Issue 84  December 21st 2018

Stamford Hospital fined for operating blood draw facility without approval

A state Department of Public Health (DPH) inspection at Feel Well Health Center in Southington in late January found that a phlebotomist who had contracted with Boston Heart Diagnostics in Massachusetts was conducting venipuncture before Stamford Hospital obtained the necessary written certificate to operate the blood collection facility, according to a consent order signed Sept. 7 by the hospital and DPH.

The order said the Stamford Hospital blood collection facility violated state law because it failed to have or display a state blood collection facility certificate with a gold seal of approval, have or display emergency procedures for a distressed patient, and have a supervisor visit the facility on at least a monthly basis. The hospital also failed to maintain the blood collection area, as inspectors found rips in chair arms and noticed centrifuges that should have been calibrated annually hadn’t been calibrated since January 2016.

“The staff members who were involved in the opening of the [Southington] draw station did so without any intention of violating legal requirements,” said Ruth Cardiello, vice president of enterprise risk management and corporate compliance officer at Stamford Health. She said the company “accepts full responsibility for these actions” and reported them to DPH.

In addition to [a] fine, the hospital agreed to appoint a phlebotomy supervisor who has at least an associate’s degree in biological, physical or chemical science and a certificate as either a phlebotomist or medical laboratory scientist, technician or technologist.

Researchers discover new strains of Hepatitis C

Scientists studying hepatitis C have identified three new strains of the virus in the most extensive population study of the infection that's ever been done in Africa. The international team that produced the data has suggested that current antiviral drugs used to treat hepatitis C in the West might not work against these new strains; clinical trials should be performed immediately to assess treatment strategies and find the best ones for patients in sub-Saharan Africa. The findings have been reported in Hepatology, and should be considered as the World Health Organization attempts to eradicate hepatitis C.

For this work, careful screening was done on 7,751 blood samples collected from individuals in the general population in Uganda. The researchers identified HCV that had not been diagnosed yet in twenty people. The team sequenced the genomes from those twenty samples as well as two from the Democratic Republic of Congo (DRC). They found three previously unknown HCV strains as well as some that are common in the [Western] world. They also found mutations that are associated with drug resistance in some of those samples.

The researchers concluded that screening methods used in Uganda, which rely on antibody detection, are inaccurate. A better method is to look for the virus itself. Because the virus may be gaining resistance to antiviral drugs, new treatment approaches may also be needed.

Can DNA testing balance sensible cannabis policies and evidence-based health strategies?

As this foundation sets [on the national conversation of cannabis legalization], there is a real opportunity for all concerned to shift the dialogue back toward safety.

Can DNA identify risk factors for cannabis users? It may also be possible to predict whether or not an individual is at greater risk of developing a certain disease, thereby allowing time for proactive steps to be taken.

Research has identified relatively common genetic variations that put those who regularly use cannabis at a higher risk of triggering psychotic disorders. For example, research has shown that approximately 20%-25% of the population can carry AKTI or COMT gene variants that could increase their risk of psychosis with cannabis use and short-term memory loss following consumption, respectively.

Genetics can also help determine how quickly a person metabolizes THC - research indicates that 15%-20% of the population break down THC at a slower rate based on their DNA - which can often lead to an increased risk of adverse reactions, including anxiety, sedation and paranoia.

When it comes to cannabis, DNA testing has the potential to complement the educational campaigns, safe consumption deadlines and health programming that governments and healthcare organizations have already launched. The primary hurdle is that DNA testing regarding cannabis consumption is very new and only now being commercialized. Healthcare organizations will take some time to decide whether or not to incorporate testing-related information into future guidelines and awareness campaigns.

Accelerating cures in the genomic age: The sickle cell example

Blog - Today, I’m heartened to report that, thanks to decades of biomedical advances, we stand on the verge of a cure for sickle cell disease (SCD). While at the American Society of Hematology (AHS) meeting in San Diego, I was excited to be part of a discussion about how the tools and technologies arising from the Human Genome Project are accelerating the quest for cures.

