Clinical Issues

Quality improvements in the preanalytical phase:
Focus on urine specimen workflow

By Ana K. Stankovic, MD, PhD, MSPH, and Elizabeth DeLauro, MBA

The preanalytical phase of the total testing process is complex. It starts with the perceived need for the test and ends with specimen processing.¹ It is not surprising that between 32% and 75% of all testing errors occur in the preanalytical phase.²

Considering the amount of automation and process controls that exist in the analytical phase versus those in the preanalytical phase, it becomes apparent why this is the case. Not all preanalytical errors cause adverse events, because many of these ‘‘upstream’’ errors may be caught during "downstream" processes or are minor enough that, if undetected, they do not impact patient outcomes.² They often are associated, however, with rework or further investigations, which result in unnecessary risk to the patient and unjustifiable costs to the healthcare system.

Preanalytical improvements primarily have centered on blood specimens, mostly driven by increasing levels of automation and need for standardization. Urine collection and processing have lagged behind and represent areas with much opportunity for improvement. Although still predominantly a manual process, urine testing is currently facing increasing levels of automation. As a result, in most markets automated urinalysis is growing faster than automated chemistry (22% growth rate in 2004). The growth of urine testing is mainly driven by automated microscopy in developed countries and traditional urine chemistry in developing markets.³

These advances in urine testing and the fact that urinalysis remains one of the three major in vitro diagnostic screening tests — after serum chemistry profiles and complete blood counts⁴ — create the need to take a hard look at the urine testing workflow and underscore the importance of reducing preanalytical variability.

There are significant opportunities for process improvements, efficiencies, and cost reductions in the area of urine testing. Worldwide, healthcare spending on urine testing is approximately $566 million annually,³ and assuming an effectiveness level of 95%, the estimated global cost of inefficiencies in urine collection, testing, and analysis is nearly $30 million per year. This figure generates a new degree of urgency to focus preanalytical improvement efforts on processes associated with this area of laboratory testing.

The preanalytical phase in urine testing can be divided into six major subphases shown in Figure 1.

Figure 1. Preanalytical urine specimen workflow.

Each of these subphases contains between two and five steps, so the average preanalytical urine testing workflow consists of at least 22 steps. Some of these steps, such as sample collection, can be subdivided into activities that further complicate the urine preanalytical testing process.

Urine specimen collection process

Urine specimen collection varies considerably, depending on the setting in which the specimen is collected. The variability in how specimens are collected — where, when, and by whom — results in a wide range of different activities within this preanalytical step and increases the likelihood of errors. For a urine specimen requisition in an inpatient setting, the requisition is provided to the nurse or appropriate healthcare provider on the unit notifying her of the test order. The healthcare provider gathers the necessary materials for specimen collection and enters the patient room at the appropriate time based on the requisition. Subsequent steps differ depending on the age and status of the patient.

For an adult patient who does not require assistance, the healthcare provider should give the patient instructions on how to perform a proper collection (i.e., a midstream, clean catch) and the required materials to capture the specimen upon voiding. The patient performs the required cleansing and voids, as appropriate, into the container provided. For a dipstick test, the healthcare provider may insert the dipstick into the specimen at the site of collection, and read and record the results into the patient’s medical record. At that point, the urine specimen and container may be disposed of in the patient’s bathroom. These steps for urine collection and handling also may be followed in an outpatient clinic setting.

For a patient who is bedridden or cannot urinate independently, a healthcare provider inserts a Foley catheter into the bladder through the urethra to collect the urine specimen. Alternately, specimens may be collected directly from a Foley catheter into an evacuated tube or transferred from syringe into a tube or cup.⁵ For infants and small children, a special urine collection bag is adhered to the skin surrounding the urethral area. Once the collection is completed, the urine is poured or transferred directly into a collection cup or transferred directly into an evacuated tube with a transfer straw.⁵

For a urine test that requires processing by the laboratory, the healthcare provider should transfer the specimen into a safe, clean transport container (e.g., a tube) and label the specimen container at the point of collection. Care should be taken to ensure that the specimen is labeled correctly at the point of collection and transferred into a transport container that is also appropriately labeled. Many urine specimen collection cups are not designed to sustain transport within a hospital’s pneumatic tube system. Multiple systems are available to enable a closed transfer of the specimen from the collection cup into a closed, transport-safe container, including transfer straws and cups with lids that contain integrated transfer devices. These systems ensure the healthcare provider’s risk in handling a potentially contaminated specimen is reduced and there are no opportunities for introducing contaminants into the specimen during transport.

