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PSQH: Patient Safety & Quality Healthcare, December 15, 2020
NIOSH confirmed that approved FFRs like N95 respirators protect the wearer, filtering particle penetration to less than 5%.
This article was originally published December 15, 2020 on PSQH by Guy Burdick
Filtering facepiece respirators (FFR) with exhalation valves, as well as a surgical mask or an unregulated face covering, can reduce a wearer’s aerosol emissions, according to a report released on December 9 by the National Institute for Occupational Safety and Health (NIOSH). With modifications, the respirators can offer the same level of source control as FFRs without exhalation valves.
Compared with other workers and the general public, healthcare workers have faced a greater risk and a longer duration of exposure during the COVID-19 pandemic. Healthcare workers have used FFRs extensively, when available, during the pandemic.
The Centers for Disease Control and Prevention (CDC) had questions about the effectiveness of FFRs with exhalation valves for source control, such as whether such respirators protect others from the wearers’ respiratory emissions.
NIOSH confirmed that approved FFRs like N95 respirators protect the wearer, filtering particle penetration to less than 5%. The report, “Filtering Facepiece Respirators with an Exhalation Valve: Measurements of Filtration Efficiency to Evaluate Their Potential for Source Control” (NIOSH Publication No. 2021-107), also confirmed that an FFR with an exhalation valve provided the same source control as commonly used measures like surgical masks, procedure masks, and cloth face coverings.
NIOSH researchers determined that modifications to FFRs with exhalation valves can further reduce particle emissions. Using an electrocardiogram (ECG) pad or surgical tape over the valve from the inside of the FFR can provide a source control similar to that of an FFR with no exhalation valve.
Exhalation valves are designed to increase the wearer’s comfort at high work rates and during longer periods of use. The exhalation valve closes during inhalation, only allowing inhaled breath to be pulled through the respirator’s filter media, and the valve opens in order to allow exhaled breath to be expelled from the respirator through the exhalation valve, as well as the filter media. Such models provide the wearer with a level of protection similar to that of an FFR without an exhalation valve.
Respiratory secretions expelled by wearers may exit along with air through the exhalation valve. NIOSH researchers set out to address concerns that FFRs with an exhalation valve could spread disease if unfiltered, virus-laden aerosols passed through the valve.
Current CDC guidance does not recommend using an FFR with an exhalation valve for source control. The CDC advises that if FFRs with exhalation valves are the only options available and source control is necessary, then the valves should be covered with a surgical mask, procedure mask, or cloth face covering that does not interfere with the respirator fit.
Questions Studied
NIOSH’s National Personal Protective Technology Laboratory developed a study with three goals:
Measure the filtration efficiency provided by FFRs with an exhalation valve both under conditions of inward airflow (inhalation) and outward airflow (exhalation).
Evaluate how particle penetration in FFRs with an exhalation valve compares with particle penetration in surgical masks, procedure masks, cloth face coverings, and fabric from cotton t-shirts.
Determine the filtration efficiency of three modifications to the exhalation valve in FFRs, with the goal of mitigating the emissions of unfiltered particles.
Modifications examined by researchers included covering the valve on the interior of the FFR with commonly available surgical tape, covering it with an ECG pad, and stretching a surgical mask over the outside of the FFR. Covering an FFR with a surgical mask was not the most effective modification. Covering the interior of the valve with either an ECG pad or surgical tape reduced particle emissions to 5%.
The researchers performed a total of 1,125 tests, examining 13 FFR models with exhalation valves. The study produced the first measurements of outward particle penetration through FFRs with an exhalation valve, which have important implications for guidance on source control and disease mitigation.
PSQH: Patient Safety & Quality Healthcare, December 9, 2020
IHI CEO Kedar Mate, MD, shared ways to create a more equitable health system during his keynote address at the virtual IHI Forum.
This article was originally published December 8, 2020 on PSQH by Jay Kumar.
In his keynote address at the Institute for Healthcare Improvement (IHI) Forum, IHI CEO Kedar Mate, MD, urged attendees to look for patient safety solutions that not only help marginalized populations but benefit the public at large.
The conference, which normally takes place in Orlando, is being held virtually this year. Mate, who was named the organization’s CEO in June, said the search for ways to build a better healthcare system should embrace the concept of targeted universalism, which is an inclusive way to implement interventions. A prime example of targeted universalism is the curb cut, which was initially created to provide public streets accessible to wheelchair users, but now benefits a wide variety of people for various reasons.
“Targeted universalism seems ready made for today’s moment and today’s challenges,” Mate said. Other examples include seatbelts, which originally created for children; smoking laws, which were enacted to help flight attendants on airplanes; and closed captioning, which was designed to help the hearing impaired.
“In fact, by focusing on the most marginalized and excluded, we just might create a system that is better for all of us,” he noted.
The spirit of collaboration needs to be encouraged, said Mate.
“Our societies are becoming increasingly polarized, and this polarization is obscuring the value of collaboration, when the present global moment that we are in demands exactly that,” he said. “It has reduced decision making to either/or constructs where someone has to lose instead of seeing the opposite that might be present in both/and solutions…Consider the curb cut as a way of seeing through that polarization.”
An important challenge for the healthcare industry is to create a more equitable health system, Mate said. Organizations should take the following steps to ensure health equity:
Make health equity a strategic priority
Build infrastructure to support health equity
Address the multiple determinants of health
Eliminate racism and other forms of oppression
Partner with the community to improve health equity
IHI launched a collaboration called Pursuing Equity that developed a framework called the “4 Ms” to create age-friendly health systems:
Knowing and understanding what MATTERS to older adults
Improving MEDICATION use
Increasing MOBILITY
Improving MENTATION (i.e., preventing, identifying, treating, and managing dementia, depression, and delirium)
“These interventions have had profound effects on older adults, reductions in polypharmacy, delirium incidents, and length of stay for our oldest adults,” Mate said. “Meaning less time to de-condition and more time at home with family and friends.”
In 2017, the IHI set the goal of having 1,000 health systems adopt age-friendly initiatives. Mate said as of this week, 1,195 care locations are recognized as age-friendly health systems. In addition, Providence Health added a fifth “M,” malnutrition, which had the added benefit of helping all patients, not just the elderly ones, he said.
“In healthcare, ignoring the disadvantaged and the systems that perpetuate these disadvantages will not only in the health of individuals but in the health of entire nations,” Mate noted. “We are living this now with COVID-19.”
Mate listed several “curb cuts for a better world” that he would like to see implemented:
Address the inequities right from the start.
Invest in public health.
Fix our long-term care environments. “Our nursing homes need our support right now, not our mistrust and suspicions.”
“De-carcerate” by reducing the prison population where possible.
Expand community health.
Improve prison health.
To find their own curb cuts, Mate said health organizations need to name their universal goals, pick a measure that’s important to them and stratify their data, and stay physically and psychologically safe.
“We need ‘psychological PPE’ to promote mental health and well-being,” he added.
