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A risk management perspective on point-of-care testing.

Most problems identified in connection with legal claims and allegations against the clinical laboratory arise from miscommunication rather than from the quality of the testing itself. Although point-of-care test sites are by definition remote from the central laboratory and are not staffed by laboratorians, lab personnel tend to be blamed for errors related to testing and test results. Yet untoward patient outcome is usually the result of system failure, not inaccurate testing.

Point-of-care testing removed many of the usual variables involved in test processing--test ordering, specimen collection and transport, and timeliness and distribution of results--and thus the opportunities for miscommunication they present. In developing a new approach to an old problem, decentralized testing requires a new perspective in providing high-quality patient care.

Technologic innovation has dramatically changed the way in which clinical laboratory services are provided. Traditionally the laboratory operated as a centralized ancillary department equipped with state-of-the-art instrumentation that required frequent calibration, monitoring, maintenance, and checks for quality control. As instruments located within the lab have been greatly improved, making not-so-old equipment obsolete, the way in which the lab operates and delivers services has shifted.

At the same time, external pressure from regulatory and reimbursement agencies has led to a movement to deliver more clinical services at the point of patient care. The new technology, permitting what is variously known as bedside, decentralized, and point-of-care testing, has created a situation that dramatically affects the operations of the central laboratory as well as activities of the nursing service and other health care providers in the institution.

* A distinction. Decentralized or Stat labs, typically located in the emergency department and critical care units, contain several instruments. The staff, usually one or more technologists from the central laboratory, provide results of commonly requested assays such as CBC, electrolytes, glucose, blood gases, and certain chemical analytes.

In contrast, point-of-care testing is usually associated with a single instrument located on patient care units or in operating rooms. Operators are more likely to be nurses or other staff than laboratory personnel. Testing on each instrument involves a specific analyte, such as blood glucose or blood gases.

The extreme variability in both situations gives rise to several issues affecting the quality of patient care and the liability of the institution. Risk management can provide a strategy for providing point-of-care lab services through a collaborative approach that can improve the quality of those services and reduce the potential corporate liability of the hospital.

* Reducing risk. Traditional risk management, first applied in industrial and corporate settings some 40 years ago, focused on reducing and managing claims and protecting financial assets. Health care risk management has evolved into a process focusing on improving the quality of service--in this case, patient care--as a means of reducing the potential for liability. Risk management thus offers a strategy for directing point-of-care services in the context of detecting, evaluating, financing, and reducing the risk of monetary loss.

To prove negligence in court, the plaintiff's attorney must demonstrate four elements: duty, breach of duty, injury, and causation. The hospital and its staff have a responsibility or duty to give reasonable care to a patient. Breach of duty in this context is failure to provide the expected standard of care. Standard of care is defined as the likely behavior of a reasonable person with the same degree of experience or expertise in the same situation or a similar one.

To pursue a lawsuit successfully, a plaintiff must have suffered an injury as a direct result of a breach of duty. This direct relationship between breach of duty and injury constitutes causation.

In response to the law of negligence, risk management involves continuous feedback regarding four events related to risk: identification, analysis and assessment, modification, and evaluation and monitoring. These considerations parallel issues addressed in the lab every day.

Identifying risk, for example, requires consideration of all processes related to the delivery of patient care for practices that could potentially injure the patient or be difficult to defend if the patient filed a claim protesting them.

Analysis of the issues leads to an assessment of exposure associated with relevant risks. This process, usually undertaken jointly with the hospital risk manager, includes the study of incident reports, quality assurance data, and any history of claims or loss.

Risk can be modified in many ways. To prevent any risk inherent in point-of-care testing, a health care institution may choose to prohibit such testing entirely. Alternatively, the facility may transfer the risk to an insurance carrier. Third, the institution may assume the risk through retention or self-insurance. Finally, risk may be controlled through risk management initiatives. The type of risk modification chosen depends on factors such as loss history, insurance rates and litigation trends, and the availability of an effective risk management program.

Evaluation and monitoring of exposure to risk is done continuously. Verifying test results and following quality assurance measures provide information used to heighten risk modification. All components of risk management require the active participation and cooperation of all health care professionals involved in patient testing.

Despite the obvious advantages of risk management, barriers must be overcome before it can be effectively implemented. The first is the laboratorian's instinctive response: Eliminate point-of-care testing. Laboratory professionals often feel threatened by or resentful of decentralized testing. Nevertheless, no resistance can prevent the inevitable. Advanced microchip technology, coupled with external pressure from regulatory and reimbursement agencies, spurs increased delivery of clinical laboratory services at the point of patient care.

* Object lesson. More to the point, turning a blind eye to point-of-care testing may result in serious liability exposure for the laboratory. Anesthesiology provides a good example of the assignment of accountability for activities remote from the parent department.

The development of pulse oximetry and capnography (end-tidal |CO.sub.2~ monitoring) has expanded the delivery of anesthesia beyond the traditional confines of the operating room to critical care units, emergency departments, labor and delivery services, and outpatient diagnostic testing centers. In response to this decentralization, the 1990 edition of the accreditation manual for hospitals from the Joint Commission on Accreditation of Healthcare Organizations makes it clear that assuring a comparable level of anesthesia care throughout the hospital is the responsibility of the department of anesthesia.

