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Online compliance and continuing education courses for clinical laboratories

Corrective Information and Courses from MediaLab, Inc.

These are the MediaLab courses that cover Corrective and links to relevant pages within the course.

Learn more about laboratory continuing education for medical technologists to earn CE credit for AMT, ASCP, NCA, and state license renewal and recertification. Or get information about laboratory safety and compliance courses that deliver cost-effective OSHA safety training and continuing education to your laboratory's employees.

Laboratories Individuals

Chemical Screening of Urine by Reagent Strip
Quality Control

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.

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Department of Transportation (DOT) Regulated Urine Specimen Collection Training
Donor provides the specimen

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.

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Laws and Rules of the Florida Board of Clinical Laboratory Personnel
Supervisor Responsibilities

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

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Technologist Responsibilities

Technologists are primarily responsible for performing testing and reporting results. Other duties include:Performing only those tests authorized by the director and for which the technologist is licensed by specialty.Following the laboratory's procedure for specimen handling, running tests, reporting results, and maintaining recordsParticipating 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 valuesUsing professional judgment to ensure test validity, including recollecting and retesting samples that may be flawed or contaminated

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Technician Responsibilities

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

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Medical Error Prevention
Which statement(s) are true about Failure Mode and Effect Analysis?View Page
RCA Steps Steps in Root Cause AnalysisView Page
Vigilance

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.

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Advantages of FMEA

FMEA encourages corrective action before errors are made--it emphasizes prevention. It identifies possible failure during systems or process development. Its structured analysis evaluates processes before implementation. Time and resources for FMEA are allocated during development, when changes are easier and less expensive to make.

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Medicare Compliance for Clinical Laboratories
Element 7

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.

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Documentation

All information related to diagnosis or other billing information received from a physician office must be documented. Documentation includes the name of the person collecting the information, the name of the person giving the information, and the date. This documentation must be linked to the original order. Billing department employees must ensure that complete records and documentation exist for all billing transactions.Not documented means not done.All communication, (either written or verbal), with government, Carrier, or Fiscal Intermediary representatives must be documented.Employees should report instances where records are missing, incomplete, or improperly filed, to ensure that corrective action is taken.

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OSHA Formaldehyde
Corrective Action

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.

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Quality Control
CUSUM Example: Exceeding the CUSUM Limit

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.

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Troubleshooting

Problems are inevitable in quality control (QC). Some problems affecting QC can be avoided simply by performing regularly scheduled cleaning and other maintenance of equipment. Other problems, though, happen suddenly and require immediate action to resolve an analysis that is “out of control”. Every clinical laboratory has its own steps that should be taken when controls are outside accepted limits. It is your responsibility to be familiar with the procedure and follow it explicitly. The steps on the next pages are examples of some corrective procedures that your clinical laboratory may use to restore precision and accuracy.

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Possible Corrective Action (1)

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.

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Possible Corrective Action (2)

Check your reagents and controls. Make certain all lot numbers and expiration dates of reagents and controls used in the testing process are current. Verify that the recommended storage conditions were followed.

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Possible Corrective Action (3)

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.

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Possible Corrective Action (4)

Review calibration of the test instrument.What was the date of the last calibration? Test instruments need to be calibrated according to the manufacturer’s instructions or more frequently if necessary. Federal requirements call for analytic tests to be recalibrated at least every six months to verify the accuracy of the testing procedure.

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Possible Corrective Action (5)

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.

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