PSQH: Patient Safety & Quality Healthcare, December 8, 2020
PSMF CEO David B. Mayer, MD, and chief clinical officer Donna Prosser, DNP, RN, NE-BC, FACHE, BCPA, detail how the group is expanding its efforts and preaching the gospel of high reliability.
This article was originally published December 4, 2020 on PSQH by Jay Kumar.
After several years of focusing on smaller improvements to eliminate preventable patient deaths, the Patient Safety Movement Foundation (PSMF) is thinking big. The group recently announced a new goal of zero preventable deaths by 2030, but with a new approach to bring about systemic change.
In an interview this week, PSMF CEO David B. Mayer, MD, and chief clinical officer Donna Prosser, DNP, RN, NE-BC, FACHE, BCPA, detailed how the group is expanding its efforts and preaching the gospel of high reliability.
Since the publication of the Institute of Medicine’s report To Err Is Human in 1999 IOM report, the healthcare industry has been working really hard to improve quality and safety, said Prosser. Patient Safety Movement was founded in 2012 with the goal of eliminating preventable patient deaths by 2020. While it fell short of that goal, the group says its hospital and health system partners saved 366,353 lives during 2012-2020 by improving processes. Still, there is much more to be done.
Instead of focusing on improvements in certain patient safety areas, the PSMF is taking its cues from the aviation and nuclear industries, which have embraced the concept of high reliability to build a foundation of safety.
“We’ve learned a lot from high-reliability organizations,” Prosser noted, adding that the expense required to carry out the organizational changes required has made high reliability previously unattainable for many smaller hospitals.
“We want to be able to help organizations in any way we can to remove the barriers to high reliability,” said Prosser.
Organizations that have done well with high reliability have the money to hire consultants, but many aren’t able to do so. The PSMF has been providing free resources such as videos, webinars, and articles, as well as its Actionable Patient Safety Solutions (APSS) blueprints, which are best-practice summaries to help organizations improve performance on various topics such as healthcare-associated infections and medication safety. As part of its new effort, the PSMF is going to offer free coaching to organizations that commit to high reliability and share their progress with PSMF. Prosser said she will oversee all coaching, with a fellowship program expected to start in the next year.
“We have a vast network of volunteers and content matter experts across the globe,” said Mayer.
The PSMF is in the process now of collecting baseline data, tracking serious safety events and near misses. Mayer said the group is in talks with Press Ganey to incorporate its Serious Safety Event Rate methodology into PSMF efforts.
For immediate goals, Prosser said the PSMF wants to get at least 50% of reporting hospitals in its network to commit to high reliability, which includes creating a person-centered culture of safety; implementing a holistic, continuous improvement framework; and sticking to an effective model for sustainment. Previously, the group was working with the heads of departments like Infection Prevention, but for this new initiative, the C-suite has to get involved, she added.
“We’re really focused on those medium and small hospitals that really want to do this work, but don’t have the time or resources,” Mayer said.
Impatient with slow progress
Mayer noted that many esteemed figures such as Lucian Leape and Don Berwick have championed the cause of high reliability and error prevention, but “we still haven’t done the critical things that are necessary,” such as ensuring the proper training and resources are available.
Medical malpractice and a lack of transparency has been a major problem, he said. The Communication and Optimal Resolution (CANDOR) toolkit developed by the Agency for Healthcare Research and Quality has provided open and honest ways for healthcare institutions to respond to adverse events.
But ultimately, change hasn’t occurred quickly enough. “We’re just tired of seeing slow progress,” said Mayer.
As the U.S. prepares for a new presidential administration to take over in January, Mayer is hopeful that patient safety efforts will be prioritized on a federal level. In 2016, then-President Barack Obama asked Vice President (and current President-elect) Joe Biden to lead the “Cancer Moonshot” effort to cure cancer in 10 years. The effort only lasted a year before Trump administration budget cuts slashed the research effort considerably.
“I’m confident the president-elect will re-engage the Cancer Moonshot,” Mayer said, adding that lobbying is already underway to encourage the incoming administration to do a “Patient Safety Moonshot” as well.
“We need a national Patient Safety Authority,” he said. “It’s going to take a lot of things to come together, but we’ve got to think big.”
The problems with patient and healthcare worker safety were evident before the pandemic, especially in OSHA worker injury rates, which are higher for healthcare than any other industry, said Mayer.
“The pandemic has exposed so many of these gaps,” he said, adding that once we provide the safest environment for caregivers, they can provide the best care for patients.
“ We’ve seen an increase in all kinds of patient safety issues because of the pandemic,” Prosser noted. “You can’t have patient safety without healthcare worker safety.”
The stress of working conditions during COVID-19 has also had a serious impact on caregivers, especially nurses. Not only are current nurses leaving the profession, the media coverage of overloaded hospitals and overburdened healthcare workers may make it difficult to attract new nurses. “I’m afraid we’ve taken out a generation of nurses,” Mayer said.
Although things look bleak right now, Prosser sees a silver lining.
“We need to focus back on the basics. This isn’t about the pandemic, this is about rebuilding our broken healthcare system,” she said. “This is actually a blessing in disguise for our system. If we can have that high-reliability mindset, we can learn from past mistakes.”
PSQH: Patient Safety & Quality Healthcare, December 3, 2020
Any professional who is currently involved in patient safety or quality improvement is welcome to submit a case study application.
This article was originally published December 2, 2020 on PSQH
Patient Safety & Quality Healthcare (PSQH) is seeking to spotlight the best healthcare quality improvement case studies. By imparting their in-the-trenches experiences and lessons learned, the chosen case studies will shed light on an issue, practice, or principle that affects stakeholders across the modern medical staff landscape.
Whether you’re a seasoned educator in search of a broader platform to share your expertise or a yet-to-present professional with big ideas, read on for the ultimate opportunity. Then, click here to apply to the 2021 PSQH Innovation Awards. Deadline to apply is January 15, 2021 and the application is free.
Any professional who is currently involved in patient safety or quality improvement is welcome to submit a case study application. The 2021 PSQH Contest Committee, in conjunction with the PSQH administrative team, will select one case study to highlight on PSQH.
The winning proposal will showcase a creative solution that the presenter(s) have helped implement at their organization. This change can have occurred at any time, as long as it reflects current industry standards and continues to benefit the organization.
The winning presentation will elegantly address the following subjects:
A specific (and widely relatable) challenge or objective that sparked a meaningful change in a key patient safety or quality improvement process
The steps that the involved parties took to conceive, develop, and implement their solution, including any hurdles they overcame along the way
The short- and long-term effects of the solution
The takeaways for the broader professional community
Potential case study subjects include the following:
Patient safety improvement
Quality improvement
Medication safety
Infection control
Reduction/elimination of “never events”
Improving readmission rates
Patient satisfaction
Innovative approaches to addressing tricky regulations and accreditation standards
To access the case study application, click here, or paste the following URL into your internet browser’s address bar: https://www.surveymonkey.com/r/8BQFTTK. We recommend that you paste your responses into the application fields from a Word document. The application period closes end of day on Friday, January 15, 2021.
