Author Archive for: Brian Ward

OSHA Raises Its Civil Penalties for 2020 by Nearly 2%

February 10th, 2020 Email This Post Print This Post

On January 15, the Occupational Safety and Health Administration (OSHA) raised its civil penalties (85 Fed. Reg. 2,292) by approximately 1.8%. The final rule implements annual inflation adjustments of civil monetary penalties assessed or enforced by OSHA and other agencies within the Department of Labor (DOL) in 2020, as required by the Inflation Adjustment Act (Pub. L. 114-74).

OSHA’s penalty increases for workplace safety and health violations include:

  • For a willful violation, in which an employer knowingly failed to comply with an OSHA standard or demonstrated a plain indifference for employee safety, the minimum penalty increases from $9,472 to $9,639 and the maximum penalty increases from $132,598 to $134,937;
  • For each repeated violation for an identical or substantially similar violation previously cited by the agency, the penalty ceiling rises from $132,598 to $134,937;
  • For each serious violation for workplace hazards that could cause an accident or illness that would most likely result in death or serious physical harm, the maximum penalty increases from $13,260 to $13,494;
  • For each other-than-serious violation, the maximum penalty increases from $13,260 to $13,494;
  • For each failure to correct violation, the maximum penalty increases from $13,260 to $13,494; and
  • For each posting requirement violation, the maximum penalty increases from $13,260 to $13,494.

The new penalty amounts take effect immediately, applying to any penalties assessed after January 15.

On November 2, 2015, Congress enacted the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, the Inflation Adjustment Act, to improve the effectiveness of civil monetary penalties and maintain their deterrent effect.

On July 1, 2016, the DOL published an interim final rule establishing an initial “catch-up” adjustment for civil penalties the Department administers. The Labor Department has issued annual inflation adjustments of civil penalties in 2017, 2018, and 2019.

The department is required to calculate the annual adjustment based on the Consumer Price Index for all Urban Consumers (CPI-U). Annual inflation adjustments are based on the percent change between the October CPI-U preceding the date of the adjustment, and the prior year’s October CPI-U.

The current adjustment is based on the percent change between the October 2019 CPI-U and the October 2018 CPI-U. The cost-of-living adjustment multiplier for 2020, based on the Consumer Price Index (CPI-U) for the month of October 2019, not seasonally adjusted, is 1.01764.

Existing penalty amounts are multiplied the multiplier, 1.01764, and then rounded to the nearest dollar.

If an OSHA Compliance Safety and Health Officer (CSHO) finds a hazard or standard violation during an onsite inspection, the inspector may issue citations and penalties. Inspections begin with a presentation of agency credentials and an opening conference and include a worksite walkaround and closing conference.

If the agency issues any citations or penalties, an employer may request an informal conference with the OSHA Area Director to discuss citations, penalties, abatement dates, or any other information pertinent to the inspection. The agency and the employer may work out a settlement agreement to address hazards found during an inspection.

OSHA has stated that its primary goal is correcting workplace safety and health hazards and ensuring compliance rather than imposing citations and collecting penalties.

Originally published on EHS Daily Advisor

Start Small to Create a Safety Culture

January 22nd, 2020 Email This Post Print This Post

By Jenny Slayton, Institute for Healthcare Improvement

We often hear about health care organizations that focus on creating a culture of safety. At Vanderbilt University Medical Center, it reminds us of how often in our journey we’ve paused and asked ourselves, “Will we ever get there?” The correct answer is that the job will never really be done because it’s an ongoing process. But we have a plan and we are on our way.

We started small. Just a few tests of change led us to establish a systemwide strategic plan for safety and quality. But it didn’t happen overnight.

Personnel in any size health care organization face massive amounts of work. This can paralyze us from trying anything new. We think we don’t have time, but just about everyone has time to start their pursuit of a safety culture.

How Vanderbilt Started Small

Start by doing something focused enough to represent a proof of concept. Run some PDSA cycles to fail fast and learn before presenting a plan to leadership. We chose something that allowed us to work out some of the kinks in our system.

We had been working on quality and safety initiatives for years, but our turning point occurred when we decided to improve our handwashing. “Choosing handwashing may seem trivial,” says Gerald Hickson, MD, Vanderbilt University Medical Center Senior Vice President for Quality, Safety and Risk Prevention. “But in years of working on this challenge, we still had difficulty performing this basic task in a highly reliable way.” Consequently, what sounded like a simple project became a stepping stone towards creating Vanderbilt’s organization-wide plan to address change.

At Vanderbilt, we didn’t ask, “Who in the world could be opposed to washing their hands?” Instead, we asked, “Are we willing to mutually support each other in our pursuit of high reliability?” This was important because the second approach is about values and our willingness to work together on our journey. It’s not about singling out individuals for blame.

In a safety culture, if one medical professional observes another who is not using the foam dispenser, they should avoid being judgmental. Instead, they should be willing to speak up about our collective commitment to our patients and each other. That is the type of culture we are pursuing.