Preanalytical variables

Common areas of preanalytical variability in urine testing include patient-related factors, specimen collection, specimen identification and labeling, specimen transfer and transport, and specimen processing. Their effect on urine testing is described here in more detail:

Patient factors : Patient factors (e.g., diet, medications) can impact various urine test results, such as color, specific gravity, pH, or clarity, and can cause testing errors.⁶ For instance, consumption of beets and rhubarb can result in change of urine color to red. Presence of a high concentration of ascorbic acid in urine has been linked with false-negative urine glucose and bilirubin dipstick results. Similarly, tetracycline therapy has been shown to cause false-negative urine glucose dipstick results.

Specimen collection : Specimen collection is an important source of preanalytical variability. The collection method affects the quality of urine specimens and, if selected properly, decreases the risk of specimen contamination and healthcare workers’ exposure. For urine culture and sensitivity testing in particular, use of the midstream, clean-catch method is preferred because it reduces the incidence of cellular and microbial contamination.⁵ Appropriate collection containers or tubes can decrease the possibility of specimen leakage in transit, particularly in pneumatic tube systems, and ensure optimal quality and quantity of specimen for analysis. Collection of unpreserved urine specimens is more likely to result in bacterial overgrowth if the specimens are not refrigerated, as refrigeration decreases urine clarity and causes false-positive nitrite and false-negative glucose results.⁶ It is also important to avoid introduction of contaminants during specimen collection. In obtaining pediatric urine specimens, for example, collecting urine from a diaper can introduce contamination from the diaper material, which may affect the test result.

Inaccurate labeling of a urine specimen : Inaccurate labeling of a specimen with patient identification, date and time of collection, and suboptimal placement of the label can compromise the laboratory’s ability to process a urine specimen and obtain a correct result. If not recognized in time, inaccurate patient information can result in laboratory errors. On the other hand, if recognized before the onset of testing, it slows the analytical process by requiring either specimen recollection or further physician approval before analysis, thereby delaying reporting of results. Improper label placement can lead to misidentification of the specimen later in the handling and analytical process if the specimen container lid with the label is removed or if the label does not adhere to the container during refrigerated conditions.⁵ As a result, the primary goals listed in The Joint Commission’s 2010 National Patient Safety Goals for the Laboratory include the use of at least two patient identifiers when providing care, treatment, or services and establishing processes for maintaining a specimen’s identity throughout the preanalytical, analytical, and post-analytical processes.⁷

Use of evacuated tubes that can be labeled at the bedside reduces the risk of identification errors. Misalignment of bar-coded labels on tubes also can be a source of identification errors, however. Instrument bar-code readers cannot ‘‘read’’ the bar codes on misaligned labels; sometimes it is enough for a label placement to deviate only a little from the ideal position to present a problem. As a result, the misaligned label must be removed and replaced with a properly placed label, which creates the possibility for an identification error to occur.

Transport of urine specimens : Improper transport of urine specimens can impact sample quality directly. Increased length of time between specimen collection and analysis, lack of temperature control, and use of non-preserved specimens that will not be analyzed within two hours of collection (e.g., samples that come from satellite locations or are collected during a 24-hour collection) contribute to overgrowth of bacteria in the specimen. This can, in turn, impact urinalysis, and culture and sensitivity test results. To prevent this from happening, the College of American Pathologists’ accreditation program requires examination of non-preserved, non-refrigerated urine within one to two hours of collection and defines non-compliance with this standard as a phase II deficiency that requires immediate and documented improvement before accreditation is granted.^8,9

