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Joining the technological evolution in health care.

The rising cost of health care has produced changes in hospital reimbursement. Pressure has heightened to reduce the length of patient stay and to provide a greater proportion of patient care services in ambulatory care and outpatient settings. Because the costs of providing care in intensive care units far exceed those incurred on general medical or surgical units,[1,2] one goal of critical care medicine is to shorten the amount of time patients spend in ICUs by instituting therapy based on the more rapid availability of test results.

In an effort to reduce the costs associated with providing surgical care, many hospitals have created same-day surgical centers in which patients undergo diagnostic evaluations as outpatients. They arrive at the hospital on the day of surgery, have the operation, and leave the hospital on the same day, eliminating the need to receive the costly "hotel" services associated with an overnight stay in the hospital.

In short, financial constraints in the funding of health care are altering the patterns of delivery of care. Hospital stays are briefer in duration while the site of care moves, whenever safe and practical, toward shorter periods of intensive care and from an inpatient to an outpatient setting.

These changes in health care financing and in delivery patterns are occurring contemporaneously with rapid advances in medical technology. Of special is the development of laboratory instruments capable of producing high-quality test results with short turnaround times when operated near the site of the delivery of care. Some physicians believe point-of-care testing enables real-time collection of laboratory data, permitting more rapid institution of therapy. The result may reduce. the length of hospitalization for certain patients[3] and thereby reduce the cost of providing health care. While this line of reasoning carries strong appeal, carefully conducted controlled studies need to be performed to validate or refute the effect of this type of laboratory testing on the overall cost of health care.

* Turnaround time. The real-time acquisition of laboratory results accomplished by the sharply reduced turnaround time of point-of-care testing may produce more accurate, reliable, or useful data than before. This information can be fed into decisions about therapy changes for the physiologically unstable or the critically ill patient. Prolonged time between specimen collection and laboratory analysis may cause certain analytes to deteriorate. The result can be preanalytical error that misguides therapeutic decisions.

Furthermore, the biologic half-life of laboratory data for critically ill patients may be substantially shorter than for stable patients. A long turnaround time for a test may yield a more accurate or reliable result for the stable patient than for the unstable patient, whose clinical condition and analyte level may have changed substantially during the time required for testing. When point-of-care testing yields almost instantaneous laboratory test results, little clinical change occurs in the patient between the time of specimen collection and test reporting. Thus little preanalytical variation occurs in association with short turnaround time, thereby eliminating decay of clinical information and permitting therapeutic decision making based on currently relevant laboratory information.

Because point-of-care testing offers potential and real benefits for health care financing and the delivery of quality patient care, a number of journals have devoted entire supplements or special issues to point-of-care testing,[4] bedside diagnostic testing,[5] and the technology and patient management of critical care medicine.[6] Equivalent phrases for testing that occurs at or near the patient's side include decentralized testing, bedside testing, ancillary testing, off-site testing, satellite testing, alternate-site testing, and whole blood testing.

Regardless of the choice of terms, features of laboratory testing embraced by these concepts include the performance of testing at or near the site of the patient; supplementation, not replacement, of the central laboratory's services; and the use of easy-to-handle specimens, such as whole blood. Many point-of-care instruments utilize whole blood, eliminating the task and time associated with separating serum or plasma. This advantage is important for two reasons: (1) Point-of-care testing may be performed by nonlaboratory personnel, such as nurses, respiratory therapists, and emergency room technicians. (2) A goal of this testing is to reduce turnaround time to the shortest interval possible. Use of whole blood is essential for ease of operation by nonlaboratory staff.

* Best niche. The best-defined niche for most point-of-care testing is the critical care setting: the intensive care units, the cardiac care unit, the operating room, the bum unit, and the emergency department. Other settings benefit from on-site patient testing as well-any site where convenience to the patient or the health care provider justifies the need for rapid results. For example, in a busy ambulatory care setting, long turnaround times in receiving laboratory results may cause delays in clinical decisions and prevent timely disposition of the patient from the clinic or office. The consequences include patient dissatisfaction, unnecessary waiting time for other patients, and inconvenience and inefficiency for physicians other staff.

Before point-of-care testing can succeed in these settings, a clear understanding of the expectations and roles of the physicians, nurses, laboratory personnel, and other staff must be developed and accepted by everyone involved in acquiring, operating, and maintaining the instruments. The success of point-of-care testing requires a collaborative effort by intensive care physicians, surgeons, emergency room physicians, ambulatory care providers, nurses, pathologists, quality assurance personnel, and hospital administrators.