PSQH: Patient Safety & Quality Healthcare, December 3, 2020
A new report from medical liability insurer Coverys takes a close look at why patient safety in this country is still far from optimal.
This article was originally published December 2, 2020 on PSQH by John Palmer
It’s been 21 years since the Institute of Medicine released its landmark patient safety report To Err Is Human. A new report from medical liability insurer Coverys takes a close look at why patient safety in this country is still far from optimal.
The report examined 20,211 closed medical malpractice claims from 2010 to 2019 to provide risk managers, clinicians, and healthcare executives a unique view into factors that lead to claims. It is intended as a tool to proactively reduce conditions that result in patient harm and financial risk.
As a conversation starter, the report seeks to create a foundation for a national-level examination into risk management issues and causation factors.
“Despite concerted efforts to improve patient safety over the past 20 years, patients continue to experience high-severity injury outcomes,” wrote lead author Ann Burke, RN, CPHRM, CPPS, senior director of risk management for Coverys before her recent retirement. “This report explores how efforts in the decade following the 10-year anniversary of To Err Is Human have not delivered optimal results. It raises vital questions and renewed areas of focus.”
The October report, titled A Call for Action: Insights From a Decade of Malpractice Claims, was written by Burke, as well as Robert Hanscom, JD, vice president of risk management and analytics; Ann Lambrecht, RN, BSN, JD, FASHRM, senior risk specialist; Amit Patel, MBA, director of advanced analytics and innovation; and Maryann Small, MBA, senior director of risk analytics.
The report is the sixth in Coverys’ “Dose of Insight” series, which explores the increased risk and liability brought on by several patient safety issues in healthcare, and offers suggestions on how to improve. Previous reports have studied medication errors, errors in the emergency department (ED), diagnostic accuracy, surgical malpractice claims, and obstetrics.
Some of the major findings of the latest report include the following:
Clinicians and organizations are seeing increasingly high financial payouts for malpractice claims. In 2010, the average indemnity paid was $342,581; by 2019 it was $411,053.
The overall number of claims reported is trending downward, but both average indemnity and expenses are trending upward.
Surgery/procedure-related allegations were the most frequent, followed closely by diagnosis-related allegations—combined, they accounted for 57% of allegations and 59% of indemnity paid.
“Surgical care is inherently risky, and when things go wrong, is a common basis for malpractice claims,” the report concluded. “Despite widely distributed guidance, checklists, team training, and simulation aimed at reducing their prevalence, events continue to occur involving retained foreign bodies, wrong site procedures, and less-than-optimal team performance.”
Sixty-three percent of claims involved a surgeon with multiple claims.
Persistent risks that lead to poor patient outcomes involve the interweaving of communication, process, and cognitive issues.
Retained foreign bodies, wrong-site procedures, and less-than-optimal team performance are still some of the most prevalent surgical complications.
In some better news, anesthesia-related claims have decreased by more than half, attributed somewhat to the fact that anesthesia is now highly data-driven with a focus on simulation training, human factors engineering, and evidence-based decision-making.
A long way to go
The underlying message of the Coverys report seems to be that there is still a lot of work to do in improving patient safety.
“Healthcare seems to push back on the notion of standardization, yet variability is what we frequently see populating a large number of malpractice cases,” says co-author Hanscom. “Most other industries, in their drive to become safer and more reliable, have focused hard on eliminating unnecessary variability.”
According to Hanscom, the industry’s refusal to change archaic practices that lead to mistakes has helped keep the past decade slow in terms of patient safety improvements.
Checklists and other standard protocols have led to safety advancements in other industries, such as aviation, and Hanscom says the secret to safety lies in the removal of variables in several areas, such as the following:
Technical performance. Organizations that have invested in surgical simulation capabilities (i.e., skills labs) are actively focusing on ways for surgeons to learn, practice, and sharpen their skills in a simulated environment. Also, hospitals need to cut down on noise and distractions in the OR.
Cognitive skill. Variability in cognitive skill is at the root of many missed diagnosis cases. Clinicians can get caught in a narrow diagnostic focus, perhaps inadvertently influenced by their own cognitive biases.
“We know that many organizations have invested in resources that provide decision support—and that emphasis should continue,” Hanscom says. “But perhaps this is an area of future innovation. Can we create cognitive simulation tools and ways by which clinicians can actively practice their diagnostic skills, even understand where they might succumb to moving too fast or jumping to a likely conclusion?”
Different healthcare specialties have different processes, and there is very little standardization in key areas. An integral component of high-reliability environments is having well-defined underlying systems to support patient care. These environments have processes that are well thought out and universally understood, leaving minimal room for care to fall through the cracks.
Communication breakdowns occur between providers when patients are transitioning from one critical domain to another—for instance, moving from the OR to recovery or the ICU, or from the ED to an inpatient bed.
As for emerging risks, the report singled out several areas that need to be watched, including new technology, novel procedures, and current events like the coronavirus pandemic. In addition, the growing use of urgent care and walk-in clinics, electronic health records, telehealth, and robotics could all be ripe for future diagnostic and communication errors, the report pointed out.
Some better news
The report identified some areas where there seems to be a declining trend in claims against some practices, such as radiology, anesthesiology, and emergency medicine.
The overall claims rate for anesthesiology was reduced by more than 50% over the 10 years of claims analyzed, which may be attributed to the use of data to drive practice improvements.
“It comes back to the old adage that you can’t manage what you can’t measure,” says report co-author Lambrecht. “When there is baseline data from which to work that identifies when in the anesthesia process the event occurred and calls out the type and severity of the injury, it becomes easier to identify the root cause or causes that contributed to the outcome. These data also tell us which interventions have the greatest likelihood to produce better outcomes.”
She adds that while the claims rate is declining in the ED, there is almost no change in claims over a 10-year period, and there is room for improvement given the significant advancements in technology and enhanced decision support tools.
“Factored into clinical judgment are patient assessment and diagnosis, selection and management of therapy, and a failure or delay in obtaining a consultation or referral,” she says. “These can be improved through using clinical decision support tools and having consultation policies that require a specialist referral and can reduce or eliminate the probability of a narrow diagnostic focus or implicit yet unconscious bias. With these aspects addressed, it may lead to more effective selection of treatment and management of therapy.”
PSQH: Patient Safety & Quality Healthcare, November 18, 2020
The technology and understanding of how to deal with drug diversion is evolving more quickly than regulations can be rewritten, and facilities are expected to keep abreast of the best practices available.
This article was originally published November 18, 2020 on PSQH by Kimberly New, BSN, JD, RN
Editor’s note: This article is excerpted from the HCPro book Drug Diversion Prevention in Healthcare, Second Edition. For more information and to order, visit https://hcmarketplace.com/drug-diversion-prevention.
