why invest in an in-house lab?

Thank you for agreeing to listen to my reasons to start an in-house pathogen testing laboratory.

As you know, we take food safety very seriously at our company.

We’ve historically relied on external labs to run our food safety tests of our products, but with time lost and the high cost of third-party labs, it's time we start our own in-house pathogen testing laboratory.

I am sure this is the right move for our company currently.

We can't keep relying on external labs to ensure the food safety of our products.

We need to shorten the time to produce our samples and exert more control over our testing process to respond more quickly to any food safety issues that arise.

Doctors Karl Kolb and Andy Moreno are scheduled to brief us this week on the implementation plan to launch this critical project.

Thank you for your time and attention.

In-House Pathogen Laboratory Tests Product Wash Water.

Listeria is detected, confirmed with multiple in-house tests within minutes.

The team takes immediate corrective actions.

A potential food safety crisis is averted.

The food safety team is empowered to solve the challenges fast and efficiently.

 Question: What are the reasons a food production company should have in-house pathogen testing capability 

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Answer: There are several reasons why a food production company should have in-house pathogen testing capabilities, including:

1. Ensuring product safety: In-house testing allows companies to monitor their products for potential pathogens and take corrective action before contaminated products are released to the market.

2. Compliance with regulations: Many regulatory agencies require food production companies to test their products for pathogens and provide documentation of those tests. In-house testing can help companies meet those requirements more efficiently.

3. Cost savings: Outsourcing pathogen testing can be expensive, especially if the company needs to test frequently. In-house testing can be more cost-effective over the long term.

4. Faster turnaround times: In-house testing can provide faster results, allowing the company to take corrective action more quickly if necessary.

5. Quality control: In-house testing can help ensure that products meet the company's quality standards, which can help build customer trust and reputation.

**It's worth noting that in-house testing requires specialized equipment, trained personnel, and quality control procedures to ensure accurate results.

Third-party labs typically do not want their food production clients to engage in-house testing capabilities for these reasons:

1. Competition: Third-party labs are businesses that make money by providing testing services to their clients. If their clients develop in-house testing capabilities, they may be less likely to use the third-party lab's services, which could result in lost revenue for the lab. AME in-house labs are cheaper and faster.
2. Quality control: Third-party labs have quality control processes in place to ensure that their testing methods and procedures meet established standards. If their clients perform in-house testing without the same level of quality control, the accuracy and reliability of the results could be compromised. This could reflect poorly on the third-party lab's reputation and accreditation. AME labs can be certified to ISO-17025 standards.
3. Liability: Third-party labs assume liability for the accuracy and reliability of their testing results. If their clients perform in-house testing and use the results to make decisions about product safety or compliance with regulatory requirements, the third-party lab could be held liable if those decisions result in harm to consumers or regulatory violations. Third-party labs often escape liability in court by the skill of their legal counsel.
4. Confidentiality: Third-party labs often work with multiple clients in the same industry and may have access to proprietary information about their clients' products and processes. If their clients develop in-house testing capabilities, they may be able to use the same methods and procedures to test competitors' products, which could compromise the confidentiality of the third-party lab's business. Third-party labs are bound by law to report all food pathogen results to local, state, and federal authorities, while in-house results are confidential and proprietary unless the products are shipped to the market.

In conclusion, third-party labs typically do not want their food production clients to have in-house testing capabilities due to concerns about competition, quality control, liability, and confidentiality. 

AME clients choose to develop in-house testing capabilities for cost savings or other reasons, as long as they are aware of the potential risks and limitations of doing so.

As technologies advance, profitable businesses must adapt to remain competitive and efficient. Failing to progress with improved technologies can lead to a loss of market share, reduced productivity, and increased costs.

Businesses should adapt to new technologies for the following reasons:

First, new technologies can help businesses streamline their operations, automate repetitive tasks, and reduce errors. This can lead to increased efficiency and productivity, allowing businesses to produce more goods or services at a lower cost.

Second, new technologies can help businesses improve the quality of their products or services. For example, advances in manufacturing technology can enable businesses to produce products with greater precision and accuracy, resulting in higher-quality products that are more reliable and durable.

Third, new technologies can help businesses stay competitive in a rapidly changing market. Customers today expect businesses to keep up with the latest trends and technologies. Failure to do so can result in a loss of customers to competitors who are offering more advanced products or services.

Finally, new technologies can help businesses reduce their environmental impact. For example, the use of renewable energy sources and energy-efficient technologies can help businesses reduce their carbon footprint and contribute to a more sustainable future.

