Root Cause Analysis of Specimen Misidentification in Surgical Pathology Accession and Grossing

Transcription

1 Root Cause Analysis of Specimen Misidentification in Surgical Pathology Accession and Grossing Izak B. Dimenstein, MD, PhD, HT(ASCP) (Department of Pathology, Loyola University Medical Center, Maywood, IL) DOI: /B7KJB4QDM7YE35CV CE Update Abstract Root Cause Analysis (RCA) in its original Eindhoven model taxonomy (technical, organizational, and human categories) has been used for exploring the initial stages of surgical pathology processing, such as accession and grossing, with the focus on the prevention of specimen misidentification. Compiled in the form of tables, RCA categories can be a framework for questioning procedures and protocols and may reveal suggestions for improvement. There can be differences depending on the specific situation in the laboratory, but the main goal is establishing a chain of safeguards focused on processing details. After reading this article, readers should be able to discuss measures that can be used to prevent specimen misidentification during accession and grossing. Generalist exam questions and corresponding answer form are located after this CE Update article on page 503. One of the priorities in modern medicine is a trend toward patient safety, which includes preventing errors in the laboratory. Each area of the laboratory analyzes the cause of errors and seeks measures for error prevention. Errors occurring during specimen accession and grossing in surgical pathology are rarely discussed and are especially underrepresented in the literature. The recent Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology (2006) by the Association of Directors of Anatomic and Surgical Pathology (ADASP), 1 while presenting the detailed roster of preanalytic (accession) and analytic (histology) monitors for error prevention, failed to mention grossing issues at all. In the Henry Ford Production System, developed by Henry Ford Health System as a quality improvement initiative, gross examination is mentioned among the defect types in surgical pathology with a general approach (wrong description, poorly sampled, etc.). 2 The presented article touches only a narrow but very important for patient safety area of preventing errors in surgical pathology, namely specimen misidentification (sometimes referred to as mistaken specimen identity or erroneous specimen identification). This article intends to give a systematic analysis of measures to prevent specimen misidentification during accession and grossing. Methods One of the root cause analysis (RCA) methods, the Eindhoven Classification Model, has been used. Root cause analysis is a commonly accepted methodological tool for solving apparent and latent problems in many areas of manufacturing, business, and technology. The Eindhoven Model of Incident Causation was originally developed for the chemical industry 3 and has been applied to medicine since the end of the 1990s. 4 A modification of the medical version of the Eindhoven Classification Model has been used for medical event-reporting in transfusion medicine 5 and is the most appropriate method for mistaken identity analysis. The Eindhoven Classification Model, as a method for RCA, is optimal for specimen misidentification prevention during accession and grossing in surgical pathology. The specimen misidentification is an unfortunate event rather than a processing or diagnostic error. The Eindhoven original taxonomy concentrates on 3 main causes of error: technical failure (equipment and software), organizational (policies, procedures, and protocols), and human operator (mistakes and violations). This RCA method combines individual knowledge and skill-based actions with managerial efforts to establish appropriate protocols. It is difficult to include particulars of a specimen s accession and grossing in 3 main error causes. The technical category should not be taken too literally as only equipment and software because grossing is predominately a manual process. In practice, the distinction between technical and organizational causes, as well as the human part in both, is blurred, although they are divided for categorization sake. All categories are overlapping each other as in a Venn diagram. In this article, RCA uses systematic dissection of the procedures during specimen accession and grossing by compiling tables for 3 Eindhoven categories. The simplicity of some lines in the tables underscores the significance of following established protocols. An RCA table method has the advantage of systematic scrutiny under specific conditions of performance. Depending on the goals and circumstances in the laboratory, the particular suggestions in the table can be adjusted to the current priorities. This article predominately reflects circumstances and patterns of a high-volume academic institution as an example. They can be applied, with some local corrections, in laboratories employing different protocols and different anatomic pathology information systems (CoPath, Meditech, PowerPath, etc.). As the clinical information system, it supports the generation of different diagnostic reports, quality assurance, and other features as a part of a laboratory information system (LIS) by using many disparate applications. Through unique specimen identifiers (patient s name and medical record number), the accession application makes the specimen simultaneously as filing and billing entities by assigning the surgical number. Downloaded labmedicine.com from August 2008 j Volume 39 Number 8 j LABMEDICINE 497

