Nature and Rate of Change in Clinical Laboratories

Abstract

In response to the accelerating changes in the healthcare field, there has been a great deal of attention devoted to creating flexible designs and furnishings in hospital-based clinical laboratories. Even so, the hypothesis that hospital laboratories require a high degree of flexibility has been essentially untested. This study aims at confirming or negating this need for flexible designs and furnishings as well as providing guidance for addressing flexibility in future hospital laboratory constructions and renovations.

On a theoretical level, an environment-based approach to studying how buildings are used over time inspired this study. Building on Frank Duffy’s “Time-layered perspective” and Stuart Brand’s “Shearing layers of change,” the framework for this study was developed around the specificity of the hospital-based clinical core laboratory. The premise of the framework is that it is important to look at the multiple physical layers in the laboratory in relation to the internal forces (the activities that are housed in them) and the external forces (the technological processes, market forces, and healthcare practices) that define or influence the activities.

To explore the nature and rate of change in clinical laboratories, a multi- methodological approach employing both survey research and case study research was used to triangulate conclusions. Self-reported data was collected from a total of 240 hospital laboratory staff from the Clinical Laboratory Management Association’s (CLMA’s) membership list using an interactive web-based questionnaire. The sample represents a national cross section of clinical laboratories in community- based hospitals. Case study research was also used to explore three common laboratory typologies—a compartmentalized laboratory, an open/flexible laboratory, and an automated laboratory—with the intent of documenting specific examples of types of changes considered or completed by clinical laboratories.

Findings are organized in three areas: specific activities, technological processes and the physical environment. The physical environment is further divided into three physical layers: infrastructure systems, space plan, and contents in the laboratory. This research supports the premise of planning and designing clinical laboratory environments that are flexible, and versatile to support multiple laboratory applications. The goal of this study is to contribute to a body of knowledge that will help reduce the recurring problem of obsolescence in healthcare buildings by understanding the relationship between activities, the technological processes and the physical environment.



Introduction

“From tasting urine to microscopy to molecular testing, the sophistication of diagnostic techniques has come a long way and continues to develop at breakneck speed. The history of the laboratory is the story of medicine’s evolution from empirical to experimental techniques and proves that the clinical lab is the true source of medical authority.”

Darlene Berger, 1999 “Ancient Times Through the 19th Century”

The practice of laboratory medicine evolves as different methods of determining diagnosis are discovered. Over the last 800 years, there have been numerous scientific breakthroughs in both diagnostic methods and tools, such as the creation of blood tests, cause of coagulation, and the invention of the vacuum flask. The current state of knowledge in laboratory science allows for a more objective method of determining a patient’s physiological condition. This objective method of determining diagnosis is remarkable, yet the consequence is that there is an increased dependency on technology, the machines that produce the data, as well as medical practices that help direct these technologies (Berger 1999).

Today, the clinical laboratory is physically enormous; it represents the third largest hospital department following surgery and radiology. It houses sophisticated instruments and equipment, which are used to analyze body fluids and tissues. Test results are used in the prevention, diagnosis, and treatment of patients. Although the laboratory is often viewed as an ancillary service, the information produced in the laboratory is indispensable to the practice of medicine. In fact, estimates have shown that clinical laboratories provide about two-thirds of all the objective information regarding the status of health (cited in Coffman 1998).

Consequently, this may be why some predict that with more improved intellectual process control and data management, the laboratory may become the most frequently used, and most important, source of diagnostic information in medicine (Felder et al. 1999). Others predict that as clinical laboratory results are refined and incorporated in outcomes optimization schemes, laboratory results will become “the focus of managed care, health maintenance, and disease management companies within the next 5 years” (Markin and Whalen 2000).



The accelerating rate of change in technology in general, medical science, the delivery of medical care, and market forces are all forcing healthcare providers to reassess the role and nature of hospital-based clinical laboratory services and facilities. As a result, providers are either contemplating, or making, significant changes in both the nature of clinical laboratory services and the facilities where these services are provided. To respond to the accelerating changes in the healthcare field, there has been a great deal of attention devoted to creating flexible designs and furnishings in hospital laboratories.

Even so, the hypothesis that hospital laboratories require a high degree of flexibility has been essentially untested. Therefore, this study aims at confirming or negating this need for flexible designs and furnishings as well as providing guidance for addressing flexibility in future hospital laboratory construction and renovation projects. This study targets clinical core laboratories located in community hospitals. The core laboratory is the primary laboratory performing comprehensive testing versus a satellite laboratory which is a smaller laboratory performing a select test menu.

A review of the literature shows that significant changes in clinical laboratories may be attributed to technological/equipment advances (Wilson 2000), pressure to contain costs and operate efficiently (Wright and Ferguson 2001), regulatory requirements (Mortland 2000), and healthcare trends (Felder et al. 1999). These four forces were studied with respect to both the physical environment and the delivery of laboratory services. Despite the articles that note the motivators of change, no recent research study was found that documents the comprehensive nature and rate of physical facility changes in hospital clinical laboratories. This study targets this gap in the research.

The fundamental question to answer is, “What is the nature and rate of change in the clinical laboratory?” To answer this general question, three areas are identified. First, it is necessary to explore the range of testing activities and human activities that are specific to clinical laboratories located in hospitals. Second, it is necessary to explore how the laboratory operates, or the technological processes that support diagnostic testing in the laboratory. Finally, it is necessary to explore the multiple layers that define the physical environment in relation to the first two areas to understand how, where and when the physical environment needs to change.



These three areas: specific activities, technological processes, and the physical environment provide a structure to ask more specific questions.

1. SpecificActivities

What specific activities change in the clinical laboratory? Where do they change? How do specific activities change? How often do they change in the laboratory?

2. Technological Processes

What technological processes change in the clinical laboratory? Where do they change? How do technological processes change? How often do they change?

3. Physical Environment

What aspects of the physical environment [infrastructure, space plan, and contents] change in the clinical laboratory? Where does the physical environment change? How does the physical environment change? How often does the physical environment change in the laboratory?

This report is organized into three sections: Methods, Findings, and Conclusions. First, the Methods section discusses the theoretical frameworks influencing this study, a proposed framework that applies to the clinical laboratory, and the research methods used: survey research and case study research. Second, the Findings section is organized around three areas: specific activities, technological processes, and the physical environment. Within each section, a series of claims have been formulated from the research. Following each claim, findings from the survey and case study research as well as the existing literature are integrated and presented as evidence. Finally, in the Conclusions section, the future of the clinical laboratory is outlined in relation to the idea of change. Responses from open- ended questions noting the clinical laboratory areas that anticipate the most changes in the next five years as well as strategies to prepare for these changes are discussed. In addition, four design principles are presented as strategies to plan for change.