Issue 27 October 14th 2016

News

Point-of-Care Testing Conference in Canada Sparks Debate

The Institute for Quality Management in Healthcare (IQMH) held a conference in Toronto last week called “The Future of Point-of-Care Testing—A Healthy Debate!” “Because of the ever-greater use of POCT in clinical settings throughout Canada, IQMH has organized this conference regularly in recent years,” stated pathologist Gregory J. Flynn, MD, CEO of IQMH. “It is one of the few clinical laboratory programs that brings together experts and users to discuss issues of quality, clinical relevance, and the challenges in using point-of-care testing in support of patient care.” One of the more controversial topics discussed was point-of-care testing in rural areas.

Quinte Health Care (QHC) uses point-of-care instruments in the emergency departments (ED) of the majority of their hospitals. “We serve an area that is primarily rural. We have four emergency departments and three of these are in very small hospitals,” stated Mark Hudgins, Point-of-Care Charge Technologist at QHC. “Because of the limited volume of specimens generated by these EDs and hospitals over the years, we found it uneconomical to operate a standard clinical laboratory in each of these sites and we turned to POCT as a solution.”

The QHC Prince Edward County Memorial Hospital (PECMH) in Picton, Ontario, has 15 inpatient beds and closed its clinical laboratory to support the ED entirely with POCT. Its ED serves 19,000 patients annually, and the budget for the clinical lab was $850,000. After setting up point-of-care testing in a space next to the ED in 2009, the cost of this lab testing dropped to $150,000—an 82% reduction.

To read about the other hospital’s successes click on the article title above.

Theranos Lays Off 43% Of Employees Due To Closure Of Clinical Labs

Theranos Founder and CEO, Elizabeth Holmes made an announcement highlighting some dramatic changes in the company this past week. Theranos will shut down all its clinical labs leaving hundreds of employees working in these labs without a job. Out of the total 790 employees working for them, they have laid off 340 people. This totals to around 43% of the employee strength.

According to Holmes, this drastic change took place after spending months on assessing their strengths and addressing their weaknesses. Theranos will close down its facilities in Arizona, Pennsylvania, and California. This is in order to focus on rebuilding its practices after multiple regulatory investigations. Moreover, a new executive team will lead the work. Various agendas taken up by this team are obtaining FDA clearances, pursuing publications in scientific journals and building commercial partnerships.

Pathology society releases new tests, treatments physicians should reconsider

The American Society for Clinical Pathology (ASCP) has added five recommendations for laboratory treatments and tests that physicians and patients should question.

The test and treatments join a list of 10 previous recommendations, issued as part of the Choosing Wisely initiative, managed by the American Board of Internal Medicine (ABIM) and Consumer Reports.

"As ASCP continues to expand our recommendations, we expect to see increasing higher quality, appropriate care with lower costs, and more effective use of our medical laboratory resources and personnel," Lee H. Hilborne, MD, MPH, FASCP, DLM(ASCP)CM, chair of ASCP’s Effective Test Utilization Subcommittee and a past president of ASCP, said.

They recommended that physicians:

Test for lipase when they suspect acute pancreatitis instead of amylase;
Do not routinely biopsy the sentinel lymph node or perform other diagnostic tests when assessing for early, thin melanoma, as testing does not increase survival;
Use breath tests or stool antigen when evaluating for H. pylori instead of serology;
Do not request an expanded lipid panel, which includes nuclear magnetic resonance and particle sizing, when screening for cardiovascular disease; and
"Do not perform fluorescence in situ hybridization (FISH) for myelodyplastic syndrome (MDS)-related abnormalities on bone marrow samples obtained for cytopenias when an adequate conventional karyotype is obtained."

Clinical Chemistry

Algorithm May Improve Accuracy of HbA1c Testing

Researchers say they have developed a way to improve the accuracy of glycated hemoglobin (HbA1c) testing, according to a report published in Science Translational Medicine.

John Higgins, MD, associate professor of systems biology at Harvard Medical School in Boston, and colleagues used an algorithm to analyze blood glucose levels through HbA1c testing. This enabled the scientists to account for variations in the age of blood cells among different people.

In more than 200 patients included in the study, Dr. Higgins said the new approach reduced significant errors from about 1 in 3 to about 1 in 10. These were errors large enough to affect treatment decisions, he added.