* Shared expectations. Physicians using point-of-care testing expect accurate results, the shortest possible turnaround time, uninterrupted availability of testing, and a suitable menu. Nurses also expect high-quality results and a short turnaround time, but as the potential primary operators of the instruments, they may be wary of acquiring new duties and tasks without having commensurate staff available to accomplish additional work. Administrators expect high-quality service to be accomplished in the most cost-effective manner possible. The quality assurance and risk management staff expect high-quality results, proper documentation of results and quality assurance activities, and compliance with rules from regulatory and accrediting agencies.

The expectations and roles of the pathologist, laboratory technologists, and other laboratory staff must be directed at maintaining the quality of laboratory testing throughout the hospital. While some laboratorians may perceive point-of-care testing as a threat to the practice of laboratory medicine, resistance to point-of-care testing should not become a strategy to avoid the inevitable growth and development of this technology. Rather, the laboratory should make the leading contribution in the management of the quality control and quality assurance aspects of point-of-care testing. Furthermore, the pathologist and other members of the laboratory staff should provide the professional evaluation of laboratory instruments.

Those evaluating and selecting instruments should consider restricting the number of different types to be located throughout the hospital. Keeping the variety within limits will bring bulk purchasing power for equipment and reagents, simplify training and quality control procedures, and avoid the possibility of establishing inconsistent and confusing reference intervals for a given analyte.

The pathologist should provide the leadership in developing the understanding of the roles of the nonlaboratorians who help select, operate, and maintain the equipment. In light of the complex interactions among physicians, nurses, technologists, administrators, and vendors, insuring a successful program requires an understanding or agreement that defines the responsibilities and roles of each person or department.

The pathologist also plays a key role in assessing the cost-effectiveness of lab technology. While centralized testing in the main laboratory usually permits tests to be performed at the lowest cost per reportable result, other factors need to be evaluated in determining the overall cost-effectiveness of laboratory testing. For example, performing tests at the bedside in an intensive care unit eliminates preanalytical error associated with long transport times to the main laboratory. The dual result is to reduce the need to repeat some testing and to allow more rapid provision of therapy based on test outcome.

To assure the success and optimum effectiveness of point-of-care testing, health care providers and administrators must select the most suitable niche for its installation in their hospital. This selection process requires choosing instruments, identifying the most appropriate sites for placement, determining operating costs, and designating the person to act as primary "customer" in dealing with sales and technical representatives of the manufacturers.

The choice of instruments depends on the clinical needs of a particular patient care unit (such as the emergency room or medical intensive care unit), the menu and operational features of the instrument, the availability of qualified personnel to operate the instrument, the availability of resources to acquire the instrument, and the cost-effective operation of the technology. Two important clinical features of point-of-care technology are rapid turnaround time and use of microsamples that decrease iatrogenic blood loss.[7] For example, blood gases, electrolytes, hematocrit, and other analyses can be performed on less than 0.5 ml of whole blood in less than two minutes.

* Representatives. Because this technology may well fit the needs of the operating room, the surgical and medical intensive care units, the cardiac care unit, and the emergency department, a number of physicians or administrative personnel can be involved with instrument evaluation and working with sales and technical representatives of various instrument manufacturers. It will be easier to achieve consistency in evaluation, unity of purpose, and effectiveness in negotiating and purchasing, however, if a single "customer" or representative is chosen to communicate with the various vendors.

The pathologist, who regularly engages in business transactions with sales and technical representatives, is in a key position to serve as the hospital's representative or principal customer in acquiring point-of-care technology. By centralizing the purchasing responsibilities to a single individual or department, the hospital achieves consistency in communication and improves its effectiveness in selecting and obtaining the equipment, reagents, warranties, and maintenance agreements. A list of some of the many features to be considered and evaluated in selecting the most appropriate technology is offered in Figure 1.

Figure I

Features to be considered in choosing point-of-care technology

Suitability of test menu for patient care area to be served

Quality of test results

Ease of use, especially by nonlaboratory personnel

Portability of instrument

Turnaround time

Use of whole blood

Amount of blood required for testing

Stability of reagents

Cost to maintain and repair instrument

Projected longevity of instrument

Cost per reportable test

Reporting format

Ability to interface instrument with an information system for reporting results and for billing

The evaluation process must determine whether point-of-care testing will meet the current standards of quality in laboratory medicine and provide clinically relevant information that directs therapy or otherwise benefits the patient. The testing must also be cost-effective, based on the need for immediate results to institute or modify therapy for the critically ill patient or to provide convenience and consumer satisfaction by achieving rapid disposition of emergency department or ambulatory care patients.

* Training. Operators must be instructed in routine use of the equipment and specimen testing, the proper performance of quality control activities, the safe handling of specimens, and instrument maintenance and repair. Much, or perhaps all, of the actual operation will be provided by nonlaboratory personnel who may be unfamiliar with laboratory instrument operation and quality control. Therefore, the laboratory staff will have to provide the technical and quality control training.

