JCAHO’s proposed rules on clinical practice guidelines
By Judy Homa-Lowry, RN, MS, CPHQ
President, Homa-Lowry Healthcare Consulting
Recognizing that data and information are being used more extensively than ever in health care, the Oakbrook Terrace, IL-based Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has made significant changes in its standards — changes that affect not only data and information but also the role of the case manager.
In particular, the recent distribution of proposed JCAHO standards for the use of clinical practice guidelines will likely have a significant impact on case managers. These JCAHO-proposed standards do not require that organizations use guidelines. Rather, they emphasize that the organization should develop a mechanism to "consider and review" guidelines that are available for the services that they provide.
The new standards appear to require that, at a minimum, organizations review and consider whether available guidelines are applicable to the patient populations that are served in their organization. These proposed standards would help to enhance the importance of other JCAHO standards, such as the information management standards that have been in place for some time. Specifically, the information management standards have required the use of medical record data, aggregate data, knowledge-specific information, and comparative information to evaluate and improve patient care.
Among the components of the information management standards that should be emphasized when discussing clinical practice guidelines are the standards related to knowledge-specific information. The term "knowledge-specific" has required hospitals to monitor and consider the use of patient care-related information in the literature to evaluate and improve patient care in health care organizations.
The development, implementation, and monitoring of clinical practice guidelines by other sources and institutions and the consideration of their potential use in your organization could be interpreted as compliance with specific information management standards. At the same time, there is compliance with some of the requirements in the proposed standards. The management of information standards were once referred to as the library standards. The library standards encouraged the same objectives that the current knowledge-based standards require. They required the use of research and other positive patient care outcome studies discussed in the literature to be evaluated for use in your health care organization.
If the proposed standards for clinical practice guidelines are accepted, they will require that health care organizations describe and implement a process to provide a link between the health care literature and literature specific to practice guidelines to evaluate and improve patient care. This is not to suggest that this is not currently happening in the field; rather, it appears that these proposed standards would become part of the accreditation process. They would represent the minimum standards for compliance.
If these standards are adopted, it may be helpful for you to have a list of the sources your organization uses to evaluate and develop guidelines. This should be done in the form of a policy. It could be a simple policy that states something like: "The following sources of information [list] are utilized on a regular basis when developing and/or revising our clinical practice guidelines." The JCAHO-proposed standards for practice guidelines reference the Agency for Health Care Policy and Research, professional organizations, etc. This is a simple policy that may already be in place in your organization.
The Joint Commission is aware of the different terminology used to describe the practice of developing and using clinical practice guidelines. As a result, it developed its own definition of clinical practice guidelines. It states: "Guidelines are evidence-based, authoritative and shown to be efficacious and effective within defined patient populations and services." This would support the linkage between these proposed standards, information management, and performance improvement. It also illustrates the importance of the linkage of these standards as well as the leadership standards for future accreditation of health care organizations.
As mentioned, the proposed standards do not require that organizations use clinical practice guidelines, but rather that organizations develop a mechanism to consider them for use. This is especially true for those clinical guidelines that have similar populations to the organization. Recent changes in the JCAHO standards have required the implementation of sentinel event policy and procedures, the development of ORYX, and revised performance improvement standards. All of these standard additions and revisions have forced organizations to develop systems and processes.
They also require that organizations consider the relationship of these standards to one another. For example, the ORYX data may illustrate that an organization has significant complications within a diagnosis-related group (DRG) or that the organization is statistically different from the organizations it is being compared to with regard to certain DRGs. During the survey process, a question could be raised about whether the organization decided to develop clinical practice guidelines for these DRGs.
Statistical tools prove systems work
To establish and maintain compliance with these standards, the systems and processes developed by the organization have to work. One of the ways in which an organization can demonstrate its ability to show the effectiveness of systems and processes is by the use of statistical tools. The use of statistical tools is necessary for data analysis. When examining all of the JCAHO standards related to patient care, the ability of the Joint Commission to raise specific patient care questions relating to patient care and treatment by a specific diagnosis is emerging. This is why it’s so important to have the case managers involved in the development of systems and processes relating to case management. This involvement also can greatly assist the organization in addressing JCAHO standards relating to case management and other related requirements for accreditation.
According to the Joint Commission, the proposed standards provide the organization with the opportunity to develop a system for selecting, implementing, and monitoring the effectiveness of guidelines in treating patients. Compliance with these proposed standards requires participation by the organization’s leadership, as well as by the interdisciplinary health care team.
In order to accomplish compliance with the guidelines’ requirements, the Joint Commission has identified four standards. They are currently proposed as follows:
• Clinical practice guidelines are considered for use in designing and improving processes.
• When clinical practice guidelines are used, the organization’s leaders identify criteria for their selection and implementation.
• Appropriate leaders, practitioners, and health care professionals review and approve clinical practice guidelines for implementation.
• The leaders evaluate the outcomes related to use of clinical practice guidelines and determine indicated refinements to improve pertinent processes.
The second standard, which addresses the implementation criteria for clinical practice guidelines, would appear to be the most challenging for organizations. The implementation criteria consist of six points, according to the 1999 Joint Commission Hospital Executive Briefing:
— modification(s) necessary to support specific level or locus of guideline implementation;
— mechanisms for anticipating and evaluating variance in guideline(s) compliance;
— recommended or selected measures pertinent to decision points, outcomes and variations relating to compliance;
— whether the guidelines can assist the practitioner in making decisions about appropriate health care for special clinical circumstances;
— whether the guidelines are based on current professional knowledge and are reviewed and revised periodically;
— mechanisms for disseminating information about implementation of selected guidelines.
For each of the six points listed above, JCAHO-accredited institutions have the responsibility for developing policies and procedures to address each of these main points if the proposed standards are approved for use. It is not adequate to rehash the verbiage of the standards. It is necessary that each standard and intent statement be addressed in a policy and/or procedure. The purpose is to illustrate how the organization is going to design systems and processes to address the standards and intent statements. The effectiveness of the clinical practice guidelines also needs to be evaluated.
The Joint Commission’s proposal of these standards for clinical practice guidelines illustrates how the performance improvement standards are being used to develop a strong relationship among other JCAHO standards. The proposed standards for clinical practice guidelines would require the development of systems and processes to design, measures, assess, and improve patient care outcomes. It is possible to use these proposed standards as an opportunity to develop a performance improvement project for your organization.
In some organizations, the development of many of the systems and processes to address clinical services and regulatory compliance may not be clearly visible. This is particularly true when one examines the relationship between policies and procedures for patient care and actual clinical practice. As most professionals would agree, there is a fair degree of variation between what is in writing and what is actually practiced. Another example of this may be in organizations making the transition from a traditional hospital model to product or service lines. If the patient care is not consistent due the design of the infrastructure, poor patient care outcomes may result.
Policies may support or oppose guidelines
This raises another issue for case managers. What if the supporting policies and procedures do not adequately reflect what is expected in terms of standards of practice or standards of care? To be blunt, do the policies and procedures of the organization support the content of the practice guidelines, or are they in conflict with one another? This may not only be a potential legal issue, but it also may place clinicians attempting to comply with the guidelines at odds with one another.
One of the first steps would be to compare new or proposed guidelines with existing standards of practice available in the organization by all health care practitioners. Bylaws, rules, and regulations also should be reviewed. All care providers should be included in the process. This includes any potential issues that may arise out of contracts. The rationale for this approach is to diminish or greatly the decrease potential for having any patient care systems and processes that may be conflict with one another. This process also may identify systems and processes that need to be developed or redesigned.
Case managers need to evaluate whether the organization’s systems and processes support the criteria in the pathway. For example, if the pathway requires tight time lines for medication administration and the medication systems of the organization are not effective, there may be difficulty in meeting the guidelines’ time line for compliance. The potential linkage is to examine not only the criteria in the guidelines, but also the effectiveness of the supporting systems and processes to ensure the organizational operations support the success of the guideline. This also would be an example of the linkage of the JCAHO standards described above.
In terms of understanding whether or not a guideline is effective, it is important that the patient outcome is not the only measure. If there are numerous approaches to treating patients because the practice guidelines are changed so frequently, it becomes difficult to determine what is the "best" or what changed in order to ensure a good outcome. Statistical methods can be used to answer these types of questions. The proposed standards also suggest that a process be developed for anticipating and evaluating variation in guideline compliance.