If a laboratory cannot analyze a non-refrigerated, non-preserved specimen within the recommended time frame, however, other acceptable options can ensure optimal specimen quality. One of them is the use of non-refrigerated, preserved urine specimens that can be analyzed up to 48 hours after collection for culture and sensitivity and up to 72 hours for urinalysis (manufacturers’ recommendations should be reviewed for product-specific guidance).¹⁰ Clinical and Laboratory Standards Institute (CLSI) recommends that refrigerated, unpreserved specimens be maintained at 2°C to 8°C. When preparing for analysis, it becomes equally important to allow refrigerated specimens to return to room temperature in order to enable temperature-dependent enzymatic reactions to occur during analysis⁶ and to prevent any false signals from crystals formed during refrigeration. When preserving specimens for transport and analysis, use of an evacuated container helps to ensure that the proper preservative: specimen ratio is adhered to, because evacuated tubes are designed to draw a specific sample volume.⁵

Specimen processing : Variables in specimen processing, such as centrifugation, impact the quality of results. Variation of speed and time can change the cellular elements obtained in the sediment.

Additional factors : The chronic struggle of laboratories to address ongoing labor shortages, budget reductions, and increasing test volumes within their own walls can impact the quality of the results the laboratory is able to generate and the revenue or reimbursement that the laboratory is able to capture. Specifically, high turnover and lack of training and education on how to properly collect and handle urine specimens can result in higher specimen contamination rates.

Opportunities for preanalytical process improvement

The various methods through which a urine specimen can be obtained and their manual nature can contribute significantly to preanalytical errors. The fact that many of the steps in the preanalytical phase are performed outside the walls of the laboratory and often by personnel not managed by the laboratory creates further challenges for the laboratory in controlling the steps that contribute to preanalytical variability. The laboratory is often accountable for the outcome (clinical and financial) of this phase and for resolving — if not overcoming — the preanalytical challenges. At the same time, clinical laboratories are constantly faced with pressures to continually increase productivity, lower costs, and improve quality. To address these challenges, the laboratories can use several cost-effective tools designed to standardize and optimize urine collection and handling and positively impact the quality of urine specimen results.

Application of LEAN management methodologies : To meet the increasing pressures that the clinical laboratories are currently facing, many laboratory administrators and pathologists are faced with the fact that radical increases in quality, productivity, and error reduction cannot be achieved using the traditional management models. ‘‘By contrast, the pioneering laboratories in the United States that use LEAN and Six Sigma to redesign workflow in their high-volume core chemistry and hematology labs found that these quality management systems — in a 12- to 16-week project —could lead to a 50% reduction in average test turnaround time for a hospital lab, a 40% to 50% improvement in labor productivity and a comparable improvement in quality of results.¹¹ When considering the more highly manual processes involved in urine specimen collection and handling, one also could hope to achieve similar benefits from application of LEAN and Six Sigma principles to the urine collection, handling, and processing areas. LEAN management centers on reducing waste and offers a set of tools that do not require significant capital investments to be effective and can have immediate and recognizable impact when applied properly. Six Sigma is a metric and a methodology that focuses on reducing variability (i.e., counting and decreasing the number of defects in a process). A process that performs at a Six Sigma level realizes defects at a rate of 3.4 occurrences per million opportunities. Used in combination with LEAN tools, Six Sigma methodology can enable an organization to monitor and improve its quality performance based on the elimination of errors where possible (i.e., LEAN) and reduce or manage them in parts of a process that cannot be eliminated (i.e., Six Sigma). For the purposes of this discussion, we focus specifically on the application of LEAN principles to the preanalytical process in urine specimen collection.

Simply put, the fundamental principles of LEAN management emphasize reduction of unnecessary and non-value-added activities to reduce total production time and effort. LEAN tools focus on identifying steps that are error prone and must be controlled if they cannot be eliminated altogether. LEAN management principles challenge doing things the way they always have been done in favor of simplified and standardized methods of performing tasks that support getting things done right the first time with minimal wasted time and effort. One highly effective tool in applying LEAN thinking is the process map, which is constructed by recording all steps in a current process or subprocess and illustrating the current state (i.e., ‘‘as is’’). LEAN tools, such as process mapping, enable organizations to take a critical inventory of the activities taking place within their laboratories and activities external to the clinical laboratory but relevant to testing processes. Armed with knowledge of what is actually taking place, as represented by a process map, laboratory management is better equipped to identify how the process should look (i.e., the ‘‘to be’’ process) in order to obtain better and more productive outcomes.