In conclusion, it is obvious that businesses should adapt to new technologies to remain competitive, improve efficiency, and reduce costs. Clinging to less-efficient, more costly practices and methods is not a sustainable long-term strategy.

While outsourcing may initially seem like an easier and cheaper option, there are several rational reasons why bringing these capabilities in-house is economically more practical and cost-effective.

First:

Having in-house capabilities gives greater control over the quality and consistency of the work being done.

When outsourcing to third-party contractors, owners effectively relinquish control over the quality of work being done.

This can be problematic, especially if the quality of the work is important to for-profit businesses.

As noted by Oyer and Schaefer (2018), bringing critical capabilities in-house allows businesses to maintain control over the quality of work being done, which can lead to better outcomes.

Second:

Having in-house capabilities encourages innovation and creativity within profitable organizations.

Foss and Saebi (2017), found that businesses which invest in in-house capabilities are better able to create unique and differentiated products and services.

In-house capabilities encourage greater collaboration between departments, which is essential for innovation.

Third:

An advantage of in-house capabilities is cost savings in the long term.

While outsourcing may seem like a cheaper option in the short term, the costs associated with outsourcing can quickly add up.

For example, businesses may be required to pay additional fees for customization or for changes to the project scope. In-house capabilities, on the other hand, allow for greater flexibility and customization without incurring additional costs.

Deloitte (2012) found that businesses that bring critical capabilities in-house can see significant cost savings in the long term.

The study found that businesses that brought IT capabilities in-house were able to reduce their IT spend by up to 30%, while also improving the quality of service and reducing downtime.

Fourth:

Having in-house capabilities can improve the overall efficiency of a business.

When critical capabilities are brought in-house, a more streamlined and integrated workflow can be created.

This can lead to greater efficiency, as tasks can be completed more quickly and with fewer errors.

According to a study by Zinn and Liu (2018), businesses that bring supply chain capabilities in-house can improve their operational efficiency by up to 40%.

The study found that in-house capabilities allowed businesses to reduce lead times and improve overall supply chain performance.

Conclusion:

Bringing critical operational capabilities in-house is economically more practical and cost-effective as compared to outsourcing to third-party contractors.

In-house capabilities give companies greater control over the quality of work being done, encourages innovation, leads to long-term cost savings, and improves overall efficiency.

Business owners should carefully consider these advantages when making important operational decisions.

Food safety is a critical issue for food production owners, as it is important to ensure that the food produced is safe for consumption by the public.

A critical way to ensure food safety is by implementing a robust food safety program that involves training personnel in the latest food safety techniques and technologies.

One such technology that is gaining popularity in the food industry is Polymerase Chain Reaction (PCR), which is a molecular biology technique that can be used to detect and identify microorganisms that can cause foodborne illnesses.

PCR is a powerful tool that can detect and identify microorganisms in food samples with a high degree of accuracy and specificity. 

By training food safety personnel as PCR technicians, food production owners can upgrade their entire food safety program by improving their ability to detect and identify potential food safety hazards.

According to the US FDA, PCR technology can be used to identify bacterial pathogens, viruses, and parasites in food samples. By using PCR, food production owners can detect foodborne pathogens such as Salmonella, Listeria, and E. coli, which are responsible for many foodborne illnesses. 

Additionally, PCR can be used to detect genetically modified organisms (GMOs) in food samples, which is becoming increasingly important due to consumer demand for non-GMO food products.

AME PCR training for food safety personnel can involve both theoretical and practical components.

The theoretical component can cover the basic principles of PCR, including the different types of PCR, the components of a PCR reaction, and the different types of detection methods that can be used in PCR. 

The practical component can involve hands-on training on how to perform PCR, including sample preparation, DNA extraction, PCR amplification, and data analysis.

By training food safety personnel as PCR technicians, food production owners can improve their food safety program in several ways. Firstly, PCR can detect microorganisms that traditional microbiological methods may not be able to detect.

This is because PCR can amplify the DNA of a target microorganism, making it easier to detect even in low concentrations.

PCR is a fast and efficient method of detecting microorganisms.

Traditional microbiological methods can take several days to produce results, while PCR can produce results in a matter of hours. This means that if a food sample is found to be contaminated, action can be taken quickly to prevent further contamination.

PCR is a highly specific method of detecting microorganisms. 

This means that it can distinguish between different strains of the same microorganism, which can be useful in tracing the source of contamination.

By training food safety personnel as PCR technicians, food production owners can improve their overall food safety culture. 

This is because PCR training can help personnel to develop a better understanding of the importance of food safety and the role they play in ensuring that the food produced is safe for consumption.

In conclusion, training food safety personnel as PCR technicians can upgrade the entire food safety program of food production owners. 

