Reliance on Checklist Cuts Surgical Deaths

The use of a simple safety checklist dramatically reduced mortality and morbidity in a study of more than 7,600 consecutive surgery patients in diverse clinical settings around the world.

The 19-item checklist, which was based on the 2008 World Health Organization guidelines for improving the safety of surgical patients, cut the rate of postoperative complications by 36% on average, “and death rates fell by a similar amount,” said Dr. Alex B. Haynes of the Harvard School of Public Health, Boston, and his associates in the Safe Surgery Saves Lives study.

The overall complication rate decreased from 11% at baseline to 7% after introduction of the checklist, and in-hospital mortality decreased from 1.5% to 0.8%. Overall rates of surgical site infection and unplanned reoperation also markedly declined.

“Applied on a global basis, this checklist program has the potential to prevent large numbers of deaths and disabling complications,” the investigators noted.

The medical literature suggests that at least half of all surgical complications are avoidable. The investigators designed the checklist and assessed its use in a prospective study at eight hospitals in North America, Europe, Asia, the Middle East, and Africa.

Each hospital identified one to four operating rooms to serve as study rooms. Consecutive inpatients undergoing noncardiac surgery in those rooms were enrolled. The 3,733 patients who underwent surgery during a baseline period served as a comparison group for the 3,955 patients who underwent surgery after implementation of the checklist.

“The checklist consists of oral confirmation by surgical teams of the completion of the basic steps for ensuring safe delivery of anesthesia, prophylaxis against infection, effective teamwork, and other essential practices in surgery,” and is used before anesthesia is administered, immediately before incision, and before the patient is removed from the operating room, according to the investigators.

They evaluated adherence to a subgroup of six key safety measures as a gauge of overall adherence: objective assessment of the patient's airway status; use of pulse oximetry at initiation of anesthesia; presence of at least two peripheral IV lines or a central venous line before incision in cases where blood loss was expected to be 500 mL or more; administration of prophylactic antibiotics within 1 hour before incision; oral confirmation of the patient's identity, the operative site, and the procedure to be performed, before commencing; and completion of a sponge count at the end of the operation.

After the intervention was implemented, it was still commonplace for some of the 19 individual steps in the checklist to be omitted. However, adherence to the key safety indicators increased by two-thirds. Appropriate use of prophylactic antibiotics, for example, rose from 56% to 83%, a single change that could reduce the rate of surgical site infection by as much as 88%, Dr. Haynes and his associates noted.

These “substantial and robust” improvements were seen at every study site, at high-income as well as low-income locations, the investigators said (doi:10.1056/NEJMsa0810119).

Implementation of the checklist should be very feasible, since it was “neither costly nor lengthy. All sites were able to introduce the checklist over a period of 1 week to 1 month.” Moreover, only two items on the checklist were potentially expensive: the use of pulse oximetry and the use of prophylactic antibiotics. Both of these were available at all the study sites before the intervention but had not been used consistently, Dr. Haynes and his colleagues said.

The use of a simple safety checklist dramatically reduced mortality and morbidity in a study of more than 7,600 consecutive surgery patients in diverse clinical settings around the world.

The 19-item checklist, which was based on the 2008 World Health Organization guidelines for improving the safety of surgical patients, cut the rate of postoperative complications by 36% on average, “and death rates fell by a similar amount,” said Dr. Alex B. Haynes of the Harvard School of Public Health, Boston, and his associates in the Safe Surgery Saves Lives study.

The overall complication rate decreased from 11% at baseline to 7% after introduction of the checklist, and in-hospital mortality decreased from 1.5% to 0.8%. Overall rates of surgical site infection and unplanned reoperation also markedly declined.

“Applied on a global basis, this checklist program has the potential to prevent large numbers of deaths and disabling complications,” the investigators noted.

The medical literature suggests that at least half of all surgical complications are avoidable. The investigators designed the checklist and assessed its use in a prospective study at eight hospitals in North America, Europe, Asia, the Middle East, and Africa.

Each hospital identified one to four operating rooms to serve as study rooms. Consecutive inpatients undergoing noncardiac surgery in those rooms were enrolled. The 3,733 patients who underwent surgery during a baseline period served as a comparison group for the 3,955 patients who underwent surgery after implementation of the checklist.

