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Protocols for bedside testing.

Protocols for bedside testing

As you develop a program for quality management of bedside testing, informally line up support from leaders of power centers in your institution. By Richard Belsey, M.D., and Daniel M. Baer, M.D.

Establishing that a quality problem hinders bedside testing at your hospital is only the first step toward gaining allocation of resources for a quality management program.

Persuading hospital administration to accept laboratory recommendations for such a program requires a carefully planned campaign (Figure I). You must sense the needs of the hospital's key power centers, develop a program that satisfies those needs as well as the lab's, and build coalitions with the power centers. Then, assuming the plan is approved, you must work with the hospital's prime movers to implement it.

It may seem expedient for the laboratory to push on unilaterally with the initial studies and develop a quality management plan for bedside testing, but little will change in the long run if the other power centers do not participate in the process. So it is better to assemble a working group of representatives from these centers to define and solve significant quality management problems. That way, at least one person in each area will understand the potential problems.

Of course, this doesn't guarantee that others, including department heads, will recognize the problems or go along with the working group's recommendations. For example, the laboratory director may insist that the laboratory exists to fill the hospital's testing needs and that it should perform all testing.

Nursing leadership, for its part, may view the group's efforts on bedside testing as an intrusion and feel it can manage without outside help. Medical technologists may take a third view -- that bedside testing should meet the central laboratory's high standards -- in order to promote the profession and enhance their employment opportunities.

The point is that unless the leaders of the units involved in different aspects of bedside testing believe there is a problem, and accept the need for change, your efforts are likely to be futile. To succeed in initiating change, you must be aware of these attitudes and armed with an effective counter-strategy.

A two-pronged approach can work very well: Use a formal process to assess bedside testing quality management problems and develop solutions, while you informally presell your concepts to leaders of each concerned unit. The informal contacts allow you to identify supporters and potential opponents and to create pockets of commitment throughout the hospital. We have found that the concern health care professionals and administrators have for the quality of patient care is a unifying concept that can frequently bridge differences between departments or individuals.

A good way to begin the formal process is to identify all groups in the hospital that have some involvement, interest, or concern about bedside testing. Picture the ripples created when a rock is thrown into a pond -- the idea is to reach all departments or interest groups, including the medical staff, that might be washed by the wave of bedside testing.

It will then be possible to solicit the broadest possible participation in evaluating current quality issues and, if necessary, in developing a quality management program. It also helps to solicit the support of key staff members in the various departments, even those who have no formal management role.

Although this may appear a cumbersome approach to what laboratorians see as a simple problem, others in the hospital community may not believe there is any problem at all. Raising these issues at diverse levels can result in a program that most of the staff and departments involved will back, a program that has a better chance for successful, economic implementation.

The working group needs to review the information you have developed about the reliability of bedside test results; then it has to decide whether the information is adequate to support going on to the next step or if further studies of specific issues are required. Should the working group agree that quality problems exist, it must communicate the findings to the medical, administrative, nursing, and laboratory leadership to enlist their support in developing a quality management program. Medical staff involvement is essential in this problem identification phase because of the impact on the quality of care clinicians provide to patients.

The planning necessary for approval and implementation of a quality management program can now begin. At this point, it is prudent to address the potential economic impact of the studies and any resulting programs.

If prospective payment is a hospital's major mode of reimbursement, initiating charges for the bedside testing (when there currently are no charges) is likely to cost more than can be collected. In that case, it may be best to stress risk management and regulatory incentives as selling points for a quality management program. In other hospitals, capturing the charges for bedside testing can generate revenues that partially offset the cost of a quality management program.

When the time comes to consider such a program, the working group must address an array of issues (Figure II). Although laboratory quality management strategies provide a starting point (see last month's article), other issues must also be addressed.

Most important, since differences in reliability are likely to persist between bedside and central laboratory results, criteria will have to be developed for new bedside testing capability. Such criteria should include patient care needs, the central laboratory's ability or inability to meet such needs in a timely manner, and system requirements that will allow intended users to produce sufficiently reliable results.

It may be necessary to rule out some bedside tests. Perhaps they are not accurate enough for the patient care problems being managed, or the testing process is too complicated or time-consuming to expect nurses to analyze the test properly.

