Technology's answer to labor and resource constraints.
The increasing stress placed on health care providers by case mix and by financial and legal concerns has challenged the laboratory as well. Physicians need fast, accurate lab services.|1~ The critical nature of patient populations in today's hospitals has forced physicians to demand faster turnaround time.
* Relieving Stat abuse. The available pool of health care workers is declining. The American Society of Clinical Pathologists identified a 45% drop in the number of medical technologists registered annually from 1985 to 1990.|2~ Trends in nursing and respiratory therapy have been similar.
Physicians' heightening needs in the face of a dwindling pool of health care providers present an administrative problem. Both laboratory and physician are responsible for creating abuse in Stat testing, which has risen uncomfortably in many institutions. Many laboratory managers refuse to believe they have a turnaround problem. When guidelines are either not established by the lab or not accepted by physicians, test ordering spirals unchecked.
Stat abuse is invariably costly to an institution. When Stat testing represents too large a proportion of the laboratory workload--10 to 35% is not uncommon--the resulting price tag is painfully high.
Recent trends in technology allow accurate and timely results of many assays that can be performed by employees other than medical technologists. Point-of-care testing therefore provides an alternative to the clinical staff to improve turnaround time for critical results and may cut down orders for Stat testing.
Historically, laboratorians have opposed clinical testing outside their own walls. The high cost of equipment, quality control measures to be established and monitored, potential difficulties of operation, and other issues have inhibited decentralization in the past. Traditional laboratory instrumentation could not be used with confidence outside the central laboratory because its maintenance, troubleshooting, and operation were too complex to take elsewhere.
In a prospective payment or managed care environment, administrators seek ways to reduce length of stay and to move patients to less care-intensive units. The higher price of remote testing is often justified by its ability to reduce costs in clinical units in the long run.
* Ease of operation. Dependable assay systems now on the market can be used by health professionals other than medical technologists. Many new instruments offer continuous long-term calibration, system controls, and internal quality control packages, all of which permit their use at the point of patient care.
Besides providing accurate results, most of these systems have been designed to be operator-friendly. A structured orientation program for all operators permits them to be used without confusion.
* Selecting operators. Instruments to be run on the patient care unit by nonlaboratory personnel, such as physicians, nurses, respiratory therapists, and nursing support technicians, should be chosen for their ability to keep reagents stable for long periods and to hold calibration for an extended time. Cooperation with the central laboratory in establishing standard operating procedures, quality control protocols, and training of operators helps prevent many problems.
Bedside testing currently functions in only limited ways. Potential test spectrums for bedside testing and decentralized laboratories are defined in Figure I. The remote testing menu should be driven by user need, not by available systems.
An alternative to bedside testing is a decentralized laboratory that will serve a unit or clusters of units or services and be managed by the central laboratory. As determined by the testing menu, the staff might include medical technologists, medical laboratory technicians, or laboratory support technicians. Instruments in such a setting would be more complex than those used directly at the bedside.
It has been speculated that making the same care provider responsible for both requesting and performing tests would cause laboratory utilization to decrease.|3~ To date, that theory has not been proved.
* Choosing the menu. While the decentralized laboratory requires extra effort by the central laboratory staff, the implementation strategy is eased in that it parallels some of the service responsibilities of the central lab. The test menu should be negotiated with users. Service levels, such as the maximum acceptable phlebotomy response time, should be defined. Expectations for test turnaround time must be discussed as well.
* Documentation. Keeping track of testing on the clinical units provides a challenge to the central laboratory staff. Training of operators and daily quality control must be documented for regulatory purposes. In addition, each set of test results must be entered in the patient's medical record in a format that will allow it to be retrieved with other laboratory data.
* Operator safety. While universal precautions are expected to be followed throughout the hospital, performing certain unaccustomed tasks related to decentralized testing may increase the direct exposure of many health care workers to patients' body fluids, particularly blood. Thorough and repeat education will be necessary regarding the disposal of blood and reagents, the potential for needlesticks, and instrument contamination. The new situation will affect not only physicians, nurses, and other health professionals who are familiar with such topics but also housekeepers and other hospital personnel who have not been involved in such issues to any great extent.
* Quick results. A substantial advantage of decentralized testing is the speed with which it makes laboratory data available. When the person managing the patient is performing the testing on site, clinical response to test results can lead to prompt therapeutic action. If a care provider needs immediate chemistry and hematology profiling, the decentralized laboratory can accommodate those needs.
* Small specimen size. With the advent of whole blood analyzers, specimens obtained for decentralized testing are usually very small. Often only 0.5 ml or less of whole blood is required to perform a complete blood gas and electrolyte analysis. Specimens need not be transported to the laboratory if analysis is done directly on the unit. Preanalytical error is minimized because testing is performed shortly after the specimen has been obtained.
* Troubleshooting in advance. Many of the potential disadvantages of decentralized laboratories can be reduced through careful planning.
* Cost. While capital costs associated with bedside testing are almost always lower than those in the centralized laboratory, the cost of reagents per test may be higher in decentralized locations. Incremental labor expense on a nursing unit should be compared with funds saved through potentially reducing labor in the laboratory. Each institution must compare the costs of providing similar services. Multiple quality control and proficiency testing programs will appear on the overall bill as well. Labor productivity in many cases will offset any incremental reagent costs and may actually reduce operating costs.
