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Webinar: USP <800>: Hazardous Drug Compliance and Safety in 2018

Presented on: 1:00-2:30 p.m. EST, Monday, October 30, 2017  

Presented by: Patricia C. Kienle, RPh, MPA, FASHP

Level of Program: IntermediateHCPro Webcast Icon

Who should listen: Accreditation specialists, regulatory officers, safety officers, pharmacists, and any healthcare staff who work with hazardous drugs

Registration: https://hcmarketplace.com/usp-800-drug-compliance-safety-2018 

Summary: Making drugs is risky business, even when it’s done in hospital pharmacies. From the person carrying the chemicals from the loading bay to the person doing the actual mixing, improper exposure to hazardous medication compounding substances can have lasting and devastating health effects.

On December 1, 2019, the U.S. Pharmacopeial Convention’s (USP) Chapter <800> will become fully enforceable by regulators. This chapter addresses the physical environment and equipment needed to maintain sterility and protect the 8 million healthcare workers potentially exposed to hazardous vapors and particles each year. USP is expected to be adopted by many regulators and accreditors, such as state pharmacy boards and The Joint Commission.

 

Join expert speaker Patricia C. Kienle, RPh, MPA, FASHP, for this 90-minute webinar, as she dives into the different types of hazardous drugs and the requirements for compliance. Kienle will also teach participants how to perform an Assessment of Risk and how to stay safe when handling hazardous drugs.

 

Registration is still open, sign up now!

 

 

Crucial accreditation deadlines on the horizon for pain management and emergency preparedness

Time is running out to meet the new emergency management (EM) Conditions of Participation (CoP) and The Joint Commission’s revised pain management standards. The EM Interpretive Guidelines go into effect on November 15 while the pain management standards go into effect January 1.

Emergency management

The new EM CoPs fill gaps CMS’ previous regulations by compelling hospitals to communicate and coordinate their emergency plans with other healthcare organizations and government agencies. They also require regular emergency preparedness training with staff and disaster contingency planning.

Steve MacArthur, a safety consultant at The Greeley Company, pointed out that a lot of the new requirements include things that hospitals should have already been doing.

“While this rule is new to the ‘marketplace,’ there are really no new concepts contained therein,” he says. “This may provide some guidance for CMS surveyors as they drill down on organizational preparedness activities. But none of this is groundbreaking or in any way representative of a change in how hospitals have done, and will continue to do, business. [It’s] just another set of official ‘eyes’ looking through the compliance microscope.”

Pain management

The Joint Commission prepublished its new pain management standards back in June. The accreditor said it used the revision to address disparities between its standards and what the literature recommended. Some of the changes include:

•    Enabling clinician access to prescription drug monitoring program databases

•    Performance improvement activities focusing on pain assessment and management to increase the safety and quality for patients

•    Identifying the leader or leadership team responsible for pain management and safe opioid prescribing

•    Involving patients in developing their treatment plans and setting realistic expectations and measurable goals

•    Identifying and monitoring high-risk patients as a way to promote safe opioid use

Facilities should assign teams to research best practices in pain management, get the medical staff working on revising protocols and deter¬mining how to gather data on pain management effectiveness, and alert your information technology and electronic health records experts that they will be needed.

The annual fire and smoke door testing requirements will also be due by January 2018.

New may not be better: hospital returns to paper and happier docs

The Illinois Pain Institute (IPI) was having trouble with its electronic health records (EHR). So they got rid of them and went back to paper. And they aren’t planning on going back anytime soon.

Two years ago, all 70 members of the IPI voted unanimously to get rid of its EHR saying it was slowing down care and alienating patients.

“We felt the level of patient care was not enhanced by an electronic health record. We saw it was inefficient and added nonproductive work to physicians’ time,” John Prunskis, MD, IPI founder and co-medical director told Becker’s Hospital Review. 

Since the switch, IPI has reported greater ease communicating information between hospital systems, less time spent on data entry, happier patients and staff.

