Retained Foreign Bodies: Risk and Outcomes at the National Level Zaid H Al-Qurayshi, MBChB, MPH, Adam T Hauch, Emad Kandil, MD, FACS
MD, MBA,
Douglas P Slakey,
MD, MPH, FACS,
Retained foreign bodies (RFB) after operative interventions are linked to an increased risk of morbidity and mortality, and represent a medico-legal liability. We aimed to identify associated risk factors and outcomes related to iatrogenic RFB in the United States. STUDY DESIGN: A cross-sectional analysis was performed on all interventions that resulted in a secondary diagnosis of RFB in the Nationwide Inpatient Sample (NIS) from 2003 to 2009. Comparative controls were randomly selected from patients who underwent similar procedures. RESULTS: We identified 3,045 cases of RFB, and 12,592 controls were included. The majority of incidents, 968 (31.8%), were reported after gastrointestinal interventions. Risk of RFB was higher in teaching hospitals (odds ratio [OR] 1.31, 95% CI [1.19, 1.45], p < 0.001). For abdominopelvic procedures, patients admitted with traumatic injuries did not demonstrate a higher risk of RFB compared with electively admitted patients (OR 1.70, 95% CI [0.94, 3.07], p ¼ 0.08). However, for procedures unrelated to abdominopelvic surgery, patients admitted for trauma had a lower risk (OR 0.62, 95% CI [0.50, 0.78], p < 0.001). Obesity (BMI 30 kg/m2) and older age (65 years) were significantly associated with a higher risk only for abdominopelvic procedures (p < 0.01 for both). Retained foreign bodies were associated with a higher average cost of health services ($26,678.00 $769.69 vs $12,648.00 $192.80, p < 0.001). CONCLUSIONS: Retained foreign bodies have unfavorable and nationally tangible clinical and economic outcomes. The risk profile for RFB at the national level seems to demonstrate an association with demographic and clinical factors including nature of the procedure, type of admission, and trauma status. Teaching hospitals are associated with a higher risk. Targeted efforts toward identified high-risk populations are needed to avoid these morbid and costly complications. (J Am Coll Surg 2015;220:749e759. 2015 by the American College of Surgeons)
BACKGROUND:
inpatient operations in the United States.2-4 Sponges are the most commonly retained items compared with needles and instruments.3,5-7 Regardless of the nature of the foreign body, the consequences of left-behind objects include grievous health implications to patients, indefensible litigations, and irreparable damage to the reputations of health care professionals and institutions.5,6,8-10 Despite the theoretically preventable nature of RFB, tackling this medical error represents a true challenge to health care policy makers.6 Several standardized protocols and regulations have been devised to mitigate this issue, like manual and automated sponge and instrument counting, radiographic screening, and goals for improvement of communication among the surgical team; however, no method has proven to be completely successful in preventing RFB.2-7,10-19 Moreover, it is hypothesized that the
Retained foreign bodies (RFB) after interventional procedures are recognized by the National Quality Forum as preventable medical errors, listed as “never events” in their updated 2011 report Serious Reportable Events In Healthcare.1 The true incidence of RFB is still elusive; it is estimated that it ranges from 1 in every 1,000 to 1,500 abdominal operations and 1 in every 8,000 to 18,000 Disclosure Information: Nothing to disclose. Presented at the Southern Surgical Association 126th Annual Meeting, Palm Beach, FL, November 30eDecember 3, 2014. Received December 7, 2014; Accepted December 9, 2014. From the Department of Surgery, Tulane University School of Medicine, New Orleans, LA. Correspondence address: Emad Kandil, MD, FACS, Department of Surgery, Tulane University School of Medicine, 1430 Tulane Ave, Room 8510 (Box SL-22), New Orleans, LA 70112. email: [email protected]
ª 2015 by the American College of Surgeons Published by Elsevier Inc.