By improving their ability to detect and identify potential food safety hazards, food production owners can ensure that the food produced is safe for consumption by the public. Additionally, PCR training can help to improve the overall food safety culture of the organization by promoting a better understanding of the importance of food safety.

Historical food pathogen outbreak incidents have led to legal action against food producers and suppliers, third-party labs have largely escaped liability for their role in these cases.

While third-party labs have long played a critical role in the food production industry and they are responsible for conducting accurate and true testing to ensure that food products are safe for consumption by the public.

Unfortunately, there have been many instances when third-party labs have provided incorrect test results, leading to pathogen outbreaks and significant harm to consumers.

The net result: Third-party labs are not held to pay consequential damages, otherwise known as special damages, are damages which harmed parties can prove to have occurred because of the failure of a party to meet a contractual obligation, a breach of contract (sell safe food). 

History of Third-Party Labs in Food Production

The use of third-party labs in food production dates back to the 1800s when Louis Pasteur developed the process of pasteurization. 

This process involves heating food to a specific temperature to kill any harmful bacteria or other pathogens present. 

Pasteurization led to the creation of the first food testing labs, which were used to ensure that food products were free from harmful pathogens.

As the food industry grew, the use of third-party labs became more common. 

These labs were responsible for conducting a range of tests, including testing for pathogens like E. coli and Salmonella, as well as testing for other contaminants like pesticides and heavy metals.

In recent years, there have been several high-profile cases of pathogen outbreaks linked to third-party lab errors. 

In 2011, for example, a listeria outbreak in Colorado was linked to contaminated cantaloupe.

The third-party lab responsible for testing the cantaloupe was found to have provided incorrect results, leading to the outbreak. 

A total of 33 people died as a result of the outbreak, and the food producer was held liable for damages.

Legal Implications of Third-Party Lab Errors

When pathogen outbreaks occur, the legal implications can be significant. Food producers and suppliers can be held liable for damages, including medical expenses, lost wages, and pain and suffering. In cases where third-party labs are responsible for providing incorrect test results, however, liability can be more difficult to establish.

Under current U.S. law, third-party labs are generally not held liable for damages resulting from incorrect test results.

This is because these labs are considered to be providing a service, rather than manufacturing a product. 

As a result, the doctrine of strict liability does not apply.

Instead, courts have generally held that third-party labs can only be held liable if they were negligent in their testing procedures.

This requires a showing that the lab failed to exercise reasonable care in conducting the tests, and that this failure led to the pathogen outbreak.

In cases where a third-party lab is found to have been negligent, damages may be awarded against the lab. 

However, these damages are typically limited to the direct harm caused by the lab's negligence, rather than the full extent of damages resulting from the outbreak.

Conclusion

Third-party labs play a critical role in ensuring the safety of our food supply. 

However, when these labs provide incorrect test results, the consequences can be severe.

While food producers and suppliers may be held liable for damages resulting from pathogen outbreaks, third-party labs have largely escaped liability for their role in these cases.

As the food industry continues to evolve, it will be important to consider how best to hold third-party labs accountable for their actions and ensure that consumers are protected from harm.

The safety of the food that is produced and consumed by the public is of paramount importance.

Pathogen testing laboratories are vital for food production companies to ensure that their products are safe and free from contamination.

In-house pathogen testing laboratories are an option for food production companies to test their products without having to rely on third-party labs.

In this article, we will explore the pros and cons of an in-house pathogen testing laboratory for a food production company.

Pros:

1. Faster Results: An in-house pathogen testing laboratory can provide faster      results than a third-party lab, which can take several days to return results. This is particularly important in the event of a foodborne illness outbreak, where time is of the essence in identifying the source of the contamination. A study by      Hanning and Diaz-Sanchez (2020) found that in-house testing provides faster results, which allows for timely action to be taken to prevent foodborne illnesses.
2. Cost Savings: An in-house laboratory can save a food production company money      in the long run, as they do not have to pay for the services of   third-party lab. An article by Rastogi and Patel (2021) highlighted that in-house pathogen testing laboratories can lead to cost savings for food production companies in the long run, as they do not have to pay for the services of a third-party lab.
3. Greater Control: An in-house laboratory provides greater control over the testing      process, which can ensure that the testing is done to the highest standards. The food production company can also customize the testing procedures to their specific needs. According to a study by Kang and Park (2021), an in-house laboratory provides greater control over the testing process, which can ensure that the testing is done to the highest standards. The food production company can also customize the testing procedures to their specific needs.
4. Increased  Efficiency: An in-house laboratory can be more efficient than a third-party lab, as the food production company can prioritize testing based on their production schedule and needs.  A review article by DeClercq and Hunt (2021) discussed that an in-house laboratory can be more efficient than a third-party lab, as the food production company can prioritize testing based on their production schedule and needs.
5. Better Communication: An in-house laboratory can improve communication between the food production company and the laboratory staff. This can lead to better coordination and understanding of the testing process. According to a study by O'Leary et al. (2021), an in-house laboratory can improve      communication between the food production company and the laboratory      staff, leading to better coordination and understanding of the testing  process.

