Although it is a responsibility of the laboratory to provide clear reports in order to prevent wrong interpretation of the results, the laboratory doesn’t always have all the patient information needed to clearly interpret a report. Thus, it is incumbent on both the laboratory and the provider to establish simple lines of communication to exchange information and ensure that the results are correctly interpreted.

In my more than 40 years of experience in the laboratory there have been many examples where the initial result reported caused confusion, and if the provider didn’t contact the laboratory for clarification, the patient treatment would have been different. Some examples of these cases are given below. One of the major causes for errors in the laboratory is the fact that providers often order tests by test name only, rather than the test number, which the laboratory can easily misinterpret. Therefore, we strongly recommend that when possible, the provider should include the National Reference Laboratory (NRL) test number when ordering a test. Moreover, for the tests discussed in this article, the test number as in the test menu of NRL is noted.

 Example 1: False Positive Laboratory Results due to Heterophilic Antibodies

A provider called because a serum pregnancy test was positive in our laboratory while the urine pregnancy test was negative. Additional tests found that the urine test was correct, and the serum test was actually a false positive. 

 There are very few reasons that such discrepancies can happen. One reason is that the patient is producing antibodies that interact with the antibodies in the immunoassay used by the laboratory. For instance, if a test uses mouse monoclonal antibodies to measure an analyte, and the patient makes antibodies to mouse antibodies, the patient antibodies can cause false positive results (or false negative results). Such antibodies, produced by patient against antibodies of another species, are known as heterophile antibodies.

 There have been many publications on heterophile antibodies both trying to determine why patients develop antibodies to antibodies from other species and to determine the frequency of such antibodies. In general, people that develop antibodies to mouse or goat antibodies don’t have a history of contact with either goats or mice. 

 One study found that patients with heterophilic antibodies tended to also have selective IgA deficiency. In the study, 38% of people with selective IgA deficiency had anti-goat antibodies, and 18% had anti-mouse antibodies. False positive test results occurred in 30% of subjects with selective IgA deficiency.

Selective IgA Deficiency is one of the most common primary immunodeficiency diseases. Studies have indicated that as many as one in every 500 Caucasian people has Selective IgA Deficiency. The rate of occurrence may be different in other ethnic groups.

The good news is that test methods developed after 2005 have intricate testing schemes to eliminate the effect of heterophile antibodies on the tests. Even so, the possibility of heterophilic antibodies should be considered if unusual immunoassay results are obtained. Since antibodies are not present in the urine, heterophilic antibodies do not affect urine assays when the serum assays are affected.

Example 2. False Negative Celiac Disease Test

A provider called our lab to ask the significance of an abnormal low Immunoglobulin A result in a celiac disease panel (e.g., NRL test #165126). Studies have demonstrated that IgA endomysial antibody tests have greater than 99% specificity for celiac disease and 70-80% sensitivity. The potential problem with using just the IgA endomysial test to detect or rule out celiac disease is that 0.5% of some ethnic groups have no IgA antibodies. Such individuals will always test negative for the IgA endomysial antibody even if celiac disease is present.

To address the problem with selective IgA deficiency causing false negative endomysial antibody IgA tests, the total IgA test is run whenever the endomysial antibody test is ordered. If the IgA result is negative or significantly low, an alternative to the endomysial IgA test is required. In such cases, the next best tests to detect celiac disease are tissue transglutaminase IgG (tTG IgG) and deaminated gliadin-derived peptides IgG (DGP IgG) should be run (NRL test #s 164988 and 161687). Since these tests don’t require the patient to have IgA antibodies, these tests can be used in conjunction with clinical findings in the diagnosis of IgA-deficient celiac disease.

 To answer the provider’s original question, the low result for the total IgA test is not a significant finding relating to the presence of celiac disease. The low result simply tells the provider that the IgA endomysial antibody test is not an appropriate assay to use to assist in the diagnosis of celiac disease in this patient.