749
http://dx.doi.org/10.1016/j.jamcollsurg.2014.12.015 ISSN 1072-7515/14
750
Al-Qurayshi et al
Retained Foreign Bodies: Risk and Outcomes
Abbreviations and Acronyms
BMI ¼ body mass index HCUP ¼ Healthcare Cost and Utilization Project ICD-9 ¼ International Classification of Disease, 9th Revision MORPI ¼ major operating room procedure indicator NIS ¼ Nationwide Inpatient Sample OR ¼ odds ratio RFB ¼ retained foreign bodies
reason behind the continuing occurrence of this complication is that some risk factors remain unexplored.20 Studies that have addressed RFB consist predominately of case reports and case series.6,21-37 The main hindrance in conducting larger scale studies is the lack of considerable aggregate data, due in part to the natural history of RFB in which an unknown number of events can go unnoticed.8,17 Additionally, some investigators have proposed that hospitals are inclined toward under-reporting such incidents because of their critical nature.5,6,8,9,38 This becomes obvious when reviewing the literature because most of the larger analytic studies depend on data from malpractice lawsuits.2,6 To date, 3 relatively large casecontrol studies, with RFB sample sizes of less than 60, have examined the risk factors for RFB after a variety of surgical interventions.2,20,38 Among these studies, discrepancies exist in identifying persistent risk factors.2,20,38 However, in a recent meta-analysis that included the previously mentioned studies, several factors exhibited significant risk for unintentional RFB, including intraoperative blood loss of more than 500 mL, longer duration of operation, involvement of more than 1 subprocedure or surgical team, unexpected intraoperative factors, and finally, lack of or incorrect surgical count.39 In this study, we aimed to assess the frequency of RFB at the national level and across all disciplines, as opposed to previous studies that have focused on certain institutions’ experiences and specific fields. We also aimed to identify the risk factors for and the clinical and economic outcomes associated with RFB in the United States by using data from the Nationwide Inpatient Sample (NIS) for the period of 2003 to 2009.
METHODS This study is a cross-sectional analysis using the Nationwide Inpatient Sample (NIS) database for the years 2003 to 2009. The NIS is part of the Healthcare Cost and Utilization Project (HCUP), sponsored by the Agency for Healthcare Research and Quality (AHRQ). This is the largest all-payer inpatient care database that
J Am Coll Surg
is publicly available in the United States. It contains data from approximately 8 million hospital stays from about 1,000 hospitals sampled to approximate a 20% stratified sample of US community hospitals.40 Although NIS data are available for the period between 1988 to 2010 up to the time of the data analysis, the data elements and the sampling methodologies were evolving and changing over the years, which put a technical restraint on longitudinal analyses, and for which the HCUP is prompting investigators to be cautious with data before and after the period included in this analysis.40 For these coding precautions, we opted to include the data analysis between 2003 and 2009 to perform a thorough, accurate, and unjeopardized investigation. The Clinical Classifications Software (CCS) was used to identify the primary procedures of interest41; the International Classification of Disease, 9th Revision (ICD-9) was used in defining the other parameters of the study. This software is a diagnosis and procedure categorization scheme developed by HCUP and based on the ICD-9; it provides a smaller number of clinically meaningful categories that are more useful for presenting descriptive statistics than are individual ICD-9 codes.41 The database was surveyed for patients who developed a secondary diagnosis of RFB (ICD-9: 998.5) during their hospital stay. Then, based on their primary procedure, controls were randomly selected from those who underwent the same procedures performed within the same year. The main risk factors for RFB that were assessed included: Age less than 36, 36 to 65, and greater than 65 years old; sex; site of procedure, determined based on the involved system by the primary procedure: gastrointestinal tract/spleen, cardiovascular system, respiratory system, nervous system, head and neck, eye, musculoskeletal system, urinary system, breast, female reproductive system, and male reproductive system; NIS major operating room procedure indicator (MORPI): not reported vs reported42; admission/trauma status: elective/nontrauma, nonelective/nontrauma, elective/trauma, and nonelective/trauma; body mass index (BMI) 30 kg/ m2; and hospital teaching status: nonteaching vs teaching. However, in assessing the above risk factors, more than 50% of the records were missing response values for race and MORPI. In order not to lose the power of the study, 2 multivariate logistic regression models were performed, primary model “A” excluding race and MORPI, and a secondary model “B” including race and MORPI. The results of both models are provided. Hospital characteristics that were examined for the risk of more than 1 incidence of RFB per year were: Hospital region: Northeast, Midwest, West, and South; hospital
Al-Qurayshi et al
Vol. 220, No. 4, April 2015
Table 1.