A parallel is clear: The central laboratory is ultimately as responsible for remote testing as for work performed within its own walls. Consequently, mechanisms must be developed to make sure the quality of decentralized procedures does not fall below that of work performed in the laboratory itself.

Laboratorians who resist getting involved in decentralized testing may wonder, "What's in it for me?" Their frustration is understandable in the current environment of rampant understaffing and an ever-increasing workload. Laboratory administration must address these issues head-on by stressing the program's benefits to the lab. Among those benefits are the opportunities to manage risk and to contribute more directly to patient care.

Furthermore, by acting as consultants, educators, and experts, laboratorians will make themselves increasingly visible among other health professionals in the institution. In addition, stretching beyond traditional clinical lab duties contributes to job enrichment.

Once convinced of the value of participating in point-of-care testing, laboratorians may encounter resistance to their new role from other health care professionals in the hospital. While specialization and compartmentalization have created a corps of highly trained care givers, they have exacerbated professional competitiveness and defensiveness as well. Departments within a health care institution may be compared to independent tribes, each harboring its own values, language, training rituals, and thinking patterns. Sometimes it takes an objective third party to overcome the barriers between these groups.

Because the laboratory already interacts with virtually all areas of the institution, laboratorians have a head start in identifying potentially conflicting groups, learning to appreciate their points of view, and finding ways to work together. This often-difficult process is essential in developing the spirit of collaboration necessary for effective risk management. Enlisting the aid of the hospital risk manager helps a great deal.

Assuming responsibility for point-of-care testing and setting up a workable risk management loop involve activities familiar to all lab administrators. These include the considerations listed in Figure I.

* Getting started. Our company's philosophy of risk management is based on identification of potential risk, cooperation among all interested parties, and education and implementation. All three elements are essential to the cycle.

The key to modifying risk is to gain interdisciplinary cooperation and commitment. All players must have a vested interest in the outcome. Similarly, identifying and discussing potential risk issues among departments encourage cooperation with procedures that are subsequently created.

* Collecting data. Because point-of-care testing is only beginning to take firm hold, some areas of a health care facility may be using it extensively while it remains in planning stages in other departments of the same institution. It is wise for a knowledgeable observer from the laboratory to make the rounds of all departments, collecting valuable information to be used as a baseline for initiating a formal hospital-wide program.

Collecting data in this way provides valuable insight into departmental values as well as customer needs and perceptions. Simple observation may not, in fact, be sufficient since health care professionals are adept at protecting their turf.

* Researching instruments. At an early stage of implementing point-of-care testing, it is wise to contact vendors and suppliers of related materials. Many are veteran players in the diagnostics field and can provide a great deal of background information. As with other laboratory products, becoming knowledgeable about the technologies and products on the market is the intelligent way to buy what is most suitable to the situation and to get the most out of it.

Manufacturers of point-of-care instrumentation have a vested interest in the success of such programs. They are accustomed to viewing the field from a dual perspective, toward high profitability and low liability. The companies are expected to ensure that results provided by their instruments are reliable and accurate. Another important role of the manufacturer is to help lab managers educate their staffs.

* Forming a task force. It's a good idea to appoint a task force to develop a plan for implementing and managing the program. Obtaining the support of the administration and the institution's risk manager is vital. The task force should include representatives of all groups that will be involved in point-of-care testing: physicians, nurses, allied health professionals, quality assurance and risk management staff, administration, technologists, and pathologists. The pathologist will have to be available to consult with clinicians on establishing reference values and interpreting results.

The laboratory representative may be a pathologist, laboratory administrator, or staff technologist. Personal qualities should include good leadership and communication skills. A staff technologist may be less threatening to other workers and therefore a better choice for this role than a laboratory administrator.

In any case, hospital administration must be represented on the task force. The hospital as a corporate entity has a clear duty to insure the quality of patient care; it follows that administrators must participate in making decisions about point-of-care testing. In addition, because point-of-care testing touches all areas of the institution in one way or another, an administrative presence may be very useful in achieving cooperation and consensus among task force members.

* Discussing operations. The task force's first order of business is to define an operational agenda. Points for consideration begin on the previous page under "Getting started." Goals include establishing procedures for selection, distribution, and maintenance of equipment, for interpreting test results, for training operators of the new equipment, and for purchasing and storing reagents.

One potential impediment to consensus is resistance to change by departments that have already established point-of-care protocols. In such cases, patience and diplomacy should reign. Risk management is a compelling argument for cooperation. The laboratory has greater expertise by far than any other department in understanding and managing testing. Gentle persuasion may pave the way to agreement.

* Developing training. The laboratory will be responsible for training personnel who will perform point-of-care testing. Points to consider include designating laboratory staff members to conduct training sessions, determining how training will be documented, establishing the frequency of retraining or review, developing a mechanism for training new employees, and assuring communication between remote sites and the central lab about changes in personnel or problems that arise after training. Consistency is imperative in a training program so that operators' techniques will not vary and potentially cause a misinterpretation or presumption of equipment problems.