2 Root Cause Analysis: Step-by-Step The optimal practice is the specimen s transport by the provider directly to the specimen receipt area. When the specimen is received in the accession area by personal interactions, many discrepancies can be solved in a timely and effective way. However, in a high-volume hospital setting, as well as in commercial and reference laboratories, this ideal is not attainable because most specimens arrive predominately by tubing systems and by outside carrier services. The latter provides only transportation. The specimens arrive through tubing system irregularly and often in bulk, which is an impediment for the timely recognition of errors in specimen identification. Accession The specimen accession is an intrinsic part of grossing in many aspects of quality assurance. Specimen accession is highly skilled work. The gravest errors in specimen identification occur at the receiving area. By essence, accession is the starting point of grossing. Three main subjects of specimen accession can be the targets of RCA in prevention of specimen misidentification: the requisition form, the timing of accession, and the surgical number. Requisition Form Requisition forms ( reqs ) are currently the specimen s main document for processing in surgical pathology. While they cannot currently be replaced by electronic forms due to technical and organizational reasons, they certainly will eventually disappear in the form they are used in today. Bar codes on both requisition forms and the specimen container s labels are now a common practice. The goal is to make them universal and compatible for the main health center and the ancillary practices, as well as to achieve uniformity. However, no bar code can prevent wrong laterality or specimen content identification errors. There is, unfortunately, the possibility of placing a label with a bar code on the wrong requisition form as well as on the wrong container. The variety of requisition forms and the incomplete information on them requires the accession personel s resourcefulness and imagination. It is not easy to extract necessary information from scant or sometimes superfluous and confusing clinical information. The type of surgical procedure or the relevant clinical diagnosis is essentially useful for specimen identification. This information should be requested from clinicians as mandatory. Educational training meetings with clinicians, as well as e-learning modules (computer-based learning [CBL]) for clinical staff regarding labeling specimens and informative requisition form can be useful. Simple, uniform, and informative requisition forms are the key to preventing specimen misidentification at the accession level. Timing of the Accession Time of specimen delivery is understandably different from time of accession. The delivery time often does not reflect the real time of the specimen receipt for many objective and subjective reasons; however, correct timing should be enforced, especially for rush specimens. Certainly, correct timing is very important in frozen sections with their 20 minutes for diagnosis requirement. Timing of accession that appears in the accession application box of the CoPath program always matters. Correct timing of the unique surgical number helps keep track of specimens arriving at different times and in different ways, especially if Table 1_Root Cause Analysis of Requisition Forms Universal and uniform bar code for specimen demographics. Scanners for every accession unit. Simple, complete, and relevant specimen description. Clearly printed clinician s name or contact person. Correct day and time of surgery. Uniform requisition documents. Educational meetings with clinicians on requisition form information. Familiarity with clinical departments of the institution. Attention to discrepancies in requisition form data. Table 2_Root Cause Analysis of Timing Adjust all timing clocks to the computer clock. Make the program s initial timing irreversible. All participants appear in the inquiry application. Implement real-time accession of more than 1 part of the specimen. Attention to immediate and correct timing. additional parts of the same specimen or different specimens from the same patient are present. Correct accession time is indispensable during all sorts of inquiries or times of confusion; for example, if the frozen section specimens arrive with a short interval between them. In its accession application, the CoPath program provides 3 options in the time received section for every next specimen if there are multiple parts: automatic actual time (by eliminating the copy down field feature), entering actual time by hand, or the same time for all next specimens or parts. The first option is obviously preferable as far as specimen misidentification is concerned, because it keeps track of specimen accession more efficiently. The program only defines the first accession person, even if there were other people who log in the next part of the specimen or different specimens of the same patient. This is an impediment for inquiries because it depersonalizes the process of prompt and effective clarification of discrepancies. This problem requires changes in the CoPath accession application software. These details of the CoPath program s accession application were mentioned as an example of the technical category of RCA. This institution s information system (CoPath in this instance) is an important tool in the prevention of specimen identification error. Other information systems will have their own specifics. Surgical Number The surgical number is the cornerstone of processing and filing in surgical pathology as the main surgical specimen s identifier. 