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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.



Chemical Screening of Urine by Reagent Strip
Quality Control

Both a normal and an abnormal urine quality control must be tested with each new lot of chemical reagent strips, and at least every day that patient testing occurs in order to confirm the accuracy of the reagent strips and the automated reader. Some automated 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 do not fall within the acceptable ranges.

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Chemical Screening of Urine by Reagent Strip (retired March 2012)
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) Federally 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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Detecting and Evaluating Coagulation Inhibitors and Factor Deficiencies (retired 5/27/2014)
Preanalytical Variables That Can Cause Falsely Elevated PT or aPTT Results

Improper collection of the blood specimen that is used for testing can cause false prolongation of PT or aPTT results. The following table covers several preanalytical variables that may affect PT or aPTT test results Preanalytical Variable Cause of False Elevation of PT and or aPTT Test Result Corrective Action Blood collection tube is inadequately filled. Improper ratio of blood to anticoagulant. Excess anticoagulant causes prolonged PT or aPTT result. Recollect specimen ensuring proper fill to achieve a blood to anticoagulant ratio of 9:1. Patient has a hematocrit level above 55% Improper ratio of blood to anticoagulant. Excess anticoagulant causes prolonged PT or aPTT result. Prepare a specimen collection tube that contains less anticoagulant. Refer to your laboratory's procedure for the proper amount of anticoagulant. Specimen is clotted. Coagulation factors have been activated; insufficient levels left in the plasma. PT and aPTT results will be affected. Recollect the specimen. Specimen collected from an arm with a heparin lock or from a heparinized vascular access device (VAD). Heparin contamination will prolong the aPTT. Collect the blood from a vein rather than a VAD. If blood must be drawn from the VAD, flush it first with 5 mL of saline, and discard the first 5 mL of blood before collecting the specimen. Patient is receiving heparin therapy. Heparin will prolong the aPTT If the patient is being evaluated for possible factor deficiencies or coagulation inhibitors, use a heparin digesting enzyme as a pretreatment before testing the PT or aPTT. .

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Emerging Cardiovascular Risk Markers (retired 12/6/2013)
LpPLA2

LpPLA2 refers to lipoprotein-associated phospholipase A2. This enzyme is also known as platelet-activating factor acetylhydrolase(PAF). The LpPLA2 enzyme is a lipase found predominantly on the surface of LDL particles. Note that LpPLA2 is a lipase enzyme and not an apolipoprotein. LpPLA2 is made by inflammatory cells (T cells, mast cells, macrophages) and then integrated onto the surface of lipoprotein particles. The enzymatic function of LpPLA2 is to hydrolyze oxidized phospholipids in LDL.LpPLA2 plays a corrective role in removing oxidized phospholipids. Thus, it might seem that having high levels of LpPLA2 would be good. However, although LpPLA2 has a positive role in removing oxidized lipids, it also generates inflammatory products in the process. So in fact, high levels of LpPLA2 are associated with increased cardiovascular risk. Researchers have identified high amounts of LpPLA2 in human atherosclerotic lesions. The LpPLA2 that accumulates in the vessel wall can come from LDL (which can carry LpPLA2 on its surface) or it can come from immune cells that have invaded the vessel wall. Since Lp-PLA2 is produced or localized in the plaque itself, it may be a more specific marker of cardiovascular function compared to systemic, more general inflammatory markers like hs-CRP.

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Laws and Rules of the Florida Board of Clinical Laboratory Personnel (retired 9/1/2010)
Supervisor Responsibilities

A supervisor is the laboratory director's designee for monitoring compliance with all applicable regulations of the board and the department. Other duties include: Performing the duties of a technologist, if needed, in the specialty area(s) where licensure is held Assigning direct supervision responsibilities to licensed technologists if needed, while ensuring that direct supervision of technicians is properly performed. Evaluating technologists' and technicians' competency in running tests and reporting results Being available to all personnel to answer questions and resolve problems Providing day-to-day supervision of test performance, including on-site direct supervision of testing that is performed by technicians Ensuring that quality control is performed and corrective action taken if necessary Ensuring that no patient testing is reported until corrective action has been taken and the test system is properly functioning Providing orientation to all testing personnel Implementing a quality maintenance program

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Technologist Responsibilities

Technologists fulfill assigned supervisory responsibilities as needed and as authorized. 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 records Participating in proficiency testing and demonstrating that proficiency samples are tested in the same manner as patient samples Following quality control and instrument calibration policies Documenting corrective action taken when results exceed the laboratory's acceptable performance values Using 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 (retired)
Which statement(s) are true about Failure Mode and Effect Analysis?View Page
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 FMECA

FMECA 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 FMECA are allocated during development, when changes are easier and less expensive to make.

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Medicare Compliance for Clinical Laboratories
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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Seven Fundamental Elements of a Voluntary Compliance Program

The U.S. Department of Health and Human Services OIG has identified these seven fundamental elements of an effective compliance program:Written policies, procedures, and standards of conduct A compliance officer and compliance committee Effective training and education Effective lines of communication Standards that are enforced through well-publicized disciplinary guidelines Internal monitoring and auditing Prompt response to detected offenses and documented corrective action An example of a Voluntary Compliance Program based on these seven fundamental elements follows on the next several pages.

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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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Medicare Compliance for Clinical Laboratories (retired)
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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OSHA Formaldehyde (retired)
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 Actions, continued

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 Actions

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, continued

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, continued

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, or calibration verification performed, at least every six months to verify the accuracy of the testing procedure.

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Possible Corrective Action, continued

Call the test manufacturer for advice. Manufacturers have additional information that may help resolve QC problems. Patient test results cannot be reported if the QC problem cannot be resolved. If the problem cannot be resolved, specimens should be stored properly for later testing or sent out for testing at another facility or reference laboratory, if that is your laboratory's protocol for this situation.

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Risk Management in the Clinical Laboratory
Risk management as it applies to the clinical laboratory is most accurately defined in which of the following ways?View Page


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