**Conflict of interest**

The authors report no conflict of interest.

#### **Source of funding**

Department of Obstetrics & Gynecology, SLUHN. The authors of this chapter disclose no other financial support or funding for this study.

Clinical Trial #: Not applicable. No human or animal subjects.

Institution Review Board: No human or animal subjects involved, exempt from approval.

#### **Author details**

Carly Madison Hornis\*, R.S. Vigh, J.F. Zabo and E.L. Dierking

\*Address all correspondence to: carly.hornis@sluhn.org

Department of Obstetrics and Gynecology, St. Luke's University Health Network (SLUHN), Bethlehem, Pennsylvania, United States of America

#### **References**


[3] Fatalities Reported to FDA Following Blood Collection and Transfusion: Annual Summary for Fiscal Year 2009. http://wayback.archive-it.org/7993/20171114162601/ https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/ TransfusionDonationFatalities/ucm204763.htm [Accessed April 27, 2018]

**9. Conclusion**

136 Vignettes in Patient Safety - Volume 3

**Conflict of interest**

**Source of funding**

**Author details**

**References**

The authors report no conflict of interest.

other financial support or funding for this study.

Clinical Trial #: Not applicable. No human or animal subjects.

Carly Madison Hornis\*, R.S. Vigh, J.F. Zabo and E.L. Dierking

\*Address all correspondence to: carly.hornis@sluhn.org

Update2\_24\_SE.pdf [Accessed January 11, 2018]

Bethlehem, Pennsylvania, United States of America

Emergency blood transfusion remains a clinical challenge, occasionally marked by improper transfusion of incompatible blood that leads to severe patient morbidity and mortality. Through this hypothetical case scenario, we have highlighted the risks of improper transfusion and discussed improvements in patient safety during emergency transfusion, including developing best practice models, integrating new technologies, as well as improvements in operational aspects via simulation and error tracking systems. By further investing in protocols and systems that enhance safeguards in transfusion medicine, we can continue to strive toward the elimination of transfusion errors and their sequelae. Ongoing research, continuous intensive analysis, and quality improvement initiatives are needed for further advancement of transfusion safety.

Department of Obstetrics & Gynecology, SLUHN. The authors of this chapter disclose no

Institution Review Board: No human or animal subjects involved, exempt from approval.

Department of Obstetrics and Gynecology, St. Luke's University Health Network (SLUHN),

[1] Clifford SP, Mick PB, Derhake BM. A case of transfusion error in a trauma patient with subsequent root cause analysis leading to institutional change. Journal of Investigative

[2] Comprehensive Accreditation Manual for Hospitals: Sentinel Events. 01/2013; The Joint Commission. Available at: https://www.jointcommission.org/assets/1/6/CAMH\_2012\_

Medicine High Impact Case Reports. 2016;**4**(2):2324709616647746


[19] Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: Simple as ABC (assessment of blood consumption)? The Journal of Trauma. 2009;**66**(2):346-352

[33] Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. American Journal of Obstetrics and Gynecology. 2011;**205**(4):368.e361-368.e368

Transfusion Error in the Gynecology Patient: A Case Review with Analysis

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[34] Macdonald M, Gosakan R, Cooper AE, Fothergill DJ. Dealing with a serious incident requiring investigation in obstetrics and gynaecology: A training perspective. The

[35] Joint Commission on Accreditation of Healthcare Organizations USA. Preventing mater-

[36] Merién AE, van de Ven J, Mol BW, Houterman S, Oei SG. Multidisciplinary team training in a simulation setting for acute obstetric emergencies: A systematic review. Obstetrics

[37] Maslovitz S, Barkai G, Lessing JB, Ziv A, Many A. Recurrent obstetric management mistakes identified by simulation. Obstetrics and Gynecology. 2007;**109**(6):1295-1300 [38] Prevention CfDCa. National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol. In. Atlanta, GA, USA: Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious

Obstetrician & Gynaecologist. 2014;**16**:109-114

nal death. Sentinel Event Alert. 2010;**44**:1-4

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Diseases, Centers for Disease Control and Prevention; 2017


[33] Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. American Journal of Obstetrics and Gynecology. 2011;**205**(4):368.e361-368.e368

[19] Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: Simple as ABC (assessment of blood consump-

[20] Linden JV, Davey RJ, Burch JW. The September 11, 2001 disaster and the New York

[21] Cipolla J. Wrong blood type: Transfusion reaction. In: Vignettes in Patient Safety. Vol. 1.

[22] 50 Largest Hospitals in America. Becker's Hospital Review 10/26/2010. https://www. beckershospitalreview.com/lists/50-largest-hospitals-in-america.html. [Accessed date:

[23] Tiwari AK, Pandey P, Dixit S, Raina V. Speed of sample transportation by a pneumatic tube system can influence the degree of hemolysis. Clinical Chemistry and Laboratory

[24] Clowse ME, Jamison M, Myers E, James AH. A national study of the complications of lupus in pregnancy. American Journal of Obstetrics and Gynecology. 2008;**199**(2):127.