Example 3: Carcinoembrionic Antigen (CEA) Result That Didn’t Make Sense

A provider called our lab to say the CEA test (NRL test #002139) at the laboratory was not correct and wanted to know if there was a problem with the assay or a heterophilic antibody present (see example 1 above). The patient had a breast tumour removed two years previous and an elevated CEA prior to the surgery. After surgery, the CEA went to 2.4 ng/mL, a normal value. In May, the value started to increase and in June, the result was significantly elevated. The provider could not find any signs of tumour recurrence and called the laboratory to question the result.

The June sample was repeated with a good repeat and the provider was told the result was good. In July, the result had increased three-fold and the provider called to say there must be some problem with the Laboratory. I sent the July sample to a competitor laboratory and also tested the sample for heterophilic antibodies (NRL test #140657) to determine if such antibodies were producing false positive results. The competitor laboratory matched our laboratory results and no heterophilic antibodies were detected. 

The provider continued to test monthly with higher results each month (see figure A) and also called me monthly. In November, the provider called to apologise for all his phone calls, as he was able to find evidence of the tumour recurrence. In this case the laboratory was able to identify the recurrence five months before the provider could find physical evidence of the recurrence.

Example 4. False Elevated Serum Pregnancy Test Caused by Post-Menopausal Production of HCG-Like Peptide

A 55-year old lady needed surgery after a car accident, and the hospital required serum pregnancy tests prior to surgery. Her Beta-HCG (NRL test #004416) result was 12 mIU/mL (reference range is 0-5 mIU/mL). The hospital continued with the surgery, but sent the patient for follow-up with her ob/gyn provider who confirmed the elevated HCG result and lack of pregnancy and then sent the patient to an oncologist to rule out gestational trophoblastic disease. 

In this case, the patient was not pregnant and did not have cancer. The problem is that the hospital and ob/gyn provider didn’t understand that HCG reference ranges are not absolute measures of elevated HCG for women of all ages.

Publications have shown that post-menopausal women can have serum HCG levels up to 14 mIU/mL as a normal response to lower estradiol levels following menopause. When estradiol decreases, the pituitary responds by increasing FSH and LH due to the loss of the estradiol feedback inhibition. In a few patients, HCG or an HCG immunoreactive material is produced by the pituitary as part of the over-production of LH and HCG.

In this case, the patient could have been spared extra medical expenses had the providers understood that low elevations of HCG are normal in post-menopausal women. Dr. Snyder developed an algorithm to identify women with elevated HCG due to post-menopausal production of HCG. In the algorithm, the sample is also tested for serum FSH (NRL test #004309) and if FSH is greater than 20 mIU/mL and the HCG is between 5 and 14 mIU/mL, pregnancy is unlikely. Also, Dr. Snyder recommends that women over 55 years of age should not be tested for pregnancy. 

Example 5. The Wrong Test is Ordered and a Patient has Incorrect Gestation Diabetes Glucose Tolerance Result

This is a general example. Many providers want to order one of the gestational glucose tolerance tests and they just order glucose tolerance. This can be confusing to the lab staff that have to interpret test orders, and this usually results in a call to the client the next day to assure the correct test is ordered. Different tests have different reference ranges, and therefore a false interpretation can occur.

There are two main reasons to perform a glucose tolerance test. One reason is to determine if a person has type 1 diabetes mellitus. The other reason is to determine if a pregnant lady has gestational diabetes. 

The diagnosis of non-gestational type 1 diabetes is now usually made without a glucose tolerance test. The American Diabetes Association diagnosis type 1 diabetes based on any one of the four criteria below: 

• A1C > 6.5%. The test should be performed in a laboratory using a method that is NGSP certified and standardised to the DCCT assay.* (NRL test #001453)
• Fasting Plasma Glucose > 126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.* (NRL test #001818)
• 2-h Plasma Glucose > 200 mg/dL (11.1 mmol/L) during an oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.* (NRL test #101200)
• In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose > 200 mg/dL (11.1 mmol/L). (NRL test #001302)

*In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.

