Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS + HIPEC) is evolving as a treatment strategy for peritoneal surface malignancies.1 However, it is an extensive oncologic procedure where multiple visceral resections are performed; hence, it has been associated with significant morbidity and mortality.2,3

In order to achieve excellent outcomes, it is not only necessary to provide outstanding surgical care but other factors such as patient safety and quality surveillance programs need to be considered. Thus, it is important to evaluate the organization as a whole, the processes, and, finally, outcomes.4 Multiple studies have assessed the effects of various interventions to improve patient safety,5 including preoperative checklists6–9 and initiatives to decrease hospital-acquired infections or to prevent complications.10–14 However, there are few studies evaluating patient safety in surgical oncology.15–19

As the indications for CRS + HIPEC are increasing, it is imperative to ensure patient safety and quality through strict surveillance programs because traditional outcome measurement may not encompass all aspects that affect patient outcomes. The aim of this study was to evaluate safety events and quality measures in a group of patients who underwent CRS + HIPEC at our institution.

Methods

Patients

Between December 2007 and March 2014, all patients with peritoneal surface malignancies who underwent CRS + HIPEC were registered in a prospective database. Pathology specimen was reviewed in all cases where initial diagnosis was established in a different institution. Patients were presented in a multidisciplinary meeting with representatives from surgical oncology, clinical oncology, pathology, and radiology.

Patients were admitted prior to the planned procedure for baseline preoperative testing that included imaging, psychiatric counseling, respiratory and physical therapy consults. In our setting, some patients experienced delays of weeks in authorization for surgery due to insurance issues, making this admission protocol essential for adequate preoperative evaluation update. Operating room supplies and equipment were verified prior to the day of surgery. Standard time out includes a 168-item surgical safety checklist which was usually completed in less than 5 min. All procedures were performed based on the technique described by Sugarbaker,20–22 and HIPEC was performed using the coliseum technique. The oncologist and anesthesiologist cross-checked chemotherapeutic agents prior to HIPEC.

Demographic variables considered for analysis included age, sex, operative time, number of blood transfusions required, and both duration in the intensive care unit (ICU) and hospital stay.

Operative findings and adequacy of cytoreduction were measured with the Peritoneal Cancer Index (PCI) score and completeness of cytoreduction (CCR).23

During the entire procedure, strict measures were taken to prevent associated occupational hazards. High-powered smoke evacuators are used to avoid exposure to fumes derived from electrosurgery and aerosolization of chemotherapeutic drugs. Doubling of specialized gloves for the entire surgical team is mandatory.24 During and after HIPEC, all personnel in the operating room were required to wear high-efficiency medical barrier surgical masks, splash-resistant gowns, and eye protection. These precautions extend to the ICU nursing staff and surgical ward.

Safety and Quality Events: Reporting and Surveillance

Safety- and quality-related events were defined according to the Medicare Patient Safety Monitoring System (MPSMS) measures in health care,25 variables from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), previously described in the literature, and variables related to CRS + HIPEC care. We collected data for the following events: hospital-acquired pressure ulcers, surgical site infections (SSIs), hospital-acquired infections, surgical instruments left in the cavity, electrosurgery-related adverse events, unplanned intubations, pulmonary embolism, deep vein thrombosis (DVT)/thrombophlebitis, drug administration events, occupational hazards, and readmissions. Other quality indicators measured were adherence to antibiotic and venous thromboembolism (VTE) prophylaxis guidelines, expanded surgical checklist, appropriate patient identification, and blood availability prior to surgery.

Major events were defined as those occurrences in which there was harm to the patient’s health or to healthcare personnel. Minor events were identified as those incidents in which damage was potential but nonetheless important for safety and quality improvement and event prevention. Patients and events were followed from the day of their admission to their 6-month outpatient visit.

Results

A total of 72 patients were included in our analysis, accounting for 74 consecutive procedures performed within the study period. Demographic data and operative variables are presented in Table 1. There was a female predominance in the sample (70.83 %). Most frequent primary tumor was of appendiceal origin (68 %), followed by ovarian origin (9.7 %). The mean preoperative PCI score was 20.5, reflecting advanced disease of patients treated at our center. A complete cytoreduction (CCR 0–1) was achieved in 65 (90.27 %) of our patients, with an average operative time of 14.9 h.

