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Based upon medical record review, review of the hospital's timeline of events, and interview with the hospital surgical and administrative staff, it was determined that the facility failed to provide a safe environment in the operating room for two of ten sampled patients (Patients #1 and #2). The hospital failed to follow through with their investigation, after the death of Patient #1 and the potential serious harm to Patient #2, by failing to analyze the information collected after the incidents. The hospital also failed to develop a system which would ensure all operating room staff are trained on all current and future equipment and the procedure to follow when not knowing how to operate or set-up any type of surgical equipment.

The current hospital census was 345 patients. The patient sample size was ten.

Findings include:

Review of the medical records for Patient #1 and Patient #2 during this investigation revealed both patients had surgery at 7:30 AM on 08/16/10 and required the use of a slush machine which is used for surgeries requiring a machine for cool irrigation. Patient #1 died as a result of the improper setup and Patient #2 was placed at risk for serious harm as a result of the improper setup of the Taylor Model 20 slush machines.

After reviewing the medical record of Patient #1 on 09/07-08/10, the surveyors requested the hospital provide evidence that an investigation was conducted into the death of Patient
#1. The hospital stated on 09/08/10 that they had not documented their investigation as of yet, but would document their investigation and provide it to the surveyors on 09/09/10.

During the morning of 09/09/10, the hospital presented the surveyors with a timeline of events that occurred surrounding the surgery and death of Patient #1:

Review of the hospital's documentation (timeline of events) revealed the following:

The hospital had two types of icy slush machines - two of the ORS-1075HS-Hush Slush System and four of an older model, the Taylor Model 20. On this day there were five surgeries scheduled that required the use of slush machines. The Taylor Model 20, was used during the surgeries of Patient #1 and #2. Neither Taylor Model 20 machine had manufacturer's instructions affixed to them.

Interview of the two scrub nurses (Staff G and J) on 9/09/2010 at 3:30 PM, who set up the Taylor slush machines on 08/16/10, revealed that both scrub nurses used the Taylor Model 20 slush machines without prior training. Both scrub nurses used the wrong mixture/solutions for their specific patient. Staff G and J stated that the surgeries performed on Patient #1 and #2 on 08/16/10, was the first time either had ever seen the Taylor Slush Machines in the operating room. Both nurses further stated that training regarding the use of the slush machines was not part of their orientation.

An interview with the Director of Accreditation Services (Staff A) was conducted on 09/07/10. He/she stated that a root cause analysis had not been initiated and that changes had not been implemented except to temporarily remove the Taylor Model slush machines from the operating rooms until further notice. There was no evidence that documentation had been completed by the hospital in response to this incident nor any other measures put into place to prevent further occurrences.

Although the Taylor slush machines had been temporarily removed and all periop staff were instructed by staff memo dated 08/17/10, not to use these machines until further notice, at the time of the exit on 09/10/10, the hospital was unable to provide evidence, that based on their investigation, an analysis of the information was completed and a plan developed to ensure safe practices were in place in the operating rooms.

There was also no evidence that the hospital had developed a system which would ensure all operating room staff are trained on all current and future equipment; had developed a procedure to follow which would include a person to contact when operating room staff have questions regarding the set-up or operation of any type of surgical equipment; or had developed a procedure which would ensure adequate supervision of surgical preparation.

Please refer to A941 for more detail.

THIS CITATION SUBSTANTIATES THE COMPLAINT

Based upon medical record review, review of the hospital's timeline of events, and interview with the hospital surgical and administrative staff, it was determined that the facility failed to provide a safe environment in the operating room for two of ten sampled patients (Patient's #1 and #2). The hospital also failed to follow through with their investigation by analyzing the information collected and develop a system which would ensure all operating room staff are trained on all current and future equipment, ensure supervision of surgical preparation and ensure that a procedure is in place which would include a person to contact when operating room staff have questions regarding the set-up or operation of any type of surgical equipment.

The current hospital census was 345 patients. The patient sample size was ten.

Findings include:

Review of the medical record on 09/07/10 for Patient #1 revealed that on 08/16/10, Patient #1 presented to Cincinnati Children's Hospital Medical Center (CCHMC) for heart surgery that required cardiopulmonary bypass, including pericardial ventricular septal defect repair, tricuspid valvuloplasty, right ventricular outflow tract (RVOT) transannular patch, and extensive muscle bundle resection. This surgery required the use of an icy slush machine for cool irrigation.

