Patient Safety and Quality Care Kelly Nelson MD PII: DOI: Reference:

S0738-081X(13)00314-3 doi: 10.1016/j.clindermatol.2013.12.001 CID 6815

To appear in:

Clinics in Dermatology

Please cite this article as: Nelson Kelly, Patient Safety and Quality Care, Clinics in Dermatology (2013), doi: 10.1016/j.clindermatol.2013.12.001

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ACCEPTED MANUSCRIPT Clinics in Dermatology: Contemporary Dermatology DERMATOLOGIC DISQUISITIONS AND OTHER ESSAYS

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Edited by Philip R. Cohen, M.D.*

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*Please submit contributions to the section to Philip R. Cohen, MD at

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[email protected] (email address)

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Patient Safety and Quality Care

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Kelly Nelson, M.D.

Correspondence:

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Kelly Nelson, M.D.

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Department of Dermatology, Duke University Medical Center, Durham, North Carolina

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Department of Dermatology Duke University Medical Center Durham, North Carolina 919-970-8565 (pager) 919-684-3432 (appointments)/919-385-3376 (patient questions) 919-684-9430 (fax) [email protected] Nelson Essay-Patient Safety and Quality Care 12-15-13

ACCEPTED MANUSCRIPT Introduction Patient safety and quality care are integral components of medical practice. The

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handling of biopsy specimens is an example of the importance of these issues.

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Part 1: The Challenge

This whole journey began with a very busy day in my procedure clinic – at this

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point in time, Duke Dermatology was in the midst of a very active growth period.

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Several new dermatologists, including myself, had joined the faculty over the previous 2 years, and our nursing support structure was in the process of growing in parallel to keep

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pace. As a result, clinics not infrequently were relatively understaffed with nursing team members. On this particular day, two patients had been added to my schedule with fairly

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short notice; I had a new resident working with me; and we had no dedicated nursing

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support.

I saw two patients that day for spot check of concerning lesions; I’ll call them Mr.

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Ear and Mr. Chest. Mr. Ear had a raised keratotic papule on his left ear; Mr. Chest had a

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stuck-on appearing thin plaque on his right upper chest that was partially avulsed. Mr. Ear was concerned that his spot might be a small squamous cell skin cancer; I agreed. Mr. Chest was worried that his spot might be a melanoma; I greatly favored a traumatized seborrheic keratosis. The resident and I were in and out of exam rooms several times to gather procedural supplies, generate specimen labels, obtain the correct paperwork, and perform the biopsies. We proceeded with shave removal of both areas of concern, submitted them for pathologic review, and the next week the results returned. Mr. Ear’s pathology report stated: anatomic site: right upper chest; diagnosis:

ACCEPTED MANUSCRIPT seborrheic keratosis. Mr. Chest’s pathology report stated: anatomic site: left ear; diagnosis: squamous cell carcinoma.

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And we had a problem.

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After speaking with my pathology colleagues, a chain of events began unfurling: First, I was essentially called to the principal’s office to participate in a “root cause

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analysis” with hospital safety leadership to explore the specific events that contributed to

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this safety event. Second, I discovered that I really didn’t like being in the hot seat – as physicians, we don’t like being wrong, and participating in a “root cause analysis”

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quickly makes you feel like you are the root and you’re being attacked with a garden hoe – not a good feeling at all! Third, I realized that as we looked at the beginning and end of

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the specimen handling process in our clinic (beginning: provider decides to perform a

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biopsy; end: specimen submitted for courier pick up) there was a lot of variability in the middle. And as we started to drill down into the individual steps in the whole process I

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felt better because we were focused on the process instead of the person (me!). But

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finally, I realized that I had a choice: This event was a fork in the road and I alone had control over my response. I could react in a defensive, ego-based manner (this is not my fault; everyone else is to blame; I don’t want to talk about this any more); or, I could react in an curious, non-ego based manner (What can we learn? How can we improve our process? Most importantly, how can we keep this from happening again?). If you find yourself in a similar scenario, the most important question to consider is: Can I put aside my ego and approach this from a place of openness and curiosity? If your answer is yes, then ask “Can we try to learn as much as possible about what happened?” If you can answer yes to those two questions you have already achieved

ACCEPTED MANUSCRIPT more than most providers involved with a safety event! Part 2: The Overhaul

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I managed to answer yes to my two questions, and, ego set aside, we began trying

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to learn as much as possible about what happened with my specimen-handling event. First, we tried to better understand the scope of the challenge: If this happened to

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me, has it happened to anyone else in our department? By partnering with our pathology

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department, we generated the following key metrics:

From 2008 to 2009, the number of specimens generated by our department had

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increased from 5800 to 6600 with the additional of new faculty members and a new clinical site

The number of specimen handling errors increased from 15 to almost 25

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The error rate per 1000 opportunities (how this sort of error event is reported in

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growth

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the literature) increased from 3.5 to 6.3: our error rate was outpacing our clinical

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We confirmed that we were generating more errors, but what could we do to reduce the number of errors? To answer that question, we began the nuts and bolts of process improvement: breaking down events into individual steps and identifying opportunities for improvement The concept of continuous process improvement began with Toyota, the car manufacturer, and focuses on identifying the first step and the last step of any process and breaking down individual actions in between. Each individual step is viewed as an opportunity for improvement. This concept can be applied towards efficiency (a Toyota assembly line), reproducibility (manufacturing high precision machine parts), and safety

ACCEPTED MANUSCRIPT (aviation, health care). In health care safety, the concept of process improvement may be utilized to

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address individual risk opportunities that add up to one large risk event. A visual

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schematic of stacked slices of swiss cheese (called, not surprisingly, the Swiss Cheese Model!), was proposed by James Reason as a model of “cumulative effect”.1 Each slice

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of cheese represents an organization's barrier against failure. Each slice of cheese has

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holes of differing sizes at different positions within the piece of cheese. When the holes across multiple slices align, a "trajectory of accident opportunity" is realized, and a

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hazard has an opportunity to pass through all the holes in all the defenses, leading to failure or a safety event.