Testing for gestational diabetes is more complicated as a number of organisations have different guidelines to make the diagnosis. An example is the ADA One-step strategy (NRL test #101000):

• Perform a 75-g oral glucose tolerance test, with plasma glucose measurement when patient is fasting and at one and two hour, at 24-28 weeks of gestation in women not previously diagnosed with overt diabetes
• The OGTT should be performed in the morning after an overnight fast of at least eight hours
• The diagnosis of GDM is made when any of the following plasma glucose values are met or exceeded:

Fasting: 92 mg/dL (5.1 mmol/L)

1 h: 180 mg/dL (10.0 mmol/L)

2 h: 153 mg/dL (8.5 mmol/L)

In summary, good communication between medical professionals is very important for patient outcome and to provide the best medical care. 

References

References available on request

Technological advances now allow high resolution scanning of whole microscope slides (“whole slide images” or WSI) and the use of secure web-based viewing applications that can link those images to clinical information to facilitate remote interpretation on a computer monitor.

These technological advances have been paralleled by an increasing demand for digital pathology information in general throughout healthcare networks with the expectation by some for eventual integration of digital pathology images and information with the laboratory information system and electronic medical record.

One of the most obvious attributes of digital pathology is to facilitate the interpretation of surgical pathology cases at a distance. This has the potential of helping distribute workload within a complicated healthcare system, as well as the ability to provide subspecialty pathology interpretations of difficult cases with rapid turnaround time. With those long-term goals in mind, the Center for ePathology at The Cleveland Clinic has validated the use of WSI for primary surgical pathology diagnosis and for consultation case. We are now regularly receiving consultation cases from several institutions in the People’s Republic of China, as well as from clients and affiliated partners in Hawaii, Cleveland Clinic Abu Dhabi and elsewhere. To date we have completed 266 consultation cases with an average turnaround time of two days, excluding waiting time for additional stains or information and weekends.

 Following in part the experience of the University Health Network experience in Toronto, we also validated the use of WSI to interpret frozen sections and are gradually implementing the remote interpretation of frozen sections from 12 different sites within the Cleveland Clinic Health Network. It is anticipated that this process will significantly increase thereby increasing productivity and efficiency by allowing the pathologist to stay in his or her office rather than traveling to numerous sites.

 Outside consult cases are obtained via two cloud-based platforms; one offshore, one domestic. The system provides email notification and workflow management between main campus and our international clients. Additional in-network consultations and frozen section interpretation among affiliated regional hospitals and ambulatory surgery centres are performed by directly accessing eSlideManager. Users log into a web front end that controls access to the database. Access to whole slide images is controlled by individual or group permissions that are configured by the ePathology manager. Slides are organised into cases, courses and research projects within the application database.

In addition to consultative support, the use of digital pathology has helped to reduce cost and facilitate better ordering practices for immunohistochemical and other special stains. Clients seeking special stains without interpretation can send paraffin blocks or unstained slides. Slides are scanned within a few hours of staining, so client pathologists can view the WSI and either proceed with diagnosis or request additional stains. This “eIHC” service allows for less upfront ordering and reduces the need to perform unneeded stains.

Our ePathology infrastructure has evolved significantly to support these activities (Fig. 2). As an overview, the digital slide system runs on an HP ProLiant DL360 GL7 Windows 2008 server with 2 quad core xenon E5620 processors and 16 GB RAM. This platform hosts eSlideManager (Leica Biosystems) software that performs the function of web server (user access), database server (SQl), image server and application server for the web-based viewer.

Digital slides are captured on Aperio AT Turbo scanners, capable of 20x and 40x magnification scanning at resolutions of 49um and 24um, respectively, with a load capacity of 400 slides. Images are stored in a non-proprietary format and viewed via a “bits on demand” type stream, similar to Google Earth. Barcoded slides are interfaced with and accessible from the Anatomic Pathology Laboratory Information System (LIS), Cerner CoPath, and case and demographics are populated and links are created. Typical 20x images range in size from 350 to 700mb per slide; 40x images can be as large as 2.4Gb. Images are streamed using a 1GB local network and stored on an EMC VNX5400 network attached storage array (NAS) at the Cleveland Clinic data centre offsite and backed up to a mirrored file system. Additionally, slides may be captured at 60x or 100x on an Olympus VS-120 scanner. These slides are converted and imported into the Aperio eSlideManager for general use. We currently have 72,000 individual images that occupy a total of 35 terabytes storage. In addition to the NAS located offsite, older images are stored on an Isilon storage area network (SAN) array. Smaller subsets of images can be downloaded to portable hard drives, primarily for resident and fellow educational use.