Drug diversion in healthcare facilities has been the subject of increasing focus by regulatory authorities in the past several years. In many cases, the expectations of these authorities are not explicit in regulations but come to light in the settlements reached between the Department of Justice/Drug Enforcement Administration (DEA) and facilities where violations or poor practices are identified.
In general, DEA and other authorities expect facilities to adhere to the best available practices for patient safety and drug security, regardless of whether those practices are spelled out in published regulations. Consequently, in terms of expectations by regulatory authorities, there is no real distinction between what is required and what is considered to be best practice.
The technology and understanding of how to deal with drug diversion is evolving more quickly than regulations can be rewritten, and facilities are expected to keep abreast of the best practices available.
Most facilities have a core group of stakeholders that recognize the scope of the problem and risks associated with diversion. Unfortunately, regulation does not explicitly mandate that facilities have a diversion program, so it may be difficult for even committed people to gain support for some of the essential processes. When I visit facilities where administrators are resistant to my recommendations, an argument I hear often is, “Just show me the regulations that require it.” They are not usually content with best-practice guidelines.
Therefore, to support the diversion program effort, refer to the controlled substance- and diversion-related requirements with which facilities must comply. Sources of such requirements include the Centers for Medicare & Medicaid Services (CMS), DEA, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), survey agencies, state regulations, and professional boards.
There are numerous best practices and guidelines available to provide direction and support. Sources for guidelines include ASHP, Centers for Disease Control and Prevention (CDC), and the Institute for Safe Medication Practices (ISMP), to name a few.
Several states have developed toolkits and roadmaps to help facilities perform their own gap analyses; many of freely available online, including the Minnesota Hospital Association roadmap, the California Hospital Association roadmap, and the Missouri Bureau of Narcotics and Dangerous Drugs Guide to Preventing and Investigating Diversion Issues in Hospitals, among others (see the URLs at the end of the chapter). Finally, additional guidance and expectations can be gleaned from DEA settlement agreements with healthcare facilities. Some of the universal requirements and expectations are discussed here.
Patient Safety
The pharmacy has ultimate responsibility for medications throughout the hospital. The Interpretive Guidelines for the Medicare Conditions of Participation (CoP) state, “The hospital’s pharmacy service must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication-related devices throughout the hospital, for both inpatient and outpatient services” (Interpretive Guidelines 42 CFR §482.25[a]).
Hospitals generally must provide a safe environment of care for patients—that is, one that is free from the threat of abuse or harm (42 CFR §482.13[c][2]). The hospital must also ensure that the medical staff is accountable to the governing body for the quality of care provided to patients (42 CFR §482.12[a][5] and 482.22[b]).
In order to comply with these patient-safety related requirements, hospitals must keep controlled substances secure so as to prevent tampering and substitution. Nursing and pharmacy staff and anesthesia providers, particularly those in procedural and operative units, who fail to keep controlled substance injections secure pose a substantial risk to patient safety.
Regardless of whether the services are provided directly by hospital employees or indirectly by contract, the hospital is responsible for requiring staff to comply with state and federal law (42 CFR §482.12[e]). In other words, even if anesthesia staff are contracted workers, the hospital is responsible for requiring them to comply with state and federal regulations and with relevant patient safety standards (42 CFR §482.12[e][1]).
The hospital is also responsible for ensuring that the care delivered by nonemployed nursing staff meets hospital policies and procedures (42 CFR §482.23[b][6]), including controlled substance handling requirements. Agency nurses are often implicated in drug diversion cases, so in order for the hospital to comply with this requirement, tit must monitor nurses closely. Due to the relatively short duration of their assignments, their controlled substance transactions should be monitored more frequently than those of employed staff.
The CoPs also require that hospitals have ongoing surveillance to identify “infectious risks or communicable disease problems” in any particular location (Interpretive Guidelines 42 CFR §482.42). This CoP requirement is meant, in part, to facilitate early identification of an outbreak. In light of the many reported diversion cases that have resulted in bloodborne pathogen transmission to patients, and in conjunction with this responsibility, infection prevention departments should be apprised of all confirmed drug diversion cases.
Patient Privacy
Hospitals and other institutions are required to protect patient information and prevent unauthorized individuals from accessing private healthcare related data (42 CFR §482.13[c][1] et seq and 42 CFR §164 et seq).
When diversion occurs, often the diverting staff member has inappropriately accessed patient records to locate patient identities under which it would be ideal to divert. It is important to review each diversion case for the possibility of a privacy violation and to work with the institutional privacy officer to ensure that any violations are addressed.
Security and Medication Handling Requirements
The CoPs require that institutions have policies and procedures in place that prevent, to the extent possible, diversion of controlled substances (Interpretive Guidelines 42 CFR §482.25[a][3]). In order to comply with this directive, facilities must have policies and procedures that explicitly address controlled substance handling, and must insist on compliance with expected practices.
For example, staff should be able to review controlled substance handling policies and obtain direction regarding how long they have to administer a controlled substance once it is removed from secure storage, and when and where they are required to waste excess controlled substances. Furthermore, institutions must review diversion-related policies regularly to ensure that they are up to date and consistent with institutional expectations.
The CoPs require that all drugs and biologicals be kept in a secure area and be locked when appropriate (42 CFR §482.25[b][2][i]). This means that controlled substances need to be stored in a way that prevents unauthorized access. Secure areas must be accessible only to authorized individuals (Interpretive Guidelines 42 CFR §482.25[b][2][iii]). Such individuals must be identified by job class in hospital policies and procedures, and those procedures must also indicate how unauthorized access is prevented.
Automated dispensing cabinets (ADC) are recognized in the CoPs as a secure option for controlled substance storage. If you are using ADCs, consider the ISMP guidelines for their use, including password security, unit-specific privileges, biometric access, locking storage in refrigerators, returning unused medications to a designated return bin, and implementing blind counts for controlled substances (ISMP Guidance).
The CoPs state that drugs can’t be administered without a valid order by a physician, and any drugs available on override must be strictly limited to those that might be needed immediately in emergency circumstances (42 CFR §482.23[c][1] et seq and Interpretive Guidelines 42 CFR §482.25[b]).
This requirement is meant to ensure that appropriate safety checks are in place prior to administration, but it is also relevant to the diversion prevention effort. One popular method of diversion is to pull controlled substances via an override transaction. Therefore, hospitals should regularly review their list of overridable controlled substances, and they should keep that list as narrow as possible.
The CoPs require that quantities of medications dispensed be limited to prevent diversion, and that patients must be assessed to ensure that medications have their intended effects (Interpretive Guidelines 42 CFR §482.25[b][1]). Monitoring for the removal of excessively large doses is one way of preventing diversion, but limiting the dosage size available based on the needs of the patient population being served is also an effective measure.
