Sometime within the next two years, the National Committee for Clinical Laboratory Standards (NCCLS) is expected to pass proposed guideline GP26-P, “A Quality Systems Model for Healthcare,” that will affect clinical laboratories nationwide.
   The guideline is healthcare’s first major attempt to initiate Quality Systems practices that will encompass the entire laboratory workflow process. For the past five years, only blood products have been regulated by a Quality Systems model under the American Association of Blood Banks’ “Good Manufacturing Practices” standards.
   The NCCLS guideline consists of “10 Quality Systems Essentials,” which closely correlate to existing ISO 9000 manufacturing standards. ISO standards, which have been adopted by more than 70 countries, have been followed in the manufacturing industry since the 1950s. Their implementation ensures consistency in the quality of manufactured goods for international trade purposes.
   The NCCLS GP26-P Quality Systems guidelines aim to do for the laboratory what ISO 9000 does for manufacturing — standardize and monitor all laboratory processes in the pre-analytical, analytical and post-analytical stages. The standards will help laboratories decrease variance, increase quality and, eventually, cut costs.

Michele Pitello, MT (ASCP) unloads samples from the AccelNet automated system in the Loyola University Medical Center core lab.

Automation prepares Loyola lab for QS
During the past year, Loyola University Medical Center near Chicago has been one of the first facilities to implement a program to integrate the GP26-P Quality Systems guideline into its core laboratory. If, as expected, the pilot program proves to be successful in the core lab, Quality Systems standards eventually will be integrated throughout all the medical center’s laboratories.
    The core lab chose this program to build upon and increase the efficiency that resulted from its previous success in restructuring and utilizing automation.
     Loyola University Medical Center, a 540-bed tertiary care, academic medical center, is a level-one trauma facility with a cancer center, a children’s hospital and 13 primary care satellites.
In 1998, the medical center responded to ongoing budgetary restraints and declining reimbursements by creating a core laboratory and purchasing automated equipment with robotics.
   Several departmental-based laboratories were restructured into one centralized core lab. The core lab consolidated general hematology, general chemistry and specimen processing into one area to streamline workflow.
   Next, the core lab purchased AccelNet, an automated robotics workcell that connects the front-end sample processor to the lab’s Synchron chemistry analyzers (both from Beckman Coulter, Fullerton, Calif.).
    AccelNet reads barcodes, sorts samples, processes samples for centrifugation and de-caps tubes for delivery to the appropriate analyzers. The automated equipment has standardized testing, decreased errors and ensured consistent test results in the core lab.
   As part of the automation process, lab workstations were consolidated, and lab staff were cross-trained to increase their flexibility. The combination of these changes allowed the new core lab to decrease turnaround times (TATs) by 11 percent, even with a 20 percent increase in testing volume and no additional staff. Additionally, a $100,000 savings in staff salaries was realized by utilizing service mixing.

Automation and the QS pilot program
Workstation consolidation and automation in Loyola’s core lab built the foundation for implementing the Quality Systems pilot program. Medical center administrators and lab personnel knew that the core lab needed a standardized process for monitoring quality to maintain and continue to improve its service. The NCCLS Quality Systems approach was used as the template for this process. The core lab automation and the integration of the Quality Systems guideline were symbiotically related, one could not occur or move forward without the other.
   Loyola’s core lab began the process of integrating the then-proposed NCCLS GP26-P guideline in January 1999. First, a Laboratory Quality Steering Committee was formed to oversee the pilot program. Using the 10 Quality Systems Essentials outlined in the GP26-P guideline, the committee began to incorporate each of the essentials into the core lab’s workflow.
   The 10 Quality Systems Essentials in the GP26-P guideline encompass laboratory functions in the areas of:

1) Organization
2) Personnel
3) Equipment
4) Purchasing and Inventory
5) Process Control
6) Documents and Records
7) Occurrence Management
8) Internal Assessment
9) Process Improvement and
10) Service and Satisfaction

Each of the 10 “essentials” include several specific measures of compliance.

The 10 essential elements
1) At Loyola, the essential element of Organization began with the Core Laboratory Quality Committee. It was clear that for this project to stay on track, it required management’s commitment. Therefore, the committee involved key medical center administrators as well as laboratory management and faculty.
   The committee developed a charter, which became a key tool for keeping the team on target. Members worked toward consensus on all decisions. The organizational element of the GP26-P guideline provides guidance for provision of services, conformance with regulatory requirements and a systematic program for monitoring quality and appropriateness of services.

2) Personnel is key with any new automation. This quality essential identifies job descriptions, orientation programs, training, competency assessments, performance appraisals and guidelines on continuing education.
   For example, the core lab’s job description included reporting responsibility, work activities/accountabilities and the physical demands of the job. Job specifications for lab employees detailed the required education, experience, skills and qualifications, as well as the necessary registrations, licenses and certifications for each position.

le02.jpg (12662 bytes) George Krempel, director of clinical laboratories and pathology at Loyola University Medical Center, in front of the AccelNet robotic work station.

3) To meet the GP26-P guideline for Equipment, the laboratory needed documentation to demonstrate that all its equipment is installed, maintained and run according to the manufacturers’ recommendations. It is also important to utilize equipment manufacturers’ recommendations for calibration, maintenance and repair and to carefully document all this information.
   Standard operating procedures for troubleshooting equipment were developed to document any equipment maintenance performed. This data is tabulated and charted to monitor automated equipment performance.
   A request for proposal (RFP) form was found to be the most effective way to assess appropriate use of equipment for the laboratory. The RFP was used to create a checklist of needs and to help choose the best possible automation solution for the core lab setting.

