The Henry Ford Production System (HFPS) work, including the article by Zarbo et al,1 is impressive for its relentless pursuit of the eradication of defects in surgical pathology processing. The laboratory was able to achieve statistically significant reduction of specimen misidentification, although such a delicate matter is often underreported or unrevealed for many reasons. Unfortunately, the article does not provide sufficient data on productivity calculations. The parameter for cutting slides per minute cannot be evaluated without main productivity data. As Renshaw2 correctly noted in an editorial the same issue of the Journal, all of the remarkable HFPS improvements come with a significant price tag that is unattainable by the vast majority of health care facilities. It is necessary to have a generous administration and an enthusiastic staff. Under current conditions, when a histology laboratory in an academic institution lays off in a second installment 3 of 15 staff along with the anatomic pathology manager, it is difficult to ask administration for redesigned workstations in U-shaped work cells, laser etchers, and computers for each of 15 histology cutting benches with their maintenance and software program expenses. However, improvements can be made gradually by small affordable increments under the specific conditions of the laboratory. LabMedicine recently published my article “Root Cause Analysis of Specimen Misidentification in Surgical Pathology Accession and Grossing.”3 We used the original Eindhoven 3 category-taxonomy in a table modification. This method addresses organizational, technological, and human categories of causes of errors and their elimination depending on the concrete situation in the laboratory. The draft of the article was sent to the HFPS group, and I received useful advice. The HFPS article concentrates attention on misidentification defects after embedding, but the grossing area is most prone to errors of specimen misidentification. A histotechnologist operates with few elements during microtome cutting. Grossing includes a variety of situations and interactions that more likely can generate a mistake. Although the article states that misidentification defects during grossing are in a 3:30 ratio in histology,1 these data might stem from unrevealed or underreported misidentification accidents during grossing. The set of preventive misidentification measures during grossing ought to be much broader than bar coding, templates, and visual data display posters presented in the HFPS article. A system of back reading with safeguards of counting grossing cassettes, comparing them with a computer log, and immediately clarifying all discrepancies prevents a misidentification error during grossing. Image 11 shows a requisition form with handwritten numbers and the patient’s name without even the date of birth. The pathology bar coding system is not integrated with the hospital’s information system. Prelabeled bar-coded slides are the significant part of the HFPS improvements. However, this is a histotechnology taboo because it is almost the sole source of specimen misidentification during cutting. According to the histology microtomy “central dogma,” the slide should be labeled from the block in the microtome, although everyone knows how often this rule is violated. Of course, the modern mass production histology laboratory uses the prelabeling method, but it is the recipe for misidentification that was rare in histology cutting before. Misidentification is obviously a slip of attention. It is easier to grab a wrong prelabeled slide than to misidentify during concentrated writing. Anyway, the blank slide and a pencil are taken to mark the histotechnologist’s initials (Figure 1, step 4).1 Histotechnologists can delegate affixing labels with the bar code to a trained laboratory aide. During this process the slide can be matched with the general log. When labels preprinted from CoPath Plus (Sunquest Information Systems, Tucson, AZ) do not match a slide with the corresponding requisitions, it is a red flag that something is wrong in specimen identification. This problem can be solved before pathologist review. The last thing that a pathologist ought to do is to sort out specimen misidentification. 2009 We were first approached by Dr Dimenstein via e-mail with an invitation to review and endorse several drafts of an article he had written. Over the phone, we corrected his misimpressions from reading about the HFPS, our innovative and successful quality initiative 5 years in the making by hundreds of employees in the laboratories of the Henry Ford Hospital System.1–3 His article missed the key point of adapting continuous process improvement and quality management in the empowered worker manner of the Toyota Motor Corporation, recognized popularly now as Lean.4 Subsequently, he sought to speak at our quarterly, national 2-day Lean Quality Training Course. We declined. Lean is relatively newly discovered by health care as a leadership and management approach to work, but it is actually about half a century old. And if we revisit the managerial approach of Henry Ford—“it’s the work not the man that manages”—it is almost 85 years of age supporting the adage “there is nothing new under the sun.”5 In fact, we have rediscovered the teachings of Deming6 and the core efficiencies of Henry Ford that were further innovated by Toyota.7 There is an old style of management that focuses on driving the horses harder (goal of productivity), not smarter (goals of increased quality, decreased waste and rework, and, therefore, increased productivity). The points we made to Dr Dimenstein are worth repeating here. The focus of our article is patient safety, not productivity. As the popular public safety advertisement says, “speed kills.” We have shown that you can be safer and more productive by using Lean