Improving the quality of point-of-care laboratory testing performed by non-laboratory staff

1. Improving the quality of point-of-care laboratory testing performed by non-laboratory staff G. Augustine, K. McKenna, S. Kahn Near Patient Testing - Clinical Laboratory Loyola University Medical Center

2. Opportunity Statement Point-of-care (POC) lab tests are diagnostic tests performed at locations outside of the main laboratory. These sites include hospital units, outpatient clinics and satellite facilities. These tests are generally performed by staff not formally trained in clinical laboratory science such as nurses, perfusionists, patient care techs and respiratory techs. While most laboratory testing continues to be performed in the main clinical laboratory, more than 25,000 tests per month are performed at approximately 80 point-of-care locations throughout the Loyola University Health System. The growth in point-of-care has provided the opportunity to ensure that laboratory testing conducted at diverse locations by non-laboratory staff is performed using good laboratory practices and in compliance with relevant regulatory standards to produce accurate test results that optimize patient safety and minimize process errors.

3. Testing performed at point-of-care in LUHS • Blood gases • Electrolytes • Activated clotting times • Glucoses • Dipstick & automated urinalysis • Flu A&B • Gastric and fecal occult blood • Nitrazine paper (amniotic fluid detection) • Hemoglobin A1c • Pregnancy (hCG) • RSV • Hemoglobin & hematocrit • Strep A • PT (prothrombin) • Microalbumin • Creatinine

4. Most likely causes of testing process errors at the point-of-care included: • Incomplete standardization of staff training and lab procedures • Inconsistency in following good laboratory practice • Random and isolated occurrences of patient identification errors • Less than optimal availability of information on point-of-care lab procedures, supplies and regulations

5. Significant quality improvement opportunities at point-of-care were identified and the following solutions were implemented: • 1. Laboratory support of POCT has been broadened and optimized by: • Establishing a quality assurance program to ensure that good laboratory practices were followed by all staff performing POC testing. • Providing a comprehensive manual containing training checklists, standardized procedures, competency assessment guidelines, supply information, regulatory requirements and quality control logs to all sites performing POC testing. • Establishing a POC steering committee to use a multi-disciplinary approach to the problems and challenges of point-of-care testing. The committee includes physicians and other healthcare professionals from CCE, risk management, nursing administration, ambulatory services, infection control, and laboratory administration.

6. Requiring that all tests performed at POC be approved by the POC steering committee to ensure that only accurate, easy to use and supportable tests are implemented with methods that can be standardized across all areas. • Implementing a web-based training program for POC waived tests. • Developing a standardized format for documenting patient test results performed by manual methods. As EPIC is implemented across the system, these manual tests will then be entered via EPIC so that results will be available for physician review.

7. 2. Quality assurance tools were developed to improve the accuracy and reliability of patient testing results (illustrated in Figure 1). • A quality assurance audit was set up to audit all sites that perform POC testing. This QA audit checks the performance and acceptability of quality controls, compliance with standardized procedures, dating and expiration of testing supplies, and safety issues. Results of these audits are provided to each manager or coordinator where POC testing is performed to ensure that corrective action is taken where violations of good lab practices or regulations have occurred. • A tracking system was established to track patient identification errors involving the Roche Accu-Chek Inform® glucometers (Roche Diagnostics, Indianapolis, IN) on a monthly basis. Unit managers are notified of patient identification errors.

8. 3. POC testing and data handling were improved (illustrated in Figures 2A and 2B). • New glucose meters (Roche Accu-Chek Inform®, Roche Diagnostics, Indianapolis, IN) were purchased and implemented which were easier to use, more reliable, more accurate and allowed automation of data handling. • An ethernet based connectivity computer system RALS® (Rapid Automated Laboratory System, Medical Automation Systems, Charlottesville,VA) was purchased and implemented which will serve as a platform for data handling of POC test results. This system allows many analyzers to be connected via the ethernet to send patient results and quality control to the laboratory. When patient results are received, orders are automatically placed and results are transferred to EPIC for physician review.

9. Figure 1 A point-of-care testing quality assurance audit was implemented in October 2001 and continues as a quality tool to monitor the performance of all areas that perform POC testing. The following graph illustrates that through continued surveillance, corrective action and assistance from the laboratory, the percentage of units passing per quarter has increased significantly.

10. Figures 2A and 2B The point-of-care glucometer patient identification monitoring tool was implemented in June 2003 and continues as a quality tool to track patient identification errors involving glucose results. The following graph illustrates that through continued surveillance, corrective action and assistance from the laboratory, patient identification errors involving glucose results have been declining despite an increasing volume of glucoses performed monthly. 2A 2B

11. Recommended Further Actions To maintain this improvement, the laboratory will continue the quarterly POC quality assurance audit and glucometer patient identification error tracking tool to ensure compliance with good laboratory practices. The laboratory will be mailing a point-of-care customer satisfaction survey to all sites to gather information on how the laboratory can improve its support of POC testing. The laboratory will continue to pursue state of the art analyzers to streamline POC testing. The laboratory will continue to optimize electronic data management in POC testing. To decrease patient identification errors, the laboratory will continue to send notification of errors to unit or satellite managers and to educate staff on proper identification procedures and use of case numbers.