Tissue Microarray (TMA) and image analysis algorithms are supported, and access to the system for authenticated users outside the Cleveland Clinic firewall is provided through a Bluecoat reverse proxy. This allows off-site pathologists to temporarily view a designated subset of images. For example, if a Cleveland Clinic pathologist is giving an invited lecture on soft tissue tumours, then WSI of unknown cases can be made available to conference participants before and after the conference, no matter where the lecture takes place.

The FDA has not yet approved the use of WSI for primary diagnosis in the United States, but several manufacturers have clinical studies under way and hope to achieve clearance in the relatively near future. Already used for primary diagnosis in Europe, the Middle East and Canada, we anticipate that Cleveland Clinic will be well positioned to utilize digital pathology in a cost-effective way for primary diagnosis of selected types of cases once it is cleared by the FDA, and we anticipate continued growth of digital pathology for consultation cases as well as for education and research

Big data is the moniker that is popular today to describe the meaningful analysis of the increasing growth of information that is collected. Originally, Big Data was defined by possessing 3 V’s - Volume, Velocity, and Variety. Today many include Veracity and Value as two additional characteristics of Big Data.

Volume refers to the sheer amount of information that is “stored” in the world. Most scientists would agree that the total amount of “data” in the world on the web is in the realm of several zettabytes (a trillion gigabytes). The amount of storage required for this amount of information would require over 50 billion smart phones with 32 GB storage capacity.

Velocity is the exponential rate of data growth. Every day over two exabytes (or a billion gigabytes) of data is created, and over 90% of the data in the world was generated in the last two years.

Variety refers to the myriad sources from which data is collected, and also the various types of data collected including text, voice, and video. Such unstructured data require more storage space and compound the velocity of data growth. More and more data is now collected on mobile devices and sensors. These are all part of what will become the “Internet of Things” and add to Variety and Velocity.

Veracity in Big Data is important to sort out the “noise” from useful information. Whether the data is consistent, accurate and validated is important to gain meaningful insight into data, and build analytic and predictive capabilities.

Finally, Value is increasingly the focus for most businesses trying to exploit Big Data. The goal is to find meaningful information that is actionable and achieving positive outcomes as the goal.

Healthcare organisations are being pushed to rapidly implement Big Data analytics incorporating the characteristics outlined above to meet changing reimbursement and population health goals. A new Healthcare Analytics Maturity Model has been suggested to assist healthcare organisations in understanding the steps required to move from retrospective scenarios (answering the questions of “What happened?”) to forward predictive and then prescriptive scenarios to understand “what needs to happen” to achieve specific outcomes.

Many healthcare organisations have not yet started on their journey. In 2011, only 10% of healthcare organisations worldwide had adopted data warehousing and analytic capabilities. However, if the US is a guide, according to Premier's Fall 2015 Economic Outlook survey, over 64% of Hospital C-Suite executives have increased capital budgets. Of which, 39% increased their budget by over 10% for technological investments to achieve value-based payment models, demonstrating future growth for Big Data initiatives in healthcare.

Healthcare Application for Big Data and Role of the Laboratory

Big Data can be useful to address problems in healthcare, right from improving operational efficiency, to ensuring quality outcomes and empowering patients toward better disease management. Big Data projects require having an appropriate governance framework in place, hardware configuration and support, and use of appropriate software to generate useful and actionable information. Healthcare providers can also learn from other industries that have leveraged Big Data and analytics to achieve organisational improvement. For laboratories, there is significant potential to contribute and leverage laboratory information. In the US, it is estimated that less than 2% of the healthcare expenditure is on the laboratory, however over 70% of clinical decisions are made based on the result of lab tests. Big Data and analytics can provide insight into all aspects of disease management across the acute and chronic care setting, and for all phases of testing.