After reviewing the medical record of Patient #1 on 09/07-08/10, the surveyors requested the hospital provide evidence that an investigation was conducted into the death of Patient
#1. The hospital stated on 09/08/10 that they had not documented their investigation as of yet, but would document their investigation and provide it to the surveyors on 09/09/10.

During the morning of 09/09/10, the hospital presented the surveyors with a timeline of events that occurred surrounding the surgery and death of Patient #1:

Review of the hospital's documentation (timeline of events) revealed the following:

CCHMC has two types of icy slush machines. The ORS-1075HS-Hush Slush System requires minimal setup and the Taylor slush machine, Model 20, requires a three step process for setup.

On 8/16/10 at 7:00 AM, surgical preparation began for Patient #1. The first step of the setup on the Taylor Model 20 slush machine was properly performed, but the last two steps were omitted. As a result, the isopropyl alcohol and saline mixture was used for irrigation in the patient's thoracic cavity. The irrigant was removed from the field by the heart-lung machine and then returned to the patient.

The alcohol and saline mixture that was used in error as an irrigant was not discovered until after the surgical repairs were performed. After the discovery, the alcohol and saline irrigation was discontinued and normal saline irrigation was initiated; however upon the rewarming of Patient #1, it was discovered that Patient #1 had no cardiac activity. Administration of alcohol was presumed to be the cause. Patient #1 was transitioned to the heart lung machine (ECMO) with hemodialysis and transferred to the Cardiac Intensive Care Unit (CICU).

The alcohol level in the patient's blood was extremely high at 2000 mg/dl at 2:00 PM on 8/16/10. Over the next several days, the patient developed progressive acidosis, elevated lactate levels, ongoing tissue necrosis, and multi-system organ failure. After consultation with CCHMC staff, the family decided to withdraw life support. Life support was withdrawn and the patient was pronounced dead at 9:55 PM on 8/21/10.

At 7:00 AM on 08/16/10, the scrub nurse (Staff G) began to set up the Taylor Model 20 slush machine. Staff G, who was assigned as the scrub nurse for Patient #1's surgery had never used the Taylor Model 20 slush machine before 08/16/10. Between 7:00 AM and 7:30 AM, Staff G asked another scrub nurse (Staff I) for instructions on how to set up the Taylor Model 20 slush machine. Staff I told Staff G to ask the Resource Tech (RT).

During the set up of the Taylor Model 20 slush machine, Staff H reported that she told Staff G that the alcohol/saline slush did not seem right and that she (Staff H) had never seen alcohol used for irrigation purposes. Staff G was documented as stating that in the Cardiac-Thoracic (CT) surgery room things were done in a different way. Staff G reported that she asked three times why alcohol would be used in the slush machine. Staff G reports that she went to another surgical room and asked another registered nurse (Staff J) if the solution setup was done correctly, and she confirmed that it had been set up correctly.

The Patient Care Facilitator (PCF) (Staff K), a registered nurse experienced in transplants and who had used the Taylor slush machine, Model 20, made AM rounds by looking in the window of the CT surgery room and saw no apparent problems.

The surgical procedure went as expected. At 11:00 AM, the scrub nurse (Staff G) handed the syringes filled with alcohol/normal saline solution to the surgeon for irrigation during the cross-clamp time and to test the heart valves. The syringes were labeled normal saline, but the label did not identify that the the syringes also contained alcohol. The end portion of the bulb syringes were clogging with frozen solution. The scrub nurse (Staff G) asked the circulating nurse (Staff L) to add normal saline to the slush mixture because of a powerful alcohol odor.

At 12:30 PM, the perfusionist stated seeing strange and concerning laboratory results. The perfusionist consulted with the anesthesiologist, surgeon and the CT team members. At 1:28 PM the surgeon stated that he smelled alcohol and the scrub nurse (Staff G) told the surgeon that alcohol was in the slush. Discussion was held between the surgeon and the scrub nurse (Staff G) as to the propriety of using alcohol in the slush solution. The scrub nurse (Staff G) insisted that the alcohol was correctly used in the irrigation slush because the machine was the Taylor Model 20 machine. The surgeon ordered the slush to be discarded. PCF (Staff M), an experienced CT registered nurse gave lunch relief and confirmed that the alcohol slush mixture was incorrect. The x-clamp was open and the heart immediately began to swell outside of the chest. The Drug and Poison Control Center was contacted and informed of the error at 1:57 PM. The patient was dialyzed and then taken to the intensive care unit.

