Example: A terminally ill patient on life support goes into respiratory arrest. A code is called immediately, and the code team responds promptly. Resuscitation is attempted but is unsuccessful, and the patient dies. This is not a Serious Event because the code was called and conducted appropriately in all respects; therefore, there is no event, occurrence or situation and the patient is presumed to have died of their illness.
Principle 2: It is not always necessary for the event, occurrence or situation to be readily apparent in order to make a Serious Event determination.
* Example: An otherwise healthy patient undergoing hip replacement has a cardiac arrest intraoperatively, moments after the prosthesis is implanted in the femur. Bone cement implantation syndrome is suspected, but not known conclusively, to be the cause. This is a Serious Event. Though the precise event, occurrence or situation that resulted in the patient's death is not known with certainty, this outcome in an otherwise healthy patient is sufficient evidence of an event, occurrence or situation.
* Example: A young and otherwise healthy patient dies unexpectedly during cardiac surgery to repair a congenital defect. A CT scan of the head following surgery shows bilateral air emboli. The bypass equipment is inspected and found to be normal, and it is not known how air entered the patient's circulatory system. This is a Serious Event. The fact the mechanism of injury (such as, the event, occurrence or situation) is not understood does not negate the fact it must have occurred and the injury resulted from the care that was provided.
Principle 3: An event, occurrence, or situation may be a Serious Event even if there was no error in the care provided and even if the injury may have been unpreventable.
* Example: A healthy patient suffers a perforated colon during a screening colonoscopy with no discernible error. This is a Serious Event.
* Example: A patient with no prior medical history of allergy to penicillin is given penicillin and has an anaphylactic reaction, requiring use of epinephrine. This is a Serious Event. The patient's unknown allergy to penicillin is the situation. Inducing anaphylaxis in the patient is the injury. Administering epinephrine is the additional healthcare service.
* Example: A guidewire fragment shears off during cardiac catheterization, with no unusual stress placed on the device and no unusual technique used by the physician. A subsequent procedure is required to retrieve the device fragment. This is a Serious Event even though the cause of the event is unknown, no obvious error was involved, and the event may or may not have been preventable.
* Example: Two days following knee replacement surgery, an otherwise healthy patient with no known cardiac history is found unresponsive in their room in a rehab unit. This is a Serious Event even though the cause of the event is unknown, no obvious error was involved, and the event may or may not have been preventable.
. . . involving the clinical care of the patient . . .
Principle 4: The clinical care of the patient includes time in which the patient is in your custody, not only the moments during which care is actively delivered. It also includes a time frame during which the patient's condition can be affected by care provided by your facility. For patients undergoing surgery, the clinical care of the patient includes the standard postoperative period.
* Example: Following discharge from an ambulatory surgical facility (ASF), a patient is admitted to an Emergency Department with excessive bleeding. The ASF's investigation reveals the surgical wound was stitched using a suboptimal suture technique. This is a Serious Event that should be attributed to the ASF that performed the surgery.
* Example: A patient falls while ambulating in the hospital hallways the day after admission and sustains a fracture. This is a Serious Event.
* Example: Seven days after discharge the patient has seizures caused by an incorrect drug given at discharge. This is a Serious Event even though the event was not detected until days after discharge.
. . . results in death . . . injury
Principle 5: The event, occurrence or situation need not be the exclusive cause of the death or unanticipated injury in order to be a Serious Event.
* Example: A patient presenting to the ED with a BP of 40 and a history of back pain is immediately and correctly diagnosed as having a rupture of an abdominal aortic aneurysm. He is promptly taken to the OR for emergency laparotomy, with anticipated 50% survival. In the haste to intubate the patient, the anesthesiologist inadvertently intubates the esophagus. The anesthesiologist does not realize the problem until a pulse ox reading a few minutes later shows an O2 saturation of 60. The anesthesiologist re-intubates the patient properly. The patient dies in the operating room. This is a Serious Event. The reportable clinical event (esophageal intubation) may have resulted in or contributed to the patient's death, even though death may be anticipated from the ruptured abdominal aortic aneurysm.
Principle 6: If the event, occurrence or situation hastens death (as in a terminally ill patient) or exacerbates a pre-existing injury, this is a Serious Event.
* Example: A terminally ill cancer patient receives a 10-fold overdose of morphine and dies within 24 hours. The patient was lucid prior to the overdose, and after the overdose is comatose and never recovers consciousness before dying. This is a Serious Event because the overdose hastened the patient's death.
Principle 7: An incorrect or missed diagnosis resulting in a delay in care that materially affects the patient's condition once the correct diagnosis is made constitutes an injury.
* Example: A woman presents to the ED with right lower quadrant abdominal pain. A pregnancy test is reported negative. She is diagnosed as having salpingitis and treated with antibiotics and discharged. The laboratory calls back later the same day saying the pregnancy report was incorrectly labeled and her test is positive. She is called back to the ED. An ultrasound confirms a tubal pregnancy, and she is treated appropriately. This is not a Serious Event because the patient's prognosis was not materially affected by the error. If the individual had suffered an adverse reaction to the antibiotics, this would have been a Serious Event.