4 Keys to Building a Safety Culture

At Vanderbilt, we’ve applied what we learned from our handwashing work to a range of other safety improvement opportunities. Says Hickson, “We first learned to wash our hands. We then decided that reliably implementing a certain practice bundle would reduce surgical site infections. Vanderbilt team members understood that [we were going to use] the same approach to roll out our new safety plan.” Here are some important lessons we’ve learned:

  • Commit to safety — We must be dedicated to preventing injury to our patients and each other. “You ensure that each new quality and safety initiative is aligned with your strategic goals,” says Hickson.
  • Demonstrate Respect — Modeling respect begins with senior leaders. You don’t have a culture of safety if people, especially leaders, don’t treat each other with respect and don’t respect safe medical practices like washing our hands, scrubbing the hub [to prevent central line infections], or using antibiotics thoughtfully. “Medical professionals have to trust that, if they speak up, what they say is going to be heard,” says Hickson.
  • Focus on quality — At Vanderbilt, this means measuring ourselves against the best health care systems in the world. We wouldn’t be satisfied with being average.
  • Focus on value — Remember that the goal should be to pursue high-quality outcomes from the patient and community perspectives. Our hand hygiene and surgical site infections prevention work, for example, have brought value to Vanderbilt, our patients, and our entire community.  

Personalizing Safety

At Vanderbilt, we have also tried to shift our culture from just thinking about rates and incidences to seeing our patients as individuals. “We harmed Sue. She was a 29-year-old mother of two.” Using our patients’ names puts our numbers into context and motivates us to design better systems to improve care. This approach reminds us why we got into health care in the first place.

Creating a safety culture also means promoting professional accountability while respecting fellow health care team members. For example, imagine someone who has repeatedly declined to follow the handwashing protocol. We sit down and have a conversation with them instead of pointing fingers. We acknowledge that team members work hard, and we all struggle from time to time. We work together to identify what’s gone well, sort out what the data tells us, and find best practices to move forward.

You also need to equip key team members to create a culture of safety and respect. For Vanderbilt, IHI’s Certified Professionals in Patient Safety (CPPS) credential has become instrumental to our organization’s mission. We have 26 individuals who are certified so far. Certification connects our team members to others outside Vanderbilt who regularly think about the pursuit of safety. Our team members also see certification as a professional development credential because they enter our leadership pipeline upon completion.  

We can’t always predict the challenge of the day, but we can prepare team members with the right training and support them throughout our safety journey. You don’t go out one day and run a marathon. You start by running for 30 minutes, and then building strength and stamina from there. The journey can begin by doing just one new thing.

Jenny Slayton, RN, MSN, is Executive Director of Quality Improvement for Vanderbilt University Medical Center.

Suicide prevention NPSG now applies to Critical Access Hospitals

January 21st, 2020 Email This Post Print This Post

By Brian Ward

Critical access hospitals (CAHs) accredited by The Joint Commission (TJC) will be expected to implement National Patient Safety Goal (NPSG) Standard NPSG.15.01.01 starting July 1, 2020. This standard is aimed at preventing suicides among patient populations and has been posted on the prepublications standards pages.
In the December edition of The Joint Commission’s Perspectives announcing the requirement, the accreditor noted concerns about the very high rate of suicides in rural communities that critical access hospitals serve. Suicide rates in rural counties are 25% higher than in urban areas.  

NPSG.15.01.01 has applied to hospitals and behavioral healthcare programs since 2007 and there were several significant standard changes that took effect in 2019. The Joint Commission released a clarification about those changes in May 2019.

Those who want to learn more about the suicide prevention NPSG are asked to contact Stacey Paul, RN, MSN, APN, PMHNP-BC, project director, clinical, Department of Standards and Survey Methods.

Medical Malpractice Rate Dropped Over 10-Year Period

January 20th, 2020 Email This Post Print This Post

By Jay Kumar

The last decade has seen a decline in the number of medical malpractice claims in the United States, which can be attributed to tort reform and improved quality of care, according to experts on a panel at the American Society for Health Care Risk Management’s (ASHRM) annual conference in Baltimore.

Looking at the findings of a 2018 benchmarking report from CRICO Strategies, there were 124,000 malpractice claims made from 2007 to 2016, said Gretchen Ruoff, MPH, CPHRM, CPPS, senior program director for patient safety at CRICO Strategies. A division of The Risk Management Foundation of the Harvard Medical Institutions Incorporated, CRICO Strategies published its report Medical Malpractice in America earlier this year and made it available for free download.

“We really feel this is a true representation of medical malpractice in America,” said Ruoff, noting that the medical professional liability case rate decreased 27% over the 10-year span. “There’s been an overall drop in risks across the country.”

Tort reform helped drive down the number of cases, said Paul Greve, JD, RPLU, DFASHRM, senior director, healthcare risk solutions, Markel Assurance.

When looking at the number of defendants per 100 physicians, the steepest decline was in OB-GYN claims with a 44% drop over 10 years, Ruoff said. The drop is possibly attributable to focused safety efforts in labor & delivery over the last 15 years, but more research is needed, she added.

A second report released by The Doctors Company examined rates of physician claims from 2006 to 2018. Ruoff said expenses and indemnity payments rose as expected. Case management expenses increased over time, outpacing inflation, Ruoff said.

From a claims perspective, the time to resolution has decreased, but experts have become increasingly expensive and costs have gone up for physician support and trial preparation, she said.