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This model is a key concept for considering risk and health care for two reasons:

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First, it introduces the concept of "active failures" and "latent failures". Latent failures are contributing organizational factors; active failures are unsafe acts.

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The following is an example of latent failures and active failures in a

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dermatology-specific safety event: provision of aluminum chloride instead of phenol on a sterile surgical field for nail matrix ablation. Contributing latent failures: both aluminum chloride and phenol were compounded in similar appearing bottles; the responsible nurse handled bottles containing both compounds, but was interrupted in the process of bringing the medication bottles from the medication closet to the operative room. The active failure: the nurse did not double-check the label of the container before pouring onto the surgical field and the matrix ablation had to be repeated because the incorrect compound was used. Second, when considering contributing "latent failures", one emphasizes the

ACCEPTED MANUSCRIPT system over the person: if latent/systems failures are unaddressed, the same errors are destined to occur again, irrespective of the specific persons working within those

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systems. This point can't be over-emphasized: if you maintain the same organizational

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factors (latent events), the same end safety events are destined for recurrence, even if all the persons are completely swapped out.

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So, going back to our scenario, what latent elements (or organizational holes)

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lined up for our safety event? Addition of last minute patients

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No designated nursing support

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Labels made outside of the patient room, placed in paper chart

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Procedure trays, paperwork not readily available

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Charts for both patients were present in both rooms

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And what was our active failure? I, as the attending physician, didn’t double-

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check the patient identifiers before placing the labels on the specimen containers.

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To move forward and address the latent and active failures with our scenario, we proceeded in the following fashion: We defined our safety team to include nursing, provider, and house staff team members. We broke down the entire specimen handling process into 17 steps (no lie!) from the provider deciding to perform a biopsy to submission for courier pick up. I discovered that my love for process flow diagrams was not universally shared by my colleagues, thus we prioritized the four “non-negotiable” steps to mitigate the most critical steps in our process, emphasizing “forced functions” where an event that must happen any way is now linked to a key safety checkpoint:

ACCEPTED MANUSCRIPT the label is placed on a specimen container: the patient verbalizes his/her of name and date of birth

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the tissue placed in the specimen container: the provider

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verifies the anatomic site on label

the provider leaves the room: the presence of tissue in the

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container is confirmed and the provider places his/her initials on the

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specimen label

the pathology requisition is matched with specimen: the

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nurses perform a critical double check confirming the match of patient demographics, anatomic sites, presence of tissue in the containers, and

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provider initials on path form

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We brought these key “non-negotiable” steps, along with our background metrics, to our faculty, nursing, and house staff teams for discussion and review and we opened

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the floor for feedback and suggestions for improvement. These discussion sessions were

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very powerful: They gave everyone a “heads up” that change was coming; they allowed everyone the opportunity to participate in the change; and they encouraged everyone to “buy in” to the new process. We set a target date for implementation and reviewed the process one month and three months following implementation. Part 3: The End Game So we did all this work and what happened? Least importantly, we published our specimen handling rates before and after implementation of our standardized specimen handling procedure, demonstrating a statistically significant reduction in the number of specimen handling events.2

ACCEPTED MANUSCRIPT More importantly, we have deliberately created a culture of curiosity and support around safety events: We have collaborated with our surgical pathology and

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dermatopathology colleagues to extend our culture of curiosity and continuous

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improvement to all steps of the specimen handing process including specimen accessioning, specimen grossing and tissue processing, and result release. We have

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quarterly departmental (nursing, faculty, house staff) morbidity and mortality conferences

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and review all safety events at a departmental level to provide process improvement updates and reinforcement of our current process standards. And with each safety event,

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we have an informal “debrief” with the involved parties, asking “what can we learn?” and “what can we do better”?

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The focus on the process over the person has provided the cultural perspective to

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engage in healthy active discussions about continued improvement. We have moved beyond our core specimen handling process to other areas of process improvement

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including standardized accessioning of small specimens; labeling standards and protocols

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for aluminum chloride; utilization of unit dose lidocaine cartridges with safety syringes; departmental communication loop standards for our newly implemented (EPIC) electronic medical record; and standardizing communication of weight-based pediatric systemic medication dosing to inpatient pediatric teams. Conclusion: Epilogue We are incredibly proud of the culture of teamwork and accountability that has fueled our continued improvements. But what happened to Mr. Ear and Mr. Chest? We performed DNA fingerprinting to confirm the correct tissue custody. I spoke with Mr. Ear and Mr. Chest and let them know that I had mislabeled their specimens;

ACCEPTED MANUSCRIPT revised pathology reports were generated; Mr. Ear’s early squamous cell skin cancer was treated and both Mr. Ear and Mr. Chest remain established patients who greatly

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appreciate being introduced to new house staff as the origin of our departmental

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standardized specimen handling process!

Reason J. Human error: models and management. BMJ 2000; 320:768-770.

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Kim JK, Dotson B, Thomas S, Nelson KC. Standardized patient identification and

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1

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specimen labeling: a retrospective analysis on improving patient safety. J Am Acad

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Dermatol. 2013 ; 68:53-56. Autobiographic sketch

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Kelly Nelson, MD is Associate Professor of Dermatology at Duke University

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Medical Center, where she specializes in high-risk cutaneous oncology, particularly melanoma and procedural dermatology. She became involved with safety and process

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improvement through specimen handling events that occurred in her own clinical practice

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and discovered a passion for process improvement through drilling down to determine what happened with her specimen handling event.