Information that is captured in the lab and Lab Information System may include patient testing results, specimen tracking information, and information across time and different points of service. These can be used to monitor individual patient condition and need for treatment intervention; populations of patients with specific conditions and optimise outcomes; operational improvements related to pre-analytical and post-analytical data points.

Change Management is Important for Successful Data Programme

There is no doubt that Big Data will disrupt current business models. And, as always with technology, we will not reap its full benefits without proper adoption and commitment by the people using it. The human side of this technology deployment cannot be overemphasised. Automating parts of the jobs of healthcare providers will make a permanent change in their roles and responsibilities. We are already seeing this with the increasing adoption of EMR worldwide, for example. Providers document and order electronically, which affects the patient-physician interaction.

For Big Data analytics to be successful, it is necessary to focus, not only on the new tools but also on how jobs are being redefined and how organisations will adapt to this culture change. Using and analysing data for evidence-based decision-making will require new competencies and even a new management style. Successful change management will result not only in adoption of the new technology but commitment—there is no going back to the “good ol’ days.” This requires strong leadership and clear communication to all stakeholders, being data-driven as an organisation (adopting a “single source of truth”), as well as achieving cross-functional cooperation.

 Public Private Partnership Is Needed to Maximise Benefit of Big Data

Healthcare occupies a unique role and essential function in society. Involvement of both private and public sectors are important to achieve optimal services and outcomes. Government have essential functions in the deployment of Big Data capabilities including regulation, governance, and oversight. Protection of the patient and healthcare “consumer” requires commitment from all parties in this partnership. Often technological advances will outpace discourse related to the ethics, privacy and security issues that will continue to present risks in addition to the rewards of new and potentially disruptive technologies. One specific area of concern is privacy of patient's records. In many countries, laws are established to protect consumer and patient rights. This is an increasingly challenging field, as the need for access and portability of information will come into conflict with the need to protect patients from unauthorised use of health information that is not related to treatment of any medical conditions. The comprehensive nature of information collected in medical and non-medical fields, ability to collect information from varying devices, and the growth of personalised and genetic medicine will all present challenges to the ethics of data collection and analysis.

Big Data will be an area of on-going interest for healthcare in the foreseeable future. The challenge will be for providers to build the appropriate technological framework and governance structure to achieve better outcomes for patients. Innovation and improvement will be the outcome of exploiting healthcare information.

References

References available on request – magazine@informa.com

In addition to the risks of exposure to infectious materials and hazardous chemicals, environmental hazards include noise, fire incidents, chemical spills, adverse events of equipment malfunction, and ergonomics.

Laboratories are increasingly aware of quality and safety best practices. Failure in compliance can lead to customer dissatisfaction.

Taking into consideration the Joint Commission International Patient Safety Goals, Occupational Safety and Health Administration (OSHA) guidelines, and local regulatory bodies, each medical facility strives to meet or exceed the benchmark requirements.

In this article we will address some of the most common safety practice guidelinesand discuss risk management approach.

Infection Control, Blood Borne Pathogens, and Preventing Needle Stick Injuries

Handling blood specimens, body fluids and other laboratory specimens as daily practice by laboratory professionals is one of the main source of ongoing risk. Appropriate use of personal protective equipment (PPE) is one of the most effective tools to minimize exposure to hazardous materials. In addition, enhancing phlebotomy practices by appropriate use of PPE, engineering controls such as self-sheathing needles, along with avoiding re-capping of needles will lower the incidence of needle stick injury.

Regular and continuous in house training, and a robust competency assessment program is essential to ensure ongoing compliance with best practices in safety. Monitoring incident reporting, analyzing data for trends, having preventive measures will prevent reoccurrences and ensure safe laboratory practice for patients and staff.

Likewise, awareness of engineering control can mitigate the likelihood of injury during sharp disposal. Design and usage of waste disposal container, location and ease of use, and size of containers are important factors in creating a safe process for sharp disposal. Functioning eyewash and showers are required elements in the laboratory in case of exposure to body fluids. Dedicated rest and eating areas for employees should be clearly identified.