Although hospitals may permit patients to self-administer their own medications, hospitals are required to keep self-administered medications safe and secure. Owing to the increased security requirements for controlled substances, hospitals should only allow self-administration of these drugs in very limited situations. In fact, the CoP interpretive guidelines state, “Hospitals … generally should not include such medications as part of a patient self-administration program” (Interpretive Guidelines 258).
ISMP guidelines suggest that wasting of unneeded controlled substances happens at the time the medication is removed from secure storage (ISMP Guidance, Core Process 2).
As discussed in more detail in a subsequent chapter, the DEA, EPA, and FDA have all identified regulations or expectations regarding controlled substance waste disposal. Local waste treatment regulations may also impact how a facility approaches controlled substance disposal. Because controlled substance waste is a common source for diversion, it is important to have a compliant process for disposal—that is, one that doesn’t facilitate diversion—in place.
Recordkeeping
The CoPs and DEA regulations require that current and accurate records be kept of the receipt and disposition of all scheduled drugs (42 CFR §482.25[a][3] and 21 CFR §1304.04 et seq). This includes having complete records for all controlled substances from the time of procurement to administration, waste, or return via the reverse distributor.
It also includes being able to track all controlled substances that leave the pharmacy and ensure that they are received into stock at the intended location, and it includes being able to track controlled substances that are removed from stock in remote locations to ensure that they are received back into stock in the pharmacy.
All institutions should have a meaningful daily or per-shift reconciliation, by a reviewer who is not involved in the workflow that is being audited, of drugs that leave or are expected to be returned to the pharmacy.
This requirement also applies to situations in which drugs are manually accounted for. For instance, many facilities use manual records to track the administration and wasting of patient-specific controlled substances. In those facilities, nursing documentation may not be sent to pharmacy as it should be, and pharmacy may not follow up to be sure that the documentation is received. Every instance in which administration and waste documentation is incomplete is a discrepancy, subject to a civil monetary penalty of up to $10,000 per violation (21 U.S.C. § 842(c)(1)(8)). In such a situation, complacency is not an option.
The CoPs require that all records demonstrating the movement of controlled drugs within the institution must be readily retrievable (21 CFR §1304.04 et seq). This means that facilities must be able to produce all records relating to controlled substances without delay, not just those that relate to procurement and inventories.
Discrepancies are required to be reconciled “promptly” (21 CFR §1304.04 et seq). The term “prompt” is explained in the CoPs by citing the Merriam-Webster online dictionary, where “prompt” is defined as being performed “readily or immediately” (Interpretive Guidelines 42 CFR §482.24[c][2]). This interpretation supports the policy that most facilities have requiring that discrepancies be resolved by the end of the shift. It also means that discrepancies cannot be left unresolved for extended periods of time.
Such resolution is essential. When I have visited facilities that regularly allowed discrepancies to go unresolved, I have found hundreds or thousands of discrepancies pending resolution across the institution. Any discrepancy, even a surplus, may be a sign of poor controls and lax accounting. The reasons given for discrepancy resolution must be reviewed consistently to ensure that discrepancies are resolved appropriately. For instance, it would not be appropriate to resolve an actual discrepancy of 32 missing tablets by stating that the discrepancy was due to a miscount.
Diversion Investigation and Response
ISMP and ASHP guidelines emphasize the need for regular review of drug usage patterns, wasting practices, and discrepancies (ISMP Guidance, Core Process 2 and ASHP Guidelines). The Interpretive Guidelines for the CoPs require facilities to be capable of readily identifying loss or diversion of all controlled substances so that the time between the loss or diversion and the time of discovery is strictly limited.
Facilities must also be able to quickly ascertain the extent of any controlled substance loss or diversion (Interpretive Guidelines 42 CFR §482.25[a][3]). In order to comply with this requirement, all facilities need to have a robust multidisciplinary diversion surveillance effort. Those required to review transaction data must be identified in policy, and the steps involved in transaction review should be set forth as well.
The CoPs require that hospitals promptly investigate and resolve patient complaints and grievances (42 CFR §482.13[a][2]). This includes complaints about poor pain relief, poor nursing care, and failure to receive documented medication, all of which may relate to diversion. Any complaint that may be related to diversion should be forwarded to the diversion specialist, as well as to the patient advocate, so that the possibility of diversion can be reviewed and addressed.
If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the CoPs require that the hospital evaluate its current medication control policies and procedures and implement the necessary systems and processes to ensure that the problem is corrected. The hospital must also ensure that patient health and safety are maintained (Interpretive Guidelines 42 CFR §482.25(b)(2)(i)).
In addition, hospitals must have in place ongoing performance improvement and patient safety initiatives (42 CFR §482.21(a)(1) et seq). These requirements speak to the need to address noncompliance in medication handling via coaching and progressive discipline.
They also underscore the need for institutions to perform a review of every diversion case and identify any performance improvement measures that can be implemented to help prevent similar events. This is a process that ASHP supports as part of the institution’s quality improvement initiative (ASHP Guidelines).
The CoPs state that diversion and loss of controlled substances must be reported to the individual responsible for the pharmaceutical service and to the chief executive officer, as appropriate (42 CFR §482.25(b)(7)). This requirement includes ensuring that all reporting required by state and federal law is accomplished. Many hospitals fail to report diversion to the DEA on a form 106, as required by law (21 CFR §1301.76(b)), but failure to do so not only violates DEA regulations but also violates the Medicare CoPs for hospitals.
CEO and Board Communication
Hospitals are required to be in compliance with the federal requirements set forth in the CoPs to receive Medicare/Medicaid payment (Interpretive Guidelines 3). The CoPs require that hospitals be in compliance with all applicable federal, state, and local laws. They also require facilities to have an effective governing body that is legally responsible for the hospital’s conduct.
Surveyors assess compliance with these CoPs in part by interviewing the facility’s CEO and reviewing Board of Director meeting minutes. A common theme with diversion cases and other crises within hospitals is that full disclosure to executive leadership doesn’t always occur in a timely fashion. There was an allegation of this type of gap in communication in a diversion case in Florida that involved allegations of patient harm (Eiselle, 2016).
With diversion, it is essential that the CEO and Board of Directors be kept abreast of suspected diversion cases as well as confirmed cases. The CEO must be familiar with the institutional diversion program components and should fully understand what diversion response entails. The Board of Directors must be kept abreast of confirmed diversion cases and any potential patient harm that may have resulted.
Facilities should also ensure that they keep up to date with State Board of Pharmacy and State Board of Nursing regulations as they apply to diversion and controlled substance handling. Both boards typically require reporting of diversion or actionable poor practice that may suggest diversion.
PSQH: Patient Safety & Quality Healthcare, November 14, 2020
Targeted radiation during lumpectomy reduces treatment time for low-risk patients.
This article was originally published November 12, 2020 on PSQH by Megan Headley
Breast cancer may be painful and invasive, but researchers have worked for years to reduce the physical and emotional toll on women undergoing treatment. Now, women diagnosed with early-stage breast cancer may have a single-day radiation treatment available to them.