The proportion of cases naming multiple defendants is growing, with the study finding the following:

  • Cases with two-plus defendants increased, adding expense costs to every case (31% in 2007 to 37% in 2018)
  • 260 additional defendants per year since 2007
  • Average expenses per defendant is $25,000
  • $6.5 million in additional expenses per year since 2007

Average expenses are rising the fastest for zero-indemnity cases, going up by 4.7% per year. Contributing factors may include provider protection-focused philosophies of resourcing vigorous defense for cases without merit, and an unwillingness to pay on cases without malpractice.

Average indemnity payments increased 3% annually. In line with expectations, increase outpaced CPI by 1.3% per year (but slower than medical inflation)

Ruoff said cases closed with indemnity payments under $1 million are going down, while payments over $1 million are up 6%.

Growth is fastest in the $3 million to $11 million layer, growing from 17% to 22% over the last decade. Growth is driven by the volume of these cases, not increase in the average severity per layer, she added.


The CRICO report findings identified several general trends that impacted medical professional liability over the 2007-2016 period, including hospitals purchasing physician practices/employment model, Greve said. Hospital merger and acquisition activity increased notably, and the rapid rise of  hospital/healthcare costs has led to a disdain of healthcare organizations, he noted.

“Our hospitals and hospital systems are being viewed, especially by juries, as sitting on a big pot of money,” said Greve. “This corporatization has caused a deterioration of goodwill toward hospitals,” which explains why we’re seeing some of these mega-verdicts.

On the physician side, “we are seeing groups grow larger and larger,” said Darrell Ranum, JD, CPHRM, vice president, patient safety and risk management for The Doctors Company. There’s a concern about the influence of investor money on these groups, he added.

This is where high reliability helps, Ruoff said. Organizations are being encouraged to “change internal culture to have an impact on these big external things.”

The report also found that deeply coded cases provide actionable insights, said Ruoff. High-severity injuries are 41% more likely to lead to an indemnity payment. In addition, medical expenses for patients under 40 with grave injuries drive costs up.

The vast majority of cases stem from three categories: Surgical, medical, and diagnosis. Surgical cases are most prevalent, diagnosis is most costly, and medical treatment is becoming more common.

Forty-four percent of surgical cases involve ambulatory care patients, Ruoff said. Orthopedic procedures are most prevalent, with perforations/lacerations as the top injury category.

Ranum said The Doctors Company report had very similar findings to the CRICO report.

Ambulatory or day surgery cases comprised 54% of the cases, with hospital operating room cases at 46%.

“When we repeat studies a few years down the line, we’re seeing fewer cases, but repeat issues,” said Ranum.

Looking at diagnosis-related cases, the majority (30%) were led by missed/delayed cancer diagnoses, including breast, lung, colorectal, uterine and ovarian, and skin cancers, noted Ruoff.

Of a total of 55,377 closed claims in the CRICO claims database, 21% were diagnostic-error claims, said Greve. The median patient age was 49 and 51.7% of patients were female.

“It’s a pervasive and persistent problem,” he added.

The “big three” disease categories of claims were cancers (37.,8%), vascular events (22.8%), and infections (13.5%). They accounted for 61.7% of all diagnostic error claims. A majority of errors (71%) occurred in the ambulatory care setting.

Ruoff said cases with clinical judgment factors are most prevalent and they increase the odds of high-severity injury and high payment. Clinical judgment is the key component of missteps during assessment, testing, and follow up, she noted.

“The diagnosis of complications that occurred in surgery that were not recognized during surgery is a huge component,” said Ranum.

Using the data

Organizations must use this data to effect change, Ruoff said. “There’s safety in numbers,” she added. “Use numbers like this to collaborate and form patient safety strategies.”

Patient feedback is valuable, Ruoff said. Complaints can be indicators of faulty systems, provider-related behavior, and issues of provider well-being.

Greve recommended creating a list of resources: Insurance company materials, CRICO Strategies website (for algorithms, case studies, practice assessment and education resources), and specialty society websites.

Review information available to you, he said. While you don’t need to do quantitative analysis, you can  look for evidence that should prompt further investigation. Then seek comparative perspective (via your patient safety organization and national medical professional liability claims data) for context and collaboration, Greve noted.

“Your data doesn’t have to be perfect,” he said.

CMS offers training on new electronic form for restraint-related deaths

January 17th, 2020 Email This Post Print This Post

By A.J. Plunkett (

As of January 1, CMS eliminated the paper version of the form to report patient deaths associated with restraint or seclusion. Form CMS-10455 must be filed through an electronic version.

CMS announced the new electronic form and provided instructions on how to use it, including a video, in an Quality, Safety & Oversight Group memo, on December 2, 2019. Memo #QSO-20-04-Hospital-CAH DPU, “Electronic Form CMS-10455, Report of a Hospital Death Associated with Restraint or Seclusion,” can be found online here:

In a newsletter to clients, Patton Healthcare Consulting noted that the requirements on which deaths to report remain the same. Only the method of reporting has changed.

“The QSO memo also details the specific fields of information which must be submitted, but this becomes somewhat easy in that you are filling in the blanks on the form,” says Patton Healthcare. “CMS also describes what the regional office will do with the information submitted including evaluating it for a potential survey and sharing of information with the accrediting bodies. Since this new process is effective immediately you will want to review the QSO memo and slide deck and make sure that the individual responsible at your hospital for reporting such deaths has the information.”