4) The quality essential for Purchasing and Inventory is easier to meet when equipment is purchased from ISO 9000 — compliant manufacturers. The core lab’s purchasing department helped ensure that suppliers met that standard. In addition, the lab’s group purchasing organization already had quality standards that made sure vendors met their contractual obligations. Loyola’s core lab used flow charts to record every step of the ordering process.
   To facilitate inventory requirements, the lab implemented “just-in-time” delivery of reagents and centralized inventory areas for monitoring purposes.

5) The Process Control quality essential deals with the design, development and validation of laboratory processes. For the automation in Loyola’s core lab, it was critical to use flowcharts to diagram the laboratory process before and after automation. The flowcharts served a variety of purposes, including identifying how an individual process is performed, documenting processes for quality management systems, simplifying complex processes and noting any problems. They also served as training aids.
   The core lab used two types of flowcharts. A general one showed the big picture, while detailed charts outlined every step of the lab process. The detailed charts are useful for documentation purposes.
   Loyola’s core lab also created diagrammed maps to show the flow of specimens in the pre-analytical stage, including the steps involved in specimen receipt, test ordering, specimen labeling, specimen processing and the distribution of tests to the proper workstations. In the analytic stage, the diagrams indicated a general overview of steps that could be applied to any of the core lab’s workstations, including maintenance, reagent preparation, calibration, controls, sample evaluation, testing and the evaluation and reporting of test results. These diagrams also serve as documentation.

6) Documents and Records is the most time cosuming of the 10 Quality Essentials. Documentation is the foundation of the whole Quality Systems program. NCCLS’ GP26-P identifies three types of required documents.
   Level A documents define policies (what to do), Level B documents are for lab processes (how each process happens), and Level C documents are for procedures (how to do it). Documentation also involves coordinating the three types of documents into a quality systems manual.
   Loyola’s core laboratory found that ISO 9000 software packages were easily adapted for the laboratory, making documentation much easier.

7) The Occurrence Management quality essential covers error detection, occurrence reporting, the timely correction of lab problems and the reporting of problems to regulatory agencies.
   During the core lab pilot program, control charts were used to monitor the automated AccelNet workcell with robotics. Error logs and variance reports made it easy to graph trend variances. Lab personnel used Pareto analysis to help prioritize any problems. Pareto analysis (the theory that 80 percent of all problems are caused by 20 percent of the possible sources), scatter plots and other statistical process control tools helped us discover and fine-tune the sources of lab errors. Once found, specific corrective measures were taken. All of this data was carefully documented.

8) The NCCLS Quality Systems guideline mandates a internal assessment program to measure performance and compliance with GP26-P in all areas of the lab. To comply, Loyola’s core lab is incorporating a “Quality Dashboard,” to graphically represent a list of metrics that demonstrate that the automated system is working.
   These monitors include results from a variety of tasks, including instrument downtime, service, TATs, waiting times on customer service lines, patient recalls, critical calls and mislabeled specimens.
   Results of these metrics are tabulated monthly and graphed on control charts. The lab staff currently is being trained to read and interpret these control charts and to help identify trends or potential problems.
Internal audits are conducted periodically to assess the lab’s overall performance. One audit takes a random sample of specimens and tracks it from specimen receipt to verified test result. The audits also look at all staff training and competency records associated with running instruments and the instrument’s record of calibration and maintenance during the time the specimen was on the equipment.

9) The quality essential regarding Process Improvement has been incorporated into Loyola’s core lab by utilizing a quality improvement (QI) approach. The QI framework is defined by JCAHO and uses a “plan-do-check-act” method to evaluate performance improvement.
   Loyola has spent considerable time creating flowcharts of the lab’s workflow, as well as brainstorming potential process-improvement projects. These actions have resulted in the development of a laboratory staff cross-training program, a better method of labeling specimens, and a program that has increased the staff’s expertise in using the laboratory information system.

10) The final quality essential, Service and Satisfaction, is designed to reduce redundancy and improve patient care and customer service.
   At Loyola, service and satisfaction monitors were developed in the core lab that addressed internal and external customer needs. This included monitoring the staff’s telephone etiquette and inserting a customer satisfaction survey in the medical center’s newsletter.

Quality Systems programs will deliver a long-term benefit to the healthcare industry in the same way that ISO 9000 standards have improved quality in manufacturing. By analyzing overall trends and the entire workflow process, as outlined in the GP26-P guideline, laboratories will minimize errors and increase their levels of service to physicians and patients. The more consistent workflow and reduction in errors also will reduce costs eventually.
   Although the pilot program at Loyola is still in its early stages, it is clear that Quality Systems can standardize and monitor automation and the entire laboratory workflow. Implementing this guideline has already led to many beneficial programs in Loyola’s automated core laboratory.

George Krempel is the administrative director of anatomic and clinical pathology at the Loyola University Medical Center in Maywood, Ill.

Amy Haara is the laboratory decision support analyst at Loyola University Medical Center.

Michelle Liszka is the central processing technician at Loyola University Medical Center.