Issue 11 March 4th 2016

News

Lab tech allegedly faked result in drug case; 7,827 criminal cases now in question

A Laboratory Technician has been accused of faking drug case test results for the New Jersey State Police Laboratory in Little Falls. He has allegedly “dry labbed” suspected CDS specimens, which means he was observed writing test results that were never completed for suspected marijuana cases. Employed for a 10 year period at the state lab, all of the accused’s cases are now being called into question for safety purposes according to state officials. However, only one incidence of misconduct was observed. "Mr. Shah was observed in one case spending insufficient time analyzing a substance to determine if it was marijuana and recording an anticipated result without properly conducting the analysis," said Elie Honig, Director of the Division of Criminal Justice. The individual has been removed from his position (believed to have retired), with charges still pending. The prosecutor's office's plan, Deputy Public Defender Judy Fallon,said, "is to submit for retesting specimens from open cases. The larger, and unanswered, question is how this impacts already resolved cases, especially those where the specimens may have been destroyed."

Virus attacks hospital’s medical laboratory department computers, crippling workflow and spreading to other departments

According to Dark Daily, “Anatomic pathology labs and clinical laboratories that continue to run Microsoft Windows XP on their computer systems now have a real threat to address.” In a recent incident at the Royal Melbourne Hospital, a computer virus infected the hospital’s Windows XP and shut down the pathology department as well as the delivery of meals and other divisions. Staff were forced to complete their workload using a manual paper based method. The Qbot virus used to infect the system general targets banking systems to steal passwords and user keystrokes. Thankfully, it was reported that patient’s medical records were not comprised during the virus invasion. The Hospital did not take Microsoft’s advisement in 2008 that Windows XP support would end by April 2014, nor the warnings that possible security consequences may occur thereafter. Maintaining up-to-date systems and monitoring for potential threats is paramount to ensuring the safety of patient, staff and the efficiency of the healthcare system. Internal reviews should not be taken lightly and proactive updating of systems should be built into IT process.

A clinical look at the future of pathology

Quote: “Laboratories and the vital role they play in the science of medicine is now at the tipping point.” Martin Wilkinson is Laboratory Product Manager at InterSystems.

The scaling up of the work completed in clinical laboratory and pathology fields has increased in part due to the rise of universal healthcare around the world, an increase in diagnostic services, the growth of precision medicine, and an aging population. Pathology is involved in 70% of all healthcare diagnoses and expected to grow into a US$149 billion industry by 2020. Valuable and predictive information comes from the abundance of tests and diagnostics, which can be used in a continuum of feedback and process improvement monitored through laboratory information management systems (LIMS). Read this interesting article to hear more about the changes and future of pathology in reference to precision medicine, information systems, new models of testing for an ageing population, expansion of point-of-care testing and the increased role laboratories will play.

Using big data to save lives in Pennsylvania

“Penn Signals” is a project by Penn Medicine that uses big data to develop predictive analytics, specifically to diagnose critical diseases early. The data set includes over 3 million patients across a 10 year span and has started to yield results as discussed below. The big data analysis project signals a continued change to focus more on proactive diagnostics and predictors in healthcare services. However, according to a recent Gartner Group study, 65% of respondents could not identify the value of a big data system and considered this as the single greatest barrier preventing them from adopting produced solutions. Take a moment and consider the importance of big data evidence produced by Penn Signals and reflect on the impact it has on patient care:

• clinical studies have shown that every hour a patient goes undiagnosed, there is a mortality rate increase of more than 7%.

• an algorithm detected 20% more patients who were trending toward cardiac failure than traditional methods, as well as identified 5% times more patients who were likely to be readmitted after heart failure.

Hematology

Researchers develop 3-D printed diagnostic device that can rapidly detect anemia

Over 2 billion people worldwide have anemia, including over 50% of preschool children and pregnant women in developing countries and at least 30% of children and women in industrialized nations. Researchers from Kansas State University have developed a device made from a 3-D printer that can detect anemia and will be highly useful for those who have limited access to health care (e.g., those living in developing countries or isolated or rural seniors in developed countries). Consisting of clear plastic slides containing microfluidics, a patient can add a drop of blood to the slide which will change colour based on the indicator result. These results are produced in less than 60 seconds and can be confirmed using a smartphone application. To expand the usefulness of this application, the researchers are also developing an additional product that submits the blood sample results directly to the patient’s physician.