Retained Foreign Bodies: Risk and Outcomes
751
Descriptive Statistics of the Study Population in Relation to Outcomes Related to Retained Foreign Body
Variable
Age, y 65 Sex Male Female Race White Black Hispanic Asian/Pacific Islander Native American Other Annual household income, $ 62,999 Service payer Medicare Medicaid Private/HMO Self-pay No charges Other Procedure site/system GI tract/spleen Cardiovascular Respiratory Nervous Head and neck Eye Musculoskeletal Urinary Breast Female reproductive Male reproductive MORPI Not reported Reported Procedure region Non-abdominopelvic Abdominopelvic Admission/trauma status Elective/nontrauma Nonelective/nontrauma
% Study population (n ¼ 15,637)
Retained foreign body status % Cases (n ¼ 3,045) % Controls (n ¼ 12,592)
p Value*
30.6 38.2 31.2
19.3 47.7 33.0
33.3 35.9 30.8
MD, MBA,
Douglas P Slakey,
MD, MPH, FACS,
Retained foreign bodies (RFB) after operative interventions are linked to an increased risk of morbidity and mortality, and represent a medico-legal liability. We aimed to identify associated risk factors and outcomes related to iatrogenic RFB in the United States. STUDY DESIGN: A cross-sectional analysis was performed on all interventions that resulted in a secondary diagnosis of RFB in the Nationwide Inpatient Sample (NIS) from 2003 to 2009. Comparative controls were randomly selected from patients who underwent similar procedures. RESULTS: We identified 3,045 cases of RFB, and 12,592 controls were included. The majority of incidents, 968 (31.8%), were reported after gastrointestinal interventions. Risk of RFB was higher in teaching hospitals (odds ratio [OR] 1.31, 95% CI [1.19, 1.45], p < 0.001). For abdominopelvic procedures, patients admitted with traumatic injuries did not demonstrate a higher risk of RFB compared with electively admitted patients (OR 1.70, 95% CI [0.94, 3.07], p ¼ 0.08). However, for procedures unrelated to abdominopelvic surgery, patients admitted for trauma had a lower risk (OR 0.62, 95% CI [0.50, 0.78], p < 0.001). Obesity (BMI 30 kg/m2) and older age (65 years) were significantly associated with a higher risk only for abdominopelvic procedures (p < 0.01 for both). Retained foreign bodies were associated with a higher average cost of health services ($26,678.00 $769.69 vs $12,648.00 $192.80, p < 0.001). CONCLUSIONS: Retained foreign bodies have unfavorable and nationally tangible clinical and economic outcomes. The risk profile for RFB at the national level seems to demonstrate an association with demographic and clinical factors including nature of the procedure, type of admission, and trauma status. Teaching hospitals are associated with a higher risk. Targeted efforts toward identified high-risk populations are needed to avoid these morbid and costly complications. (J Am Coll Surg 2015;220:749e759. 2015 by the American College of Surgeons)
BACKGROUND:
inpatient operations in the United States.2-4 Sponges are the most commonly retained items compared with needles and instruments.3,5-7 Regardless of the nature of the foreign body, the consequences of left-behind objects include grievous health implications to patients, indefensible litigations, and irreparable damage to the reputations of health care professionals and institutions.5,6,8-10 Despite the theoretically preventable nature of RFB, tackling this medical error represents a true challenge to health care policy makers.6 Several standardized protocols and regulations have been devised to mitigate this issue, like manual and automated sponge and instrument counting, radiographic screening, and goals for improvement of communication among the surgical team; however, no method has proven to be completely successful in preventing RFB.2-7,10-19 Moreover, it is hypothesized that the
Retained foreign bodies (RFB) after interventional procedures are recognized by the National Quality Forum as preventable medical errors, listed as “never events” in their updated 2011 report Serious Reportable Events In Healthcare.1 The true incidence of RFB is still elusive; it is estimated that it ranges from 1 in every 1,000 to 1,500 abdominal operations and 1 in every 8,000 to 18,000 Disclosure Information: Nothing to disclose. Presented at the Southern Surgical Association 126th Annual Meeting, Palm Beach, FL, November 30eDecember 3, 2014. Received December 7, 2014; Accepted December 9, 2014. From the Department of Surgery, Tulane University School of Medicine, New Orleans, LA. Correspondence address: Emad Kandil, MD, FACS, Department of Surgery, Tulane University School of Medicine, 1430 Tulane Ave, Room 8510 (Box SL-22), New Orleans, LA 70112. email: [email protected]
ª 2015 by the American College of Surgeons Published by Elsevier Inc.