The memo also includes a link to the video for surveyors on how the deaths are to be reported. That can be viewed at:

IHI Pushes Safety as a Primary Business Strategy

January 15th, 2020 Email This Post Print This Post

By John Commins, HealthLeaders Media

Hospital leaders must adopt safety and quality as primary business strategies, rather than regarding them as tertiary metrics that rank below finances and other stressors on the C suite’s list of top priorities.

That’s according to Derek Feeley, president and CEO of the Institute for Healthcare Improvement.

Speaking to reporters here this month at IHI’s 31st National Forum, Feeley says there are moral and financial imperatives for making safety a priority.

“The thing that should be uppermost in every healthcare leaders’ minds is safety,” he says. “If we create high-quality, safe healthcare systems, they are much more likely to be thriving and financially viable than healthcare systems that are unsafe and delivering a quality of care that patients need or want.”

Given the stressors of hospital operations, Feeley says it’s not surprising that hospital leaders get sidetracked.

“It’s the way the system works. The current environment is one of growing consolidation and (people) are trying to figure out how to make sense of these often-conflicting payment models,” he says. “Some of it’s also what the board of governance and senior executives value, and part of that is the financial vitality of the institution.”

“I keep trying to bring them back to there’s another way to think about this. Is it at least possible to conceive that we can make quick progress on safety as our business strategy?” he says.

In August, the World Health Organization issued a report that one-in-10 hospital patients in “high-income countries” suffer harm, and that half of those adverse events are preventable.

IHI President Emeritus and Senior Fellow Donald M. Berwick, MD, was asked by reporters to assess what progress the healthcare sector has made over the past 20 years since the Institute of Medicine’s landmark 1999 To Err is Human report.

“I’d say it’s a B+ on the project-level improvements,” Berwick replied, citing notable reductions in infections, pressure ulcers, ventilator pneumonia and surgical complications.

“Place-by-place you can see pretty serious improvements once people decide to work on it,” he says.

The problem, he says, is that safety improvements are missing on a system level and can vary greatly among healthcare providers, and within geographic areas.

“We’re at the really the point now where it’s time to get serious,” Berwick says. “We now know we really don’t need to have pressure ulcers. We really don’t need to have surgical site infections. We know how to virtually eliminate them.”

“The bad news is we’re seeing surveys, and when you ask healthcare executives and senior teams to rank what’s on their mind, whereas safety was pretty high up there, number one or two a few years ago, it’s now five or six, and we’re finding places backing away,” he says.

Rick Pollack, president and CEO of the American Hospital Association, disagreed “categorically” with the IHI leaders, adding that the “focus on quality in the DNA of our own organizations.”

He noted that, between 2014 and 2018, hospitals in the AHA’s Hospital Improvement Innovation Network program saved $1.2 billion in health care costs, prevented 141,000 patient safety events and saved 14,000 lives.

“To coin a phrase, quality is job one. If you’re not providing the highest quality possible, then you’re not serving your mission,” Pollack told HealthLeaders. “The reality is that what you often see is people will rather shut down the service completely in order to provide the highest quality and services that they do provide.

That commitment to quality and safety metrics plays out in executive compensation.

“We see more performance-based compensation linked to quality Improvement than we ever have the past,” he said.

Feeley said quality and safety are being address, but not quickly enough.

“It’s not that we haven’t made progress, but 20 years on, this ought to be the norm,” he says. “We should have already moved on from patient safety being something we do and our project being a way (to do it), but it’s not yet embedded. It still requires constant attention and maybe it always will.”

“That’s why I’m feel so passionately about this, as I see the risk of that diversion of attention and energy. It’s right that we remind people that what started 20 years ago in earnest has made some progress but there’s still so much to do,” he says.

John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.

Q&A: What You Need to Know About CMS’ Antimicrobial Stewardship Rule

January 15th, 2020 Email This Post Print This Post

By John Palmer, PSQH

Editor’s note: The following is a Q&A with two experts at Chicago-based Lumere, a healthcare think tank focused on helping health systems eliminate medical errors and cut unnecessary costs. Gina Thomas, BSN, RN, is chief nursing officer, and Samantha Bastow, PharmD, is pharmacy solution advisor.

On September 26, 2019, the Centers for Medicare and Medicaid Services (CMS) released revised Conditions of Participation for hospitals and critical access hospitals that require the development and implementation of antimicrobial stewardship programs (ASP) to help reduce inappropriate antibiotic use and antimicrobial resistance. The rule, first proposed by CMS in 2016, also finalized requirements for nursing facilities to have a stewardship program.

The Joint Commission also requires acute care hospitals, critical access hospitals, nursing homes, and ambulatory care centers to have an antibiotic stewardship program to maintain their accreditation.

PSQH spoke with two experts to get their thoughts on the new regulations and what measures healthcare facilities should be putting in place.

Q: What are the top five things all hospitals need to know about the new CMS ruling?

Samantha Bastow: It is encouraging that more regulatory agencies like CMS and The Joint Commission, among others, are establishing standards to promote safer antibiotic prescribing practices for our patients and communities. In fact, shortly after the CMS ruling was announced, the Society for Healthcare Epidemiology of America (SHEA) praised the CMS decision, stating “the update by CMS moves U.S. hospitals closer to the goal of making patients safer by reducing inappropriate antibiotic use by 20% in inpatient settings by 2020.”