Evidence indicates that for patients with low risk and good prognosis, localized treatment with targeted intraoperative radiotherapy (TARGIT) may be equally as effective as standard radiation, with potentially less damage to normal tissues and organs.
Research outlining a TARGIT clinical trial and its results, published in the August 2020 issue of The BMJ, concludes that a single targeted dose of radiation delivered during lumpectomy helped patients finish their radiation treatment the same day as surgery and begin recovery faster. It proved equally effective as postoperative external radiation, which can last several weeks.
“Defeating cancer is not enough. Our jobs must be to find effective therapies that also consider treatment time, side effects, and the overall impact for cancer survivors,” explains Sheldon M. Feldman, MD, who is chief of the division of breast surgery and surgical oncology, director of breast cancer services at the Montefiore Einstein Center for Cancer Care, and professor of surgery at the Albert Einstein College of Medicine. Also a member of the TARGIT Collaborative Group, Feldman says the study “validates intraoperative radiation therapy as a safe, patient-friendly breast cancer treatment and marks a significant step forward in how we can and should be partnering with our patients to help them survive this dreadful disease.”
Steps for reducing treatment time
Dr. Michael Alvarado, a breast surgeon and professor of surgery at the University of California-San Francisco and a co-author of the BMJ research, sees the TARGIT approach as the culmination of decades of work in reducing the time women spend in follow-up radiation after a lumpectomy. While the radiation may be well tolerated, it is also invasive and inconvenient. For standard whole-breast radiation, a patient could need daily 10- to 15-minute treatments, Monday through Friday, for five weeks. That’s time spent in travel to the hospital that takes away from work, caregiving, and life—on top of the fatigue and soreness that comes with radiation.
We’ve already seen some scientific progress on this front. With the advent of a therapy known as hypofractionation, radiation treatment could be reduced from five to three weeks. From there, experts have examined strategies for moving to partial-breast radiation, focusing solely on the tumor-infected area. Doing so would decrease risks associated with whole-breast radiation, including small likelihood of cardiomyopathy, secondary cancers, and other side effects due to radiation scatter. These more targeted approaches shorten the timeline to only five days of treatment, twice a day.
However, nearly 20 years ago, a group of researchers at the University College London began examining whether it might be effective to offer some patients a single dose of targeted radiation during the lumpectomy, eliminating the need for follow-up radiation altogether. This conjecture from professors Jayant Vaidya, Michael Baum, and Jeffrey Tobias was the genesis of intraoperative radiation therapy (IORT)—which is what TARGIT delivers.
Alvarado explains, “The question was, could you give one dose and have that be equivalent to other types of radiation?”
Tests of this approach have all utilized the Intrabeam® device made by Carl Zeiss. Though the study design randomized patients to receive either TARGIT or standard whole-breast radiotherapy, researchers also took a risk-adaptive approach: If a TARGIT patient was revealed to have a higher risk at the final pathology report than assessed at the original pathology, they were also given whole-breast radiation. In essence, the TARGIT served as the first “boost” of radiation for higher-risk patients.
“It wasn’t truly randomizing one dose in the OR versus standard radiation,” Alvarado says. “It was a risk-adaptive approach where you get a one-time dose and some people might get additional radiation.”
Since the start of this research in 1998, more than 40,000 patients have been treated in 350 breast cancer centers in 10 countries using the TARGIT method. Alvarado’s team at UCSF became the first institution in the United States to utilize this approach in 2005. Data remained promising throughout this research period. As the BMJ study indicates, the risk of a local recurrence at five-year follow-up was 2.11% for TARGIT, compared to 0.95% for external beam radiotherapy—a difference of about 1%. There was no statistically significant difference in survival between either method.
During this time, researchers also tracked the level at which women were willing to accept a low increased risk of local recurrence with no difference in survival for the convenience of having a one-time dose of radiation. The patient preference trial found about 70% of women would make that tradeoff. The average amount of risk that women would accept was about 2.5%, indicating a strong preference for a solution of this type.
And while Alvarado says, “I don’t know that we can hang our hat on it just yet,” there is also an indication that the TARGIT approach offers a statistically significant reduction in the number of cardiovascular deaths compared to standard radiation. “As breast cancer treatment gets better and better and more women are surviving breast cancer, there are these other competing risks from the treatment that we do,” he adds.
The next steps for TARGIT
Alvarado sees the TARGIT approach as “one of the most impactful trials for locoregional treatment of breast cancer in 20-plus years.” Yet despite decades of research, there are still hurdles to overcome to broaden acceptance of this treatment.
“It’s a paradigm shift, to be able to give one dose in the OR compared to smaller doses over time,” Alvarado says. However, while from his perspective it’s often easy for physicians to add new treatments to address illness, it’s much harder for them to accept the idea of lessening treatment. “Most physicians tend to be very conservative about withholding treatment, even with data that shows that it’s OK.”
He points to data on the Oncotype DX Breast Cancer Assay as an indicator. “They’ve had data for 15 years showing that women are overtreated with chemotherapy,” he says. “The data was exceptionally good in 2006. It was really great in 2010. It was really good in 2016. And people were still getting chemotherapy when they didn’t need to.”
There’s another aspect Alvarado says may sway adoption. “This procedure doesn’t reimburse very well,” he says. “Surgeons who do this don’t really get anything for taking the extra 40 minutes in the operating room to do the biology. Radiation oncologists can actually bill less for the one-time dose. No one likes to say that out loud, but that does play into it.” That said, health systems focused on patient experience may value the care improvements much more highly.
Now, Alvarado says, the TARGIT researchers are reaching out to the American Society for Radiation Oncology and the American Society of Breast Surgeons to broaden both awareness and guidelines.
“It’s going to take both physician advocates for this as well as patient advocates,” he says. “We’re not asking that it becomes the standard of care, but it should be allowed in the discussion with the patient, so the doctor and patient can make their best decision for treatment.”
PSQH: Patient Safety & Quality Healthcare, November 14, 2020
At Children's Health in Dallas, our partnership with over 225 schools across the Dallas metro area provides vital access to specialty support for children and teens and guidance around infection control.
This article was originally published November 12, 2020 on PSQH by Karen Kaighan and Jason Isham
As schools face heart-wrenching decisions around how to educate kids during the COVID-19 health crisis while keeping students and staff safe, school nurses are perhaps feeling the most strain.
These days, school nurses are often responsible for assessing children and faculty presenting with COVID-19 symptoms. And with the health crisis putting a pause on access to some regular healthcare services, many children are not getting the care they need. This puts an even bigger responsibility on school nurses, some of whom were busier than ever when schools shut down last spring.
Telehealth increasingly is helping school nurses meet students’ physical and mental health needs, both in school and virtually—and lawmakers are recognizing its importance. At Children’s Health in Dallas, our partnership with over 225 schools across the Dallas metro area provides vital access to specialty support for children and teens and guidance around infection control.
