clinical laboratory versus industry: the view from both sides

acute bronchopulmonary aspergillosis and cystic fibrosis. J. Allergy Clin. Immunol. 69:539-546.

29. Watson, K. C. et al. 1985. Distribution of biotypes of H. influenzae and H. parainfluenzae in patients with cystic fibrosis. J. Clin. Pathol. 38:750-753.

30. Wood. R. E. et al. 1976. State of the

art: cystic fibrosis. Am. Rev. Respir. Dis. 113:833-878.

31. Wright, P. F. et al. 1976. Evaluation of the safety of amantadine-HC1 and the role of respiratory viral infections in children with cystic fibrosis. J. Infect. Dis. 134:144-149.

32. Wu, B. J., and S. T. Thompson. 1984. Selective medium for Pseudomonas ce-

pacia containing 9-chloro-9(4-diethyl- aminophenyl)- 10-phenylacridan and polymyxin B sulfate. Appl. Environ. Microbiol. 48:743-746.

33. Zierdt, C. H., and R. L. Williams. 1975. Serotyping of Pseudomonas aer- uginosa isolates from patients with cystic fibrosis of the pancreas. J. Clin. Microbiol. 1:521 - 526.

Editorial

Clinical Laboratory Versus Industry: The View from Both Sides

Beatrice Miceika, M.S. Technical Specialist

Michael Graves, M.S. Manager, Biosciences, New Initiatives Vitek Systems, McDonnell-Douglas Health

Systems Co. Hazelwood, Missouri 63042

As clinical microbiologists who have left the hospital laboratory and now work for a company that manufactures products for our field, we have often been asked by friends, "What is it like to go into industry?" The questions range from, "Why did you want to leave the clinical laboratory? . . . . Why did you go commercial? . . . . Were you burnt out?" to "Do you like it?" and, "What is it really like?" The answers to these questions are not necessarily straightforward or simple and probably vary among individuals who work for different companies.

Both of us had been in clinical microbiology for more than 10 years. At the time we left, we both were senior laboratory supervisors at university medical centers with staffs of approxi- mately 25. Our work in progressive clinical laboratories was challenging and stimulating, but also often frus- trating and exhausting. Managing a clinical laboratory is not an easy task, but it can be gratifying. We both were able to conduct small-scale research/ evaluation projects, teach microbiology to various types of students, and attend continuing education seminars and na- tional meetings. So why did we leave the laboratory?

We both felt a need for a change; new challenges, new experiences, and new ways to have a professional impact on clinical microbiology. We felt that, without a doctoral degree, we could not advance much further in the clinical laboratory. Because microbiology re- mained our profession of choice, we independently sought positions in a diagnostic products company. Our present individual positions within the company are quite different; one in marketing and one in product development. Both paths have given us op- portunities for growth and professional development. We will attempt to convey our impressions about working for a company that manufactures products for the clinical microbiology laboratory.

There are some general differences between the hospital and the industrial environment. In the most simplistic terms, a company's goal is to make money, while the hospital's goal is to cure the patient (although hospitals are becoming increasingly "business- like"). These basic goals affect the work environment/culture. For example, when instituting a certain test in the hospital, factors considered are based on clinical relevance and cost-ef- fectiveness. Within a company, factors considered for developing and selling a given product include market size, development costs, production costs, and product competitiveness.

In the clinical laboratory, the amount and mix of work is dictated by the workload, which is a function of the physicians' propensity to order tests as well as the patient population in the hospital at the particular time. In industry, the work is dictated by "The

Market," that is, a composite of all customers. What an individual customer needs or desires is a company's major concern, but because of the eco- nomic need to make universal products, the needs of individual laboratories must be balanced against the needs of all microbiology laboratories.

In the clinical laboratory, the crises tend to be day-to-day (such as a patient with some unusual test results or an in- strument failure). In industry, the crises tend to be more lengthy, such as a change in a raw material that could affect product performance. Tracking down the exact component that is causing trouble and then finding an al- ternative component or making a for- mulation change can take months.

To a great extent, in a hospital environment, the technical information one is trying to communicate is understood by physicians, nurses, and other allied health-care workers. In an industrial setting one has to communicate to di- verse groups of people and disciplines. For example, in our company, probably only 10 to 15% of the people who spend their work day making and sup- porting microbiology products really know what Escherichia coli is. On the other hand, shuffling papers and at- tending meetings seem to be universal functions in any institution.

A successful business provides useful, cost-effective, high-quality products that the customer wants. For a laboratory, the product is a timely, accurate test report of clinically useful information for the physician. For our company, the goal is to make products that enable the laboratory to generate results easier, faster, and more accu- rately. The laboratory is our immediate

Clinical Microbiology Newsletter 10:2,1988 © 1988 Elsevier Science Publishing Co., Inc. 0196-4399/88/$0.00 + 02.20 13

customer and both we and the laboratory have a common end-customer, the physician.

