Simple QA Can Lower Laboratory Costs
Reprint from Focus On, 2001 Issue 4
Each year the mainstream media grabs a report about an unfortunate medical accident that strikes fear in the hearts of all potential patients. These sensational reports usually focus upon the extreme errors such as a medication error that results in death of a patient or the surgery that ends with amputation of a wrong limb or breast. The media remains unaware of other errors that contribute to the high cost of health care because a patient did not overtly suffer any adverse action.
According to a recent report that was published by the National Academy of Press and the Institute of Medicine, approximately 44,000 people die annually because of medical errors. This rate exceeds the rate from motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516).(1) Laboratorians have always emphasized the importance of maintaining a safe work environment. However, we must provide our patients with a safe environment through accurate laboratory test results.
Laboratory errors have a direct relationship with increased healthcare cost because of the cost of repeat testing. Errors contribute to the loss of laboratory credibility and the loss of patient confidence in laboratory test results. An error-ridden laboratory has a higher operating expense due to the cost of repeat testing than an error free laboratory. Low laboratory errors yield increased patient satisfaction and greater patient confidence in the clinician's treatment.
James Reason, a respected expert on industrial errors, divided errors into two main categories: the correct action does not advance as intended (an error of execution)(2) or the original planned action is not correct (an error of planning). Thus, errors are not solely related to a specific person or individual. They usually result from a system failure in either execution or planning.
The history of one industry that made significant positive changes in their error rates shows that healthcare could implement changes for a safer performance. For example: the commercial airline industry spent the last five decades focused on systems. Consequently, commercial aviation in the United States has recently reported a fatality rate less than one-third of the rate experienced during the 1950's. In fact, there were no deaths in the commercial airline industry in 1998.(3)
This brings us to the role of quality assurance in our laboratories. A strong quality assurance program helps ensure patient safety, improves employee morale and productivity, and elevates patient confidence in your facility. A quality assurance program requires more than just counting the errors and finding someone to blame. Quality assurance enables you to look at the systems utilized in your laboratory and determine why there was a failure.
A Quality Assurance Program Becomes an Evolving System
When you develop your quality assurance system, you provide a structure to measure your success. The system should enable your lab to identify problems, develop solutions, and monitor the success or improvement after the changes were implemented. The most successful programs have at least four major components: training, competency, error tracking, and proficiency testing. Other secondary activities may be incorporated in the program such as quality control testing, equipment preventive maintenance, and parallel testing of kit lots.
Training: All personnel who work in your laboratory require training in your specific methods and procedures. If you expect a person to walk into your facility and run laboratory tests successfully without training, you place that person and your laboratory in a high-risk position. Each laboratory has specific and unique characteristics that can affect how a test or method performs. For consistent results, new employees need training. Keep a file of all training records for all personnel. Inspectors appreciate such documentation. Well-trained employees should produce fewer errors, have a higher productivity, and be willing to accept ownership and responsibility for their work. Good training gives an employee the tools for a successful work experience in your laboratory.
Competency: The competency portion of quality assurance has often been met with fear and trepidation by laboratory staff from coast to coast. However, competency testing adds the laboratory director's stamp of approval to the employee's performance of all laboratory test procedures. The competency may be structured in the form of a quiz about a particular procedure/laboratory test, the direct observation of the performance of a specific test, or a self-learning/quiz packet. As with all laboratory activities such as temperature checks and instrument maintenance, keep records about all competencies and any corrective actions that were implemented to resolve unsuccessful competency performance. In case of an unsuccessful competency, map out the steps for remedial action such as re-training and repeat the competency. Maintain all documents on this action.
Error Tracking: The benefit of monitoring errors through quality assurance allows a laboratory to study their system and not just find someone to blame. This helps employee morale. For example, in laboratory "X" a manager notices a discrepancy in the fasting glucose results for two patients. The manager pulls the samples for a repeat of the tests. The repeated results agree with the patients' historical fasting glucose. The manager examines the specimens and discovers that both patients had similar last names and the same first name. However, the handwritten last name on the tubes was unclear. Because of this error, the manager designs a different labeling system for patient samples that should make such an error less likely. After implementing the new system, the manager reviews the error rate for mis-identified samples and demonstrates how the error rate has been decreased. The emphasis in the above situation is placed upon the system and not the employee error.
Proficiency Testing: Successful proficiency test performance should reinforce confidence in the laboratory. Proficiency samples consist of unknown materials just like patient samples. However, all participants in a proficiency test program will receive the same samples. Each laboratory handles the specimens the same way they handle patient samples. All people who perform testing on patient samples should have the opportunity to participate in proficiency testing. The proficiency provider calculates the acceptable values from all laboratories that performed tests with the same methodology to determine the acceptable grading range. Through the proficiency test process, your laboratory is measured against other laboratories using the same instrumentation and testing the same materials. Proficiency testing provides the laboratory with a national performance evaluation and an overview about the various testing methods on the market.
These are just a few examples of areas that can be included in a laboratory quality assurance program. Each program should be tailored to the individual laboratory. The monitoring needed to prevent errors in larger full-service laboratories is much different from that needed in a small laboratory with a limited test menu. The laboratory director must decide what elements will benefit the individual laboratory. This will result in a successful quality assurance program that will enhance the comfort level for test performance by your staff and ensure the safety of your patients.
(1) Centers for Disease Control and Prevention (National Center for Health Statistics). Births and Deaths: Preliminary Data for 1998. National Vital Statistics Reports.47(19):27, 1999.
(2) Reason, James T., Human Error, Cambridge: Cambridge University Press, 1990.
(3) Berwick, Donald M. and Leape. Lucian L. Reducing Errors in Medicine, BMJ.319:136137, 1999.
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Related Laboratory Websites
- Centers for Medicare and Medicaid Services (CMS)
- CMS Regional Offices Contact List
- Centers for Disease Control and Prevention (CDC)
- TJC (formerly Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- State Agencies Contact List
- American Society of Clinical Pathology (ASCP)
- Clinical and Laboratory Standards Institute (CLSI)
- Occupational Safety and Health Administration (OSHA)
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