“The EHR hinders data exchange,” he says. “One EHR doesn’t talk to another EHR, and there’s many reasons for that. The other thing is when you dictate a paper note with the relevant clinical findings and history, it’s rather succinct, but with the EHR, there’s a problem. The EHR is pages and pages of mind-numbing text, where important labs and information can be lost. Before, a note might be a half-page long, but now it can be five, six pages long, and doctors frequently can’t find what’s relevant through the reams of text and clutter.”

The IPI’s feelings are echoed by many physicians, according to the Mayo Clinic, which in 2016 found in EHR usage reduces physician satisfaction and increases burnout. Another study from the same year found that for every hour physicians spend with patients, they spend two hours interfacing with their EHR.

“Electronic health records hold great promise for enhancing coordination of care and improving quality of care,” said Tait Shanafelt, MD, Mayo Clinic physician and lead author of the study, in a statement. “In their current form and implementation, however, they have had a number of unintended negative consequences including reducing efficiency, increasing clerical burden and increasing the risk of burnout for physicians.”

 

Joint Commission revises Medication Management EPs

The Joint Commission has revised Medication Management elements of performance (EP) for several of its programs. The changes will go into effect on January 1, 2018 and will impact hospitals, ambulatory care, behavioral care, home care, nursing care centers, critical access hospitals, and office-based practices accredited by The Joint Commission. The revisions will require organizations to:

•    Record the date and time of any medication administered in the patient’s clinical record.
•    Implement a policy to provide emergency backup for essential medication dispensing equipment and for essential refrigeration for medications.
•    Have a written policy addressing the control of medications between when they are received by a provider and given to a patient. Those policies should now include what to do for the “wasting of medications.”
•    Implement a policy describing the types of medication overrides for automatic dispensing cabinets that will be reviewed for appropriateness and the frequency.

The revisions vary depending on the program.

AAMI takes action on medical cart fires

Last year, the Food and Drug Administration (FDA) released a report warning that mobile medical carts have been overheating, igniting, smoking, burning, or exploding. This July, the Association for the Advancement of Medical Instrumentation (AAMI) responded by convening a group of experts to talk about this new fire hazard.Explosion

Similar to the infamous Samsung Galaxy 8, the fires are caused by carts’ lithium batteries and are extremely hard to extinguish. In some cases, firefighters have had to bury medical carts to put out the flames.

“Surely, we’re not going to wait until there’s a patient incident to do something,” said Ram Dhurjaty, president of Dhurjaty Electronics Consulting, during the AAMI meeting.

A 2016 FDA survey revealed that half of hospital respondents have experienced a cart battery or electrical-related problem during the previous two years. In response, the agency put out a letter to healthcare professionals about the dangers. 

“We’ve learned that for most medical cart fires, the products in question met all applicable battery safety standards, including cell-level, pack-level, and product-level standards, and we believe a majority of these were legitimate certified products,” Pete Segar, CEO of medical cart manufacturer Ergotron, told HFAP. “There is good reason to believe that incidents of lithium battery fires will continue. We need to take action to reduce the likelihood of fires that could cause serious safety events in a healthcare setting.”

“Current industry standards have not been adequate,” he continued. “Most likely because the failures are caused by low likelihood contamination or defects that are not present in the nominal designs tested during the certification process. Developing new standards would be influential in driving innovations that could have a major impact on improving safety.”

In response, the AAMI has created three priorities and work groups to help hospitals with this problem.

1.    “Conduct failure analyses for high-capacity batteries in the health care setting and develop a feedback loop with device and battery manufacturers so this information can be incorporated into future designs.”
2.    “Develop new or update existing battery design standards to reflect the best practices found in UL’s Safety Issues for Lithium-Ion Batteries, AdvaMed’s Successful Practices for Battery-Powered Medical Devices, and other published documents.”
3.    “Train health care technology management professionals about safe battery management practices.”

Those interested in joining AAMI’s workgroups should contact Joe Lewelling, AAMI’s vice president of emerging technologies and health IT, at jlewelling@aami.org.

Policies for the Use of Personal Mobile Devices in Surgical Suites

Written by Anne V. Irving, MA, FACHE, CPHRM, DFASHRM and published in PSQH 

cellphone

When is it okay to text and operate?