A back-to-school approach to telehealth
Even before COVID-19 was a blip on the radar screen, we saw the benefits of using telehealth in school settings. In 2014, the health system began partnering with schools to bring virtual primary and specialty care into the building, such as by providing one-on-one virtual education and support for asthma management. The impact: 72% of parents whose children have relied on our school-based telehealth services say the initiative helped their children avoid an emergency department visit.
However, when COVID-19 struck, we quickly realized that a broader virtual approach would be critical.
In mid-March, when schools closed their doors to in-person learning, our technology team brought school-based telehealth equipment and devices back into the hospital, where they could be sanitized and used. Team members provided urgent care and behavioral health services virtually for students who ordinarily received these services in a school environment.
Staff also offered free assessments of COVID-19 symptoms in students via telehealth and directed students to in-person treatment, where needed. From March through September, we recorded a 500% increase in telehealth urgent care visits among students compared with the same period in 2019. As school start dates approached, the health system distributed 150,000 masks to students to help limit exposure to the virus.
Then, as the 2020–2021 school year approached, we partnered with school nurses to ensure children and faculty were kept safe as they returned to the classroom. We started by launching a “Back-to-School COVID Conference,” bringing together more than 900 school nurses throughout the Dallas metro area to discuss what school-based care delivery should look like during a pandemic and how nurses could most effectively protect themselves.
Collaborating with UT Southwestern, we shared best practices that would help ensure nurses felt comfortable providing complex as well as routine care. We also supported school nurses by providing fit testing for them as well as for essential school and college personnel. And we offered school districts a daily quick-screen COVID-19 symptom checker for staff, student, and teachers before entering school.
Education was a key pillar of our strategy, thus we also expanded on our programming for Children’s Health℠ LIVE, an accredited, web-based continuing education series. Our “The Nurse Is In” and “Teacher Talk” series give nurses and school staff the clinical educational support they need to provide care in school. While we originally kicked off the program in 2015, we knew we had to keep creating new education to help bridge the gap between the presentation of symptoms, diagnosis, and referral.
Team members coached nurses on how to provide virtual care, as many school nurses were doing so for the first time.
The team also supplied devices that could work in tandem with the telehealth platform, such as a digital otoscope that sends virtual images of the inside of a child’s ears to an online physician or a scope that captures images of a child’s throat.
These devices will be particularly important as cold and flu season ramps up, as they can help nurses evaluate children who present with ear, nose, and throat complaints.
Our health system also reached out to parents to help guide them in the decision to send children with a medical condition back to an in-person school setting.
By examining the health history of high-risk kids and teens, physicians and nurses could provide the right guidance for families on whether face-to-face instruction or e-learning would best meet a child’s needs.
To maintain continuity in care for in-person and e-learning students alike, our “School Telehealth at Home” program provides families with in-home school telehealth support.
By downloading the Children’s Health Virtual Visit app, parents can schedule a virtual health visit for their children. The health system also offers a 24-hour nurse hotline that families can call for answers to health questions.
Behavioral health services
The need for school-based behavioral health services rapidly expanded during the pandemic as children and families increasingly struggled with mental health. In fact, a study from the American Academy of Pediatrics found that one in seven parents reported worsening behavioral health for their children since coronavirus began to spread in March.
We have long offered behavioral health services virtually in school settings, such as our Teen Recovery Program, which assists students who are recovering from substance use disorder or facing mental health challenges.
Because school-based telebehavioral services could easily be conducted in home settings, team members were able to continue offering virtual behavioral health support to students while schools were closed.
Through June 2020, our health system conducted 963 telebehavioral health visits with students in the Dallas area, ensuring continuity in care for students in need.
During the 2020–2021 school year, we will offer both school-based and at-home telebehavioral health services to eliminate gaps in care for vulnerable populations.
Families can access a behavioral health provider by scheduling an appointment via the Children’s Health app. When prescriptions are needed, our team works directly with parents to meet the child’s needs and provide assistance around medication adherence.
The program has demonstrated strong results among Dallas-area students. Children and teens experience a 32% improvement in their clinical goals for treatment based on self-ratings conducted before and during treatment.
As the program continues to expand during the pandemic, we will offer telebehavioral health in nearly 180 campuses this fall, with continued availability in students’ homes as well.
Measuring the impact
Today, school-based telehealth is our fastest-growing telehealth program—and it continues to expand.
Since January 1, we have conducted more than 14,000 telehealth encounters with children and teens—from rapid strep and flu testing to asthma treatment, behavioral health, and sports medicine. We worked with 93 schools in 2018, then grew to partner with 145 schools in 23 school districts across the Dallas metro area in 2019.
Currently, for 2020, we’re working with over 225 schools in 27 districts. That’s a 64% increase since 2018, demonstrating the rising need for telehealth support for schools and students during the pandemic.
Our efforts at Children’s Health in Dallas point to some important lessons learned:
Work with school nurses in building out your organization’s telehealth platform.
These professionals’ familiarity with families in your community can point to the services that are needed most, giving you the insight to develop a high-value approach.
Our experience with schools in the Dallas metro area indicates that some schools had been looking for a health system partner; however, they could not find a healthcare provider willing to take the leap.
Focus on continuity in care. Establish a dedicated panel of providers to supply telehealth services for e-learners and in-person students, and ensure that follow-up visits can be performed in the same setting as the initial visit, where possible.
Provide a hotline for students and their families to ask questions about their medications or care after hours, and enable parents to contact providers directly, if needed.
Make sure your telehealth workflow model matches that of the school-based offering. For instance, the way in which students and families connect with your telehealth team during school hours should match the process for receiving support after hours.
By collaborating with school health professionals to design the right platform of services and approach, healthcare providers can help ensure children receive the right care in the right setting during COVID-19 and beyond.
Karen Kaighan is director of school health programs and Jason Isham is director of integrated behavioral healthcare at Children’s Health in Dallas.
PSQH: Patient Safety & Quality Healthcare, November 13, 2020
Health System Owned Specialty Pharmacy Alliance to advocate for better access to more seamless care.
This article was originally published November 12, 2020 on PSQH by Megan Headley
Specialty pharmacies, which focus on delivering medications for more complex and chronic illnesses, are no longer the rarity they once were. In 2016, the American Society of Hospital Pharmacists reports, about 9% of health systems owned an integrated specialty pharmacy; by 2018 that had jumped to 20%, and today the number is closer to 25%. It’s a model that promises tremendous benefits for patients by making medication management more seamless.
Yet, with approximately 70% of specialty prescription revenue still being dispensed by the biggest four specialty pharmacy companies—CVS Specialty, AllianceRX, Optum, and Accredo—these health system-owned specialty pharmacies have limited leverage in securing affordable access to the medications their patients need.
That comparatively smaller “voice,” explains Louis Sokos, BS Pharm, MBA, WVU Medicine Allied Health Solutions Specialty Pharmacy director for the WVU Health System, is a significant part of the goal behind the newly formed nonprofit Health System Owned Specialty Pharmacy Alliance (HOSP). “We’re working to band together to show the value of what we’re doing for our patients at our health systems,” says Sokos, a board member of HOSP.