discipline and new technology that reinforces those principles. In a Lean cultural work environment of multiskilled and cross-trained workers who continually seek to reduce non–value-added effort, very little work time is not productive. One of Deming’s more difficult-to-comprehend points for management is to eliminate numeric goals for the workforce. Why? Low productivity and low quality come from the system that we the leaders are responsible for. Fixing this problem is not typically within the realm of the worker, but rather the responsibility of management. Roughly one third of current laboratory work is waste and rework that if reduced will enhance the capacity for productive work.3 This is not to say that we do not need work standards and goals, but that arbitrary numeric quotas without worker empowerment and education to reasonably achieve continual improvement toward reasonable goals are destabilizing and demoralizing. As one transitions from a workforce tackling conventional large batches of bolused work to Lean continuous flow production of single cases, the staffing, nature, and definition of histology productivity change. Its best metric is now turnaround time achieved within the system, with histology fulfilling a key role alternating as a customer then a supplier in the timeline sequence from specimen collection to report transmission. This is the real value to the customer of anatomic pathology services that is addressed by Lean management. Dr Dimenstein writes of layoffs. Staff reductions without preparation describes a nonprogressive environment without support or appreciation of the critical role of anatomic pathology from senior management. His is the cry of the middle manager tasked with disassembling his workforce with minimal forewarning. It is just the scenario he relates of workforce downsizing related to cyclical economic or business downturns that seasoned leaders have all lived through. Knowledge of this expectation should be sufficient learning to prompt us as leaders to adopt a proactive management stance, focused on developing a culture of continual process improvement. Lean gains are not typically rapid but derive from iterative changes with cumulative and often dramatic effect over some time as we described in our article.8 As the “Big 3” American automobile manufacturers have learned the hard way, it is difficult to play catch-up if your competition has been continually “Leaning” their operations for years with thousands of worker-involved process improvements. We are fortunate to have a very supportive executive leadership in the Henry Ford Health System that is willing to invest in novel but well executed innovations like the Henry Ford Production System. This, in fact, costs very little. Quality is not free, but lack of a quality focus is potentially much more expensive than you could possibly budget should 1 misstep be adjudicated in our court system. There is a cost to maintain a quality infrastructure, but if one leads through a quality focus, it is the same cost as maintaining appropriate levels of leadership anyhow. In fact, most laboratories, to achieve accreditation, are required to have proficiency testing programs and a quality management program that continuously monitors indicators of quality as a basis for improvement. This is a significant but often unmeasured expense in reagents, time, and staff for most laboratories. We are an inner-city hospital with an uncompensated care burden that would bankrupt any inefficient hospital operation. The bar code–specified work process system we described in our article was a practical, academic, and patient safety developmental program by the senior authors during a 5-year period, designed to be aligned with our Lean culture.8 It was not purchased with one large check but rather built incrementally, partnering with industry along the way to minimize out-of-pocket costs. All hospitals must continually invest capital, even in histology operations. But as leaders, we must plan to invest it wisely with a long-range vision of our quality goal. Newfangled rapid tissue processors cost far more than the bar-coded histology technology that we have developed ab initio to reinforce Lean work principles and to create a system that allows all histotechnologists to consistently enhance patient safety by markedly reducing misidentifications. If you are a leader, the laboratory is your experimental playground to create a better system for the worker to produce a consistently better product. Cultivate your system and your workforce culture well, and you will reap the bounty of a creative and dedicated workforce joining you daily, on all shifts, to improve the quality of operations and your outcomes. What we have described is a very effective culture, measures, work rules, and tools that engage all workers in our focus on quality.1–3,8 Why lead part way, giving lip service to quality without the full gain? Why pass on reducing wasteful work in all its forms—defects, rework, motion, transport, excess inventory? Why not enhance patient safety and worker and customer satisfaction? We have described our challenges and successes along our Lean journey so that you may learn from our challenges and join us in adopting Lean management and leadership for the benefit of the patients and clinicians we serve. The most important lesson of a constant quality focus on continual process improvement is that whatever progress in production you have obtained, there is further opportunity for improvement. Or, in the words of Henry Ford—“We know from the changes that have already been brought about that far greater changes are to come, and that therefore we are not performing a single operation as well as it ought to be performed.”5
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Dimenstein et al. (2009) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: