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A model QA program as a management tool.

The first step in producing an effective QA program for total performance management of a large, diverse, and highly productive pathology department is to engage the commitment of every staff member, with no exceptions. Each laboratorian must be ready and willing to help make quality of service the top priority.

Critical to the improvement of quality is a team of quality-oriented professionals who recognize that the extra effort and costs of QA will be recaptured in enhanced customer service and improved job satisfaction.

How can this level of commitment be achieved? The solution is to involve key employees from each area of the lab in developing and monitoring the QA program. These employees will "buy into" the program by providing input and becoming involved in solving QA problems. Through these activities, they will become active role models for QA in every area of the laboratory. Subsequently, these role models will develop other employees' understanding of what is needed and help obtain their commitment to the program. o History. About six years ago, our pathology department organized its first formal QA effort. (Before 1984, quality control was our main focus.) The department is located in an 871-bed tertiary care teaching hospital with active trauma and transplant services. We perform approximately two million test procedures per year and employ 240 staff members.

The size and scope of our services called for a coordinated QA program with input from all lab sections. Laboratory management, after deciding to apply the role model concept, organized a QA committee. The group included a clinical laboratory scientist from each lab section, a supervisory-level employee, a phlebotomist, an accessioning clerk, and the department QA director as chairman. Although the members were all volunteers, lab supervisors also asked individuals who showed an interest or had demonstrated a special commitment to quality to represent their sections.

The QA committee reported directly to the chairman of the pathology department. The chairman then reported the committee's activities and findings to the pathologists' professional practice committee. This committee includes medical and administrative directors of the hospital QA department, thus providing an important communication link between the laboratory and other areas of the hospital. o Changing requirements. Before 1989, our lab tallied and monitored various quality and volume indicators, such as the number of incident and corrected reports per month. Our QA activities had minimal measurable impact on patient outcome and quality improvement. The system was incident driven rather than performance managed. Although the program met JCAHO requirements at that time, it failed to meet the needs of lab management. Furthermore, JCAHO's stepped-up requirements in the past year made it necessary to modify our program extensively.

JCAHO now requires a QA program that is planned, systematic, comprehensive, and ongoing. The program must use indicators (events that may have an impact on patient care) and set thresholds (action limits) for their evaluation. It must evaluate the lab's performance level against established thresholds and prescribe corrective action when those thresholds are exceeded.

JCAHO recommends that information derived from these activities be shared with other departments and services in the hospital. Priority in developing indicators is to be given to aspects of care that occur frequently and affect many patients or that may have serious consequences for individual patients. * improvement. As I reflected on our lab services, it became clear that their quality was influenced by many related factors: laboratory proficiency and standards, specimen adequacy (collection, receipt, and processing), diagnostic accuracy in pathology, accuracy and precision of testing (quality control), test and blood utilization, turnaround time, report timeliness and accuracy, adequacy of supplies, equipment maintenance, competence of employees, employee safety, staffing workload, and morale. Since all these activities affect both patient outcome and the operational aspects of the laboratory, they became our focal points in developing QA indicators and criteria. Our ultimate goal was total performance management and quality improvement for the lab while staying within the boundaries of the JCAHO requirements. With this in mind, we devised our new program.

Our program monitors performance as it pertains to technical competence and efficiency, operational factors of the lab, and personnel. Staffing adequacy, employee morale and safety, technologist competence, and continuing education are important elements of the program. Personnel administration is closely tied to the program because the quality of the staff has the greatest impact on quality of services.

The comprehensive program uses 26 indicators, listed in Figure 1, and the criteria listed in Tables I and 11. These indicators and criteria, which have considerable impact on test quality and patient care, are used in monitoring performance in every area of the department: clinical and anatomic pathology, transfusion service, cytopathology, and phlebotomy.

We developed detailed criteria for measuring performance from the broader indicators presented in Figure 1. The criteria indicated which data were to be accumulated and reported monthly by each lab section. In addition, the criteria provided a fairly complete picture of the effectiveness of the tab operation and target areas for improving quality

The QA committee member and supervisor in each lab section were responsible for designing a system to collect the required data. Tally sheets, tailor-made for each area of the department, include a column for indicators and criteria, which vary by section; another for data reported; and a third for comments, including corrective steps taken. if comments are too extensive to fit, a separate sheet is attached, with a notation to that effect on the form.) The QA committee member, section supervisor, and pathologists in each area record and submit these sheets monthly.

The QA coordinator collates, calculates, and explains these raw data and comments on the department's monthly QA report (Table 111). The column headed "Data explanation" has been particularly helpful to laboratory management in evaluating the submitted data for accuracy and identifying any problems. o Developing thresholds. The most difficult area to tackle in implementing our new program was to develop "action" thresholds that is, levels of adequate performance for each criterion above which the lab will take corrective action. it didn't help to find out that few references in the literature provide thresholds for performance in laboratory medicine. Certain criteria, such as the number of surgical pathology cases accessioned or the number of gynecologic cases examined, are volume indicators and do not require thresholds. Having an established threshold helps determine when an aspect of lab performance that is monitored by an indicator needs to be evaluated. Some thresholds are expressed in percentages; others on raw data. The laboratory director and I based our threshold levels on three months of previous data, references of appropriate thresholds, and a general feel" for what the threshold should be in a large hospital lab setting. Thresholds do not have to be set at 100 per cent or zero occurrences initially unless that criterion is critical to patient outcome and each deviation must be evaluated.

Threshold levels require active review and regular evaluation. They may be adjusted as performance levels indicate. The thresholds listed in Tables I and 11 may be used by other labs in establishing their own. * Reviewing data. QA data are reviewed monthly at separate meetings of the laboratory supervisors, the QA committee, and the pathology professional practice committee. Data for the current month that exceed the thresholds we established are printed on the report in bold type. Laboratory management and pathologists evaluate these aspects of performance to identify opportunities for improvement. The director of the lab discusses causes of the problems and possible solutions with supervisors, pathologists, and staff members. Corrective actions to be taken are documented on the final report. * Completing the circle. The final loop in QA is to evaluate the effectiveness of actions taken. We perform this task by evaluating the following month's data to see whether corrective actions brought the wayward data within threshold limits. If not, we develop alternatives. We may have to adjust the threshold level itself, for example, to reflect current performance levels more accurately.

Laboratory management can use a well-defined quality assurance program to examine total laboratory performance and adjust it through subtle means. The team approach is the only approach for managing quality in the lab. The quality assurance program described in this article provides a system of objective reporting and accountability designed to solve problems and improve quality. It works for us because the entire staff provides thorough and thoughtful assistance. 2
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Title Annotation:quality assurance
Author:Best, Michele L.
Publication:Medical Laboratory Observer
Date:Jun 1, 1990
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