This training must promote high-quality testing by emphasizing the concepts of quality control and proper record keeping of quality control and patient results. A plan of action must define and cover episodes when quality control results fall outside an acceptable range. When a nonlaboratory operator is unable to proceed with patient testing because quality control results are unacceptable, an individual in the laboratory should be available to provide consultation and assistance in problem solving so that testing can be restored as rapidly as possible.

* Quality control. The quality control program must include provision for proficiency testing equivalent to that used in the central laboratory. Users of point-of-care instruments must be able to demonstrate ongoing competence and ability to perform high-quality testing while complying with the standards of accrediting agencies. Each institution's department of laboratory medicine can offer leadership in proficiency testing and accreditation matters by providing consultation to users, by evaluating the results of proficiency testing to identify trends in performance, and by interpreting guidelines, regulations, and standards for nonlaboratory users and operators.

The laboratory can, however, encounter knotty problems if it is held responsible for the quality of point-of-care testing without holding commensurate authority to make changes in existing practices and outcomes whenever nonlaboratory operators fail to achieve appropriate standards of quality. If the laboratory is required to play a leading role in the management of quality and is to be held responsible for the quality of testing, clear institutional policies must exist to define the actions and authority required to meet accreditation standards, to succeed in proficiency testing, and to provide the highest-quality patient test results achievable.

Because much of the testing will be performed by nurses, they must participate in all planning and decision making related to evaluating and acquiring point-of-care instruments. Similarly, nurses must be full partners with members of the laboratory staff in developing the educational goals and objectives I-or training users of the equipment. For the training and implementation to be successful, the operators must perceive this new testing modality to be beneficial to their work rather than as an added burden for which they are inadequately trained or staffed.

* Staffing. The staffing requirements for point-of-care testing remain unsettled. When nurses perform the testing, they acquire an additional task. Yet one of the major advantages of point-of-care testing is to eliminate other tasks such as the transport of specimens and the need to call the laboratory for patient test results. In the latter case, the laboratory benefits by receiving far fewer telephone calls for Stat results. A comprehensive evaluation should be undertaken to determine the distribution of staffing required to make this testing successful. If more nursing staff time is required to support point-of-care work, eradicating other tasks, such as bagging, icing, and transport, may provide a shift in manpower to support the testing with no net gain in personnel costs. This issue needs to be evaluated with careful analysis of the labor needs and labor costs of point-of-care testing.

The successful transfer of testing to the site of patient care can alleviate two resource problems encountered in the clinical laboratory. First, the large volume of Stat tests in some laboratories sometimes precludes accomplishing the work within the laboratory turnaround time desired. Reducing the number of Stat specimens received in the main laboratory should permit more rapid response. Second, many laboratories have experienced shortages of technical personnel, making it extremely difficult to furnish test services in a timely manner. The shift of work to the point of care can alleviate some workload issues in laboratories experiencing staffing problems. o Multitude of changes. Point-of-care technology has now evolved so that,it permits reliable testing in a variety of clinical settings. This evolution is forcing change in the delivery of laboratory services to patients in the operating room, in critical care units, in emergency departments, and in ambulatory care settings. The authors of the articles in this special issue of MLO address salient factors related to technologic performance, economic impact, and risk management associated with the development of point-of-care testing. The professional men and women of the laboratory will lead the hospital in managing this vital and evolving technology.

[1.] Birnbaum, M.L. Cost-containment in critical care. Crit. Care Med. 14: 1068-1077,1986, [2.] Detsky, A S.; Stricker, S.C. Mulley, A.G.; et al. Prognosis, survival, and the expenditure of hospital resources for patients in an intensive care unit N. Engl. J. Med. 305:667-672,1981. [3.] Zaloga, G.P. Evaluation of bedside testing options for the critical care unit. Chest 97:185S-190S, 1990. [4.] "Point-of-Care Testing: A Laboratory Guide to Meeting Changing Demands." MLO 23(9S), September 1991. [5.] Bedside diagnostic testing. Chest 97: T83S-214S, 1990. [6.] Critical care medicine: Technology and patient management. Clin Chem. 36:1533 1622, 1990. 7 Chernow, B. The bedside laboratory: A critical step forward n ICU care Chest 97:183S-184S, 1990.
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Title Annotation:Special Supplement: Point-of-Care Testing
Author:Geyer, Stanley J.
Publication:Medical Laboratory Observer
Date:Sep 1, 1992
Previous Article:Should lab managers be well versed in finance?
Next Article:Controlling error in laboratory testing.

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