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3 Table 3_Root Cause Analysis of Surgical Number Simple accession application program. Training in correct labeling of processing cassettes. Printed processing cassettes in large cases. Additional specimen identifiers on the cassette. Steady work flow. Specimen triage. Minimizing or eliminating distractions for additional tasks such as insurance and billing problems, grossing, frozen section, etc. Concentration with double check; back reading after case accession. The surgical number connects the patient, the specimen, and the day of service for billing purposes. This is a common practice in most institutions with some local insignificant deviations. As the main measure for preventing specimen misidentification at the receiving area, the standard course of action must be followed: comparison of demographics with data on the specimen s requisition form and the container, as well as with data in the computer application boxes which were generated during the patient s accession. An important part of preventing specimen misidentification is the printed name of the doctor and the contact nurse on both the requisition form and the container for immediate clarifications of any discrepancy. The printed name of the doctor on the bar-code label is not useful because, in many occasions, this is not the name of the actual provider. The specimens initial triage allows the accession person to reveal obvious discrepancies. This helps start the clarification process earlier, which is essential for the effective prevention of specimen misidentification. The main organizational issue is, however, the concentration of the accession person on creating the correct surgical number without diverting attention to billing issues and other tasks. Clarification of discrepancies in insurance coverage, which should dealt with in the customer and billing offices, brings some confusion to the accession process that opens the way for specimen misidentification. For example, sometimes the specimen requires immediate processing before billing clarifications. Processing with or without a provisional surgical number is an obvious path to specimen misidentification. Depending on the institution, the adequate amount of processing cassettes is generated while accessioning. Labeling the processing cassettes is a very important task that can lead to specimen misidentification. Mechanical on first sight, labeling cassettes requires understanding and training on grossing issues. The problem is not how to label (by hand or printed) but what to put on the cassette. Unfortunately, the practice shows the variety of incorrect labeling, which must be caught by the following steps of processing. There are many technical details in cassette labeling that are important for correct specimen identification, including the positioning of identifiers on the cassette. Additional specimen identifiers can be placed on the cassette (laterality and type of procedure, such as shave or punch in skin biopsies, etc.). Every detail counts, including the size and place of identification (surgical number, specimen parts) on the cassette. It is also important how the cassettes are combined with the containers, and how the containers are placed on the trays for processing. Printed cassettes are optimal and technically appropriate, for now, in large cases. Although free from deficiencies of personal handwriting (an obvious advantage), they lack the flexibility for adding additional identifiers on the cassette that are significant in grossing practice. Printed cassettes are more a matter of convenience and labor, but they are not a significant contributing factor in preventing specimen misidentification because the same lack of attention can occur when using the computer or writing on the cassette. The next step in technical advancement could be bar-coded cassettes or blocks. 2 Grossing Grossing can contribute to both prevention of erroneous specimen identification and generating a mistaken specimen identity. The classic pattern of grossing is: handle 1 specimen at a time; Table 4_Root Cause Analysis of Grossing Specimen-requisition form-processing and cassette line up. Standardization of dictation pattern for specimen s identification. Surgical number-name-container s content with double match on the container s label. Additional specimen s identification on the cassette. Enter the computer histology information with matching histology application with requisition form data. Matching accession log with cassettes during loading of the processor with immediate clarification of discrepancies. Uniform template for dictation of specimen s identification. Continuous work flow without processing specimens in bulk. The empty and wet specimens containers being stored should be easily accessible for at least during one month. Concentration on the pattern of grossing processing. Optimal set up of the grossing table and specimen s containers for grossing. Back reading after case grossing completion. Downloaded labmedicine.com from August 2008 j Volume 39 Number 8 j LABMEDICINE 499