749
http://dx.doi.org/10.1016/j.jamcollsurg.2014.12.015 ISSN 1072-7515/14
750
Al-Qurayshi et al
Retained Foreign Bodies: Risk and Outcomes
Abbreviations and Acronyms
BMI ¼ body mass index HCUP ¼ Healthcare Cost and Utilization Project ICD-9 ¼ International Classification of Disease, 9th Revision MORPI ¼ major operating room procedure indicator NIS ¼ Nationwide Inpatient Sample OR ¼ odds ratio RFB ¼ retained foreign bodies
reason behind the continuing occurrence of this complication is that some risk factors remain unexplored.20 Studies that have addressed RFB consist predominately of case reports and case series.6,21-37 The main hindrance in conducting larger scale studies is the lack of considerable aggregate data, due in part to the natural history of RFB in which an unknown number of events can go unnoticed.8,17 Additionally, some investigators have proposed that hospitals are inclined toward under-reporting such incidents because of their critical nature.5,6,8,9,38 This becomes obvious when reviewing the literature because most of the larger analytic studies depend on data from malpractice lawsuits.2,6 To date, 3 relatively large casecontrol studies, with RFB sample sizes of less than 60, have examined the risk factors for RFB after a variety of surgical interventions.2,20,38 Among these studies, discrepancies exist in identifying persistent risk factors.2,20,38 However, in a recent meta-analysis that included the previously mentioned studies, several factors exhibited significant risk for unintentional RFB, including intraoperative blood loss of more than 500 mL, longer duration of operation, involvement of more than 1 subprocedure or surgical team, unexpected intraoperative factors, and finally, lack of or incorrect surgical count.39 In this study, we aimed to assess the frequency of RFB at the national level and across all disciplines, as opposed to previous studies that have focused on certain institutions’ experiences and specific fields. We also aimed to identify the risk factors for and the clinical and economic outcomes associated with RFB in the United States by using data from the Nationwide Inpatient Sample (NIS) for the period of 2003 to 2009.
METHODS This study is a cross-sectional analysis using the Nationwide Inpatient Sample (NIS) database for the years 2003 to 2009. The NIS is part of the Healthcare Cost and Utilization Project (HCUP), sponsored by the Agency for Healthcare Research and Quality (AHRQ). This is the largest all-payer inpatient care database that
J Am Coll Surg
is publicly available in the United States. It contains data from approximately 8 million hospital stays from about 1,000 hospitals sampled to approximate a 20% stratified sample of US community hospitals.40 Although NIS data are available for the period between 1988 to 2010 up to the time of the data analysis, the data elements and the sampling methodologies were evolving and changing over the years, which put a technical restraint on longitudinal analyses, and for which the HCUP is prompting investigators to be cautious with data before and after the period included in this analysis.40 For these coding precautions, we opted to include the data analysis between 2003 and 2009 to perform a thorough, accurate, and unjeopardized investigation. The Clinical Classifications Software (CCS) was used to identify the primary procedures of interest41; the International Classification of Disease, 9th Revision (ICD-9) was used in defining the other parameters of the study. This software is a diagnosis and procedure categorization scheme developed by HCUP and based on the ICD-9; it provides a smaller number of clinically meaningful categories that are more useful for presenting descriptive statistics than are individual ICD-9 codes.41 The database was surveyed for patients who developed a secondary diagnosis of RFB (ICD-9: 998.5) during their hospital stay. Then, based on their primary procedure, controls were randomly selected from those who underwent the same procedures performed within the same year. The main risk factors for RFB that were assessed included: Age less than 36, 36 to 65, and greater than 65 years old; sex; site of procedure, determined based on the involved system by the primary procedure: gastrointestinal tract/spleen, cardiovascular system, respiratory system, nervous system, head and neck, eye, musculoskeletal system, urinary system, breast, female reproductive system, and male reproductive system; NIS major operating room procedure indicator (MORPI): not reported vs reported42; admission/trauma status: elective/nontrauma, nonelective/nontrauma, elective/trauma, and nonelective/trauma; body mass index (BMI) 30 kg/ m2; and hospital teaching status: nonteaching vs teaching. However, in assessing the above risk factors, more than 50% of the records were missing response values for race and MORPI. In order not to lose the power of the study, 2 multivariate logistic regression models were performed, primary model “A” excluding race and MORPI, and a secondary model “B” including race and MORPI. The results of both models are provided. Hospital characteristics that were examined for the risk of more than 1 incidence of RFB per year were: Hospital region: Northeast, Midwest, West, and South; hospital
Al-Qurayshi et al
Vol. 220, No. 4, April 2015
Table 1.
Retained Foreign Bodies: Risk and Outcomes
751
Descriptive Statistics of the Study Population in Relation to Outcomes Related to Retained Foreign Body
Variable
Age, y 65 Sex Male Female Race White Black Hispanic Asian/Pacific Islander Native American Other Annual household income, $ 62,999 Service payer Medicare Medicaid Private/HMO Self-pay No charges Other Procedure site/system GI tract/spleen Cardiovascular Respiratory Nervous Head and neck Eye Musculoskeletal Urinary Breast Female reproductive Male reproductive MORPI Not reported Reported Procedure region Non-abdominopelvic Abdominopelvic Admission/trauma status Elective/nontrauma Nonelective/nontrauma
% Study population (n ¼ 15,637)
Retained foreign body status % Cases (n ¼ 3,045) % Controls (n ¼ 12,592)
p Value*
30.6 38.2 31.2
19.3 47.7 33.0
33.3 35.9 30.8
