"Medical errors are the third leading cause of death in the country," says Marcus Schabacker, MD, president and CEO, ECRI Institute. "This guidance can help healthcare leaders and clinicians save lives."
Healthcare providers rely on EHRs to help with clinical decision support and tracking test results. But that technology is just one tool in the diagnostic process, said William Marella, executive director of operations and analytics, at ECRI Institute PSO.
"We have to recognize the limits of current technology and ensure that we have processes in place to close the loop on diagnostic tests," Marella said. "This safety issue cuts across acute and ambulatory settings, requiring teamwork across the health system."
ECRI Institute’s 2019 list of concerns addresses systemic issues facing health systems, such as behavioral health concerns, clinician burnout, and skills development. Mobile health technology, number four on the list, opens up a world of opportunities by transporting healthcare to the home, but also presents potential risks.
The report also highlights ongoing clinical issues with infections from peripheral IV lines, sepsis, and anti-microbial stewardship. In the outpatient setting, at least 30% of antibiotic use is unnecessary.
The 2019 Top 10 Patient Safety Concerns are:
Diagnostic Stewardship and Test Result Management Using EHRs. "Providers have begun relying on the electronic health record (EHR) to help with clinical decision support, to track test results, and to flag issues. However, the EHR is only part of the solution."
Antimicrobial Stewardship in Physician Practices and Aging Services. "Perhaps the most significant challenge facing antibiotic stewardship is managing patient expectations. Moreover, unnecessary antibiotic administration puts patients at unnecessary risk of adverse drug reaction. And the broadest concern is that overprescribing leads to antimicrobial resistance."
Burnout and Its Impact on Patient Safety. " The electronic health record is a contributing factor, but burnout goes beyond providers’ oft-described frustrations with documentation. Healthcare is evolving rapidly and keeping up with the changes can be a challenge."
Patient Safety Concerns Involving Mobile Health. "Risks of mobile health technology include lack of regulation of new technologies, barriers to ensuring that providers are accurately receiving the data a device collects, and the possibility that a patient is not using the technology correctly or is not using it at all."
Reducing Discomfort with Behavioral Health. " In many healthcare settings, behavioral and physical health are siloed. But people with behavioral health needs are in every setting, and it is not always obvious when an individual has such needs."
Detecting Changes in a Patient’s Condition. " Sometimes staff are inadequately trained in recognizing changes in a patient’s condition or in responding to an alarm that is alerting caregivers to check on a patient.
Developing and Maintaining Skills. "Patient harm can occur if staff are uncomfortable using medical equipment or performing a procedure, or are unaccustomed to an organization or care area’s processes."
Early Recognition of Sepsis across the Continuum. "To facilitate timely diagnosis and management, healthcare organizations across the continuum should have protocols for response when sepsis is suspected, much as they do for chest pain."
Infections from Peripherally Inserted IV Lines. "Increased awareness of PIV-catheter-related infections, coupled with routine active surveillance and follow-up reporting, can help reduce the risk."
Standardizing Safety Efforts across Large Health Systems. "Regardless of organization size, the goal is to institute structures that effectively allow patient safety leaders to support organization leadership in engaging with patient safety priorities."
ECRI’s list does not necessarily represent the most frequently or most severe safety issues.
It identifies new risks, how existing concerns may be changing because of new technology or care delivery models, and persistent issues that need renewed attention or that might have additional solutions.
The nation's largest physicians' association warns that the proposed rules 'may lead to unintended consequences for patient privacy and physician burden.'
The American Medical Association is asking federal policy makers for an additional 30 days or more to review and comment on two proposed federal rules that address interoperability and information blocking.
The policy, published and detailed this month in the federal registry, comes from a mandate in the 21st Century Cures Act and Executive Order 13813 "to improve access to, and the quality of, information that Americans need to make informed health," the Centers for Medicare & Medicaid Services summarized.
The new policy "would improve access to data about healthcare prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers," CMS said.
While supporting the policy, AMA Executive Vice President and CEO James Madara, MD, asked CMS to push back by one month the May 3 deadline for stakeholder input.
"Expediency should not take precedence over deliberation as we confront a true paradigm shift in healthcare. I therefore urge that the comment periods for both rules be extended by at least 30 days," Madara said in a one-page letter to CMS Administrator Seema Verma, and Donald Rucker, national coordinator for health information technology.
Madara did not raise specific concerns about the lengthy proposed rules, but noted that they are "interwoven, complex in nature, and include multiple detailed requests for information."
"To ensure that the rules are as successful as possible in meeting your goals, it is vital that stakeholders be given adequate time to provide comprehensive, thoughtful, and detailed comments," he said.
"I recognize and appreciate the desire for swift rulemaking. However, such rapid change in healthcare policy, technology, and business practices may lead to unintended consequences for patient privacy and physician burden."