4 match the requisition form with the container and the processing cassette; and double-check the identity of the specimen during dictation. If the case, especially in biopsies, contains many parts, they should be lined up to check completeness of the case with all possible discrepancies in specimen identification. However, the principle of processing every part of the specimen as a separate entity must be honored. Although practice sometimes makes correction to this general rule, every grossing person knows that violation of this grossing central dogma is dangerous and can lead to specimen mix-up. Although some institutions do not use dictation while grossing, it is a commonly accepted practice. The pattern of dictation is very important for preventing specimen misidentification. Dictation must include, with clear pronunciation, the surgical number, the patient s name, and specific identifiers on the container (number, site, content, etc.). Frozen section grossing requires a separate RCA beyond the scope of this article. This area is prone to specimen misidentification by specifics of the processing. The frozen section area is especially vulnerable if the specimens arrive simultaneously from different patients or as parts of the same patient s specimen but in bulk (up to dozens of specimens), as it is practiced in some institutions. There are many technical details specific to each institution s facilities. Details of the grossing table configuration are very important for preventing specimen mix-up; for example, an overcrowded tray with specimens. Unfortunately, sometimes the grossing person grabs a wrong container or processing cassette. Some technical means can be useful for preventing specimen mix-up. For example, separation of specimens by tray dividers and a rational and visible combination of specimen containers and processing cassettes can be used depending on the workspace arrangement in the laboratory. Additional specimen identification on the cassette is common practice. Depending on the institution, these marks are different. Defining laterality, type of specimen, or type of procedure sometimes can be useful not only for embedding orientation but as a safeguard in preventing specimen mix-up. The grossing person should confirm or correct the identifier placed during accession. This is a very important part of preventing specimen misidentification. For example, if the sign p (punch) is on a cassette with a kidney biopsy, this is obvious evidence that something is wrong with the specimen identification. As future technical improvements are made, a scanner for matching the specimen s identifiers at a grossing station equipped with a computer unit can be considered. The next step, with digital imaging in grossing pathology, can be an additional safeguard in preventing erroneous specimen identification. The pathologist would see on the screen not only the specimen s identification documents but actual specimen features (shape, color, size, etc.). Digital imaging in microscopy is a well established trend, but digital imaging in grossing pathology is still a work in progress. This is a possible perspective, but it cannot be included in RCA categories because the technical part is currently experimental. Another perspective might be an interface between electronic medical records and physician order entries in EPIC form, anatomic information system, for instance CoPath- Plus, and a pecimen bar-coding system. This would enable tracking a specimen s surgical number, grossing cassettes, embedded blocks, and even microscopic slides during the processing cycle. The CoPath program provides an opportunity to double check all entries of specimen identification while logging histology information, as well as providing an additional check during processor loading. These are crucial safeguards against specimen misidentification. Histology information must to be entered into the computer by the grossing person, who solely knows all details of the specimen, by using the requisition form as the main document. Many discrepancies can be revealed during this process, such as an incorrect name or surgical number, as well as a wrong protocol of processing that is also the specimen s identifier, because a wrong protocol can be an indirect warning of specimen misidentification. By comparing the accession log, generated by the CoPath program, with actual count and colors of the processing cassettes, additional discrepancies can be revealed during processor loading by a responsible person who understands grossing issues. This procedure is far from a mechanical process of counting cassettes. The breaks in sequence of the surgical numbers or parts of the specimen, double numbers, unexplainable discrepancies between the color of the cassette and the specimen s description in the accession log, and the suspicious absence of the cassette according to the log, are all safeguards in preventing specimen misidentification. This is actually the last line of defense in preventing specimen misidentification in surgical pathology grossing. After this, the histology component begins. It can contribute to the task of revealing errors that were missed or generated by