‘‘To be’’ processes are streamlined processes that are flexible, reduce waste, optimize the process, improve process control, and improve use of resources. For the clinical laboratory, improved use of limited resources is a continuous quest, and the benefits to the laboratory of application of process mapping and LEAN thinking becomes clear. Figure 2 provides a simplified example of a current state process workflow analysis, focused on the subprocess within the laboratory from urine specimen accessioning to specimen disposal, at a hospital before a LEAN workflow implementation. All of the major process steps are captured, regardless of whether they support good practice or whether they represent value-added activities or contribute to delays in providing results. Steps that represent potential for error and steps that do not contribute value to the target end product, or result, but consume time or resources are indicated as such.

Figure 2. This process map shows 17 steps for urine specimen transport and handling in the laboratory; 11 steps can be eliminated to implement a LEAN process.

The Xs in Figure 2 illustrate the impact of applying LEAN management principles to the urine specimen collection and handling process shown. Non-value-added or error-prone steps are either removed or controlled in the revised process, resulting in a more efficient, timely, and standardized process. Specifically, by changing the method of urine specimen collection, 11 steps were removed from the process. All three of the error-prone steps were eliminated, two of them in the preanalytical phase, including the open transfer of specimens into tubes from cups and the relabeling of specimens. This change created a safer environment for the laboratory staff and decreased the risk of testing errors for the patient. Five non-value-added steps were eliminated, three from the preanalytical phase, which increased the efficiency and reduced the waste of the laboratory staff and materials. Overall, the eliminated steps represented 64% of all steps in the process.

This example illustrates how the use of a simple tool, which does not require significant capital investment to execute, can lead to visible quality improvements by simplifying the preanalytical process in the lab and eliminate opportunities for errors.

Additional LEAN tools, such as value-stream mapping, also can be applied. This tool determines the amount of time taken for completion of the entire process, as well as each step in a process flow, and categorizes those activities into value-added and non-value-added activities. The total time to perform value-added and non-value-added activities is then quantified in the pre- and post-LEAN implementation flow charts. The reduction in non-value-added time can be quantified as potential savings based on the wage data of laboratory and other hospital personnel involved in performing those steps. Based on the resulting total time indicated from collection to analysis, tools and products can be applied to the new process flow, such as the introduction of tubes with urine preservative. For example, if unpreserved, unrefrigerated urine specimens are not analyzed within two hours of collection, then the laboratory can further reduce its specimen errors and improve quality of results in the first attempt by refrigerating the specimen at 2°C to 8°C or preserving specimens until the specimen can be analyzed appropriately.¹⁰

Additional tools : Additional tools are available to aid in standardizing work across various collection settings and among various individuals involved in performing urine collections.

Devices : Devices are available to provide further support to the laboratory in ensuring quality urine specimens. In manual and automated analytical settings, urine containers with preservative enable the laboratory to balance the flow of specimens requiring analysis that come into the laboratory with the available resources to complete the analysis in a timely manner. For organizations that currently face staffing challenges without adequate volume to justify automation, using preservatives with urine specimens enables the analytical workload to be balanced over the peaks and troughs during a longer time frame — up to 72 hours for urinalysis and up to 48 hours for culture and sensitivity testing — without refrigerating specimens.

Closed systems for transfer and transport of specimens : Closed systems reduce the risk of exposure of healthcare workers to contaminated specimens and the exposure of specimens to contaminants during transfer and transport. Amber-colored urine containers protect specimens from light sensitivity for certain urine tests (e.g., bilirubin).

Instructions for clean, midstream catch : Instructions posted in areas where patients are voiding into urine containers — translated to languages other than English, if necessary — can reduce the risk of contamination of specimens and mitigate insufficient training caused by high turnover in staff.