In order to determine if the process is in control and consistent, the data from the guidelines should be incorporated into a statistical tool for analysis. Using the appropriate control chart can greatly assist the organization in analyzing the consistency and effectiveness of the practice guidelines. Clinical practice guidelines should foster interdisciplinary meetings of clinicians to define processes that outline how patients will receive clinical services for various diagnoses. They outline the interventions, medications, procedures, etc. for a certain disease or clinical condition. It is during this process that case managers and/or performance improvement professionals should determine what types of control charts can be used — and how — to measure the effectiveness of the clinical outcomes and the systems and processes that support these outcomes.
By designing the measurement tools during the development of the practice guidelines, it may make the review, analysis, and potential changes in the pathways easier to examine. It also will provide quantitative and qualitative data for decision making in terms of the effectiveness of the guidelines.
As one develops practice guidelines, they can be designed as flowcharts that may provide a "picture," or as a form of an algorithm for patient care services. The potentially meaningful part of this process is that it allows for an organization to examine how it is currently providing patient care in certain diagnosis through a flowchart. A second flowchart should then be developed to describe how the organization would like to deliver care for a diagnosis. This allows for a visual comparison of what is and what should be. This approach could be used to evaluate whether practice guidelines obtained from the literature would be acceptable for the organization. If a process is not currently in place, this could be the part of the mechanism to evaluate whether or not a guideline should be accepted by the organization according to the proposed JCAHO standards.
By using this method, the practice guidelines can be developed including a statistical method of measurement built into the process. This will help identify variations in practice. It also may provide insight into the effectiveness of existing systems and processes. It also may reduce the need for developing or maintaining separate systems and processes in the organization to measure regulatory aspects of the guidelines through another mechanism such as a committee, i.e. blood use. This could be done through the pathway and the information addressed in the product line meeting, or it could be forwarded to the appropriate committee.
Combining the clinical practice guidelines with the issues that managed care companies are focusing on helps to provide additional information that may be considered when developing a pathway for review. At times, the clinical practice guidelines are developed in response to conditions that require high utilization of resources. The managed care company targets a diagnosis/procedure. The health care organization tends to also target the same diagnosis/procedure.
There are situations when the aggregate utilization data are not shared with the case manager in the hospital. Managed care companies have their own mechanisms for collecting data. In some companies, case management staff do not receive aggregate data. The result would be case-by-case reviews without an examination of trends and patterns by the very staff that can effectively intervene to assist with compliance with the guidelines. They also are the ones who can examine the need for a revision to the guideline. It is important these people be included in the process of pathway development, review, and evaluation.
Examination of the trends and patterns can assist in the refinement of clinical guidelines as well as communicating the "expectations" with staff. This also may confirm whether the issue was related to the specific intervention by a single practitioner or was part of a contributing trend or pattern.
Personnel participation encourages buy-in
The proposed standards for clinical practice guidelines require all of the appropriate personnel to be invited to participate in the process. The obvious reason is to have buy-in and input into the process. Some organizations invite the "resident expert" to discuss the standards of practice or care in a service or a unit at a meeting where the pathway is being developed. The individual should have baseline data to support how care is actually being delivered on the unit. It is important that current practice is measured prior to developing new guidelines.
As mentioned previously, leaders need to be involved in the process. This supports the JCAHO leadership standards holding that state leaders also should be involved in the development of new systems and processes. They also can provide necessary resources and support to get the system implemented. New systems and processes should be pilot-tested. The leaders also need to approve and evaluate the outcomes resulting from the use of clinical practice guidelines. They need to refine the practice guidelines if the assessment of the outcomes indicates opportunities for improvement.
Finally, in terms of getting ready for the JCAHO-proposed standards for the use of clinical practice guidelines, it is important to determine whether or not your organization is a JCAHO-accredited facility. If it is, it is important that someone in the organization is assigned to monitor the progress of the standards for approval and the time line for becoming part of the accreditation process. This can be done through the JCAHO Web site or the JCAHO publication Perspectives.
A copy of the proposed standards discussed in this article already may be available in your facility. If not, you can contact the Joint Commission and obtain a copy.