"We think our approach will enable many patients and their doctors to do a better job controlling blood sugar levels and reduce the long-term risks of heart attack, stroke, blindness, and kidney failure" associated with diabetes, Dr. Higgins said.

Transfusion Medicine

Clinical Practice Guidelines From the AABB

Research was conducted to provide recommendations for the target hemoglobin level for RBC transfusion among hospitalized adult patients who are hemodynamically stable and the length of time RBCs should be stored prior to transfusion.

Reference librarians conducted a literature search for randomized clinical trials (RCTs) evaluating hemoglobin thresholds for RBC transfusion (1950-May 2016) and RBC storage duration (1948-May 2016) without language restrictions.

Recommendation 1:

A restrictive RBC transfusion threshold in which the transfusion is not indicated until the hemoglobin level is 7 g/dL is recommended for hospitalized adult patients who are hemodynamically stable, including critically ill patients, rather than when the hemoglobin level is 10 g/dL (strong recommendation, moderate quality evidence). A restrictive RBC transfusion threshold of 8 g/dL is recommended for patients undergoing orthopedic surgery, cardiac surgery, and those with preexisting cardiovascular disease (strong recommendation, moderate quality evidence). The restrictive transfusion threshold of 7 g/dL is likely comparable with 8 g/dL, but RCT evidence is not available for all patient categories. These recommendations do not apply to patients with acute coronary syndrome, severe thrombocytopenia (patients treated for hematological or oncological reasons who are at risk of bleeding), and chronic transfusion–dependent anemia (not recommended due to insufficient evidence).

Recommendation 2:

Patients, including neonates, should receive RBC units selected at any point within their licensed dating period (standard issue) rather than limiting patients to transfusion of only fresh (storage length: <10 days) RBC units (strong recommendation, moderate quality evidence).

Read the full article here.

Microbiology

Scientific methods identify potential antivirals against chikungunya

A team of researchers has shown that several existing compounds have potent activity against the critical CHIKV protease enzyme. The research was published October 10 in Antimicrobial Agents and Chemotherapy, by the American Society for Microbiology.

Chikungunya is a mosquito-born, largely tropical disease which can cause fever, severe joint pain, headaches, nausea, and fatigue. "Here we exploited an approach that should, at least in theory, be a fast track for the development of compounds useful both for studies of the virus and as leads for development of antivirals," said corresponding author Andres Merits, PhD, Professor of Applied Virology, University of Tartu, Estonia.

Then virologists on the team tested the compounds' abilities to inhibit the CHIKV protease' activity in biochemical systems, and then in cultures of infected cells. Several of the compounds proved to be potent inhibitors of both RNA synthesis and virus replication. Interestingly, it appeared that some compounds used more than one mechanism to inhibit CHIKV replication. "While none of these compounds is ready to be used as an antiviral drug, they represent promising leads and excellent tools for follow-up studies," said Merits.

Safety

Formaldehyde Discovered to be Damaging to Proteins

A new report published in the American Journal of Pathology indicates that formaldehyde is even more dangerous than previously known; it can cause cell death by damaging protein.

The team led by Anatoly Zhitkovich, Professor of Pathology and Laboratory Medicine in the Warren Alpert Medical School of Brown University demonstrated that when three different kinds of human lung cells are exposed to formaldehyde, the cells had a reaction that was similar to exposure to extreme heat. Clearly, there was a buildup of damaged proteins. The cells were exhibiting massive amounts of polyubiquitination - a way for cells to tag proteins for destruction before they can accumulate. After the polyubiquitination occurred, a heat shock response was mounted by the cell, which is another attempt at a clean up. Finally, the majority of the cells died, in spite of the efforts to mop up the damage. In one experiment, the researchers took one of the heat shock proteins out of commission; the cells were then even more likely to perish.

Zhitkovich suspects that these results could explain why formaldehyde is disruptive to the nervous system. Since neurons don’t divide, their DNA isn’t vulnerable to harm in the way that other cell type are. However, neurons are very susceptible to the accumulation of damaged proteins, something that is a feature of Alzheimer’s disease, for example. Zhitkovich notes that formaldehyde can negatively impact brain functions like learning and memory.

Read the full article: Formaldehyde Is a Potent Proteotoxic Stressor Causing Rapid Heat Shock Factor Protein 1 Activation and Lys48-Linked Polyubiquitination of Proteins

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