Given this, hospitals need to consider the following:

  1. Start working on these updated requirements now. Each organization has six months from the decision date to implement their ASP.
  2. Explicit instructions in meeting CMS requirements aren’t provided in this ruling, but hospitals are encouraged to seek guidance from established organizations like the CDC, Infectious Diseases Society of America (IDSA), and SHEA.
  3. Hospitals should also collaborate with other institutions who have well-established ASPs. Check out some examples online.
  4. An interdisciplinary team of quality, patient safety, infectious disease physicians, pharmacists, and information systems analysts should collaborate to develop, implement, and expand ASPs.
  5. Keep in mind resource constraints often pose one of the biggest challenges with implementing ASPs. Hospitals should identify where they can tap into existing resources and where new or repurposed resources are needed.

Q: What does the optimal ASP look like in terms of required staffing and the specific outcomes to measure? What are the things to consider when either creating or revamping your ASP?

Gina Thomas: One of the biggest challenges to consider is that there is a major education gap among patients that antibiotics can cure all manner of ills. Therefore, providers need to be equipped with patient education materials so they can explain what the potential consequences are of overuse.

Providers also must be equipped to help patients manage their discomfort with alternative methods.

Bastow: While CMS does not specifically outline what the ASP must consist of, organizations such as the CSC, IDSA, and SHEA provide guidance on the following areas:

  • Formulary management. Set formulary restrictions for select antibiotics and establish a clear approval process for restricted antimicrobials.
  • Consistently review organizationwide antimicrobial prescribing patterns (especially those which are restricted) and use this information to provide targeted education to providers.
  • Outcomes measures. Determine which outcomes will measure the impact of ASP efforts and the resources required to pull and analyze this data. Examples of outcomes may include the rate of hospital-acquired infections, the rate of antibiotic-associated adverse drug events, the rate of resistance for specific pathogens, annual expenditures for antibiotic medications, etc.

Other recognized best practices include standing up formal education processes, developing clinical guidelines and/or pathways, establishing de-escalation practices, and antibiotic cycling. Fortunately, there is a plethora of resources for hospitals to use to develop or improve an ASP.

Q: How do you manage the most common barriers to developing a top-notch ASP? What are the problems surrounding antibiotics in hospitals, and why can’t they seem to get it right?

Thomas: Antibiotic stewardship, isn’t a new concept and hospitals have been focused on this for years. The most successful ASPs would include alignment with outpatient providers and walk-in clinics. However, this has historically been a challenge because of the fragmentation between healthcare systems and outpatient providers. Another challenge is building greater awareness of antibiotic stewardship among the public. For years, the public has been conditioned to ask for antibiotics as a first-line treatment. This is where widespread education programming comes into play. However, patient education has typically been deprioritized due to lack of resources and budget. An important point to remember is that these costs will be offset by a decrease in both inappropriate utilization of antibiotics and denied reimbursement claims.

Bastow: Sometimes resource constraints limit how robust an ASP is at a given institution. Because it often requires additional staff, information systems support, and quality measures processes, this may be difficult for a hospital to prioritize if it is not viewed as an “essential” function for providing patient care. Using the business case and proposal examples provided by other hospitals is a great way to illustrate long-term payoff.

Q: How are factors such as increasing rates of antimicrobial resistance and government programs supporting the development of new agents that are making strong ASPs more important than ever?

Thomas: While pharmacists have been tackling appropriate utilization of antibiotics for some time, we see continued antibiotic over-prescription. This has given way to a rise in superbugs which make strong ASPs more necessary than ever. In fact, the CDC estimates at least 2 million people get an antibiotic-resistant infection and at least 23,000 people die in the U.S. each year. These superbugs wreak havoc on individuals’ health (especially those who are immunocompromised) as well as impact the out-of-pocket costs for individuals and increase the potential for decreased hospital reimbursement for inappropriate utilization.

Bastow: The CDC also reports that one in three patients who die in a hospital are diagnosed with sepsis, further emphasizing the importance of having effective antimicrobial medications for life-threatening diseases such as this. The reality is that resistant bacteria are being identified faster than new antibiotics are being developed to treat them. However, support is growing from regulatory agencies such as CMS and The Joint Commission as well as national organizations like IDSA, SHEA, and the CDC. There is now better guidance for developing rigorous ASPs as well as enforcement of these “best practices.” With more support from legislative action, we hope to see more development of new antimicrobial agents to target multidrug-resistant organisms.

Q: Some new antibiotics demonstrate superior outcomes despite very high cost. Can you elaborate on some of the latest analysis?

Bastow: In the past five years, there have been four new beta-lactamase inhibitor combination products approved: Zerbaxa® (ceftolozane and tazobactam) in 2014, Avycaz® (ceftazidime and avibactam) in 2015, Vabomere® (meropenem and vaborbactam) in 2017, and Recarbrio® (imipenem, cilastatin, and relebactam) in 2019.