Table 1 Demographic data and operative variables of patients who underwent CRS + HIPEC (n = 72)
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Safety and Quality Outcomes

We experienced a major and minor event rate of 37.5 and 47.22 %, respectively. Table 2 summarizes the safety and quality events. A 100 % compliance for informed consent policies, proper patient identification, and antibiotic and VTE prophylaxis guidelines was registered. Despite this policy, a high incidence of thromboembolic events was registered early in our experience (initial 20 cases), which led to inferior vena cava filter placement routinely. The availability of blood products was confirmed 24 h before the planned procedure, including packed red blood cells, fresh frozen plasma, and platelets, and there was no mismatch regarding blood groups.

Table 2 Safety and quality events registered for patients who underwent CRS + HIPEC (n = 72)
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There were three (4.17 %) intraoperative events: one major intraoperative atrial fibrillation prior to the beginning of a procedure associated with central venous catheter placement that was successfully cardioverted, and two minor events related to surgical instrument and materials count discrepancy prior to closure of the abdominal cavity. There were no cases of foreign objects left in the abdominal cavity.

Two (2.78 %) hospital-acquired pressure ulcers were diagnosed in the early postoperative period despite specific padding requiring wound care throughout hospital stay. The most common registered events were SSI, accounting for 18.06 %, none of which required surgical management. Additionally, there were five (6.94 %) hospital-acquired infections. One unplanned intubation was registered in a patient who self-extubated.

With regard to chemotherapy administration, there were two minor events. There was one chemotherapy spillage without exposure, and two medication-related events (2.78 %) due to delayed administration of postoperative intraperitoneal chemotherapy (EPIC). One patient experienced clinically significant intra-abdominal bleeding secondary to anticoagulation and managed with blood transfusions alone.

The overall length of stay was 28 days. It is worth mentioning that we do not have long-term acute-care facilities available for recovery in the postoperative period, and many of our patients come from other cities; thus, patients remain in the hospital until safe discharge to home is possible. A third of our patients (29.17 %) experienced prolonged hospitalizations. There were 14 (19.44 %) early readmissions, the majority of which were due to partial small bowel obstruction managed non-operatively, followed by thrombotic events and bowel fistula. There was an overall 30-day mortality rate of 2.78 %.

Discussion

Establishment of a safety and quality surveillance program in CRS + HIPEC centers is essential for the development of strategies to improve care since there are many variables that affect patient outcomes, such as complexity of surgery and postoperative complications. We presented a group of patients in which strict assessment of safety events and outcomes was recorded since the beginning of the program. In this series, approximately one in three patients had a major safety or quality event, and almost half presented with a minor event. Although most of these events did not represent actual patient harm or impact clinical outcomes, they can affect cost, operative times, and hospital stay. The high incidence of adverse events reported in this study is evidence of the strict measurement of variables related to patient safety and potential harm. Pressure ulcers, intraoperative events related to disparity in instrument counts, unplanned extubation, errors in drug administration, and occupational hazards, amongst others, are variables that are not traditionally accounted for in standard outcome measures. When looking at overall morbidity, we reported a 26 % incidence,26 which is similar to other series in the literature.

The number of safety-related adverse events has increased in surgical conditions25 during the last few years. The number of preventable adverse events after major cancer surgery has also increased over the last decade.16 Although prior studies have documented the incidence of postoperative morbidity and mortality in CRS + HIPEC patients,1–3,27–29 there are a paucity of data regarding safety events in this group of patients and interventions to prevent them. The rigorous surveillance program implemented at our center has led us to implement expanded checklists, 100 % compliance in Surgical Care Improvement Project (SCIP) measures, no cancellations of cases due to equipment failures, no occupational or needle-stick injuries due to compliance with strict biosafety precautions, no chemotherapy-related health care personnel exposure, routine surveillance for deep venous thrombosis in the postoperative period, 24-h in-room nursing supervision of patients, and no falls. Despite these interventions, safety events occur frequently and it is important to implement plans to effectively identify them.