Post-exposure response, investigation, and treatment also need to be adequately addressed for the affected employee. Hospitals may want to establish an employee health service department to specifically attend to these incidents. The laboratory shall optimize its procedures to handle all types of incidents along with appropriate investigations and root cause analysis (RCA) to identify preventive measure . 

Hazardous Materials

In addition to infectious materials, the laboratory is home to many hazardous non-infectious materials including, chemicals, carcinogens, flammables, corrosives, toxins, and radioactive materials. All chemicals must be properly stored and labeled. The Material Safety Data sheets (MSDS) are usually provided with chemicals from the manufacturers, and laboratory staff shall be aware of the hazards mentioned in these sheets. Where applicable, monitoring to assess compliance with the permissible exposure limits (PELs) must be documented.

The National Fire Protection Association (NFPA) hazard identification system uses a color-coded diamond to represent four different hazards (Figure 1). These colors represent three different types of hazard that may be associated with chemicals, blue for health, red for flammability, and yellow for reactivity. A white color represents other hazards such as violent reactivity with water or an oxidizer. Numbers in the blue, red and yellow diamonds are used to indicate the severity of the hazard for that category as follows,

0 = no or minimal hazard
1 = slight hazard
2 = moderate hazard
3 = serious hazard
4 = extreme hazard

Storage, shipping, management of spills, and transport of chemicals must be addressed in procedures with adequate controls. OSHA, part of the Department of Labor in the United States specifies that a Chemical Hygiene Plan (CHP) must include discussion of eight basic elements that will indicate specific measures to ensure employee protection. These mandatory elements include:

1. Standard Operating procedures;

2. Criteria that the employer will use to determine and implement control measures to reduce employee exposure to hazardous chemicals;

3. Fume hoods and other protective equipment;

4. Provisions for employee information and training;

5. Prior approval from the employer, especially when employees are working alone with hazardous materials;

6. Provisions for medical consultation and medical examinations;

7. Designation of personnel responsible;

8. Provisions for additional employee protection for work with particularly hazardous substances.

Particularly hazardous substances include at least three groups: select carcinogens, reproductive toxins, and substances which have a high degree of acute toxicity. Lists of these chemicals can be found in the OSHA specific standard 29 CFR 1001. Some examples of chemicals requiring special procedures include lead, hydrofluoric acid, methylene chloride, perchloroethane, and thiourea. 

Fire Safety

Laboratory fires are one of the most devastating avoidable incidents. Laboratories have all the requisite elements that can lead to ignition and fire. Monitoring environmental factors, temperature controlled instruments, electrical hazards, flammables are key elements in preventing fire. Regular maintenance with attention to faulty or worn electrical wiring and circuits will avert preventable electrical fires due to negligence. Flammable agents need to properly labelling, and storage in separate and adequately ventilated space. Laboratory design requires attention to appropriate number and location of fire exits, staff awareness of escape routes, and unobstructed access is critical for successful evacuation in case of fire and prevent loss of life. Conducting regular fire drills and training lab professionals on the proper use of fire extinguisher is essential part of fire safety plan. Acronyms commonly used to facilitate appropriate response in a fire include RACE (rescue, alert, contain, evacuate), and these should be known by all employees and the response should be automatic and second nature.

Ergonomics

Laboratory personnel are at risk of repetitive movements and musculoskeletal disorders (MSD). In the USA, MSD is frequently seen in healthcare workers, and may cause up to a third of workplace injury and illness. Most complaints involve body areas such as the neck, extremities or lower back. Awareness and training are important to minimize the occurrence of MSD. Proper workplace design and choice of equipment and chairs can influence staff posture and minimizes repetitive action and decrease the likelihood of injury. Conducting workload study and avoiding prolonged repetitive activity is important to avoid MSD. Minimizing MSD in workplace will help to improve efficiency of laboratory staff and have more productive workforce.

Risk Management Approach to Laboratory Safety

Risk management is the process of identifying, addressing, prioritizing, and eliminating potential sources of risks to patients, staff and visitors. Risk management means more than preparing for the worst; it also means taking advantage of opportunities to improve services.

Risk management in health care organizations deals with the response to the malpractice incidents. One goal of risk management is to limit one’s liabilities, financial loss and preventable harm. As such, every defect in laboratory department is a treasure, and identifying a defect, finding the root cause, eliminating it, and improving patient outcomes.