* Example: A woman presents to the ED with right lower quadrant abdominal pain. A pregnancy test is reported negative. She is diagnosed as having salpingitis and treated with antibiotics and discharged. The patient returns to the ED the following day in profound shock. An ultrasound confirms a tubal pregnancy, and she is treated appropriately for both the tubal pregnancy and the hypovolemic shock. This is a Serious Event because the delay in treatment caused or contributed to a worsening of the patient's condition.
. . . compromises patient safety . . .
Principle 8: An event that results in an unanticipated injury requiring additional healthcare services presumes compromise of patient safety, and the absence of such an event presumes patient safety is not compromised. Therefore, this clause in the definition is redundant and not necessary for making Serious Event determinations.
. . . unanticipated injury . . .
Principle 9: The disclosure of a potential injury on a patient consent form does not, in itself, constitute anticipation of the injury by the patient. Even though death is a conceivable outcome of an appendectomy, patients undergoing appendectomies do not expect to die as a result of the surgery or aftercare provided. Informing the patient of a risk does not mean the patient or the provider anticipates that the untoward outcome will actually occur.
* Example: A patient must undergo a surgical procedure that requires general anesthesia. The standard anesthesia consent form lists many possible complications, including mouth and throat pain, injury to blood vessels, awareness while under anesthesia and death. Following the procedure the patient complains of feeling the incision and being aware of discussions during the surgery. Investigation finds that the dose of anesthesia was low for this patient's weight. This is a Serious Event because the proper dose of anesthesia medication was not administered and the patient suffered anesthesia awareness. The patient did not anticipate being given too little anesthesia when agreeing to undergo surgery.
* Example: A patient must undergo a surgical procedure that requires general anesthesia. During the anesthesia consent process, the anesthesiologist learns that this patient has previously demonstrated awareness while under general anesthesia. The anesthesiologist explains to the patient that their prior history increases their risk of awareness under anesthesia and explains how the care plan will be adjusted to minimize this risk and to monitor the patient intraoperatively for awareness. Following the procedure the patient complains of feeling the incision and being aware of discussions during the surgery. This is not a Serious Event because the patient was aware of their increased risk of anesthesia awareness, the plan of care was adjusted and implemented appropriately, and the outcome was unavoidable despite the care provided because of the patient's history.
Principle 10: A mid-procedure change in the plan of care in response to new information discovered during the procedure does not constitute an injury, so long as this potential change was discussed with the patient at the time of consent.
* Example: A patient is scheduled for a laparoscopic cholecystectomy. During the consent process, the surgeon explains that, depending on the difficulty of the procedure, they may decide during the procedure that they need to convert to an open procedure. The surgeon explains an open procedure would result in longer recovery time, more pain and discomfort during recovery and a longer hospital stay. The surgeon further explains an open procedure increases the risk of infection, wound dehiscence, bleeding and other complications. The patient decides to undergo the procedure, and the laparoscopic procedure is converted to an open procedure due to encountering significant adhesions. This is not a Serious Event because the conversion to an open procedure was discussed with the patient pre-operatively.
Principle 11: The unanticipated nature of the injury is from the perspective of the patient. While every provider ''anticipates'' some rate of complications from the procedures they perform, these complications are rarely anticipated by the patient unless the patient is somehow at increased risk. While we do not specify an exact threshold for the frequency of complications that makes a particular complication transition from unanticipated to anticipated, complications that occur rarely would be unanticipated by most patients.
* Example: Two days following an outpatient surgery, a patient suffers a wound dehiscence of the surgical incision. This is a Serious Event. In the absence of any reason to believe this particular patient was at heightened risk of having a wound dehiscence, the patient likely did not anticipate this complication.
* Example: A patient with prostate cancer chooses to have a radical prostatectomy with the knowledge that up to 80% of men who have this procedure will experience erectile dysfunction. Following the procedure, this complication occurs and is treated with medication. This is not a Serious Event because the patient understood that this complication was frequent and was likely to occur.
* Example: A healthy 50-year-old male patient undergoes his first routine colon cancer screening. While removing a polyp, his colon is perforated, which is quickly recognized by the physician. He is transferred to a hospital where the perforation is surgically repaired. This is a Serious Event. While this complication is always a possibility with this procedure, the patient had no reason to anticipate his colon would be perforated.
Principle 12: A Serious Event that is within statistical norms or within benchmarks available in the clinical literature must still be reported. There is nothing in the law that allows for reporting Serious Events only when they exceed a statistical norm or benchmark.
* Example: A patient falls while ambulating and fractures his ulna. This unit's fall rate (3 per 1,000 patient days) has been steadily decreasing over the past few months, and is well below a benchmark rate of 6 per 1,000 patient days cited in the literature. This is a Serious Event that must be reported. The fall rate is irrelevant to the Serious Event determination.