During this investigation, based upon confidential interview, it was learned that Patient #2 also had surgery using the Taylor Model 20 slush machine. Review of the incident report on 09/08/10 for Patient #2 revealed that the patient presented to CCHMC for a heart defect surgical repair on 08/16/10 at 7:30 AM. The Taylor Model 20 slush machine was also set-up improperly. Due to the type of surgery, only 40cc's of the irrigation solution was used over a five minute period, so the patient did not suffer any adverse effects.

Interview of the two scrub nurses (Staff G and J) on 09/09/10 at 3:30 PM, who were on duty during the above incidents on 8/16/10, revealed that both scrub nurses, in two separate operating rooms, used the Taylor Model 20 slush machines without prior training. Both scrub nurses used the wrong mixture/solutions for their specific patients (Patient #1 and #2) and stated 08/16/10 was the first time they had ever seen the Taylor Model 20 slush machines in the operating room. The Resource Tech (Staff N) instructed the nurses on the use of the Taylor Slush Machine on 08/16/10 prior to the surgeries. Both nurses further stated that training on the slush machines was not part of their orientation.

On 09/07/10, on the first day of the survey, only the two OR nursing staff involved in the incidents had been educated on the Taylor slush machine (Staff G & J). However, after the surveyors discussion with the surgical administrative staff on 09/09/10 in the afternoon hours, there was an in-service scheduled for all the staff beginning 9/10/10 on the Taylor slush machine. There was no documentation of any other in-services presented to the surveyors prior to exit related to the proper operation of slush machines available for use in the operating room and the chain of command to follow when questions arise.

Upon entry to the hospital during the morning hours of 09/07/10, a meeting was held with the administrative staff. The Risk Manager (Staff Q) stated at this meeting there was no documentation of a plan to prevent a reoccurrence of this incident. On 09/08/10 in the afternoon, interview with the hospital legal representative (Staff F), revealed that there was nothing in writing to present to the surveyors in regard to any formalized incident analysis but they could compile an unofficial written statement and present to the surveyors on 09/09/10, the next day (timeline document).

During an interview of the Risk Manager (Staff Q) on 09/07/10 at 11:00 AM, it was revealed that a multidisciplinary team, that included individuals from surgery, cardiology, patient services, anesthesia, hospital leadership, operations, and patient safety had been assembled. That team would investigate the event, determine its most basic causes and recommend interventions to prevent a similar event from occurring in the future.

Further interview with the Risk Manager (Staff Q) on 09/07/10 at 11:00 AM CCHMC planned to fully analyze this event over the course of three meetings. The first meeting was scheduled for 09/08/10. The team was to discuss the facts of the case and identify why certain decisions were made. During the second meeting, the team was to identify the most basic reasons why the safety systems at CCHMC did not perform as expected and what system deficiencies could be corrected. During the third meeting, the team was to make recommendations on specific interventions to eliminate system deficiencies and prevent future events like the one mentioned above. The team was to complete its work on September 28, 2010 and the team was to report its recommendations to the Joint Commission by October 10, 2010. The Risk Manager (Staff Q) further stated that there was nothing in writing other than the planned meetings toward the root cause analysis.

An interview with the Director of Accreditation Services (Staff A) was conducted on 09/07/10. He/she stated that a root cause analysis had not been initiated and that changes had not been implemented except to remove the Taylor Model 20 slush machines from the operating rooms. There was no evidence that documentation had been completed by the hospital in response to this incident nor any other measures put into place to prevent further occurrences.

There was also no evidence that the hospital had developed a system which would ensure all operating room staff are trained on all current and future equipment; had developed a procedure to follow which would include a person to contact when operating room staff have questions regarding the set-up or operation of any type of surgical equipment; or had developed a procedure which would ensure adequate supervision of surgical preparation.


THIS CITATION SUBSTANTIATES THE COMPLAINT