“The checklist consists of oral confirmation by surgical teams of the completion of the basic steps for ensuring safe delivery of anesthesia, prophylaxis against infection, effective teamwork, and other essential practices in surgery,” and is used before anesthesia is administered, immediately before incision, and before the patient is removed from the operating room, according to the investigators.

They evaluated adherence to a subgroup of six key safety measures as a gauge of overall adherence: objective assessment of the patient's airway status; use of pulse oximetry at initiation of anesthesia; presence of at least two peripheral IV lines or a central venous line before incision in cases where blood loss was expected to be 500 mL or more; administration of prophylactic antibiotics within 1 hour before incision; oral confirmation of the patient's identity, the operative site, and the procedure to be performed, before commencing; and completion of a sponge count at the end of the operation.

After the intervention was implemented, it was still commonplace for some of the 19 individual steps in the checklist to be omitted. However, adherence to the key safety indicators increased by two-thirds. Appropriate use of prophylactic antibiotics, for example, rose from 56% to 83%, a single change that could reduce the rate of surgical site infection by as much as 88%, Dr. Haynes and his associates noted.

These “substantial and robust” improvements were seen at every study site, at high-income as well as low-income locations, the investigators said (doi:10.1056/NEJMsa0810119).

Implementation of the checklist should be very feasible, since it was “neither costly nor lengthy. All sites were able to introduce the checklist over a period of 1 week to 1 month.” Moreover, only two items on the checklist were potentially expensive: the use of pulse oximetry and the use of prophylactic antibiotics. Both of these were available at all the study sites before the intervention but had not been used consistently, Dr. Haynes and his colleagues said.

The use of a simple safety checklist dramatically reduced mortality and morbidity in a study of more than 7,600 consecutive surgery patients in diverse clinical settings around the world.

The 19-item checklist, which was based on the 2008 World Health Organization guidelines for improving the safety of surgical patients, cut the rate of postoperative complications by 36% on average, “and death rates fell by a similar amount,” said Dr. Alex B. Haynes of the Harvard School of Public Health, Boston, and his associates in the Safe Surgery Saves Lives study.

The overall complication rate decreased from 11% at baseline to 7% after introduction of the checklist, and in-hospital mortality decreased from 1.5% to 0.8%. Overall rates of surgical site infection and unplanned reoperation also markedly declined.

“Applied on a global basis, this checklist program has the potential to prevent large numbers of deaths and disabling complications,” the investigators noted.

The medical literature suggests that at least half of all surgical complications are avoidable. The investigators designed the checklist and assessed its use in a prospective study at eight hospitals in North America, Europe, Asia, the Middle East, and Africa.

Each hospital identified one to four operating rooms to serve as study rooms. Consecutive inpatients undergoing noncardiac surgery in those rooms were enrolled. The 3,733 patients who underwent surgery during a baseline period served as a comparison group for the 3,955 patients who underwent surgery after implementation of the checklist.

“The checklist consists of oral confirmation by surgical teams of the completion of the basic steps for ensuring safe delivery of anesthesia, prophylaxis against infection, effective teamwork, and other essential practices in surgery,” and is used before anesthesia is administered, immediately before incision, and before the patient is removed from the operating room, according to the investigators.

They evaluated adherence to a subgroup of six key safety measures as a gauge of overall adherence: objective assessment of the patient's airway status; use of pulse oximetry at initiation of anesthesia; presence of at least two peripheral IV lines or a central venous line before incision in cases where blood loss was expected to be 500 mL or more; administration of prophylactic antibiotics within 1 hour before incision; oral confirmation of the patient's identity, the operative site, and the procedure to be performed, before commencing; and completion of a sponge count at the end of the operation.

After the intervention was implemented, it was still commonplace for some of the 19 individual steps in the checklist to be omitted. However, adherence to the key safety indicators increased by two-thirds. Appropriate use of prophylactic antibiotics, for example, rose from 56% to 83%, a single change that could reduce the rate of surgical site infection by as much as 88%, Dr. Haynes and his associates noted.

These “substantial and robust” improvements were seen at every study site, at high-income as well as low-income locations, the investigators said (doi:10.1056/NEJMsa0810119).

Implementation of the checklist should be very feasible, since it was “neither costly nor lengthy. All sites were able to introduce the checklist over a period of 1 week to 1 month.” Moreover, only two items on the checklist were potentially expensive: the use of pulse oximetry and the use of prophylactic antibiotics. Both of these were available at all the study sites before the intervention but had not been used consistently, Dr. Haynes and his colleagues said.