* Example: A healthy elderly male patient is undergoing a routine colon cancer screening. While removing a polyp, his colon is perforated, which is quickly recognized by the physician. He is transferred to a hospital where the perforation is surgically repaired. This gastroenterology practice monitors its rate of colon perforations; their rate is 50 per 100,000 procedures, below the average rates available in the literature. Some level of complications is to be anticipated. This is a Serious Event. The practice's complication rate is irrelevant. The provider's anticipation of some level of complications in general does not mean either that the surgeon anticipated a complication in this particular patient or that the patient anticipated such an injury.
. . . additional healthcare services . . .
Principle 13: Healthcare services provided to prevent an injury from occurring are excluded from this term for the purpose of Serious Event determinations.
* Example: Four hours following cataract surgery, a patient with glaucoma develops a rise in intraocular pressure (IOP). If left untreated, this rise in IOP could cause serious complications, including blindness. The surgeon reduces the patient's IOP by paracentesis, aspirating some of the vitreous fluid. Thereafter the patient recovers from the procedure normally. This is not a Serious Event. A rise in IOP is not in itself an injury. The paracentesis is performed to avoid an injury that could result from the rise in IOP if it were not reduced.
* Example: A postsurgical patient receiving morphine intravenously via patient-controlled analgesia, developed apnea, respiratory arrest and a code is called. The patient is successfully resuscitated after the administration of a reversal agent. This is a Serious Event. The event is the overdose, which caused the respiratory arrest. The respiratory arrest is the unanticipated injury. The use of a reversal agent and resuscitation are the additional healthcare services needed to treat the unanticipated injury.
Principle 14: Any unnecessary procedure or procedure performed in error constitutes an injury, and performance of the correct or intended procedure then constitutes the additional healthcare services.
* Example: A patient with breast cancer undergoes a sentinel node biopsy to determine whether the cancer has spread. Following the biopsy, the tissue is lost before reaching pathology, requiring the patient to undergo another biopsy. The loss of the lab specimen is the event, occurrence or situation and the second procedure is the additional healthcare service. This is a Serious Event.
* Example: A hand surgeon performs trigger finger surgery on the wrong finger. Before the dressing is applied, he realizes the mistake. He then performs the procedure on the correct finger. This is a Serious Event.
* Example: A left chest tube is placed, in error, to treat a pneumothorax. When the healthy lung is deflated, the wound is repaired and a chest tube is placed on the correct side. This is a Serious Event.
Principle 15: Services that could be provided by someone other than a licensed healthcare practitioner outside the clinical setting--essentially, first aid care--do not constitute additional healthcare services.
* Example: A patient falls and sustains a 1 cm by 1 cm skin tear on her forearm, requiring cleansing, steri-strips and a sterile bandage. This is not a Serious Event because the services required to treat the injury did not rise above first aid care.
* Example: A patient falls and sustains a 3-inch laceration that requires 10 sutures. This is a Serious Event because the treatment of the injury requires additional healthcare services that must be provided by a licensed healthcare provider.
Principle 16: If a patient sustains an unanticipated injury for which no additional healthcare services are possible, but treatment would be provided if options were available, this is considered a Serious Event.
* Example: During surgery on the neck, the surgeon accidentally cuts the nerve to a vocal chord. Currently there are no treatment options to repair the severed vocal chord; nevertheless, this is a Serious Event because additional healthcare services would be provided if any treatment options were available.
Principle 17: If a patient sustains an unanticipated injury, and additional healthcare services are possible, but the risk of those services outweigh the negative consequences of the injury, this is considered a Serious Event.
* Example: During an orthopedic procedure, a fragment of a surgical instrument breaks off in the surgical field and cannot be easily retrieved. The surgeon decides the risk of retrieving it outweighs the risk of leaving it in place. This is a Serious Event.
Principle 18: If additional healthcare services are required to treat an unanticipated injury, and these additional healthcare services are not provided either because of unintentional omission or because the patient declines treatment, the occurrence is still a Serious Event.
* Example: A terminally ill cancer patient who is designated DNR suffers kidney failure after a drug overdose. The family declines treatment for the kidney failure, which would involve dialysis. The lack of treatment does not negate that an overdose occurred. The overdose is the event, occurrence or situation and must be reported, even though dialysis was refused.
Principle 19: It is not necessary to report a Serious Event that occurred in another healthcare setting. If your facility learns of a Serious Event that occurred in another facility, and you have reason to believe the other facility may be unaware of it (that is, as in a retained foreign body), you should inform the other facility.
* Example: Another hospital in your area transfers a patient to you for wound care for a Stage 3 pressure ulcer. A skin assessment on admission documents the presence of the ulcer, and the patient is treated in your facility. If the Stage 3 pressure ulcer developed in the transferring facility, this is not a Serious Event for your facility. It should, however, be reported by the transferring facility as a Serious Event.
* Example: A patient who underwent a hernia repair surgery at another hospital presents to your hospital complaining of abdominal pain. An X-ray reveals a retained instrument. This is not a Serious Event for your facility. It should, however, be reported by the transferring facility as a Serious Event.
MICHAEL E. DOERING,
[Pa.B. Doc. No. 09-383. Filed for public inspection February 27, 2009, 9:00 a.m.]
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