The Observatory and Fast Facts

July 23, 2019

Antimicrobial resistance

Antimicrobial stewardship requirements for ambulatory healthcare organizations introduced. Effective January 1, 2020, new antimicrobial stewardship requirements will be applicable to Joint Commission-accredited ambulatory healthcare organizations that routinely prescribe antimicrobial medications. The rationale, references, and requirements behind the updated standards are detailed in a new R3 Report: Antimicrobial Stewardship in Ambulatory Health Care from The Joint Commission.

This project is a continuation of The Joint Commission’s ongoing initiative to promote the appropriate use of antimicrobial medications in the hospital, critical access hospital, and nursing care center programs.

With improving patient safety as its goal, The Joint Commission developed new requirements to help decrease misuse of antimicrobial medications, which contributes to antibiotic resistance and adverse drug events.

The new Medication Management standard includes five elements of performance (EPs) to address antimicrobial stewardship in the ambulatory setting.

The new EPs align with current recommendations from scientific and professional organizations and address the following concepts:

(1) Identifying an antimicrobial stewardship leader;

(2) establishing an annual antimicrobial stewardship goal;

(3) implementing evidence-based practice guidelines related to the antimicrobial stewardship goal;

(4) providing clinical staff with educational resources related to the antimicrobial stewardship goal; and

(5) collecting, analyzing, and reporting data related to the antimicrobial stewardship goal.

In addition to an extensive literature review and public field review, The Joint Commission obtained expert guidance from a Technical Advisory Panel (TAP) and a Standards Review Panel (SRP). The prepublication version of the antimicrobial stewardship requirements will be available on the Prepublications Standards section of The Joint Commission website until the end of December 2019:


Hepatitis B vaccine for non-responders. CyTuVax B.V. (Maastricht, The Netherlands) unveiled the results of the HBAI20 Phase 2 “BE-Responder” trial. The trial focused on “non-responders” to hepatitis B vaccination—persons who have been vaccinated with at least one complete vaccination course (three injections of a licensed hepatitis B vaccine) without achieving a protective immune response.

In this study, the HBAI20 vaccine can reduce the percentage of non-responders to eight percent compared to 21 percent in the HBVaxPro-10 group (p = .068 Fisher). A statistical evaluation using a generalized linear mixed model demonstrates that subjects who have received the HBAI20 vaccine are 3.5 times more likely to attain seroprotection at the end of the study compared with subjects who received the licensed HBVaxPro-10 vaccine (p < .05).

With the HBAI20 vaccine, seroprotection was achieved earlier than with the HBVAxPro-10 vaccine. Eighty-three percent of the non-responders attained seroprotection after two vaccinations. In contrast, with the licensed HBVaxPro-10 vaccine, after three injections only 79 percent of the non-responders achieved seroprotection.

The safety profile of HBAI20, as compared to HBVaxPro-10, showed a temporary higher number of transient mild and moderate local side effects including: Impaired arm movement, redness, and pain at injection site. This indicates that HBAI20 induces a stronger immune response. No differences regarding systemic side effects were observed in the study.


Study of multiethnic genomes identifies 27 genetic variants associated with disease. In a study published in the journal Nature, researchers identified 27 new genomic variants associated with conditions such as blood pressure, type 2 diabetes, cigarette use, and chronic kidney disease in diverse populations.

The team collected data from 49,839 African American, Hispanic/Latino, Asian, Native Hawaiian, Native American, and people who identified as others and were not defined by those ethnic groups.

The study aimed to better understand how genomic variants influence the risk of forming certain diseases in people of different ethnic groups. The work was funded by the National Human Genome Research Institute (NHGRI) and the National Institute on Minority Health and Health Disparities (NIMHD), both parts of the NIH.

In this study, researchers specifically looked for genomic variants in DNA that were associated with measures of health and disease. Everyone has DNA sequences that consist of the chemical bases A, C, G, T. Genomic variants occur in DNA regions where one of those bases is replaced with another, across various individuals. The team found that some genomic variants are specifically found in certain groups. Others, such as some related to the function of hemoglobin, are found in multiple groups.