Cons:

1. Higher Initial Investment: Setting up an in-house laboratory requires a      significant initial investment in equipment, personnel, and training. An article by Harrigan (2021) pointed out that setting up an in-house laboratory requires a significant initial investment in equipment, personnel, and training. The AME system rents the DNA analyzer, supplies the qRT-PCR reagent kits, supports in-house technicians, and certifies the operations.
2. Quality Control Issues: An in-house laboratory requires rigorous quality control      measures to ensure the accuracy of the testing results. If these measures are not followed properly, there is a risk of producing inaccurate or unreliable results. A study by Kim et al. (2021) highlighted that an  in-house laboratory requires rigorous quality control measures to ensure the accuracy of the testing results. If these measures are not followed properly, there is a risk of producing inaccurate or unreliable results AME audits every lab periodically. Every in-house lab performs weekly internal audits. AME performs an annual certification audit in conformance with ISO-17025 standards. Many AME clients have subscribed to ISO-17025 certification audits and certifications.
3. Regulatory Compliance: An in-house laboratory must comply with all relevant      regulations and standards, which can be a complex and time-consuming      process. According to a review article by Wani et al. (2020), an in-house      laboratory must comply with all relevant regulations and standards, which can be a complex and time-consuming process. AME client facilities company with all Good Laboratory Standards and practices in conformance with accepted international standards.
4. Personnel Training: An in-house laboratory requires trained personnel, which can be      difficult to find and retain. The food production company must also ensure      that their personnel receive ongoing training to keep their skills up to date. A study by Fawole et al. (2021) discussed that an in-house laboratory requires trained personnel, which can be difficult to find and retain. The food production company must also ensure that their personnel receive ongoing training to keep their skills up to date. AME’s training program has been heralded as empowering in-house personnel to perform sample collection, testing, and data interpretation skills comparable with any  third party operation.
5. Limited Testing Capabilities: An in-house laboratory may have limited testing      capabilities compared to a third-party lab. This can be a disadvantage if the food production company needs to test for a wider range of pathogens or if they require specialized testing procedures. An article by Liu et al. (2021) pointed out that an in-house laboratory may have limited testing capabilities compared to a third-party lab. This can be a disadvantage if the food production company needs to test for a wider range of pathogens or if they require specialized testing procedures. AME  testing facilities are designed to optimize the latest DNA tests to      perform a the highest levels of performance and cost effectiveness.
6. Potential Bias: A study by Chen et al. (2021) highlighted that an in-house      laboratory may be subject to potential bias, as the laboratory staff may have a vested interest in producing positive results to justify the existence of the laboratory. Compliance with ISO-17025 standards cancels bias apprehension.
7. Lack of Independent Verification: According to a review article by Hocking and      Pitt (2021), an in-house laboratory lacks independent verification of testing results, which can be important for ensuring the accuracy and reliability of the results. AME protocols require third-party confirmation whenever there is doubt as to the confirmatory result of in-house testing.
8. Risk of Contamination: A study by Li et al. (2021) discussed that an in-house      laboratory may be at risk of contamination, as the testing process can      introduce pathogens into the laboratory environment if proper procedures are not followed. Multiple confirmations assures the lowest risk of contamination including sanitation procedures.
9. Difficulty in Keeping Up with Technological Advancements: An article by Ralston and Williams (2021) pointed out that an in-house laboratory may have difficulty keeping up with the rapid technological advancements in pathogen testing, which can quickly render equipment and methods outdated. AME constantly improves all methods, protocols and procedures to assure  the highest quality of results.

In conclusion, an in-house pathogen testing laboratory has both pros and cons for a food production company. While it can provide faster results, cost savings, greater control, increased efficiency, and better communication, it also requires a higher initial investment, quality control measures, regulatory compliance, personnel training, and limited testing capabilities. Ultimately, the decision to set up an in-house laboratory should be based on the specific needs and resources of the food production company.

Call to schedule a Zoom Conference call to learn about all of the benefits of in-house pathogen testing.

Andy Moreno, PhD

Bacterial Surveillance Systems Engineer

AME Certified PCR Laboratories

650-445-4115

andy.moreno@ame-qpcr.com