By ThinkReliability Staff

Shoulder dystocia (SD) happens during childbirth when a baby’s shoulder gets stuck in the pelvic opening.  Shoulder dystocia can cause injury to or death of the baby and maternal injury.  These are impacts to the patient safety goals.

A very basic Cause Map shows that the potential for maternal and infant injury occurs from difficulty delivering the baby.  The difficulty is caused by a combination of shoulder dystocia (which occurs during vaginal delivery when the fetal shoulder width is greater than the pelvic opening) and improper management of the delivery.  Based on this very simplified Cause Map, two solutions are to plan for a cesarean section (C-section) when there is the potential for shoulder dystocia, and to define the process for delivery when shoulder dystocia occurs.

We can define a very basic process map for delivery management. First, the patient should be evaluated for the potential for shoulder dystocia.  Then, the labor team prepares for the potential for shoulder dystocia.  If shoulder dystocia is diagnosed, the team should perform the appropriate response, deliver the baby and then administer post-partum follow-up.  The key to this, of course, is to define the appropriate response.

We can add more detail to part of this process map.  Specifically, the additional detail outlines the “HELPERRZ” process used by some medical facilities for the management of  shoulder dystocia.  (To view the Outline, Cause Map and Process Map, click on “Download PDF” above).

By ThinkReliability Staff

In last week’s healthcare root cause analysis blog we looked at an incident where a California hospital left a surgical lap band (sponge) inside a patient’s abdomen after a Cesarean section in a Cause Map.  This week we will look at the sponge counting procedures developed as a result of this incident.  (Since these procedures, as well as additional training and frequent audits, have been implemented, there have been no retained objects at the facility.

Based on the changes to procedure made by this facility, as well as the recommendations from The Journal of Family Practice and the Annals of Surgery, we can put together a sample procedure for sponge counts during an operative procedure which is shown on the downloadable PDF (click “Download PDF” above).

In our sample procedure, a sponge count is required before the surgical site is opened, each time sponges are added to the surgical field, an incision or body cavity is closed, and if a scrub or circulating nurse is replaced (such as at a shift change).   Once the procedure is complete, a sponge count, as well exploration of  the surgical area is performed before skin closure.  In addition, if the procedure indicates a high risk for retained sponge (examples are shown below), a radiograph of the surgical area is taken.  Because only sponges with radio-opaque markers are used, this creates another layer of assurance.

The procedure shown above may be more comprehensive than the sponge counting procedure used in some facilities.  As such, it requires more time, dedication and resources.  Is it really worth it?  The effort required to implement changes to a procedure have to be balanced with the risk of what the procedure attempts to prevent.  In this case, the sponge count procedure attempts to reduce the risk of object retention after surgery.  The risks of retaining an object after surgery include severe injury, possibly even death.  The retention of surgical sponges is a fairly common surgical complication, estimated to occur once for every thousand to five thousand surgeries.  Additionally, the financial and legal consequences for a facility and operating team for a retained foreign object can be severe.  Each organization must consider its own risks and available resources while determining the appropriate level of effort for a procedure.  However, because of the high level of risk of a retained foreign object, the procedure in this case should involve significant effort.

By ThinkReliability Staff

In May, the California Department of Public Health (CDPH) fined nine California hospitals for noncompliance which was likely to cause serious injury or death.  One of these hospitals was fined for leaving a surgical sponge inside a patient’s abdomen after a Cesarean section.  We can look at the issues leading to this unfortunate event in a Cause Map, or visual root cause analysis.

First we define the problem in an outline.  Within the outline we capture the basic information about the incident – the what, when and where.  We also capture the impacts to the organization’s goals.  In this case, there was a risk of death or serious injury to the patient, which is an impact to the patient services goal.  Two of the employees involved received disciplinary action, which impacts the employee impact goal.  The compliance goal was impacted because hospital policy/procedure was not followed.  The organization goal was impacted because of the $50,000 fine levied by the CDPH.   The patient services goal was impacted because the sponge was left inside the patient.  The property and labor goals were impacted due to the second surgery performed to remove the sponge.

Once we have defined the what, when, where and impact to the goals, we can look at the “why”.  First, we begin with the impacted goals and asking “why” questions, fill out the Cause Map to the right.  In this case, the risk of death or serious injury was caused by an intestinal obstruction caused by the sponge being left within the  patient’s abdomen post-surgery.  The sponge was used within the abdomen to aid in the Cesarean section.  The sponge could not be seen visually and the sponge count (used to prevent objects from being left within patients) was performed incorrectly.  There were 20 sponges opened in the operating room (OR).  The hospital’s procedures required that each sponge be placed in its own “easy count” bag.  Then, the OR staff could ensure that the number of bags matched the number of sponges used in the surgery.  Of the 15 sponges that were used in the surgery, 14 were placed into bags and counted.  Of the remaining sponges, 5 were not used, and were not placed in bags (but were counted), and one was left within the patient.  The staff believed that the sponge was within the surgical field and the surgeon did not report placing the sponge within the patient.

As a response to this incident, the hospital updated its procedures and re-trained its staff.  Frequent audits of surgeries were also implemented. Since the changes were updated, there have been no cases of objects retained after surgery.

Check back next week as we look at the sponge counting procedure developed by this facility in response to this incident.