Apart from finding new genomic variants the study assessed whether known disease associations with 8,979 established genomic variants and specific diseases in European ancestry populations could be detected in African American, Hispanic/Latino, Asian, Native Hawaiian, and Native American populations.

Their findings show that the frequency of genomic variants associated with certain diseases can differ from one group to another. For example, a strong association was found between a new genomic variant and smokers and their daily cigarette usage in Native Hawaiian participants. However, this association was absent or rare in most other populations. Not finding the variant in all groups despite large numbers of participants in each group strengthens the argument that findings from one population cannot always be generalized to others.

A variant in the hemoglobin gene, a gene known for its role in sickle cell anemia, is associated with greater amount of blood glucose attached to hemoglobin in African Americans. The paper in Nature is the first to confirm this association within Hispanic/Latinos, who have shared ancestry that is mixed with European, African, and Native American ancestry.

Such an effort is vital because a vast majority of human genomics research use data based mostly on populations of white European ancestry. For example, a separate study showed that among 2,500 recently published human genomics papers, only 19 percent of the individuals studied were non- European participants. 

Molecular diagnostics

New solution for high throughput molecular diagnostic testing. BD announced the CE-IVDD certification of the BD COR System in Europe. The high throughput solution for infectious disease diagnostics sets a new standard in automation for molecular testing.

The BD COR System integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result. The system will be initially available with the BD Onclarity HPV Assay for the detection and extended genotyping of human papilloma virus (HPV). The system enables the processing of samples directly from liquid based cytology vials, the creation of molecular aliquot tubes and assay testing, replacing labor-intensive and error-prone manual processes with automated ones.

The company plans to continue seeking regulatory authorizations to sell the BD COR System around the world while expanding the content menu to include many other assays for infectious diseases.

The BD COR System is modular and scalable, designed to address multiple lab needs for expanding molecular testing and increasing test volumes. It has on board capacity for reagents and samples that provide six to eight hours of system processing, eliminating multiple technologist interactions per shift.

The BD Onclarity HPV assay detects and identifies 14 high-risk HPV types and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Vial and in the Hologic PreservCyt Solution (not approved in U.S.). The assay can be used in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer prevention. Different test configurations are CE marked and FDA approved.


New clues on tissue damage identified in rheumatoid arthritis and lupus. Research supported by the Accelerating Medicines Partnership (AMP) on Rheumatoid Arthritis and Systemic Lupus Erythematosus (RA/SLE) provides new insights into tissue damage for these autoimmune conditions.

Findings include the identification of novel molecular signatures related to immune system signaling in kidney cells that may reflect their active role in disease process; molecular targets, including specific white blood cells, for potential treatment in lupus nephritis; and specific types of fibroblasts and white blood cells that are involved in rheumatoid arthritis. These discoveries set the stage for uncovering potential drug target candidates that could advance to experimental treatments. Results of the studies were published in three papers in Nature Immunology.

A primary goal of the AMP RA/SLE program, which is led by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is to study tissues where the disease is active in patients, whereas most previous work studied mouse models or only human blood samples.

AMP researchers looked at all the cell types in either biopsy samples from kidneys of people with SLE or the synovial tissues of joints from people with RA. The program seeks to quickly find the most promising treatment targets so less time is lost chasing unsuccessful leads.


Most Americans have never had an HIV test. According to a report published on June 27 in the CDC’s Morbidity and Mortality Weekly Report (MMWR), it recommended that everyone between the ages of 13-64 years be screened at least once in their lifetime for HIV, yet less than 40 percent of people in the U.S. have ever been tested. The new data underscores the urgent need to scale up HIV testing to end America’s HIV epidemic. The analysis of 2016-2017 data from a national population-based survey suggests most people are not getting the recommended screening, even in areas with a high burden of HIV.