Corrective Information and Courses from MediaLab, Inc.

Both a normal and an abnormal urine control must be tested with each new lot of reagent strips, and at least every day of patient testing to confirm the accuracy of the reagent strips and the dipstick reader. Some dipstick readers also require periodic calibration. Follow the manufacturer's instructions for calibration procedure and frequency. Quality control results must be recorded, and corrective action must be taken when the results are not in the acceptable range.

The collector directs the donor to go into the restroom and provide a specimen. The collector must remind the donor to guard against flushing the commode or washing hands until the donor has handed his or her specimen to the collector. (Note: Inadvertently flushing the commode does not automatically require any corrective action by the collector or a recollection. However, to avoid this happening, the collector may want to place obvious signage in the restroom with instructions not to flush the commode or to wash hands.)The collector may set a reasonable time limit for the donor to be inside the restroom. Since the temperature of the specimen must be read without four minutes of urination, a time limit of four minutes in most cases is not unreasonable. The collector should pay close attention to the donor during the entire collection process to note any conduct that clearly indicates an attempt to substitute, adulterate, or dilute the specimen.

A supervisor is responsible for the day-to-day performance of laboratory testing and adherence to laboratory procedure. Other duties include:Performing technologist or technician duties as needed, if properly licensedConducting direct supervision of technologists and technicians if required by the test or the technologist's or technician's licenseEvaluating technologists' and technicians' competency in running tests and reports resultsBeing available to all personnel to answer questions and resolve problemsEnsuring that quality control is performed and corrective action taken if necessaryScheduling tests and personnelUpdating policy manualsProviding methods to identify, access, store, transport, and dispose of specimensFollowing company policy

Technicians perform laboratory testing under direct and general supervision, as required by the test and the conditions of the technician's license. Other duties include:Performing tests only as authorized by the director and the technician's licensed specialty.Following the laboratory's procedure for specimen handling and running testsParticipating in proficiency testing and demonstrating that proficiency samples are tested in the same manner as patient samplesFollowing quality control and instrument calibration policiesDocumenting corrective action taken when results exceed the laboratory's acceptable performance valuesIdentifying potential problems with tests or report resultsNotifying a technologist or supervisor if results are outside the laboratory's acceptable performance levels

Error prevention depends on vigilance. Without this watchfulness, human factors can override systems designed to prevent mistakes. For example, people can make mistakes when they operate computerized analyzers. Ignoring or overriding warning messages about abnormal operating conditions can lead to testing errors. Medical professionals should be vigilant and remain open to corrective input.

Element 7: The laboratory has a duty to respond to problems it detects either through its auditing or monitoring system or as reported by employees.It is required to take corrective action and review policies and procedures to ensure the problem does not occur again.It is required to discipline or retrain employees if necessary.The laboratory will report problems to appropriate government agencies and return any money to which it is not entitled.

When monitoring results exceed the STEL or PEL, the employer must: Develop a written plan to reduce exposure to levels below the PEL and STEL. Provide written notice of corrective actions to employees.

On March 10, the CUSUM is nearing the CUSUM Limit calculated in formula E. This should serve as a warning. While patient results are still "in control," there is a trend indicating that they will soon not be. Sure enough, on March 11, the CUSUM reaches -4, which is the CUSUM Limit, and patient results cannot be accepted as accurate. It is important to observe daily any trends in the CUSUM values so that corrective action can be taken before the limit is reached.

Rerun the control that is out-of-range.Random errors in sampling may be resolved by simply running the test again using the same control and a fresh testing device.

Run the control using a new unopened bottle of control. Improper storage may have accelerated the deterioration of the original control or the testing material may have expired.

Call the test manufacturer for advice. Manufacturers have additional information that may help resolve QC problems. Specimens should be stored properly for later testing if the problem cannot be resolved.