Within a company such as ours, which is focused on products for microbiology, a wide variety of jobs are filled by microbiologists. They range from product support of existing test kits and software, quality assurance (i.e., quality control of incoming mate- rials and finished products), sales, market analysis, clinical trials coordi- nation, test kit production, research and development, and technical services and support to customers. We would like to share some information about our particular positions. One of us is a technical specialist, and the other a manager in new product development.

Technical Specialists A technical specialist "out in the

field" for our company is a frontline representative to customers and, some- times, prospective customers. The technical specialist plays a vital role in sales and marketing. The primary responsibility of the technical specialist is to instruct customers about how to operate and use our instruments and test kits, to troubleshoot technical problems, and to keep them informed about the latest product developments and enhancements. Each technical specialist has a number of customers spread over a small (if densely popu- lated) or large (if less densely popu- lated) geographic area. Our office is our home, but we are in constant contact with the company's central office. Many of the technical specialists have Master's degrees and have been laboratory supervisors, but all have substan- tial clinical microbiology experience.

Although the positions of technical specialist/representative (tech rep) and clinical laboratory supervisor have many different aspects, there are also some basic similarities. Both jobs carry a great deal of responsibility. The laboratory supervisor is responsible to the physician, to hospital administration, and, indirectly, to the patient. The technical specialist is responsible to the customer and the company. The supervisor must deal with employee, physician, and administration problems whereas the tech rep has to contend

with customer and corporate problems. Politics abounds in both the hospital and laboratory as well as within a company. The hours spent on the job are usually long for both positions. The supervisor may need to put in overtime, work weekends, and answer calls at home. The technical specialist usually spends many evenings and weekend hours on the telephone keeping com- munications going with customers, in- house coworkers, or with other field personnel. Many extra hours are spent catching up with paperwork that could not be completed during the day. Tech reps also spend considerable time in the evening traveling from one customer location to another.

Although the transition from supervisor to tech rep in industry may not seem difficult, some demands of the two positions are basically different. The tech rep's work schedule is much less structured and is subject to constant change whereas the supervisor's job is defined by the tasks that must be performed within a certain time period. The tech rep must be extremely self- motivated and independent because there is little direct supervision in the field. In contrast, the supervisor is often more driven by the tasks at hand or, possibly, by a directive from the laboratory manager or director. Tech reps must adapt to a constantly changing environment as they work, moving from one customer's laboratory to another. The tech rep must like people ("the customer is always right"), be versatile, and adjust quickly to different personalities. The laboratory supervisor must deal with different personalities among employees, di- rectors, or administrators, but, in most cases, they do not change as frequently. Tech reps supervise only themselves as compared to supervisors who manage a few to several dozen employees.

Technical specialists have the unique opportunity to visit, work with, and really get to know personnel in many different clinical laboratories. Often the tech rep acts as a liaison between these laboratories by relaying information about procedures, unusual or- ganisms, and other problems that may occur in the laboratory. A tech rep can

often be a resource person for smaller laboratories by obtaining technical information from other customers at large institutions. Technical specialists are also the customer laboratory's direct contact with the company. They relay to the company the customer's requests for product improvements or for new products that would facilitate better clinical microbiology.

Product Development Working in a product development

section is quite different from working in the clinical laboratory. In the clinical laboratory, the supervisor must manage people, procedures, and mate- rials so as to obtain an optimal workflow for turning a specimen test request into a meaningful test result. The goal is to have all "systems" ready any time they are needed. Our product development section is project oriented. People are usually assigned to a given project from the time the project is proposed or approved through the time clinical trials are ended and the finished product is ready for sale.

Our research and development (R and D) group develops new test kit systems in cooperation with other companies and research groups. The various activities in which a microbiologist is involved include: reagent development, production scale-up, developing analysis procedures for in- strument software, clinical trials, working with our Regulatory Affairs Department on Food and Drug Admin- istration submittals, product documen- tation, development of standard methods, and consulting with marketing on new product specifications. In the hospital laboratory, the subject (patient or test) varies during the day, but the discipline (microbiology) is usually constant. In industry, the subject (spe- cific test) is usually constant but the discipline varies during the day. To get out a product, which in its final form is a clinical microbiology product, we deal with people from many disciplines. These include engineers. chemists, biochemists, programmers, production staff, marketing analysts, financial analysts, technical services support, and, almost incidentally, other microbiologists.