There are also at least four more antibiotics in this class in Phase III trials. Hospitals will need to evaluate the evidence to gauge whether these new agents result in superior outcomes when compared to older antibiotics like Zosyn®. Once the evidence is better understood, hospital pharmacy leaders can decide if these products should be added to the formulary and how to best steward the use of these broad-spectrum antibiotics. If there is no clear benefit to patients beyond what is currently available, then hospitals should consider reserving new agents in the event resistant organisms are uncovered.

It’s important to note that some of these newer agents are more than 1,000 times the cost of oral therapy within this drug class and up to 15 times the cost of older IV options in the class. Hospitals need to consider whether it makes sense to restrict the use of the newer agents to patients who are infected with pathogens demonstrating resistance to all other options. Not only does this type of restriction help from a cost perspective, but limited exposure prevents resistance.

There is currently a high volume of persistent drug shortages among antimicrobials. According to an American Society of Health-System Pharmacists report, antimicrobials are in the top five categories of medications affected. Therefore, drug shortages remain an impediment to successful antimicrobial stewardship.

John Palmer is a freelance writer who has covered healthcare safety for numerous publications. Palmer can be reached at

CMS updates its surveyor’s manual for first time in more than a year

January 13th, 2020 Email This Post Print This Post

Just in time for the holidays, CMS is offering the gift of a newly revised State Operations Manual (SOM), one of the first significant overhauls in more than a year, especially for hospitals. Expect updated standards from accrediting organizations (AOs) to follow.

The updated interpretive guidelines for CMS surveyors includes most—but not all—of the new or revised Conditions of Participation (CoP) for discharge planning and burden reduction outlined in two final rules published in September.

There are revisions for the SOM appendices to the interpretive CoP guidelines are for hospitals, psychiatric hospitals, home health agencies,  portable x-ray units, rural health clinics and federally qualified health centers (RHC/FQHC), end stage renal disease facilities (ERSD), comprehensive outpatient rehabilitation facilities, ambulatory surgical centers, hospice care,  religious nonmedical healthcare institutions, critical access hospitals (CAH), organ transplant programs and emergency preparedness.

The updates were published December 20, in a 608-page memo from CMS Quality, Safety & Oversight Group to CMS’ state regional offices and state survey agencies, as well as AOs. The memo can be found here:

While the two final rules were for the most part effective on November 29, 2019, the memo does note that changes regarding antibiotic stewardship programs for hospitals and CAHs, are not effective until March 30, 2020, and regulations quality assessment and performance improvement programs (QAPI) are not effective until March 30, 2021.

The revised interpretive guidelines for antibiotic stewardship and QAPI are expected in the spring, says CMS.

The final rules were “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction” (CMS 3346-F) and “Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies” (CMS 3317-F).

Other changes in this SOM release, as outlined in the Dec. 20 memo, include:

“• CAH- Revisions to Appendix W also include renumbering the C-Tags; inserting regulations §485.601, §485.603, §485.604, and §485.606; and inserting the CAH Distinct

Part Unit and Emergency Medical Treatment and Labor Act (EMTALA) C-Tags for reference. The changes also include updates to the Life Safety Code (LSC).

• Hospital/CAH/RHC/FQHC- Detailed requirements of United States Pharmacopeia (USP) have been removed from Appendices A, G, and W accordingly, as CMS requires compliance with applicable Federal and State law and adherence to accepted general standards of practice or guidelines for pharmaceutical services and medication administration issued by nationally recognized professional organizations.

• Psych Hospitals- The Special Conditions of Participation (CoPs) for the regulations §482.60 through §482.62(g)(2) psychiatric hospitals have been moved from the SOM Appendix AA to the SOM Appendix A. Appendix AA is being deleted as surveyors will now refer to Appendix A.

• Transplant Programs – Requirements at §482.82 that state that transplant centers must meet all data submission, clinical experience, and outcome requirements for Medicare reapproval have been removed. In addition, the special procedures for re-approval at §488.61 (f) through (h) is revised to remove the requirements with respect to the reapproval process for transplant centers. The change corresponds to the remove of the provisions at §482.82.

• ESRD Facilities: Appendix H updates the regulatory text based on requirements set forth in the 2008 Conditions for Coverage for ESRD Facilities and also includes revisions based on recent Federal regulation changes set forth in “Fire Safety Requirements for Certain Dialysis Facilities (CMS–3334–P).

• RHC/FQHC – Revisions to Appendix G include updates to regulatory text and interpretative guidance for both §491.9(b)(4) and §491.11(a) changing the requirement for an annual review to a biennial review.”

CMS officials say they are also developing online training for its surveyors on the revisions.

Sections of the main SOM have been revised over the last months and years, as have the individual appendices for each organization type that must adhere to the CoPs. The appendix for hospitals, for instance, was last updated online in October 2018. However, the appendix for ambulatory surgical centers has not been updated online since 2014.

Other sections have been added, such as Appendix Z on emergency preparedness, while the appendix for swing beds was deleted and folded into requirements for hospitals and CAHs.

The opening sections of the manual can be found online here:

The appendices can be found here:

Indiana Hospital: Sterilization Issue Put 1,200 Patients at Risk of Infection

December 2nd, 2019 Email This Post Print This Post

Patients who underwent surgery at Goshen (Indiana) Hospital between April 1 and September 30 may have been exposed to dangerous diseases after a breakdown in the facility’s surgical instrument sterilization process.