Human factors studies indicate that distractions and multitasking increase the likelihood of error (Feil, 2013; Wiegmann, ElBardissi, Dearani, Daly, & Sundt, 2007). Allowing personnel to bring their cell phones, smartphones, or other mobile devices into a surgical suite introduces a new distraction into an already complex, noisy, high-stakes environment. Rather than assume that perioperative personnel will always use their best judgment, health systems should adopt formal, written policies, procedures, or guidelines for the use of personal devices in order to provide:

  • Clarity regarding specific performance expectations
  • A basis for enforcement, if instances of noncompliance are reported
  • A clear message that patient safety is the highest priority at all times

Several perioperative professional associations have weighed in on the use of personal mobile devices, including the Association of periOperative Registered Nurses, the American Association of Orthopaedic Surgeons, and the American Association of Nurse Anesthetists. See the appendix for the American College of Surgeons’ statement on the use of cell phones in the operating room and links to policies of other organizations.

Choosing a risk mitigation strategy

Healthcare leaders who decide to limit use of personal mobile devices during work hours must balance multiple considerations: patient safety, the impact on workflows in the organization, and the potential effect on employees and affiliated providers. Policies to control the use of personal devices can be perceived as positioned at various points on the risk mitigation continuum (Figure 1).

Option A

Choosing not to develop a formal policy regarding the use of personal devices (Option A) offers little, if any, risk mitigation. With no guidelines to follow, some staff members may feel compelled to look at or use their mobile device when engaged in direct patient care that requires their full attention. Such mental distractions increase the likelihood of medical errors. [more]

Celebrating World Hepatitis Day 2017

July 28 is World Hepatitis Day, and the World Health Organization (WHO) and the Joint Commission have reaffirmed their commitment to eradicating Hepatitis B and C by 2030.

The WHO says there’s promising data coming out of the 28 countries that represent 70% of the global hepatitis burden. Nearly all of those countries have established high-level national hepatitis elimination committees (with plans and targets in place) and over half have allocated dedicated funding for hepatitis programs and education. The organization also added a new generic treatment to its list of Hep C medicines to increase access to therapy this week.

“It is encouraging to see countries turning commitment into action to tackle hepatitis,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a public statement. “Identifying interventions that have a high impact is a key step towards eliminating this devastating disease. Many countries have succeeded in scaling-up the hepatitis B vaccination. Now we need to push harder to increase access to diagnosis and treatment.”

Viral hepatitis affected 325 million people worldwide in 2015 and caused 1.34 million deaths—more those people killed by HIV deaths. Of cases worldwide, 257 million were of Hep B and 71 million were Hep C, which are the two main killers of the five types of hepatitis. And while Hep C can be cured, only 7% of those infected have access to treatment.

“If you’ve been paying attention to health news, you’ve probably heard that everyone, especially Baby Boomers, should be screened for Hepatitis C,” Lisa Waldowski, DNP, PNP, CIC, Joint Commission infection control specialist wrote in a press release. “Testing for the disease, which produces few, if any symptoms, leads to treatment and, eventually, eradication of the Hep C virus that was transmitted at its highest rates from 1960 to 1980.”

The promotion of blood safety and infection control are also key factors in reducing both Hep B and C transmission. However, a 2016 study found that only 17.4% of U.S. nurses follow all the standard blood-borne disease precautions. http://goo.gl/jn7i2y The study also found that many nurses had several misconceptions about Hep C including:

  • 26% incorrectly believed Hep C is commonly spread through sexual activity (it’s spread primarily through blood)
  • 14% incorrectly think most Hep C victims will die prematurely
  • 12% didn’t know that people can have Hep C antibodies without currently being infected
  • 11% didn’t know that there’re multiple Hep C genotypes

“The national response towards hepatitis elimination is gaining momentum. However, at best one in ten people who are living with hepatitis know they are infected and can access treatment. This is unacceptable,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department and Global Hepatitis Programme. “For hepatitis elimination to become a reality, countries need to accelerate their efforts and increase investments in life-saving care. There is simply no reason why many millions of people still have not been tested for hepatitis and cannot access the treatment for which they are in dire need.”

The Joint Commission has made a list of several resources about hepatitis, and the WHO press release came with a list of injection safety tools and resources.

