About Patient Safety
In the Pathology / Histology Laboratory
Patient Safety should be more than just a buzz word for an institutional program. It should really mean something. Like helping patients in the healthcare system. That can be done in a variety of ways to help provide better care. But it should also be used to mean helping ensure that patients are getting the right care, which starts with creating the right information on the right patient.
Anatomic Pathology is still fundamentally practiced in a manner which was first developed in the late 1600's with gross examination. In the past four decades there has been an explosion in the complexity of examinations, but fundamentally all examination start in the same way with patient tissues and their entry into the healthcare system. Up to recently there has not been any systemic approach to improving the essential first step - ensuring that the tissue taken from the patient is accurately labeled with the patient's name and identification so the answers that come out at the end of the analysis are properly assigned to the correct patient.
Many studies have been performed and published on the incidence and nature of errors in the modern anatomic pathology laboratory and representative references are listed below. Despite the identification of these error points, there has not been any systemic effort in correcting these deficiencies....until now.
With the advent of the patented Safety-Spec Gross Room Tray (TM), that void of quality assurance and patient safety of this essential function has been filled.
We encourage you to explore many of these publications and how the Safety-Spec Gross Room Tray (TM) can potentially help you with your own Patient Safety initiatives. References may be provided with a short summary of how you can apply the Safety-Spec Gross Room Tray (TM) to help correct these error points. Ultimately the design and implementation of your safety program is your responsibility. Although you may choose to use the Safety-Spec Gross Room Tray (TM) as part of your safety program, you alone remain responsible for its effectiveness. Safety-Spec (TM) does not provide any guarantees or warranties to any laboratory program as to its ability to reduce identification errors.
A well designed patient safety program can help reduce the potential for identification and contamination related laboratory errors, improving patient safety as well as potentially assisting in the defense of such legal actions.
Safety-Spec, "Gross Room Tray" and "Patient Safety: One Specimen At A Time"
are Trademarked by Safety-Spec, LLC
Safety-Spec Gross Room Tray: US Patent #9993823. Other patents pending.
Note: The Safety-Spec Gross Room Tray is a tool that can be used in the development of your laboratory's safety program to help reduce identification and contamination errors, however the effectiveness of the program is solely dependent on your institutional program and it's implementation. The Safety-Spec Gross Room Tray does not, and cannot provide any guarantees or warranties for your laboratory's accuracy. Your laboratory is solely responsible for the actions you take, or fail to take, in relation to your patient safety initiatives.
Patient Safety References
Safety-Spec provides these references and links "as is" and does not provide any guarantee or warranty as to their content.
An Analysis of Pathology Closed Claims
Carolyn Akland, MBA,RN, CPHQ,LNCC
SVMIC Sentinel, Jan 2017
Specimen loss and mix-ups accounted for 78% of system failures, including:
Collection and handling by submitting physician
Processes withing the lab transport and receiving
Accessioning and slide ID
Sorting, routing and pour-off errors
Specimen Contamination (22% of errors)
*Specific steps where the Safety-Spec Gross Room Tray (TM) can assist in reducing these errors.
"Having well-documented and consistently used processes for accessioning, handling specimens and identifying slides in the process of being read is essential to accurate and timely diagnosis as well as to the defense of a claim"
The Unsafe Archaic Processes of Tissue Pathology
Am Jour Clin Path, 2022
"If you are a medical director, responsible for the quality and safety of your laboratory operations, or if you have been the unfortunate pathologist associated with a contaminant related sentinel event and, possibly worse, a medical-legal claim, you will understand. If not, you may want to read on."
We could have not said it better that in this editorial by Dr. Zarbo. There are a large number of high-risk points in the processing of tissues in surgical pathology. He rightly points out that these have not been sufficiently addressed. However it's likely that some of the conclusions of risk in this article would have not been found to be as significant, had he known about the Safety-Spec Gross Room Tray (TM). We don't fault him, as this article was released prior to the roll out of this important product.
Surgical specimen identification errors: a new measure of quality in surgical care
Makary, et. al.
4.3 specimen identification errors per 1000 cases identified. All of these were pre-laboratory in nature.
However, this article does outline the significant error potential.
An in-laboratory patient safety program focusing on prevention of labeling errors can assist in the reduction of in-laboratory errors and can also highlight the importance of labeling to other non-laboratory sites.