The Goshen News reported this week that the hospital sent a letter to affected patients earlier this month, announcing that one of the hospital’s seven surgical instrument sterilization technicians failed to complete one of the steps required in the sterilization process with certain instruments. This potentially exposed surgical patients to a variety of infections, including hepatitis C, hepatitis B, and HIV.

“The surgical instruments in question were still treated with our usual chemical disinfection and machine sterilization processes which include a wide margin of safety; however, such instruments may or may not have been completely sterile,” according to the letter, which was quoted by the paper. “While we believe the risk is extremely low, out of the utmost caution, we want to notify you that it is possible that this action may have exposed you to infections. To be very conservative, we want to offer patients free lab testing services to verify the absence or presence of any of these viruses.”

A hospital official told the newspaper that a total of 1,182 surgical patients may have been exposed to disease, but did not say whether any have tested positive for any diseases.

Goshen Hospital Chief Operating Officer Daniel Nafziger told the paper that the hospital took quick action to address the issue.

“As with any patient safety concern, we rigorously investigated all aspects around the incident,” Nafziger said. “We have put strict policies and additional safety measures in place to ensure it does not happen again. We also want to express our concern for each of these patients.”

Proper sharps management in senior living helps reduce risk for needle stick injuries

November 12th, 2019 Email This Post Print This Post

The following article is an excerpt from HCPro’s book Disaster Planning, Infection Control, and OSHA Compliance: A Toolkit for Senior Living, written by Karen T. Stratoti, RN, BSN, LNHA, CALA

In the senior living environment, many of the residents come in with their own ways of handling their needles and syringes. It is not uncommon to find medical waste sharps in empty tin coffee cans, used needles placed in large baggies, and used needles and syringes stored in laundry detergent containers. Many times, residents do not come into the facility with a proper disposal system. Facility administrators must make sure that the residents get the proper container for needle and syringe disposal, and that residents are given an inservice on how to use these containers to avoid staff getting a needle stick injury.

How should sharps containers be handled?

Each sharps container must either be labeled with the universal biohazard symbol and the word biohazard, or be color-coded red. Sharps containers must be maintained upright throughout use, replaced routinely, and not be allowed to overfill. Also, the containers must be:

  • Closed immediately prior to removal or replacement, to prevent spillage or protrusion of contents during handling, storage, transport, or shipping;
  • Placed in a secondary container if leakage is possible.

The second container must be:

  • Closable,
  • Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and
  • Labeled or color-coded according to the standard.

Reusable containers must not be opened, emptied, or cleaned manually or in any other manner that would expose employees to the risk of percutaneous injury.

Upon closure, duct tape may be used to secure the lid of a sharps container, as long as the tape does not serve as the lid itself.

Where should sharps containers be located?

Sharps containers must be easily accessible to employees and located as close as feasible to the immediate area where sharps are used (e.g., resident care areas, resident apartments). If a mobile cart is used in these areas, an alternative would be to lock the sharps container in the cart.

What type of container should be purchased to dispose of sharps?

Sharps containers are made from a variety of products, from cardboard to plastic. As long as they meet the definition of a sharps container (i.e., containers must be closable, puncture resistant, leak proof on sides and bottom, and labeled or color-coded), OSHA would consider them to be of an acceptable composition.

For tools and interactive training activities to improve safety and satisfaction in your facility, click here.

This story originally ran in Post-Acute Advisor, a free, weekly e-newsletter focused on delivering information, education, and guidance on complex topics such as MDS and care planning to help long-term care administrators and managers, reimbursement professionals, and clinical staff members break down confusing regulations into easy-to-understand processes and procedures.

LeapFrog Releases Biannual Hospital Safety Grades

November 7th, 2019 Email This Post Print This Post

By John Commins

One third of the 2,600 general, acute care hospitals across the nation rated in The Leapfrog Group’s fall 2019 Hospital Safety Grades got an ‘A,’ grade, while 1% flunked, the patient safety monitors said.

Leapfrog grades are based upon process and structural measures such as hand hygiene, risk mitigation, and discharge communication, as well as outcome measures such as falls, pressure ulcers, and infections.

The safety ratings’ release coincides with the 20th anniversary of the Institute of Medicine’s shocking report, To Err Is Human, which showed that nearly 100,000 people die every year due to preventable medical errors. Other research has shown that number could be twice as high.

“The findings of the IOM report, published two decades ago, laid the foundation of what The Leapfrog Group stands for today,” said Leah Binder, president and CEO of The Leapfrog Group. “In stark contrast to 20 years ago, we’re now able to pinpoint where the problems are, and that allows us to grade hospitals.”

“It also allows us to better track progress. Encouragingly, we are seeing fewer deaths from the preventable errors we monitor in our grading process,” she said.

Among the findings:

  • More than 2,600 hospitals graded with the breakdown as follows: 33% earned an “A,” 25% earned a “B,” 34% earned a “C,” 8% a “D” and just under 1% an “F.”
  • The five states with the highest percentages of “A” hospitals are: Maine (59%), Utah (56%), Virginia (56%), Oregon (48%) and North Carolina (47%).
  • There are no “A” hospitals in three states: Wyoming, Alaska and North Dakota.
  • Notably, 36 hospitals nationwide have achieved an “A” in every grading update since the launch of the Safety Grade in spring 2012.