* Lack of standardization. In large institutions, it is often difficult but always crucial to standardize methods throughout the facility, By taking a leadership role in training and troubleshooting, the laboratory should be able to disentangle any complications caused by using multiple systems for the same analyte. Correlation studies should be completed to determine bias, if any, between instruments.
When the central laboratory is responsible for decentralized laboratory areas, procedures are more likely to be standardized. Technical accuracy and precision are easier to achieve in a controlled environment. The impact of current and future regulations can be managed best in this way as well.
* Staffing. In most regions it is difficult to find staff to run decentralized laboratories properly. The still-limited levels of technology available for decentralized laboratories will not permit significant reduction of staff in the centralized laboratory. Through the 1990s, labor-intensive functions such as microbiology, blood banking, special chemistry, toxicology, special hematology, and immunology will continue to be performed centrally.
Much of the responsibility of bedside testing is expected to be assumed by the nursing staff. Yet in many institutions, the resources of the nursing department are no less limited than they are in the laboratory. Facilities that rely heavily on nurses from temporary agencies should restrict nurses' performance of decentralized testing.
If laboratory testing is forced into nursing function queues on patient units, it will compete for priority with responsibilities of direct patient support, such as distributing medications and monitoring vital signs. Placing testing at the end of a long line of high-priority tasks could delay testing considerably.
Use of the clinical laboratory may well increase in the near and distant future. Such heightened utilization would have an impact on patient cost and specimen priority. If volume becomes so large that all specimens must enter a queue, little will have been gained by the proliferation of decentralized laboratories.
Unless local regulations forbid it, some testing in decentralized sites can be delegated to laboratory assistants and nursing assistants. Taking advantage of this strategy requires installing simple technology, providing excellent training programs, and maintaining intensive supervision at all times. A remote testing program centered on testing done by such employees should be carefully planned and monitored. This role may be expanded as appropriate.
* Insufficient test volume to justify. Medical urgency in certain areas of the hospital invites the introduction of off-site testing even when volume is low. The monitoring of diabetic or anemic patients, for example, may be improved by having a decentralized laboratory available nearby. The need for fast turnaround time, small specimen size, and efficient communication of results in such circumstances would overshadow the question of test volume generated.
* Space. Initiating decentralized testing forces the laboratory to obtain patches of real estate on already crowded clinical units. If space cannot be found for mini-laboratories, bedside testing is an alternative. As manufacturers downsize instrumentation, space limitations will become less of an issue.
* Appropriate technology and setting. The decision to implement point-of-care testing should not be based on a desire to use the most advanced existing technology throughout a hospital. The driving force in determining which tests are candidates for decentralized testing should be medical need. Because rapid turnaround of blood gas results greatly eases the tedious process of weaning a patient from a ventilator, for example, decentralized testing would be appropriate in such a setting.|4~
No single type of testing is likely to be appropriate for all units in any medical institution. In a geographic area where care per day or even per hour is expensive, a decentralized laboratory can dramatically speed patient care and shorten length of stay. Intensive care units and emergency rooms are excellent candidates for decentralized laboratories. Bedside testing might be best utilized on medical floors and in operating rooms and small emergency rooms.
In contrast. installing decentralized testing to support psychiatric or orthopedic floors may not be cost-effective. Planning the sites of such testing requires a careful assessment of medical needs and a financial analysis of each unit under consideration.
* Bedside versus other decentralized testing. Implementation programs for bedside testing differ substantially from those for other kinds of decentralized laboratories. Although decentralized laboratories require considerable initial input from the user, they can be designed for fairly permanent accuracy and efficiency that leaves little room for error. Bedside testing, a greater managerial challenge, involves constant communication between the central laboratory and nurses, physicians, and administrators. To insure a strong focus on technical and procedural issues, all decentralized laboratories should be staffed with personnel who have reporting relationships with the central laboratory.
Early in the planning process it should be established who will operate the equipment and to whom they will report. Bedside testing need not necessarily be the full responsibility of the nursing staff; nevertheless, it should employ some form of matrix management that involves the clinical units.
* Coordinator. A medical technologist should be appointed ancillary testing coordinator, communicating directly with operators, physicians, nurses, the institution's purchasing department, and outside vendors. This person must therefore be experienced in managing troubleshooting, logistics, operator turnover, training, and quality control.
* Training. Staff orientation given by the coordinator is key to a successful program. In-service sessions should cover all aspects of operating the instruments and the proper methods for documenting data. Since new operators may not be experienced in quality control protocols, a basic introduction to QC should be given. Procedures, quality control, quality assurance, and training must be defined in a format similar to that used in the central laboratory. Considerable time should be spent orienting personnel to a patient-focused environment.
Most important, the operators need to understand when the instrument is not working and what to do about it. Each operator should demonstrate the ability to perform an unknown. Only operators who have successfully completed a full training program should be allowed to use the instruments. To insure accuracy, the equipment must be easy to use. To help prevent unauthorized use of the equipment, it is essential to install continuous system safeguards.