While the reduction is impressive, it's still short of the 40% reduction goal set forward by the Utah-based health system when it announced the initiative in 2017.
Intermountain Healthcare reduced the number of opioid tablets prescribed to patients in acute pain by 3.8 million in 2018.
The 3.8 million fewer opioid pills prescribed by the health system in 2018 represents about a 30% reduction, falling short of the 40% reduction that Intermountain had targeted when it announced the initiative in 2017.
Intermountain executives say they're proud of the success, but will use 2019 to drill down into health system operations to identify opportunities to reduce opioid prescriptions by 5%.
"We knew these would be lofty goals and we're encouraged by the reduction in opioid tablets and the success of our other opioid-reduction efforts. We knew these were the right steps to take," said Intermountain CMO David Hasleton, MD.
"We're continuing our focus to implement appropriate evidence-based opioid treatments, provide alternative forms of pain control for our patients, and educate providers and the public about the safe use of opioid medications," Hasleton said.
Among the accomplishments touted by Intermountain:
Intermountain exceeded its goal to increase medically-assisted treatment for opioid use disorders by more than 10%.
Intermountain reduced by 29% the number of patients prescribed both opioids and benzodiazepines, the combination of which could suppress breathing.
Intermountain pharmacy drop-boxes have received over 26,000 pounds of medication since February 2015. Intermountain has also helped give out more than 2,644 naloxone kits.
Intermountain pharmacies offer naloxone kits for purchase without a prescription and the system has helped to fund additional kits for nonprofit Utah Naloxone.
Lisa Nichols, Intermountain Healthcare’s Community Health executive director, spoke with HealthLeaders about the health system's efforts to reduce opioid prescriptions. The following is an edited transcript.
HLM: How did you recognize that you had a problem with opioid prescriptions?
Nichols: We as a health system certainly watched the morbidity and mortality incidents and prevalence data in our community at the time we started our opioid initiatives. For several years, Utah was in the Top 10 in terms of overdose deaths and we're the largest health system in the state. If we've got a large number of overdose deaths, we understood that we have to intervene.
HLM: Initially you sought a 40% reduction in opioid prescriptions. How did you come to that number?
Nichols: We had surveyed about 16,000 patients post surgery around how many of the tablets they were given, did they use them and how did they dispose of their medication. We learned that most people were using 50% or less of the tablets that we were giving them. That really helped us feel comfortable that we could prescribe at least 40% less and still adequately manage people's needs.
HLM: You fell a little short of that goal. What happened?
Nichols: With each percentage reduction it became incrementally harder. We had some really good improvements at the beginning and then and then it just became harder. It's hard to find that balance between treating pain and ensuring people were safe.
HLM: Do you still consider the initiative a success?
Nichols: We're proud of where we got, but a lot of 2018 was also spent building the infrastructure to support this work. We put up digital dashboards and we did a lot of education with leaders and we have a continuous improvement huddling system for our goals.
We think that we can go further now that we have this incredible foundation set and we're able to drill down on who are high prescribers or are there geographic areas or facilities that are problematic. We think we can get at least another 5% reduction.
At least part of that 30% was the low-hanging fruit and that's why it got incrementally harder. But now we really can focus in, to the detail of are there specific procedures where they're prescribing more? It's not just focusing on prescribers. We continue to focus on our community and their awareness of the dangers of opioids, their understanding that over the counters are really effective.
We want to continue to build that knowledge and empowerment of our patients to say to their prescribers. "Do I really need this?"
HLM: Where do you go from here in 2019?
Nichols: We have this 40% goal as a system and one of our improvements this year is we're now able to look at each clinical program and we can see where they are in their prescribing. If we want to get an additional 5%, how much would each clinical program need to reduce? So we're working much more granularly with each clinical program around "this is our expectation for your program. Is that realistic?" We're doing it in a much more targeted way.
HLM: What sort of patient metrics are you seeing that would indicate this initiative is working?
Nichols: Utah is one of only a handful of states that saw a decrease in opioid overdose deaths last year. We had a 12% decrease in overdose death. That's multifaceted. It's also because Naloxone has become much more available and treatment as become much more available. You need all of those components for this very complex problem.
The Trump administration says offering health insurance across state lines will enhance competition and lower premiums, but states may raise objections if their regulatory authority is challenged.
The Centers for Medicare & Medicaid Services wants suggestions on how to "eliminate regulatory, operational and financial barriers" that hinder the sale of health insurance plans across state lines.
"Americans are in desperate need of more affordable health insurance options," CMS Administrator Seema Verma said Wednesday in a media release announcing the request for information.
"Eliminating the barriers to selling health insurance coverage across state lines could help provide access to a more competitive and affordable health insurance market," she said.