At the ASH meeting, that first wave of this progress was evident. A team led by NHLBI’s John Tisdale, in collaboration with Bluebird bio, Cambridge, MA, was among the groups that presented impressive early results from human clinical trials testing novel gene replacement therapies for SCD. In the NIH trial, researchers removed blood precursor cells, called hematopoietic stem cells (HSCs), from a patient’s own bone marrow or bloodstream and used a harmless virus to insert a sickle-resistant hemoglobin gene. Then, after a chemotherapy infusion to condition the patient’s existing bone marrow, they returned the corrected cells to the patient.

Researchers also presented very encouraging pre-clinical work on how gene-editing technologies, such as CRISPR, can be used in ways that may open the door to curing everyone with SCD. Currently, two groups - CRISPR Therapeutics/Vertex Pharmaceuticals and Sangamo Therapeutics/Bioverativ - are gearing up to begin the first U.S. human clinical trials of gene-editing for SCD within the next few months. While they employ different technologies, both approaches involve removing a patient’s HSCs, using gene editing to knock out the BCL11A red cell enhancer, and then returning the gene-edited cells to the patient. The hope is that the gene-edited cells will greatly boost fetal hemoglobin production, thereby offsetting the effects of SCD.

Continue reading the article to learn more!

Researchers develop global checklist for hospital antimicrobial stewardship programs

There has been increasing interest in developing and implementing hospital-based antimicrobial stewardship programs (ASPs) to reduce and improve antibiotic use and to slow the emergence and spread of antimicrobial resistant pathogens.

Researchers at the Center for Disease Dynamics, Economics & Policy (CDDEP), in collaboration with researchers, developed the Checklist for Hospital Antimicrobial Stewardship Programming (CHASP). CHASP was based on an expert panel's review of published scientific research and existing checklists including the US Centers for Disease Control and Prevention's Core Elements of Hospital Antibiotic Stewardship Programs, and was published in the journal Clinical Microbiology and Infection.

The seven core components of CHASP address:

• Senior hospital management and leadership
• Accountability and responsibility
• Access to infection management professionals
• Education and practical training
• Continuous monitoring and surveillance of stewardship activities
• Reporting and sharing of antimicrobial resistance and antimicrobial monitoring data
• Actions aimed at responsible antimicrobial use

The checklist was tested in 12 Leading Health Systems Network hospitals across nine countries including low-income countries. The most commonly missed checklist items were staffing standards, regular training for ASP staff, and adequate information technology services. Barriers to CHASP implementation and success included lack of expertise, limited financial resources, and insufficient collaboration.

When less is more: A promising approach for low-cell-number epigenomic profiling

Scientists at Kyushu University and Tokyo Institute of Technology in Japan have developed a technique that enables analysis of DNA-protein interactions using very small numbers of cells, ranging from 100 to 1,000.

The technique, called Chromatin Integration Labeling sequencing (ChIL-seq), could open up new opportunities for scientists to study rare cell types and other cell samples in short supply. ChIL-seq requires only a fraction of starting cellular material.

For the past decade, ChIP-seq has been the dominant technique for analyzing epigenomic data and identifying important binding sites of DNA-associated proteins. However, one limitation has been that ChIP-seq requires at least 10,000 or typically millions of cells to start off with, mainly due to the fact that samples tend to be lost during two key steps: chromatin preparation and immunoprecipitation. The research team overcame the problem of sample loss by replacing the two steps mentioned above with immunostaining, a non-destructive method suitable for analyzing tissue specimens.

Using ChIL-seq, the team also detected genomic regions associated with histone marks at the single-cell level - an achievement that brings biologists closer to the long-held goal of establishing single-cell profiling.

Overall, they are confident that ChIL-seq holds promise due to its precision, which makes it suitable for single-cell applications, and its flexibility, meaning that in future, it could be combined with other powerful sequencing techniques.