grossing. The histology contribution in this regard, however, is limited. Nevertheless, a discrepancy between cassette color and the character of specimen can be a clue that something is wrong with the specimen identity. Unused, preprinted slide labels might also be a reason to raise a red flag. The histology component (embedding, microtomy, staining, and labeling) requires separate discussion due to many technical particularities. Of course, histology can contribute to the specimen s mix-up but much less than accession and grossing. Discussion The Eindhoven Classification Model, as a casual classification system, uses terms for RCA as benign errors, precursor events, or near misses/close calls, in opposition to sentinel events. The latter represents a major accident with adverse consequences. The iceberg concept of errors and accidents presents the sinking of the Titanic as an example of a sentinel event. 5 A near-miss reporting system is used in high-risk industries and in some areas of medicine, such as cardiac surgery, anesthesia, and blood bank operations. It includes events that were averted before negative consequences occurred. The most complete recent review of the problems of error reduction in pathology was presented at the College of American Pathologists Special Topic Symposium on Errors in Pathology and Laboratory Medicine Practical Lessons for the Pathologist. 6 Most of the errors in surgical pathology specimen misidentification are near misses. The goal of RCA is to avoid them and, of course, prevent sentinel events. There are 2 main modes of RCA conduct in health care: investigative ( detective ) and brainstorming root causes. The difference between the 2 is in the methodology of the approaches to the concrete organizational situation. The brainstorming methodology includes surveys, observations, or Downloaded 500 from LABMEDICINE j Volume Number 8 j August 2008 labmedicine.com

5 computer simulations of the process. The investigative method is, in most instances, caused and related to an actual unfortunate event. In an ideal world, there would be a blend of the 2 approaches depending on local circumstances; however, these 2 birds often do not flock together because their feathers (methods) are different. The investigative questioning process has an advantage of the details; however, despite the principle of RCA including a no blame provision, actual participants in the event are often on the defensive. The existence of a blame culture in medicine, opposed to some blame-free cultures in many other industries, is determined by real or possible individual and institutional legal liability. There is no way to overcome this firewall. However, even insufficient investigative RCA provides the participants with some clues for improvement. The presented materials reflect the second variant of RCA, brainstorming, a more or less comprehensive approach with changes and adjustments depending on the specific situation. The traditional Eindhoven s 3-dimensional model provides an opportunity for permanent detailed analysis and enforcement of proposals. The right columns of the tables can be filled with different content depending on current circumstances in the laboratory and the results of RCA questions and goals. The wish-list content of the tables with 3 RCA categories opens managerial opportunities. This method stems from practice but returns to practice with summarization of common procedures and underlining local particularities. Actually, this is a shopping list of affordable items. Three categories are focused towards a designed goal: in this instance, prevention of erroneous specimen identification. Both Eindhoven s organizational and technical categories of the tables are subjugated to the human category that usually is defined in vague terms. The human error reflects often unbelievable twists of the human mind, as apparent confusion of laterality, wrong writing, printing, or typing numerals, choice of wrong cassette or container, etc. The task of technical and organizational categories is laying the groundwork for preventing, catching, and fixing human errors in a timely fashion. Rooted in human psychology, human error is inevitable. Root cause analysis cannot offer a panacea for preventing specimen misidentification, as bar-code or special protocols, but there might be remedies to substantially minimize mistaken specimen identity by the systematic comprehensive approach to details of the processing. Instead of cherry picking measures, RCA offers a universal model of questioning possible narrow places with attempts toward solutions. In the case of preventing specimen misidentification in surgical pathology grossing, the most beneficial seems to be the chain of safeguards during accession, grossing, and collecting processing cassettes. Using a military term, this is a deep-echelon defense. As pointed out in an article from Johns Hopkins Medical Institutions, this is to have a system that s routinely done over and over again, and to have multiple backups, multiple fail-safe mechanisms. 