14 0196-4399/88/$0.00 + 02.20 :t, 1988 Elsevier Science Publishing Co.. Inc. Clinical Microbiolog~ Newsletter 10:2.1988

Clinical microbiologists in R and D tend to push for the development of tests that are either new and exotic or desirable because current laboratory procedures are either too tedious or complicated for routine testing. The first question we are quickly asked after proposing such a test kit is, "What is the market for such a test?" Usually these proposed tests are not performed in high volume (for example, fungal serology or detecting Legionella spp.), but would cost as much to develop as some high-volume tests. Low-volume, high development-cost tests quickly lose their appeal to the financial analyst.

Nevertheless, R and D microbiologists do have input into how a product will work. Thus, they can affect laboratory workflow and patient care in the many health care facilities throughout the world that may eventually use the new product. Clinical laboratory supervisors, on the other hand, usually establish procedures and influence workflow only in their own laboratory, but have a more direct and immediate effect on patient care.

We have tried to relate what it is really like for two clinical microbiologists working in industry. Although the work is not the same as supervising

a large clinical laboratory, we do like it. The challenges and problems can be very different. Personal rewards and satisfaction can be gained in both types of positions, however. By leaving the laboratory, we have lost the day-to-day contact with those ever-changing mi- croorganisms and the possibility of being the first to find some new bug. However, we think we have gained the opportunity to affect the development of new products for the field of clinical microbiology which will eventually impact laboratory efficiency and patient care in health facilities throughout the world.

Letters to the Editors

To the Editors: A few important points may be

gleaned from the recent editorial by Dr. Lentino (1), although not necessarily supportive of his final conclusions. He finds, and correctly states: 1) purulent sputum is recovered as frequently from patients without pneumonia as those with pneumonia; 2) the positive predic- tive value of a purulent Gram stained specimen which yields pathogens on culture is 46.2% (slightly less than flipping a coin); and 3) a diagnosis of pneumonia is made by clinical evi- dence.

The only sensible conclusions are that sputum specimens are worthless as a diagnostic indicator of pneumonia, that they may be useful to identify the pathogens in patients already clinically diagnosed with pneumonia, and that they should be cultured only from a patient with diagnosed pneumonia. Only then does it make sense to request another sputum based upon a low Bart- lett's score. The emphasis should be the nonvalue of sputum specimens for the diagnosis of pneumonia, screened or unscreened, and the value of such material only for identification of or- ganisms.

Reference 1. Lentino, J. R. 1987. The nonvalue of

unscreened sputum specimens in the

diagnosis of pneumonia. Clin. Micro- biol. Newsl. 9:70-72.

Gerald S. Tomory, M.D. Associate Pathologist

William Boughton, Ph.D. Supervisor, Microbiology Laboratory Eisenhower Memorial Hospital Rancho Mirage, California 92270

The Author's Reply: The decision to entitle the editorial

"The Nonvalue of Unscreened Sputum Specimens in the Diagnosis of Pneu- monia" was made by the editor. I would refer the readers to the Journal of Clinical Microbiology 25:758-762, 1987.

Joseph R. Lentino, M.D., Ph.D. Chief, Infectious Disease Section Hines VA Hospital Hines. Illinois 60141

The Editor's Reply: In response to the letter by Drs. To-

mory and Boughton, who objected to the title of Dr. Lentino's editorial (1), I must take responsibility for asking Dr. Lentino to insert the word "unscreened" into the title "The Nonvalue of Unscreened Sputum Specimens in the Diagnosis of Pneumonia". This request was prompted by the observa- tion that Dr. Lentino's editorial included the following conclusions:

"Consequently those laboratories that screen sputa by Gram stain can ade- quately predict the recovery of pathogens and the absence of clinical disease among the patients producing these nonpurulent specimens."

"Our data support the notion that clinical microbiology laboratories may re- ject for culture those sputum specimens from nonneutropenic patients that fail to meet Bartlett's criteria for purulence."

With the perspective and possible bias of a clinical microbiologist, I felt that it was misleading to leave the editorial with a title that was inconsistent with the author's conclusions.

It should be pointed out that Drs. Tomory and Boughton misinterpreted Dr. Lentino's data when they com- mented that he had found that purulent sputum was recovered as frequently from patients without pneumonia as from those with pneumonia. Dr. Len- tino's Table 1 included only data from sputa that contained potential pathogens and/or purulence. The table did not include the data from 256 specimens that contained neither purulence nor potential pathogens.

The numbers in the following Tables 1 and 2 were extracted from Dr. Len- tino's editorial. They show that purulent sputum was recovered from 50 of 88 (56.8%) patients with pneumonia

Clinical Microbiology Newsletter 10:2,1988 © 1988 Elsevier Science Publishing Co., Inc. 0196-4399/88/$0.00 + 02.20 15

clinical laboratory versus industry: the view from both sides

Documents