[26] Curry N, Rourke C, Davenport R, et al. Early cryoprecipitate for major haemorrhage in trauma: A randomised controlled feasibility trial. British Journal of Anaesthesia.

[27] Wafaisade A, Lefering R, Maegele M, et al. Administration of fibrinogen concentrate in exsanguinating trauma patients is associated with improved survival at 6 hours but not at discharge. Journal of Trauma and Acute Care Surgery. 2013;**74**(2):387-383 discussion

[28] Roberts I, Shakur H, Coats T, et al. The CRASH-2 trial: A randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technology

[29] Shahid A, Khan A. Tranexamic acid in decreasing blood loss during and after caesarean section. Journal of the College of Physicians and Surgeons–Pakistan. 2013;**23**(7):459-462

[30] Zareh M, Davis A, Henderson S. Reversal of warfarin-induced hemorrhage in the emergency department. The Western Journal of Emergency Medicine. 2011;**12**(4):386-392 [31] Ng WL, Short TG, Gunn KN, Fuge GS, Slon B. Accuracy and reliability of the i-STAT point-of-care device for the determination of haemoglobin concentration before and

[32] Butwick AJ, Goodnough LT. Transfusion and coagulation management in major obstet-

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ric hemorrhage. Current Opinion in Anaesthesiology. 2015;**28**(3):275-284

[25] SGe G. Obstetrics: Normal and Problem Pregnancies. Seventh ed

tion)? The Journal of Trauma. 2009;**66**(2):346-352

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393-385

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Assessment. 2013;**17**(10):1-79


**Chapter 9**

**Provisional chapter**

**Patient Safety Issues in Pathology: From Mislabeled**

Catastrophic breaches in patient safety often involve point-of-care settings such as the operating theater or intensive care unit, quite frequently without due consideration given to the elements leading up to such errors. Among such occurrences, wrong site procedures (WSPs) and diagnostic discrepancies continue to result in significant morbidity and mortality among patients. Addressing adverse events is difficult for all stakeholders involved. Furthermore, clinician familiarity with the workflow specific to particular disciplines or procedures may be poor, amplifying communication lapses that precede patient safety occurrences. The patient care paradigm has become increasingly multidisciplinary, and it is important to discuss, improve, and be more cognizant of measures required to achieve "zero defect" performance. Despite the rarity of "never events," their consequences may damage patient and community trust, provider morale, and institutional reputation. This chapter aims to assess current preventive measures and risks in the context of errors involving surgical pathology in the setting of the operating theater utilizing the framework of clinical vignettes. The discussion below will further center on the practical and interpretative errors that occur in the pathological workflow, and the potential for compounding of such errors in the operating theater. Definitions concerning WSP and diagnostic discrepancies will be outlined to characterize potential outcomes of communication errors.

**Keywords:** never events, patient safety, patient safety errors, safety protocols,

The seminal 1999 Institute of Medicine report was significant for U.S. health care, citing that approximately 100,000 annual deaths resulted from medical errors [1]. This report motivated a

pathology, laboratory medicine, diagnostic uncertainty

**Patient Safety Issues in Pathology: From Mislabeled** 

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

DOI: 10.5772/intechopen.79634

**Specimens to Interpretation Errors**

**Specimens to Interpretation Errors**

Michael S. Firstenberg and Thomas J. Papadimos

Michael S. Firstenberg and Thomas J. Papadimos

Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

Derek Tang, Peter A. Dowbeus,

Derek Tang, Peter A. Dowbeus,

http://dx.doi.org/10.5772/intechopen.79634

**Abstract**

**1. Introduction**

#### **Patient Safety Issues in Pathology: From Mislabeled Specimens to Interpretation Errors Patient Safety Issues in Pathology: From Mislabeled Specimens to Interpretation Errors**

DOI: 10.5772/intechopen.79634

Derek Tang, Peter A. Dowbeus, Michael S. Firstenberg and Thomas J. Papadimos Derek Tang, Peter A. Dowbeus, Michael S. Firstenberg and Thomas J. Papadimos

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.79634

#### **Abstract**

Catastrophic breaches in patient safety often involve point-of-care settings such as the operating theater or intensive care unit, quite frequently without due consideration given to the elements leading up to such errors. Among such occurrences, wrong site procedures (WSPs) and diagnostic discrepancies continue to result in significant morbidity and mortality among patients. Addressing adverse events is difficult for all stakeholders involved. Furthermore, clinician familiarity with the workflow specific to particular disciplines or procedures may be poor, amplifying communication lapses that precede patient safety occurrences. The patient care paradigm has become increasingly multidisciplinary, and it is important to discuss, improve, and be more cognizant of measures required to achieve "zero defect" performance. Despite the rarity of "never events," their consequences may damage patient and community trust, provider morale, and institutional reputation. This chapter aims to assess current preventive measures and risks in the context of errors involving surgical pathology in the setting of the operating theater utilizing the framework of clinical vignettes. The discussion below will further center on the practical and interpretative errors that occur in the pathological workflow, and the potential for compounding of such errors in the operating theater. Definitions concerning WSP and diagnostic discrepancies will be outlined to characterize potential outcomes of communication errors.

**Keywords:** never events, patient safety, patient safety errors, safety protocols, pathology, laboratory medicine, diagnostic uncertainty

#### **1. Introduction**

The seminal 1999 Institute of Medicine report was significant for U.S. health care, citing that approximately 100,000 annual deaths resulted from medical errors [1]. This report motivated a

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

cultural shift into the research of various topics including medical errors and their prevention. More specifically, health care initiatives concerning public reporting of outcomes, provider and institutional reimbursement, and methods to improve existing systems, combined with individual accountability, were introduced. Beyond public and private agency investment, government involvement was also increased with the Agency for Health Care Research and Quality providing funds for identification of best practices, in addition to patient safety indicators and standardizing metrics. Despite the above measures, contemporary analyses suggest that medical errors may actually result in over 400,000 deaths per year [2], with the U.S. Department of Health and Human Services Offices of the Inspector General reporting 180,000 deaths resulting from medical errors among Medicare beneficiaries in 2008 [3], and an annual cost exceeding \$17 billion [4].

Anatomic and Surgical Pathology, drafted several *recommendations* aimed at avoiding interpretative errors, ultimately designating case review as an effective deterrence to error [11].

Patient Safety Issues in Pathology: From Mislabeled Specimens to Interpretation Errors

http://dx.doi.org/10.5772/intechopen.79634

143

In order to familiarize other surgical subspecialties with potential procedural weaknesses within the pathology workflow, a conceptual framework of practical and interpretative errors derived from Meier [12] is outlined (**Table 1**). A brief overview of the taxonomic

> Selection of tissue specimens Labeling and specimen transport

Receiving sampling specimens Fixing, embedding, cutting section Mounting, staining, and labeling slides Delivery of slides to pathologist(s)

Case reports Amendments—changes that are not pure additions of information

Misinterpretation: **i.** Overcalls **ii.** Undercalls

**Table 1.** A taxonomic framework for discussing errors in pathology; derived from Meier [12].

Examination, collation, and interpretation of slides Consideration of ancillary tests, Other information Composition of report for subsequent review Reception and interpretation of report Interpretive errors Errors of commission—wrong or incorrect diagnoses, false positives (i.e., overcalls)

Addenda—changes that purely add information

sampling, absent/inappropriate ancillary testing

diminish redundancy in information, presented as:

**ii.** Dictation/transcription errors—typographical errors

**iii.** Aberrations in electronic formatting (i.e., "computer glitches")

ers, procedure, billing)

Errors of omission–mixed diagnoses, false negatives (i.e., undercalls)

Specimen defects—Specimens that are lost, of inadequate sampling size and/ or volume, absent or discrepancy measurements, inadequately representative

**iii.** Confusion/conflation which results in not altering primary (positive/negative or benign/malignant) or secondary (grade, stage, margin, etc.) characteristics

**i.** Absent or incorrect non-diagnostic information (e.g., concerning practition-

Report defects—do not directly influence diagnostic information but often

Specimen accession

**2. Definitions**

**Classification Definitions**

Practical errors (in stepwise order) Patient identification

Medical errors continue to illuminate the fragility and complexity of the medical system. Within this context, it is critical to point out that most of these errors are potentially preventable [2]. For example, it has been estimated that roughly 1 in 113,000 surgical procedures involve an incorrect operative intervention [5]. Subsequent analyses performed by the Joint Commission further revealed that communication errors (70%), procedural noncompliance (64%), and leadership (46%) were significant contributors to such events. However, other commonly cited antecedents to sentinel events include team competency, availability of information, organizational culture, failure to mark or clearly mark the operative site, inadequate medical record review, and of paramount importance, deficient continuum of care [6]. It is important to recognize the systemic and procedural breakdowns that often preclude postdiagnostic procedures that may not be operative in nature but may be catastrophic for the patients if improperly conducted (or erroneously delivered and/or interpreted).

There are two broad categories of occurrences in terms of potentially introducing serious medical errors into the arena of laboratory medicine:


At the same time, reporting of errors that occur across the various sub-specialties of laboratory medicine often proves difficult. For example, validated studies have demonstrated increased propensity toward error through the inherent systematic complexity (e.g., due simply to the increasing number of process-related steps) [7]. Surgical pathology is particularly vulnerable to breaches in patient safety, in part due to the wide variability in tissue types, anatomic nuances, biologic sampling, inconsistency and human involvement in diagnostic interpretation, as well as time constraints (and pressures) [8]. The Quality Practices Committee and College of American Pathologists (CAP) designed validated guidelines and metrics in laboratory quality, with data collection and peer review initiatives such as Q-PROBES (a peer-comparison quality assurance service offered by the College of American Pathologists that was created in 1989), in order to establish patient safety benchmarks [9]. However, despite increased awareness, the necessity of improving pre-existing pathology paradigms has only been considered recently [10]. Additionally, an expert panel from The CAP, as well as the Pathology and Laboratory Quality Center, in association with the Association of Directors of Anatomic and Surgical Pathology, drafted several *recommendations* aimed at avoiding interpretative errors, ultimately designating case review as an effective deterrence to error [11].