7 There is a difference in handling discrepancies in specimen identification at intradepartmental and institutional levels, but the main principle is common: immediate response to achieve a clarifying result. Most of the intradepartmental specimen misidentifications can be and should be solved without managerial involvement at the level of the person next in the line of processing. Practice shows that if managers let the immediate performers solve discrepancy problems, everything goes better and faster. Figure 1_Pattern of actions in specimen identification discrepancy. Almost all institutional discrepancies should be handled at the managerial level. The pattern to delegate this task to accession and grossing personnel is wrong because it diverts them from their duties, which require a high degree of concentration. It is less effective because a higher level of communication and involvement has a preventive effect for future discrepancies. In large institutions especially, the incident/ occurrence report is a necessary instrument to keep track of unfortunate events for analysis of weak points in the sequence of procedures. These reports provide a broader, systematic approach to problems. Of course, the option of a designated person, as at Johns Hopkins Medical Institutions, could be optimal, but this requires additional staffing. 7 Figure 1 offers a pattern of 3 directional actions if a discrepancy or any incongruity in specimen identification were revealed. Depending on the concrete situation, there could be different sequences of involvement, if any, of three main participants in clarifications, or the specimen rehabilitation process, as it is defined by the Henry Ford Production System. 8 Any diagram inevitably simplifies complicated realities in laboratory practice. Sometimes diagnostic considerations require both parallel processing and discrepancies clarifications. For example, in a product of conception specimens, when the question of extra uterine pregnancy often exists, the procrastination of processing might compromise the patient s care. Common sense ought to prevail. A different pattern of actions is used when the specimen misidentification is revealed with a delay (especially at the pathologist s level), or worse, when the case had been signed out and reached the clinician. The sequence of action literally turns backwards. All safeguard documentation, including accession and histology information logs, should be referenced immediately. In this situation, timing of requisition forms and, especially, in the computer program application, is essential. This is the reason why timing, as well as computer identification of participants, has been discussed in detail in the accession section of this article. All participants should be involved in clarifications simultaneously for prompt and effective results. Of course, every institution establishes specific mechanisms of quality assurance in handling discrepancies in specimen identification depending on staff and traditions. Root cause analysis might be an integral part of quality assurance as a tool for revealing narrow places and determining ways of improvement. Unfortunately, many quality assurance reporting systems focus more on the facts collected rather than analysis. Downloaded labmedicine.com from August 2008 j Volume 39 Number 8 j LABMEDICINE 501

6 Root cause analysis conclusions are often incomplete and, more importantly, involve no follow-up. For example, RCA of a wrong laterality in a breast biopsy has revealed some specifics of specimen identification on the requisition form, container, grossing dictation, and cassette labeling categories. The task of quality assurance is in consistency of implementation measures that were determined during root cause analysis. Conclusion Scrupulously and consistently following procedure protocols with an established chain of safeguards can be beneficial for preventing specimen misidentification at the accession and grossing stages of surgical pathology processing. The RCA table method in its original taxonomy (technical, organizational, and human categories) can be used as a framework for the detailed questioning of narrow places in performance and as suggestions of possible measures for improvement. This structural analysis would be a contribution to a quality systematic approach. LM 1. Association of Directors of Anatomic and Surgical Pathology Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology. Am J Surg Pathol. 2006;30: D Angelo R, Zarbo RJ. The Henry Ford Production System. Measures of process defects and waste in surgical pathology as a basis for quality improvement initiatives. Am J Clin Pathol. 2007;128: Van der Schaaf TW. Near Miss Reporting in the Chemical Process Industry. 1992; Thesis, Eindhoven University of Technology, Eindhoven, The Netherlands. 4. Van VuurenW, Shea CE, Van der Schaaf TW. The Development of an Incident Analysis Tool for the Medical Field. Eindhoven, Netherlands: Eindhoven University of Technology; Battles JB, Kaplan HS, Van der Schaaf TW, et al. The attributes of medical event-reporting systems. Experience with a prototype medical event-reporting system for transfusion medicine. Arch Pathol Lab Med. 1998;122: College of American Pathologists Special Topic. Symposium on errors in pathology and laboratory medicine Practical lessons for the pathologist. Arch Pathol Lab Med. 2005;129: Makary MA, Epstein J, et al. Surgical specimen identification errors: A new measure of quality in surgical care. Surgery ;141: Zarbo RJ, D Angelo R. The Henry Ford Production System. Effective Reduction of Process Defects and Waste in Surgical Pathology. Am J Clin Pathol. 2007; 128: Downloaded 502 from LABMEDICINE j Volume Number 8 j August 2008 labmedicine.com