Simple but detailed procedures for bedside testing should be written and standardized across all clinical units. Working with clear, concise lab worksheets helps operators to maintain the logical flow of data.
* Result reporting. There are numerous ways to communicate test results to care providers. These include the telephone, personnel or mechanical transport, facsimile machines, and various electronic means. Considerable review is necessary in the selection of an efficient and accurate mechanism for result reporting.
* QC/QA. Quality control protocols should meet all regulations while remaining reasonable for each site. Quality assurance programs should focus on the impact of the laboratory data on patient care (see "Challenges in maintaining quality control and quality assurance"). No staff orientation or laboratory analysis should be performed until these procedures have been defined and approved by the medical director of the laboratory.
Both the pathologist and medical staff should take an active role in utilization review. Laboratory workload before the decentralized laboratory was established should be compared with the workload after the service was implemented. Increased laboratory utilization during that period may indicate problems in the new laboratory or with physicians' test ordering practices. The goal of decentralized testing is not to increase laboratory utilization but to optimize patient care. Any increases in testing should be closely reviewed.
* Transition. The migration of laboratory testing to the patient's side can have a positive effect on patient care. While some laboratorians may find this transition difficult to accept, technology will continue to fuel this trend in the 1990s. Laboratory leadership is essential to the process. Without it, the transition may even be harmful to the patient.
Decentralized testing is a management challenge different from most others faced by the central lab in a health care institution. If the laboratory management team identifies needs, reviews available resources, forecasts problems, and plans strategically with a view to effects throughout the hospital, decentralized testing can provide chances to work closely with the clinical staff to improve patient care. For a decentralized program to be effective, the staff of the central lab should be part of the critical care team.
1. Chernow, B. The bedside laboratory: A critical step forward in ICU care. Chest 97: 183S-184S, 1990.
2. Boyd, R. (personal communication). American Society of Clinical Pathologists, Chicago.
3. Marks, V. The clinical laboratory: Nearer the patient. Adv. Pathol. 1: 1-30, Chicago Year Book Medical Publishers, 1988.
4. Zaloga, G.P. Evaluation of bedside testing options for the critical care unit. Chest 97: 185S-190S, 1990.
5. Belsey, R., and Baer, D. The technologist's role in quality management, Part II. MLO 19(10): 45-53, October 1987.
Figure I Alternate-site testing options Bedside testing Decentralized laboratory Glucose Electrolyte profile Hemoglobin BUN, creatinine Urine dipstick Glucose Sodium, potassium, Blood gases ionized calcium Ionized calcium Blood gases Pregnancy testing Select therapeutic drugs Complete urinalysis Coagulation screening Phlebotomy function
Challenges in maintaining QC and QA
Like testing in the central laboratory, a well-rounded decentralized testing program is continuously examined through not only the use of quality control data but also a comprehensive system of quality assurance.
* Quality control. Using some of the same quality control measures as the central laboratory offers many benefits to the decentralized site. Shared QC material can increase the database and assist in troubleshooting. QC packages in the laboratory information system (LIS) can often provide statistical data summaries. Frequency of QC sampling should be based on the nature of the technology being used. Sampling in decentralized locations may be done at a frequency different from the protocol used in the central laboratory.
Whether an internal or an external proficiency program is chosen will depend in part on local regulations. Internally, unknowns can be distributed to the units from the central laboratory. External programs are available from the College of American Pathologists and from vendors of instruments and of quality control material.
It is imperative that unit operators treat unknowns as patient specimens. The central laboratory, providing feedback to users in decentralized locations, should have the authority to halt testing when problems arise.
The success of decentralized testing depends upon the activities of alert and dedicated operators. Training programs must focus on proper technique and documentation. Lengthy discussions of methodology are to be avoided. The key is to teach the operator to recognize when data are suspect and what to do about it.|5~
Operators should be able to perform at least one unknown properly. Users should complete a written test that includes procedural questions and situations in which the decision must be made to accept or reject data. Only operators who have successfully completed this program should be allowed to use the instruments.
Simple worksheets should be designed to capture reagent lot numbers, quality control data, patient results, and operator identification. A medical technologist should review all worksheets on a regular schedule.
* Quality assurance. Among the many issues to be addressed are accuracy of results, continued competence of operators, appropriate use of data, and documentation for internal reference and to fulfill the requirements of regulatory agencies. Expertise in these matters acquired in the central laboratory is an asset in orchestrating a suitable QA program.
A good quality assurance program continually assesses the value to the patient of data obtained from decentralized sites. Effective monitors include the calculation of turnaround time from physician order to patient chart and data utilization for patient management. A thorough program of quality assurance will have a positive impact on patient care.
The author, Allen E. Valentine, is manager of central laboratory services in the department of laboratory medicine at the Johns Hopkins Hospital, Baltimore, Md.
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|Title Annotation:||MLO Special Issue: Point-of-Care Testing|
|Author:||Valentine, Allen E.|
|Publication:||Medical Laboratory Observer|
|Date:||Sep 1, 1991|
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