* Setting up QC. The lab is expert at establishing normal values, frequency of control checks, and documentation of quality control. The reliability of point-of-care test results can be determined through correlation with values used in the central laboratory. Because QC is integral to risk management, the task force must develop a series of fail-safe protocols to which every department is committed. The potential need for disciplinary action to insure compliance should be acknowledged.

* Documenting and retrieving results. Diagnostic and therapeutic decisions will be based on point-of-care test results. Documentation of those results is therefore key to risk management efforts. The institution's medical records department, business office, and information management staff can help the laboratory develop a workable system for documenting results in the patient record and coordinating the interface between the laboratory and hospital information systems.

* Monitoring and evaluating. Establishing consistent procedures is only the beginning. The entire process must be monitored continuously for efficiency, accuracy, and benefit. Ongoing evaluation will help participants in the program to identify additional risk issues that must be addressed, thereby bringing the risk management process full circle.

Monitoring point-of-care testing will soon be a requirement rather than merely a good idea. To comply with the Safe Medical Devices Act of 1990 (Public Law 101-629), to be implemented Nov. 28, 1991, hospitals must report to the Food and Drug Administration as well as the manufacturer any adverse patient outcome associated with a medical device. The risk management implications of this law will make it crucial to establish procedures for tracking and reporting these occurrences.

* Total management. To implement point-of-care testing, health care professionals, led by the clinical laboratory, must cooperate to formulate a comprehensive plan. The risk management process necessary in tracking results resembles the continuous improvement process required to preserve and enhance high-quality test results. Risk management and quality assurance represent two philosophies vital to a facility's effort and ability to provide excellent patient care.

General references:

Barman, M.R. Alternate-site testing: Mixed feelings about the inevitable. MLO 22(12): 22-29, December 1990.

DeBruine, P.H. |CO.sub.2~ monitoring in endotracheal intubation--use in operating and non-operating room settings. Advisory (MMI Companies, Inc.) 6(4): 1-2, December 1990.

DeBruine, P., and Napier, J.A. Insurer studies, cuts risks. Anesthes. Patient Safety Foundation Newsl. 3(1): 1-5, March 1988.

DeBruine, P.H., and Napier, J.A. The anesthesia risk modification program--a comprehensive clinical approach. Advisory (MMI Companies, Inc.) 4(3): 1-5, September 1988.

Hungate, R. Viewpoint: Continuous quality improvement. Clin. Lab. Manage. Rev. 4(6): 466-468, November/December 1990.

Joint Commission on Accreditation of Healthcare Organizations. "Accreditation Manual for Hospitals/91, Volume 1--Standards," p. 162. Oakbrook Terrace, Ill., JCAHO, 1991.

Kellerman, A.L.; Cofer, C.A.; and Hackman, B.B. Impact of portable pulse oximetry on arterial blood gas test ordering in an urban emergency department. Ann. Emerg. Med. 20(2): 130-134, 1991.

Lord, J.T. Risk management in pathology and laboratory medicine. Arch. Pathol. Lab. Med. 114: 1164-1167, 1990.

McGregor, R.K. Pulse oximetry as a risk management tool. Advisory (MMI Companies, Inc.) 3(3): 5-6, September 1987.

Neuhauser, P.C. "Tribal Warfare in Organizations." Cambridge, Mass., Ballinger Publishing Company, 1986.

Salman, S.L. Risk management processes and functions. In: Troyer, G.T., and Salman, S.L., eds., "Handbook of Health Care Risk Management," chap. 6, pp. 149-179. Rockville, Md., Aspen Publishers, 1986.

Valitutti, R.F., and Drutchas, G.G. Hospital law: Theory and application. In: Troyer, G.T., and Salman, S.L., eds., "Handbook of Health Care Risk Management," chap. 4, pp. 101-136. Rockville, Md., Aspen Publishers, 1986.

Zaloga, G.P. Evaluation of bedside testing options for the critical care unit. Chest 97: 185S-190S, 1990.

Figure I

Areas of concern in point-of-care testing

Training and credentialing operators Proficiency testing Selecting, calibrating, and maintaining equipment Documenting results Disposing of infectious waste Reliability of test results for diagnosis and treatment Quality assurance, data management

Figure II

Risk management as continuous improvement

Addresses customers' needs and expectations

Uncovers root processes and problems

Involves all players

Identifies systems and processes that the health care team can control or influence

Is objective, based on data, and focused on measurable outcomes

Improves systems; reduces or eliminates failures in them

Contributes to the quality and safety of patient care

Reduces potential risk exposure

The author, Michelle M. Cooney, is director of health care education services at MMI Companies, Inc., a health care risk management company in Deerfield, Ill.
COPYRIGHT 1991 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

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Title Annotation:MLO Special Issue: Point-of-Care Testing
Author:Cooney, Michelle M.
Publication:Medical Laboratory Observer
Date:Sep 1, 1991
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