Earlier this year, Leapfrog commissioned the Johns Hopkins Armstrong Institute for Patient Safety and Quality to update its estimate of deaths due to errors, accidents, injuries and infections at “A”, “B”, “C”, “D” and “F” hospitals.

The study estimated that 160,000 lives are lost each year from the avoidable medical errors identified in the Leapfrog Hospital Safety Grade, down from 205,000 avoidable deaths in 2016.

The Johns Hopkins analysis found that “D” and “F” hospitals have nearly twice the risk of mortality of “A” hospitals, and that more than 50,000 lives could be saved if all hospitals performed at the level of “A” graded hospitals.

John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.

Wildfire Preparation Tips for Your Organization

October 28th, 2019 Email This Post Print This Post

By Christopher Douyard, EHS Daily Advisor

Wildfires can happen at any time, though changes in land use combined with the steady and continuing rise of global temperatures over the past decades have helped create the perfect environmental conditions for them to thrive. To compound the problem, more and more people are living and working in communities where the risks posed by wildfire are most severe. It’s imperative that your facility takes every precaution to ensure that it doesn’t become another casualty of these increasingly common natural disasters.

The good news is that despite a great cause for concern, there are steps that you can take to assess and protect your buildings in advance. Here are some tips to help you prepare in the event that a wildfire threatens your organization.

Assess Your Facility’s Current Risk

There are several factors to consider when determining the potential risk for wildfire damage at your facility’s site. Foremost, it is important to understand the conditions at your facility, including weather patterns, types of local vegetation, and topography. Some regions are more fire prone than others, though there are a few key factors that apply, regardless. During your initial visual assessment, take note of the following:

  • The presence of wild vegetation, including wild grasses, brush, and timber, as these can be highly combustible. However, vegetation used in landscaping can be equally combustible.
  • Plants with a higher probability of combustion:
    • Contain volatile oils or resins. These are typically aromatic;
    • Have long and/or narrow leaves or needles;
    • Have leaves that are fuzzy or waxy;
    • Have loose or paper-like bark; and
    • Will have dead plant material accumulating beneath them.

Keep in mind that wildfires move both horizontally and vertically. Some of the most devastating fires start on the ground and then travel to bushes and shrubs, where they can then move into treetops or to a roofline. Take note of tall shrubs or overhanging tree branches near your facility or its outbuildings.

Also, recognize that these factors work in reverse. A fire that starts inside your facility can easily spread from your building by jumping to nearby vegetation, from which it can spread outward into the community.

Create a Defensible Space

Once you’ve assessed the vertical and horizontal risks posed by the vegetation and outbuildings adjacent to your building(s), you must create a defensible space around them. This space should consist of three nested zones, each with a unique set of requirements.

Zone 1: within 30 feet (ft) of facility

  • Remove all combustible materials, such as fire-prone vegetation, firewood, furniture (such as picnic tables), and/or lumber decking.
  • Remove combustible litter from the roof and/or gutters.
  • Trim branches that overhang your facility.

Traditionally, the landscaping closest to a building helps keep the facility attractive and inviting to workers, clients, and the community, but it should also be as fire-resistant as possible. For example, plant drought-resistant native plants that are low maintenance instead of ornamental species, and any lawn needs to be well-irrigated. Hardscapes are also good in Zone 1, and features like stone, gravel, or otherwise paved walkways can serve as firebreaks across the property. Using crushed stone rather than mulch for beds that are placed up against the building will also help mitigate the risk of fire reaching the building.

Zone 2: between 30 and 100 ft from facility

  • Incorporate hardscape features into your property to act as firebreaks.
  • Plant fire-resistant vegetation, and limit trees to individuals or small clusters.
    • Prune dead or dying branches regularly, and be sure to remove them.

In addition, any outbuildings located on the property should be placed in Zone 2 and should be a minimum of 50 ft from your facility if they are used to store combustible materials. Double-check your state and local building codes to make sure any fuel tanks are properly located at the minimum required distance (if not farther) from the building. If they are required to be above ground, make sure they are placed on a noncombustible pad.

Zone 3: more than 100 ft from facility

The health of the vegetation should be the maintenance focus in Zone 3. Though the trees may be more densely packed, especially if your facility is in a relatively unpopulated area, you should still prune and remove any dead or dying branches. Be sure to prune both horizontally and vertically to help minimize the potential for fire to spread.

While you don’t need to “rake the forest,” remove any larger concentrations of dead materials from the ground.

Other Steps to Consider

If you have any questions or concerns about how a wildfire event would impact your facility, first and foremost, you should reach out to your local fire department, state fire agency, or a qualified fire management specialist for an on-site consultation. Any of them can help you assess your facility’s risk and help prepare a plan for addressing issues. You could also reach out to your local planning and zoning office if you’re unsure about requirements in your area.

It’s also important to keep in mind that any codes or requirements represent the minimum effort that you should incorporate into your facility. If your building(s) are located in an area with an elevated wildfire risk, it doesn’t hurt to spend a little more on design, materials, and maintenance that could be the difference between keeping your facility safe or having to make a very expensive insurance claim.

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