How does one design a hospital and laboratory program to reduce the incidence of risks, defects and errors?

At its core, risk management is a paradigm shift from a reactive approach of controlling variances, to proactively eliminating potential sources of failure, enhancing the safety of patients, visitors, and employees. Education is critical, hospital-wide and department-specific, as one creates a culture of safety and awareness.

Categories of risks in the laboratory can be classified as non-infectious risks (like fire, burns, physical agents, chemical agents, sharp Injuries, MSD), and infectious risks (HIV, viral hepatitis, and other infections). The adverse results can lead to bodily injury, property loss, financial liability and loss.

A typical process for managing risks includes the following steps:

1. Risk Planning.
2. Risk Identification.
3. Risk Analysis.
4. Response Planning.
5. Risk Monitoring and Control.

There are many tools commonly used for risk management including PESTLE analysis, and SWOT analysis primarily for managing projects and new initiatives. PESTLE examines risks from multiple, mostly external domains, including Political, Economical, Sociological, Technological, Legal, and Environmental factors. SWOT analyses looks at the competitive environment for risks in terms of Strengths, Weaknesses, Opportunities and Threats. Another framework is to examine all aspects of laboratory operations with regards to platform (technology), process (documents and actual practice), policy (governance), and people (training and competency), for systemic framework to identify high risk practices.

Upon planning and identification of different risks in the laboratory, these risks can be further analyzed in terms a matrix based on their probability of occurrence, and impact/consequence. A typical tool is the Failure Modes and Effects Analysis (FMEA). Teams brainstorm and develop an extensive list of potential modes of failure. Each failure mode is then scored based on three parameters which include:

1-Occurrence (O): The likelihood that a failure occurs by a specified cause or failure mode that is under current control.

2-Severity (S): The degree and significance or impact(s) of failure.

3-Detection (D): Our ability to preemptively and effectively detect, correct or mitigate the failure mode.

From these three parameters, a Risk Priority Number (RPN) is obtained by multiplying Occurrence, Severity, and Detection (O x S x D). Risks are then ranked, and prioritized for focused risk reduction strategies and failure mode prevention based on the RPN score.

Variations on the FMEA may include the likelihood and impact of occurrence (Figure 2). The highly-likely and high-impact failure are most critical (Figure 1, upper right, red boxes). These would require immediate attention with responses to reduce likelihood and impact (move from “green” to “blue” dots). Risk reduction and loss prevention techniques may encompass financing strategies (insurances and risk sharing schemes), risk avoidance (e.g. avoid mycobacterium cultures in non-equipped laboratory) and risk shifting (e.g. using referral laboratories for high complexity testing).

Benefits of Occupational Safety in the Laboratory

Occupational safety and health are important for moral, legal, and financial reasons. Healthy workers are productive assets for organizations. Occupational injury and illness are not only healthcare issues, but also economic issues. Good safety practice boost employee satisfaction and improve efficacy, reduce employee injury and illness related costs and liability. Thoughtful design of the laboratory working environment for safety contributes to efficiency, productivity, quality, and value.

Financial management of the laboratory is not just simply finding areas to cut costs. Identifying economic value requires examining efficient and effective use of resources, with an eye to quality and safety. Appropriate automation, especially of repetitive manual processes allow employees to work smarter, not just harder. A comprehensive hazardous material management plan can reduce the costs associated with procurement, handling, and disposal. Employee occupational health screening program will mitigate the impact of infectious pathogens and preventable outbreaks.

Conclusions

The clinical laboratory has a key role in providing health care services. The need for a safe working environment is essential for ongoing provision of service, and safety to employees and patients. This brief overview with suggested risk management approaches to address safety concerns in the laboratory will allow readers to examine their own setting and practices to improve the safety, and quality.

The medical technologists, are well trained and experienced professionals, they need initial training and ongoing refresher courses on safety - including how and when to use safety measures, infection prevention with use of proper PPE, biological and chemical spill management, and fire safety. A continuous system to monitor threats and incidents must be in place.