Risk Management in the Laboratory

The laboratory as a fundamental component in provision of health care has procedures that transform the physicians order into laboratory information (Berte, et. al 2004). A lot of care should be taken while working in the laboratory due to the many risks it presents. Quality management and patient safety must be observed by setting of conventional rules in form of standard operating procedures to be followed in all clinical laboratories.

Workers can reduce risk upon themselves by keeping safe and being responsible.

Some of the measures to be taken towards patient safety include patient and specimen identification, provision of accurate information, specificity and sensitivity in analytical procedures and correct interpretation of results (Noble, 2010). In addition, patient consent and identification, specimen transport and identification should be thoroughly monitored during the pre- analytical stage.

For the laboratory management, they include financial, liability and safety (Wayne, 2007). The following paper will discuss biological agents as one of the potential risk in laboratories to the workers, the patients and the laboratory organization and site the steps a laboratory can take to assess possible risk failures.

Some of the categories of potential risk for laboratory workers, patients and the laboratory organization include chemical that can poison, burn or irritate depending on the material, biologic agents which have the potential to cause diseases, ionizing radiations like ultraviolet lamps, non-ionizing radiations such as x-rays, machinery used for purposes they are not intended, sharps in the form of hypodermic needles and blades, electrical apparatus which carry the potential of electric shock and fires and burns caused by ignition of flammable components (Jewell, 2009).

Biological Agents Microbiologic contamination poses a risk of contamination and infection and is the greatest hazard in clinical microbiology laboratories. Laboratory infections are dangerous not only to the clinical laboratory personnel but also to anyone else who enters the laboratory, including maintenance personnel, and visitors. The frequency and length of contact with the infectious agent, its virulence, the dose and route of administration, and the susceptibility of the host determines the risk of infection.

The common hazard of an infectious agent is affected by factors such as the volume of infectious material present, material handling, effectiveness of safety containment equipment, and soundness of laboratory methods. Samples from patients in form of body fluids and especially blood, are considered potentially infectious for blood-borne pathogens, and must be handled in the right manner. It is recommended that agents that are treated differently, such as viruses as opposed to bacteria should be handled in different laboratories or in different parts of the same laboratory.

Determination of an agents risk category is important for it to be handled in an area with suitable control. All specimens sent for microbiological studies and all organisms sent to the laboratory for identification should be considered as having the potential to cause infections. There should be a separate area for the receipt of specimens. Personnel should be aware of the potential hazards of improperly packed, broken, or leaking packages and of the proper methods for their handling and decontamination (McClatchey, 2002).

In order to reduce the risk of infection, workers should wear moisture-proof laboratory coats always, observe hand washing before and after wearing gloves and at the end of each potential exposure to etiologic agents, avoid mouth pipetting, and not eat, drink, smoke, or apply cosmetics in the laboratory. It is also appropriate for those in constant exposure to certain infectious agents such as rabies and hepatitis B to be immunized. When handling samples, nosocomial infections can be avoided through frontline involvement, washing hands, special education and routine surveillance (Wayne, 2007).

Regular precautions, isolation of body substances, and other mandated practices involve the use of personal protective equipment and engineering controls to minimize laboratory scientists’ exposure to blood-borne pathogens, even when the risk of infection is unknown (McClatchey, 2002). Internal and external audits, preventive and corrective actions and offering room for improvement are some of the measures that can be taken in risk reduction through quality systems and improvement.

Internal audit provides an opportunity to identify and avoid nonconformance thus enabling provision of quality services while external audits are performed to assess whether the set rules are being followed (Wayne, 2007). Assessment of Possible Risk Failures Through patient identification error, accession errors and provision of new tests and services risk management procedures can be applied. However, preventive measures are more appropriate in the reduction of risk opportunities in quality management systems. Consequently, major steps can be taken by a laboratory to assess possible failure risks.

These are risk analysis, which employs quality assurance and quality control techniques that should be developed using quality management techniques like Failure Modes Effect Analysis( FMEA ) team which uses a work sheet( Beauregard, Mikulak ; McDermott, 2008) to identify current and potential risks, risk evaluation, that makes use of the Failure Reporting, Analysis and Corrective Action Systems FRACAS (Cappucci ; Samardelis, 2009),and risk control which involves risk management; a systematic application of management policies, procedures, and practices for the purpose of identifying, analyzing, evaluating, controlling, prioritizing and monitoring risk.

This leads to coordinated and economical use of resources to minimize, monitor, and control the probability and/or impact of unfortunate events. Manufacturers are familiar with risk management principles, as devices must go through extensive risk assessments before they are cleared (Nichols, 2010). With these precautions they acquire documents that incorporate quality control in the clinical laboratories (Hubbard,; Douglas, 2009). FMEA and FRACAS are quality tools that can be used to identify and control potential causes of risks, which form a central part of a well run quality management. FMEA uses people, materials, equipment, methods and environment to assess how process failure can affect efficiency and service.

In conclusion, preventive measures should be used more in the laboratory as opposed to corrective measures. References Beauregard, M. , Mikulak, J. R. , ; McDermott, R. , 2008, The Basics of FMEA,2nd. Ed. , New York, US: Productivity Press. Berte, M. L. , Boone, J. D. , Cooper G. , James, L. P. , Kallner, A. , Noble, M. A. ; Tholen, W. D. , 2004, Application of a Quality Management System Model for Laboratory Services; Approved Guideline,3rd Ed. , 24(36). Cappucci, W. , ; Samardelis, J. , 2009, Applied Quality Risk Management: Case Study Laboratory Computerized Systems, Journal of Pharmaceutical Engineering, 29 (5). Hubbard W. D. , 2009, The Failure of Risk Management: Why It’s Broken and How to Fix It,

New York, US: John Wiley and Sons. Jewell, P. , 2009, LAB1 Generic Risk Assessment for General Laboratory Procedures. McClatchey, D. K. , 2002, Clinical laboratory medicine: Hazards of Clinical Laboratory Work, Volume 2001, 2nd Ed. , Hagerstown, Maryland: Lippincott Williams & Wilkins. Nichols, J. H. , 2005, Laboratory Quality Control Based on Risk Management. Retrieved from on 4th june,2010. Noble, A. M. , 2010, Reducing Risks in the Clinical Laboratory. Wayne, P. A. , 2007, Management of Nonconforming Laboratory Events: Approved Guideline, Clinical Laboratory Standards Institute, 27(27).

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