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Joint Commission seeks comments on proposed National Patient Safety Goal on pediatric CT imaging

The Joint Commission is seeking input on a proposed National Patient Safety Goal (NPSG) on Pediatric Computed Tomography (CT) Imaging. The NPSG is being used to examine how often CT scans are used unnecessarily on children, increasing their exposure to radiation.

Interested parties can click here to read the proposed requirements. The comment section will be open until March 31, 2016 and you can respond to the Joint Commission via:

The Joint Commission
Standards and Survey Methods
NPSG on Pediatric Computed Tomography
One Renaissance Blvd.
Oakbrook Terrace, IL 60181


New Diagnostic Imaging Services standards released

The Joint Commission has just released new prepublication standards for any facilities with diagnostic imaging services. The requirements address the minimum qualifications needed for personnel to conduct diagnostic computed tomography exams. The changes will be released in print on July 1 but won’t go into effect until September 1.

CMS: Nationally recognized hospital quality measures released

CMS and a consortium of health organizations and insurers on February 16 revealed a new agreement to create a nationally accepted set of quality measures for hospitals and physicians. The agency said the new measure sets will improve consumer decision-making, value-based payment and purchasing, reduce the variability in measure selection, and decrease the collection burden and cost for providers.

“In the U.S. healthcare system, where we are moving to measure and pay for quality, patients and care providers deserve a uniform approach to measure quality,” acting CMS Administrator Andy Slavitt said in a news release. “This agreement today will reduce unnecessary burden for physicians and accelerate the country’s movement to better quality.”

CMS has been working with members of the Core Quality Measures Collaborative (CQMC) on the seven measure sets, with links to the new measures included below:

  1. Accountable Care Organizations (ACO), Patient Centered Medical Homes (PCMH), and Primary Care
  2. Cardiology
  3. Gastroenterology 
  4. HIV and Hepatitis C 
  5. Medical Oncology
  6. Obstetrics and Gynecology 
  7. Orthopedics

CMS says the promotion of evidence-based measurement will help patients, consumers, and physicians.  Some of the CQMC members now recognizing the new measures include:

  • Aetna
  • America’s Health Insurance Plans, Inc.
  • Anthem
  • BlueCross BlueShield Association;
  • Cigna
  • HealthPartners
  • Humira
  • Kaiser Permanente
  • The American Academy of Family Physicians
  • The American Medical Association
  • The National Partnership for Women and Families
  • The National Quality Forum
  • United Health Insurance




Report: Vaccines the key to reducing superbugs

Developing new antibiotics is a notoriously difficult task and the rampant misuse of existing antibiotics have made them ineffective against many types of diseases, known as superbugs. Superbugs have become a global health concern, with governments and drug makers joining forces to tackle the problem.

Suggested solutions have included behavioral changes to how doctors prescribe antibiotics, increased collaboration between medical researchers and no longer giving antibiotics to livestock.

The United Kingdom’s Review on Antimicrobial Resistance (RAR), which hosts the industry’s “Declaration on Combating Antimicrobial Resistance” on its website, issued a new report on February 11 saying increasing the use and spread of vaccines can drop the number of superbug cases.

“Vaccines prevent infections and so reduce the need to use antibiotics,” wrote RAR Chairman Lord Jim O’Neill in the report. “This is true for vaccines that prevent bacterial infections, and it is also true for vaccines that prevent viral infections, such as the flu, which should not be treated with antibiotics but often are anyway.”

The report urges governments and drug makers worldwide to increase the distribution of existing vaccines, as well as develop new vaccines for common ailments. O’Neill singled out the pneumococcal conjugate vaccine, which treats Streptococcus pneumonia, as an example. The vaccine is widely used in parts of the world. O’Neill wrote that global coverage could prevent 800,000 annual deaths of children under five and reduce antibiotic usage.

“Universal coverage by a pneumococcal conjugate vaccine could potentially avert 11.4 million days of antibiotic use per year in children younger than five, roughly a 47% reduction in the amount of antibiotics used for pneumonia cases caused by S. pneumonia,”the report states.

The RAR’s report estimates that antimicrobial resistance could kill 10 million people per year and cost up to $100 trillion by 2050 if not brought under control.

Click here to read the full RAR vaccine report. 

FDA releases fact sheet about new opioid action plan

Amidst the growing opioid epidemic, the Food and Drug Administration (FDA) has now released details about its Opioid Action Plan. The fact sheet details the agency’s policy changes and the outcomes it hopes will result.

Expanding use of advisory committees

  • The FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties.
  • The Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved.
  • The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when it raises novel issues.

Outcome:Before the approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling, it will be reviewed by external experts who will give advice on the drug. In addition, there will be opportunity for public input for every new opioid.

Develop warnings and safety information for immediate-release (IR) opioid labeling

  • The agency is developing changes to IR opioid labeling, including additional warnings and safety information, similar to the labeling for extended-release/long-acting (ER/LA) opioid analgesics.

Outcome:Better information for doctors about the risks and how to prescribe safely.

Strengthen postmarket requirements

  • There is a substantial lack of an evidence base to guide the use of opioid medications, particularly for their long-term use.
  • The agency is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids.

Outcome:Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.

Update Risk Evaluation and Mitigation Strategy (REMS) Program

  • ER/LA opioids are currently subject to a REMS program that requires sponsors to fund low-cost or free continuing medical education courses on the appropriate use of ER/LAs.
  • The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements.

Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs to decrease inappropriate opioid prescribing.

Expand access to ADFs to discourage abuse

  • The FDA will issue draft guidance with its recommendations for the approval standards for generic ADFs.
  • Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs.

Outcome:Spur innovation and generic ADF product development.

Support better treatment

  • The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone.
  • The FDA also supports the Centers for Disease Control and Prevention guidelines for prescribing opioids and will facilitate the development of evidence and improved treatments.

Outcome:Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.

Reassess the risk-benefit approval framework for opioid use

  • The FDA will seek advice from its Science Board in March 2016 on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them.
  • The FDA is already working with the National Academies of Sciences, Engineering, and Medicine on the same topic.
  • Once completed the reports will be made publicly available.

Outcome:Formal incorporation of the broader public health impact of opioid abuse in approval decisions.

Check out our previous coverage on the FDA and CDC’s response to the opioid crisis. 

Sure-footed surveyors: Lean Six Sigma tools reduce Joint Commission falls

A new report in the International Journal of Six Sigma and Competitive Advantage has found that by following the Lean Six Sigma DMAIC (Define, Measure, Analyze, Improve, Control) methodology, there has been a significant decrease in falls and tripping among Joint Commission field staff. The report finds that since adopting DMAIC, Joint Commission field staff have reduced their falls per month by 64.8% for four years.

Some of the methods The Joint Commission used to reduce falls were seasonal emails about appropriate footwear for changing weather and a pamphlet on the risks associated with walking surface conditions, carrying work-related or personal items, and types of luggage.


Study: Use teamwork to reduce surgical infections

A study published in The Journal of the American College of Surgeons found a direct link between a “safety culture” within surgical departments and surgical site infections (SSI). A “safety culture” is defined as the non-technical skills of teamwork, care-coordination and ownership over the delivery of care.

There was a huge variation of SSI rates in studied hospitals, with facilities having rates anywhere between 0%-30%, with an average of 11.3%. The disparity between surgical safety culture scores was even larger, ranging between positive scores of 16%-92%. Of the 12 safety culture factors studied, 10 were found to have a direct impact on SSI:

  • Overall perceptions of patient safety
  • Organizational learning
  • Teamwork within units
  • Teamwork across units
  • Management support for patient safety
  • Communication openness
  • Supervisor and manager expectations of actions promoting safety
  • Non-punitive response to error
  • Frequency of events reported
  • Feedback and communication after errors

The study found that handoffs and transitions, the other two dimensions measured, had no impact on SSI rates. The dimension that varied most from hospital to hospital was “feedback and communications after errors,” with some hospitals receiving between a 21%-79% positive score. Meanwhile, “teamwork across units” had the least variation with hospitals getting a positive score ranging from 24%-49%.

Lead study author Martin Makary, MD, MPH, FACS, said in a press release that the findings illustrated the significance of three characteristics of good safety culture: an ability and willingness to learn from past mistakes; a high degree of interest in adopting best practices; and an ability to collaborate to benchmark performance.

“The study supports what many surgeons have known for a long time, and that is that the organizational culture matters,” he said. “While we have traditionally only studied the incremental patient benefits of different medications and surgical interventions, it turns out that organizational culture has a big impact on patient outcomes.”

Medical devices enter the realm of partisan politics

Duodenoscopes received a lot of publicity in 2015, most of it bad. The final straw was when a Senate committee report linked defective scope designs to 25 infection outbreaks since 2012, 19 of which involved drug-resistant superbugs.

The Food and Drug Administration (FDA) took the brunt of the blame in the Senate report for its handling of the issue. The reports show that while the FDA was aware of the potential risks of dirty scopes, it didn’t warn the public until after a 17-month investigation. By the time the FDA warning was released, there were seven more scope-caused outbreaks, with 68 patients contracting antibiotic-resistant infections.

The report dragged the issue into the public eye and now Democrats and Republicans are both condemning the FDA’s handling of the situation. The Washington Post reports that while both sides agree changes need to be made, they disagree over what needs to be done.

Democrats argue that implementing a bar code system for medical devices would allow hospitals to track what devices are linked to infections or other issues. The Washington Post reports that the bar code program is already being phased in and will cost around $250 million.

Republicans argue that instead of a new system the FDA should simply use the power it  already has, noting that the agency already has the (often unused) power to impose civil and criminal penalties against manufacturers for not reporting injuries or deaths.

You can read the full Senate committee report here,  along with some of our previous coverage on duodenoscopes. 

Joint Commission now taking applications for Patient Blood Management Certification

Healthcare facilities that conduct blood transfusions can now apply for The Joint Commission’s new Patient Blood Management Certification program. The program was developed with the AABB, an international association focusing on cellular therapies, transfusion medicine, and blood management. The certification is based on the AABB’s Standards for a Blood Management Program and is aimed at educating hospitals on the benefits of an evidence-based, multidisciplinary approach to the transfusion decision-making process.

For more on the certification, click here.

Joint Commission unveils new prepublication standards for substance abuse, palliative care

The Joint Commission has released two sets of prepublication standards on its website. The first is for a new certification option on community-based palliative care (CBPC) for home health and hospice care facilities. Home health and hospice facilities already accredited by the Joint Commission will be able to receive CBPC certification for providing a community-based palliative care program.

The second set of standards is an update on the substance abuse and mental health services administration (SAMHSA) guidelines for accredited opioid treatment programs.

Both standards go into effect on July 1.