Impact of preanalytical process workflow on automation

Opportunities for automation of urine specimen analysis continue to improve, including the ability to perform urinalysis and microscopy of urine sediment on a single platform. Further opportunities include autoverification of results, which can eliminate the need for medical technologists to review thousands of normal test results before releasing them. Automation of urinalysis enables the clinical laboratories to absorb substantial volume increases without adding staff.

Implementation of automation without improvement of the preceding preanalytical processes often creates a new set of issues for the laboratory to resolve. Experience shows that automating a bad process only serves to speed up problems, and potentially magnifies the problem and its associated cost. The value of investing effort in streamlining or redesigning current preanalytical processes before implementation of automation should not be underestimated. LEAN management and Six Sigma are only two examples of quality-management methods that can be used to improve processes before investing in automation.

Business case for preanalytical process improvement

Before determining the appropriate steps that will lead to the reduction of preanalytical variability in urine specimen collection and handling, an institution must understand what factors impact the preanalytical phase of urine testing the most, in order to determine the true causes for preanalytical errors and apply the right solutions to get optimal results the first time.

The business case for reducing preanalytical variables can be as simple as measuring the number of urine tests that do not get reimbursed because of preanalytical quality issues, such as urine culture contamination or urine bacterial overgrowth. At its most conservative, the lowest urine test reimbursement rate could be used, such as the Medicare rate for manual urinalysis without microscopy. At the higher end, the Medicare reimbursement for urine bacterial culture could be used.¹² These figures represent the billable charges that a laboratory could capture but did not because of lack of a result. This does not begin to factor in the lost productivity of employees who are already challenged in a resource-constrained laboratory environment. Whether viewed as a revenue opportunity or a cost-avoidance opportunity, a laboratory can do a simple calculation to qualify the value of controlling preanalytical variability.

Simple principles such as LEAN — eliminating unnecessary activities and getting it right the first time — can be applied easily without sophisticated technology when the right focus and tools are applied. Given the pressures prevalent in the modern laboratory environment, laboratory management cannot afford to ignore the options available to control processes, drive efficiencies, and gain improved charge capture for urine specimens.

Primary constraints that laboratories currently face are personnel shortages and lack of financial resources. The business case for quality improvement is a critical component for justifying the resources required to implement change in the preanalytical process. Fortunately for laboratorians, cost-effective external resources are available to conduct the required analyses to identify an organization’s specific areas for improvement and implement the required changes and process controls. Laboratory success stories exist that support the cost justifications to pursue quality improvement, whether through LEAN and Six Sigma applications, use of readily available devices, or other similar approaches.

Summary

In the past, laboratories have addressed issues of preanalytical variability in an opportunistic way, addressing discrete parts of the preanalytical process, such as patient identification, specimen rejection, and blood/urine culture contamination. To obtain needed quality improvements and error reduction, it is necessary to look at the preanalytical process as a whole — from test ordering to the moment the specimen is processed by the analyzer and apply process improvement methodologies, such as LEAN and Six Sigma. To achieve this, laboratories should map the preanalytical phase in its entirety, identify steps that are potential causes of unnecessary variability that lead can to laboratory errors, and find ways either to remove them or error proof them. At the same time, by using this approach it is possible to reduce unnecessary waste and obtain needed process efficiencies.

The authors — Ana K. Stankovic, MD, PhD, MSPH, Medical and Clinical Affairs, and Elizabeth DiLauri, MBA, Alternate Specimen Management — work with BD Diagnostics, Preanalytical Systems in Franklin Lakes, NJ. The views expressed in this article are those of the authors and not of Becton, Dickinson and Company.
Reprinted from Clinics in Laboratory Medicine, Vol. 28/Issue 2; Ana K. Stanovic, MD, PhD, MSPH, and Elizabeth DiLauri, MBA; Quality Improvement in the Preanalytical Phase: Focus on Urine Specimen Workflow/pp. 339-350; Copyright 2008, with permission from Elsevier.

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