There are various strategies that can be established to improve safety. Multiple studies have suggested that surgical checklists are associated with a reduction of postoperative complications and mortality,6,7,9,30 although this is still a matter of debate.31 The surgical checklist used by our group is composed of 168 items that are verified prior to and during the procedure itself. This list was designed specifically for the operating room scenario, and its implementation has led to a low incidence of intraoperative safety and adverse events. Other authors32 have used perioperative checklists in lengthy cases, as well as a strategy to decrease patient safety events. Their use is helpful as they allow for early detection of intraoperative occurrences that may affect patient safety, promote structured communication between all health care personnel,8,9 and may help decrease operative costs.33 Our list has avoided all intraoperative equipment failure events, which is important since equipment-related failure is responsible for 23.5 % of total errors in the operating room.34

Implementation of surgical time out in conjunction with the safety checklist has resulted in correct prophylactic antibiotic administration in all cases. Some authors have suggested that surgical safety checklists can also improve compliance to the SCIP measures.35 Correct timing of antibiotic administration is important because it is associated with a substantial decrease in the risk of SSIs.14 The use of protocols and checklists in the ICU, the attending surgeon and intensive care attending hand-off meetings, and policy against the use of verbal orders have also led to avoiding potential sources of error and adherence to postoperative care interventions such as DVT prophylaxis guidelines.36 The use of IVC filters has decreased the incidence of symptomatic events. Since we perform routine postoperative lower extremity venous Doppler and contrasted tomography of the abdomen, the incidence of asymptomatic events is high.

How to best collect and report safety events in CRS + HIPEC needs further study. The measures used in this analysis include MPSMS variables, others from the ACS-NSQIP program, and, lastly, some that are specific to this procedure. In the US, surgical quality care has been measured using the Agency for Healthcare Research and Quality Patient Safety Indicators (AHRQ-PSI) and ACS-NSQIP program, but these have very different methods to obtain information.37 The ACS-NSQIP is based on manual review of medical records, while the AHRQ-PSI uses computer algorithms to detect specific codes. The method of obtaining data is important since there is currently no standardization of key safety and quality outcome variables relevant to CRS + HIPEC. Current methods of data procurement may not acquire all relevant information. For example, more than 72.8 % of patients in the NSQIP cancer surgery program have missing preoperative, intraoperative, or postoperative data.38

There is a relationship between case volume and health outcomes, especially in surgical diseases.39 Peritoneal surface malignancy is an infrequent pathology, and the learning curve for CRS + HIPEC is steep.28,29,40,41 Centers early in their learning curve are more vulnerable to safety event occurrence, and it is important to pursue quality care through outcome measurement. Furthermore, accreditation in cancer care and subsequent higher patient volumes are not the only variables that relate to positive outcomes. Merkow et al.17 showed that accredited cancer centers perform better on most process and patient-experience measures but have worse performance on outcome measures. Hospitals complying with safety practices have less failure to rescue rates and decreased mortality,42 meaning that safety awareness may play a role in the prevention of safety events.19 Thus, safety and quality measures and outcomes relate to both high- and low-volume centers.

This study has several limitations. The definition of CRS + HIPEC safety events needs to be examined in a multi-institutional fashion. Larger patient samples are needed in order to evaluate the incidence of rare events that can affect patient safety. The incidence of safety events has different etiologies, such as the process of care and human error, and not only disease severity. From this data, it is not possible to distinguish the specific risk factors associated with each safety and quality event and further studies need to address these issues.

Conclusions

Since traditional outcome measures do not address all aspects of care in this complex pathology, centers treating patients with peritoneal surface neoplasms need to develop and adhere to surveillance programs designed to measure variables relevant to peritoneal neoplasm patients in regard to safety and quality of care. Future studies and guidelines under the leadership of established centers need to be developed in order to ensure that new and low-volume centers provide adequate quality of care to this challenging group of patients.