What they’re doing may have significant ramifications for patient safety. As Sokos explains, the biggest benefit to this specialty pharmacy model is that the communication between the pharmacy provider, the patient, and the physicians becomes much more seamless.
The level of integration varies among health systems. Some health systems have pharmacists embedded in the clinics, while others manage their patients centrally from their operations center. In both scenarios, the documentation of education and patient counseling is captured in the health system’s electronic health record, in which both providers and pharmacists work.
“When we manage our patients at our own health system in our own specialty pharmacy, it’s clear that the provider knows what’s happening with prior authorization, patient education, and actual start date and continued management of the therapy with their patient,” Sokos says. “That transparency and integration between pharmacist, provider, and patient [leads] to better outcomes for our patients.”
Given that medication management has tremendous impact on patient care—perhaps more impact than the specific treatment itself, the World Health Organization says—this insight and in-room education can help improve the management of complex illnesses.
However, integrated specialty pharmacies face a range of challenges. These largely center around securing access to specific medications from the medication manufacturer or in securing a cost-effective reimbursement from the insurance company. That latter issue, Sokos says, can be particularly ornery since the prescription benefit management companies that own the competing specialty pharmacies would prefer to direct patients to their owned entities.
Data collection and reporting is another challenge Sokos hopes HOSP can help address. “There’s a lot of data that needs to be collected and recorded with regard to rare disease states and how patients are managing these disease states,” he says.
Of the approximately 7,000 known rare diseases, less than 10% have an FDA-approved treatment available. According to the FDA, rare disease drug development is challenged by a limited understanding of the variability and progression of each disease. To improve treatment options for many complex disease states, establishing common practices for data collection and reporting is a foundational need.
In addition, Sokos says, the combined advocacy of a group like HOSP could help more health systems work together to advocate for the 340B Drug Pricing Program. This federal drug discount program was developed to extend resources to an underserved patient population and increase the affordability and accessibility of pharmaceutical care.
“We’re in West Virginia. It’s a small rural state, and 40% of the patient population that we manage is Medicaid,” Sokos says. “The savings from the 340B drug discount program allow us to cover some of those losses we incur in managing a less fortunate patient population, and still keep our doors open.”
HOSP aims to leverage members’ experience to share best practices for navigating these challenges and delivering the best patient care and patient outcomes. Having been in the integrated specialty pharmacy space since about 2014, WVU Health System has developed its share of best practices.
Now, Sokos says, it’s time that health system–owned specialty pharmacies had a bigger voice in engaging manufacturers and insurance providers. “We want our collective voice represented in that discussion,” Sokos says. As he points out, “I don’t see the health system specialty pharmacies competing against each other. … We’re just trying to serve the patients that come through our doors at our health system. I think most of us are of the same mindset, so we’re willing to help each other.”
HOSP general membership is open to any qualified health system that seeks to embrace the organization’s mission of delivering critical care excellence through health system–owned specialty pharmacies. To learn more about HOSP, visit http://hospalliance.org/membership.
PSQH: Patient Safety & Quality Healthcare, November 5, 2020
The agency insists that workers wear respirators when necessary, such as when in close contact with a resident of a long-term care facility with suspected or confirmed coronavirus infection.
This article was originally published November 5, 2020 on PSQH by Guy Burdick
The Occupational Safety and Health Administration (OSHA) issued respiratory protection guidance for assisted living, nursing home, and other long-term care facilities. The guidance focuses on the use of respirators while emphasizing a primary reliance upon engineering and administrative controls for controlling exposures, consistent with good industrial hygiene practice and the agency’s traditional adherence to the “hierarchy of controls.”
The industrial hygiene “hierarchy of controls” is a series of workplace safety and health interventions that begins with elimination of hazards, followed by substitution, then engineering controls, administrative controls (including work practices), and personal protective equipment (PPE).
The agency insists that workers wear respirators when necessary, such as when in close contact with a resident of a long-term care facility with suspected or confirmed coronavirus infection. Employees then must wear an N95 filtering facepiece respirator (FFR) or equivalent or a higher-level respirator approved by the National Institute for Occupational Safety and Health (NIOSH).
The guidance describes other source control measures, including the use of cloth face coverings, face masks, and U.S. Food and Drug Administration (FDA)-cleared or -authorized surgical masks. Healthcare workers should wear such source control products or devices at all times while inside a long-term care facility, according to the agency, including in break rooms or other spaces where they might encounter other people.
OSHA told employers that they should reassess their engineering and administrative controls, such as ventilation and practices for physical distancing, hand hygiene, and cleaning and disinfecting surfaces, to identify changes that could avoid over-reliance on respirators and other PPE. OSHA reminded employers that the agency has temporarily allowed for some enforcement flexibility regarding respirators, including requirements for annual fit testing that consumes disposable respirator supplies.
However, the agency also reminded employers that when respirators must be used, employers must implement a written, worksite-specific respiratory protection program that includes medical evaluation, fit testing, training, and other elements of the agency’s respiratory protection standard (29 CFR 1910.134).
OSHA offered employers the following advice for administering a respiratory protection program during the ongoing pandemic:
Consider alternatives to N95 FFRs, including other FFRs (for example, P100s and N99s); reusable elastomeric respirators; and powered air-purifying respirators (PAPRs), given shortages of N95 FFRs during the pandemic.
Choose eye and face protection to be worn with the type of respirator used, but exercise care to ensure the eye or face protection does not interfere with the seal of the respirator.
Consult NIOSH’s list of approved N95 FFRs and warnings about counterfeit respirators or misrepresentation of NIOSH approval.
Assign a suitably trained program administrator to oversee all elements of the program, such as an infection prevention and control practitioner or a nurse administrator, or consider hiring a local industrial hygiene consulting service if no suitably trained administrator is available on staff.
Conduct a risk assessment to identify which workers are at risk of exposure to any airborne hazards such as SARS-CoV-2, tuberculosis (TB), Legionella, or certain hazardous chemicals, and classify exposure risk to SARS-CoV-2, according to OSHA’s four risk exposure levels.
Implement procedures for performing medical evaluations of workers required to use respirators to determine their ability to safely wear a respirator before needing to wear one in the workplace; identify a physician or other licensed healthcare professional who can conduct medical evaluations and maintain confidentiality.
Ensure that any worker using a tight-fitting respirator is fit tested following OSHA-approved fit-test protocols before initial use and whenever a different respirator size, style, model, or make is used.
Establish procedures and schedules for the maintenance and storage of any respirators used beyond a single use, including procedures for cleaning, disinfecting, storing, repairing, and discarding respirators.
Train workers who wear respirators on how to properly put them on (donning) and take them off (doffing), as well as how to conduct proper user seal checks and recognize respiratory hazards in their workplace and the capabilities and limitations of respirators.