Mislabeling of cases, specimens, blocks, and slides: a college of american pathologists study of 136 institutions
Nakleh, et al
Arch Pathol Lab Med 2011
136 institutions provided information on 1811 mislabeling occurrences. Mislabeling rates were 1.1 cases, 1.0 specimen, 1.7 blocks, and 1.1 slides per 1000 cases. Of all mislabeling events, 27.1% were cases, 19.8% specimens, 25.5% blocks, and 27.7% slides. The work locations at which the errors occurred were 20.9% before accessioning, 12.4% at accessioning, 21.7% at block labeling, 10.2% during gross pathology, and 30.4% at tissue cutting.
Many error points in this study (bold and italic) can be directly positively impacted by a properly designed patient safety program with the utilization of the Safety-Spec Gross Room Tray (TM).
Identification errors in pathology and laboratory medicine
Valenstein, et al
Clin Lab Med 2004
Patient identification errors (are) ... around 1%. Anatomic pathology, which involves multiple specimen transfers and hand-offs, may have the highest identification error rate. Certain unavoidable cognitive failures lead to identification errors. Technology, ranging from bar-coded specimen labels to radio frequency identification tags, can be incorporated into protective systems that have the potential to detect and correct human error and reduce the frequency with which patients and specimens are misidentified.
This paper suggests that technology can help solve identification problems. While we agree with this suggestion, we further suggest that simple, non-technology intensive tools may also provide a significant contribution to the reduction or elimination of identification errors in the surgical pathology gross room.
The Laboratory and Patient Safety
Wagar, et al
Clin Lab Med 2007
Abstract of Article: Laboratory data are used extensively in patient care; consequently, laboratory errors have a tremendous impact on patient safety. Clinical laboratories were early leaders in efforts to minimize medical errors and improve patient safety. These efforts continue in many areas, including patient and specimen identification, laboratory result notification, and assistance in laboratory data interpretation. Emerging ideas on identifying and reducing laboratory errors, as well as specific strategies are reviewed and discussed with examples.
Errors DO have an enormous impact. Gross room labeling errors may be difficult to detect and can have a devastating impact on all patients involved.
Surgical Specimen Management: A Descriptive Study of 648 Adverse Events and Near Misses
Steelman, et al
Arch Pathol Lab Med 2016
Six hundred forty-eight surgical specimen events were reported in all stages of the specimen management process, with the most common events reported during the prelaboratory phase and, specifically, with specimen labeling, collection/preservation, and transport. The most common contributing factors were failures in handoff communication, staff inattention, knowledge deficit, and environmental issues.
Handoff communications include the transfer of surgical specimens from the "delivery bag" , through accessioning, then movement to the gross room table. In this short period there are multiple "handoff" points which can result in identification errors. This is the portion of the examination where the Safety-Spec (TM) Gross Room Tray can make an enormous impact in your patient safety procedures.
Patient Misidentification in Laboratory Medicine: A Qualitative Analysis of 227 Root Cause Analysis Reports in the Veterans Health Administration
Dunn, et al
Arch Pathol Lab Med 2010
Compared with the clinical laboratory and transfusion service, surgical pathology was acknowledged as more vulnerable to specimen misidentification because of the number of handoffs with tissue specimens: collection, labeling, transport, accessioning, dissection, transfer to cassette, transfer to block, transfer to slide, transcription of findings, and reporting.
Errors in the anatomic pathology laboratory are well recognized, yet little has been done to correct these critical risk points, until the release of the Safety-Spec (TM) Gross Room Tray.
Specimen labeling errors in surgical pathology: an 18-month experience
Layfield, et al
Am J Clin Pathol 2010
During an 18-month period the percentage of errors were calculated on a per case, block, and slide basis. There were 75 labeling errors (0.25% of cases) detected; 55 (73%) involved patient name, and 18 (24%) involved site. The majority of mislabelings (52 [69%]) occurred in the gross room. Although infrequent, labeling errors involved misidentification of patient or specimen source. Of the errors, 73% (55/75) of errors resulted in slides assigned to an incorrect patient. Most errors occurred in the gross room. Newer technologies such as bar coding and radio frequency chip methods may reduce the frequency of specimen labeling errors.
The number of errors identified is well characterized. They correctly state that "newer technologies" may reduce the frequency of labeling errors. However, "low-tech" solutions should be employed first, such as the Safety-Spec (TM) Gross Room Tray, because of its ease of use, resulting in quick, effective implementation, reduced barrier to "entry" of use and low cost.