A process for evaluating, selecting, and approving the use of new bedside analytic systems must be developed. Clinical laboratories are accustomed to bringing in new analytic systems to evaluate their day-to-day performance. They use standardized criteria to determine whether a manufacturer's specifications are realistic under field operating conditions and whether an instrument's precision and accuracy are adequate for their patients' needs.

We think it is reasonable to subject all of the hospital's testing systems to similar evaluations. Those who will actually use a system should perform the trial tests.

The working group can suggest formation of a standing committee to weigh the hospital's bedside testing needs, oversee the evaluation process, and make recommendations concerning adoption of new bedside test methods and acquisition of specific analyzers.

Once you have completed consideration of the basic issues that are critical to appropriate use of bedside testing systems, you can proceed to identify the activities that will provide ongoing monitoring and quality management. These should include calibration frequency, periodic instrument maintenance requirements, the frequency of quality control testing, certification, continuing education and competency evaluation of the testing staff, indications for testing, documentation of procedures and results, critical value criteria and reporting policies, approved test uses for patient management, and indications for retesting by the central laboratory.

As policies and procedures are developed, it becomes essential to negotiate departmental responsibility for the various elements of quality management. Your earlier involvement with decision makers throughout the hospital can ease the way. Each department needs a clear picture of its projected authority, responsibility, and reporting relationship with regard to bedside testing.

It is best to assign overall supervisory responsibility for all aspects of bedside testing and quality management to a single individual or department (or a standing committee within a department).

Once the working group drafts a comprehensive proposal for bedside testing quality management, including program goals and evaluation criteria, and the laboratory is sure it has adequate support, it is time to seek formal approval of the program. Approval should come quickly if the program has been effectively presold. With preselling, the departments also can start thinking early about how to handle their bedside testing responsibilities.

An effective bedside testing quality management program requires that all department heads have a clear picture of the goals and their responsibilities without feeling that their authority has been usurped. The group presenting the proposal must make sure that program participants realistically assess and secure the necessary resources. Otherwise, these managers cannot expect to fulfill their bedside testing responsibilities. The working group, or the manager in charge or the standing committee, must be sure that all essential aspects of the program have been put in place before implementation.

The proposed program should include evaluation criteria suitable for periodic assessment of its effectiveness. Any program proposal can only be an initial approximation of meeting the institution's needs. Experience is critical to the development of enhancements to more effectively and economically achieve the program's goals.

To sum up, developing a bedside testing quality management program calls for more than merely identifying a problem and formulating a solution. The effort impinges on a variety of departments within the hospital community, and they all should be actively involved in developing the quality management program.

The best way to deal with issues that involve cross-departmental responsibility is to move ahead on the formal evaluation and approval process and, at the same time, consult with critical opinion makers about their concerns and suggestions. This allows the constituency for approval to grow while program goals and details are worked out. Figure 1

Steps leading to a bedside testing Quality management program Determine who needs to be involved in the process Establish a working group to consider the issues and develop a program Identify current problems associated with bedside testing

Result reliability

Patient care needs

Risk management issues

Potential cost and reimbursement Determine criteria for evaluating the clinical reliability of test results Establish evaluation criteria, including clinical reliability standards, for new analytic systems Develop a quality management program to promote consistent production of results that meet the clinical reliability standards

Figure II

Policy and procedure issues in managing bedside test quality Determination of clinical need and analytic system requirements Evaluation, selection, and approval process for new systems Definition of quality management activities

Frequency of calibration

Periodic instrument maintenance and repair

Frequency of testing with quality control specimens

Competency testing

Certification of operators

Continuing education of operators

Documentation of procedures and results

Notification of critical values

Retesting when results indicate a need to change therapy

Indications for testing Determination of quality management responsibilities Determination of supervisory responsibility for overall program management Charges for tests and confirmatory testing Program evaluation criteria and intervals for periodic review

Photo: "I told you I was going to be in the centrifuge for the next 15 minutes"
COPYRIGHT 1988 Nelson Publishing
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Copyright 1988 Gale, Cengage Learning. All rights reserved.

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Title Annotation:part 3
Author:Belsey, Richard; Baer, Daniel M.
Publication:Medical Laboratory Observer
Date:Apr 1, 1988
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Next Article:How to tell when a good employee is job hunting.

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