Joint Commission: Half of blood transfusions are unnecessary and cost millions  

Hospitals could save more than $1 million per year by eliminating unnecessary red blood cell (RBC) transfusions, according to a new study. Blood transfusions are the most frequently performed hospital procedure in the country and costs $1,000 per unit of blood. Transfusions also come with potential health risks like allergic reactions, fever, and iron overload.

A study in the August 2017 issue of The Joint Commission Journal on Quality and Patient Safety found that RBC transfusions have increased 134% between 1997 to 2011. However, 50% of them may be unnecessary, costing each hospital an average $1 million per year.

“The cost and risks of RBC transfusions, along with evidence of overuse, suggest that improving transfusion practices is a key opportunity for health systems to improve both the quality and value of patient care,” the study’s authors wrote. “Excessive transfusions have been identified as an improvement priority in the Choosing Wisely lists of wasteful practices by six professional organizations, including obstetric, hematology, critical care, and anesthesiology societies, and the Society of Hospital Medicine (SHM), and reducing excessive transfusion is the subject of an SHM-Society for the Advancement of Blood Management improvement guide. The Joint Commission, the AABB, and the U.S. Department of Health and Human Services have recognized the importance of improving blood management.”

The study looked at ways to reduce unnecessary blood transfusions as well; these include educational tools, real-time clinical decision supports to reduce unnecessary blood products and costs, providing information at point-of-care to inform decisions about a patient’s care, and enhancing health systems’ computerized provider order entry system. By using these methods, test hospitals were able to decrease RBC transfusions per 1,000 patient days from 90-78% during the study to 72.1% following the interventions.

NQF launches opioid stewardship initiative

The National Quality Forum earlier this month announced the creation of an Opioid Stewardship Action Team. The team will summon experts together to develop new best practices, strategies, and tactics to curb the opioid epidemic in America.

“As an emergency medicine doctor, I’ve seen first-hand the devastating effects of opioid misuse on our nation’s health, and it is imperative that we all work together to address it,” said Shantanu Agrawal, MD, NQF’s president and CEO, in a press release. “This new initiative will provide those on the frontlines with essential guidance for better, safer management of patients’ pain.”

Nearly 2 million people suffer from prescription opioid disorder and the number of opioid prescriptions written annually has quadrupled in under two decades.

Along with the NQF team, there are several ongoing efforts to stop the problem, including controversial guidelines released by the Centers for Disease Control and Prevention in 2016.

The team will consist of nurses, physicians, consumers, and others to build upon on current efforts to address the opioid epidemic, with a focus on improving prescribing practices. The team is being modeled after successful NQF action plans, such as NQF’s playbook on antibiotic stewardship.

Those interested in joining or supporting the Opioid Stewardship Action Team should contact the National Quality Partners at nationalqualitypartners@qualityforum.org.

(TBT) Diffusing disruptive physician behavior

Disruptive behavior can come in a variety of forms, from yelling and inappropriate language to physical altercations in the worst-case scenario.

A report released in May by QuantiaMD indicated that disruptive physician behavior is still an issue in hospitals around the country. The report surveyed more than 840 physicians and physician leaders at QuantiaMD and the American College of Physician Executives. Survey results showed that 70% of those physicians said disruptive physician behavior occurs at least once per month and 11% said it occurs daily. An overwhelming­ 90% of respondents also indicated that disruptive physicians ultimately affect patient care, and 21% reported experiencing adverse clinical events that could be ­attributed to disruptive physician behavior.

Although patient safety is the primary concern in any healthcare facility, disruptive behavior must be dealt with regardless of who it affects, says Dean White, DDS, MS, a medical staff consultant in Granbury, TX.

“Disruptive behavior, particularly repetitive disruptive behavior, doesn’t necessarily have to be tied to patient safety or quality,” White says. “In other words, it’s just unacceptable. You don’t have to have a bad outcome because of the behavior to make it wrong. It’s not the outcomes we’re looking at here, it’s the behavior.”

The ultimate decision on how best to deal with or punish a disruptive physician usually falls to medical staff leaders and hospital administrators.

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