Anatomic Pathology

The budget impact of cervical cancer screening using HPV primary screening

Human papillomavirus (HPV) screening with genotyping has been found to be “a sensible combination of clinical effectiveness and cost”, according to a recent publication in the American Journal of Managed Care. This study examined the clinical and budgetary impacts of HPV primary screening with HPV16/18 genotyping, in contrast to current US based cervical cancer screening strategies (payer perspective). The model used in the study took into consideration patient noncompliance (loss to follow-up) at all phases. Conclusions drawn from the study show that HPV screening with genotyping every 3 years decreases the incidence of cervical cancer compared to traditional guideline strategies (cytology every 3 years or co-testing every 5 years). The results indicate that there were 6.2 cervical cancer cases per 100,000 women versus 11.7 and 7.4, respectively. In addition, the cost per disease detected was lower with the new suggested guideline ($32,123 vs $36,876 and $36,196, respectively). The authors cautioned that evaluating new strategies for screening should not be quick to ignore the juxtaposition between clinical benefits that can be achieved with a screening change and the incremental costs of that change.

Diagnostic and prognostic value of SHOX2 and SEPT9 DNA methylation and cytology in benign, paramalignant, and malignant ascites

Although considered the gold standard for malignant cell detection in ascites, cytology is recognized to have limits in regards to its sensitivity. A study, published this month in Clinical Epigenetics, investigated the ability of DNA methylation biomarkers to determine differential diagnosis between benign, malignant and paramalignant ascites. Samples were obtained from 134 cancer patients and 149 benign patients presenting with ascites, cytopathological investigation and methylation specific real-time PCR were used in the evaluation. Results indicated that overall survival was less for DNA methylation positive patients in comparison to negative presentation patients. Also, combining the methylation with the cytopathological analyses increased detection rate by 47% for malignant ascites cases, demonstrating the diagnostic and prognostic efficiency for differential diagnoses.

Research

Analyzing genetic tree sheds new light on disease outbreaks

“It turns out that three different types of transmission histories are possible between two persons who might have infected each other,” said Thomas Leitner, Los Alamos National Laboratory, “Using phylogenetic inference in the epidemiological investigations of HIV transmission, we’ve determined that between two sampled, potentially epidemiologically linked persons, we can now evaluate the possibility that an unsampled intermediary or common source existed, even without a sample from that individual.” In a study published in the National Academy of Sciences, researchers used computational phylogenetic analysis to compare HIV strain transmission in computer modeling compared to real-life case studies. This is the first time that there has been a systematic evaluation of phylogeny expectancy from different transmission histories. The process goes beyond the implications of HIV and can move to any large scale epidemiological investigation, including forensics and outbreak scenarios.

Blood test developed to detect five early-stage cancers

Quote: “Finding a distinctive methylation-based signature is like looking for a spruce tree in a pine forest. It's a technical challenge to identify, but we found… the gene known as ZNF154 that is unique to tumors” states Laura Elnitsk a senior investigator.

Published in the Journal of Molecular Diagnostics, a team from the National Human Genome Research Institute examined 184 tumour samples from five different cancer types (colon, lung, breast, stomach, and endometrial) in addition to 34 normal samples. The study found a consistent genetic change from tumor DNA in the blood stream across the five different types of cancer, giving way to the possibility of a universal cancer marker. A DNA methylation (high levels decrease gene activity) investigation showed that the methylation was detectable even at very low concentrations in the blood, indicating the ability to create a blood test to detect early-stage tumors. “Furthermore, in a computational simulation of circulating tumor DNA, they were able to detect limited amounts of tumor DNA diluted with normal DNA: 1% tumor DNA in 99% normal DNA.”

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