In an October 2017 executive order, President Donald Trump mandated that CMS "facilitate the purchase of health insurance across state lines," which the administration said would "provide relief from rising premiums by increasing consumer choice and competition."
CMS said it wants feedback on how states can take advantage of Section 1333 of the Patient Protection and Affordable Care Act, which provides for a regulatory framework that allows two or more states to enter into a Health Care Choice Compact to facilitate the sale of health insurance coverage across state lines.
Specifically, federal policymakers are looking for input on how to expand access to health insurance coverage across state lines, effectively operationalize the sale of health insurance coverage across state lines, and understand the financial impacts of selling health insurance coverage across state lines, CMS said.
Trump's 2017 executive order also directs the Secretary of Labor "to consider expanding access to Association Health Plans, which could potentially allow American employers to form groups across State lines." That would allow health insurance providers to bypass state coverage requirements.
Health insurance oversight is left largely to the purview of states, which has created a regulatory patchwork that varies widely from state to state.
State and federal lawmakers, mostly Republican, have for the past decade pushed to sell health insurance across state lines, but the issue has proved to be nettlesome. The National Association of State Legislatures reportsthat at least 23 state legislatures have considered the idea over the past 10 years.
The National Association of Insurance Commissioners hasn't taken a firm stand on the idea, because it represents independent state insurance commissioners, many of whom may have varying levels of support for the idea.
In the past, however, state insurance commissioners have been reluctant to support any federal initiatives on the issue that weaken states' regulatory oversight.
A NAIC spokesman on Wednesday declined to comment, but said the association would respond to the RFI.
The RFI will be open for public comment for 60 days.
Healthcare information managers urge Congress to address a burdensome and costly healthcare regulatory environment that is driving up costs and diverting resources away from optimal patient care.
If Congress wants to stem rising healthcare costs, they could start by taking a look at expensive federal mandates.
That's one of several suggestions put forward by the College of Healthcare Information Management Executives in a six-page letter to Sen. Lamar Alexander, (R-TN) chairman of the Health, Education, Labor and Pensions Committee.
"Despite the infusion of nearly $40 billion for healthcare providers to adopt electronic health records, the costs to maintain those systems and ensure they are capable of enabling successful participation in federal programs comes with steep price tags," CHIME CEO Russell P. Branzell and CHIME Board Chair Shafiq Rab said in their joint letter.
"The 21st Century Cures Act recognized the need to bring transparency, especially around costs, to the EHR purchasing process, but there are many other financial burdens associated with participating in federal reporting programs," the letter said.
CHIME complained that while the Promoting Interoperability Program "altered the trajectory of EHR adoption… countless costs have continued to plague health systems to maintain compliance with the program mandates."
"The costs associated with new versions of certification, interface fees, quality reporting tools and patient engagement modules have forced health systems to choose between innovation or clinician requests and meeting federal mandates," CHIME said.
"Capital budgets are limited and as federal mandates amp up expectations, more and more resources continue to be dedicated to the Centers for Medicare and Medicaid Services or the Office of the National Coordinator's wishes, rather than those of the patient or clinician," the letter said, adding that "Congress must work with the administration to continue to infuse flexibility into the PI program, so it better aligns with patient and clinician needs."
CHIME highlighted other areas of concern, including:
Quality Measurement: "The burden of quality measurement that our members shoulder to meet reporting requirements levied by CMS is significant. Hours of work and expertise are required to comply with these reporting demands and such burdens are exacerbated by a lack of technical harmonization."
HIPAA Compliance: "The complexities with meeting HHS privacy and security requirements can be staggering. Audits by the Office for Civil Rights are perceived as being punitive and not assisting the organization to recover and learn from a breach. It is vital that Congress and HHS identify a pathway for ensuring providers do not unduly shoulder the burden of protecting PHI in situations outside their control."
Harmonizing Privacy and Consent Laws: "The exchange of data among providers in various locations and settings will require the harmonization of state and federal privacy laws. As an example, consent policy varies by jurisdiction and personal health information type, and similar to most privacy policy, there is no national consent policy."
Rethinking Telehealth policies: "Whether public and private payers cover telehealth services and adequately reimburse hospitals and other healthcare providers for providing those services, is a complex and evolving issue and, as a result, a possible barrier to standardizing the provision of these valuable services."
Researchers looked at the time to first breast cancer diagnostic testing, diagnosis, and chemotherapy among a group of women whose employers switched from low-deductible to high-deductible health plans.
Low-income women enrolled in high-deductible health plans delay chemotherapy treatments for breast cancer by nearly nine months, compared with low-income women enrolled in low-deductible plans, a new study shows.
Delays also occurred at the diagnosis and testing stages, including a 1.6 months delay to initial breast imaging, a 2.7 months delay to first biopsy, and a 6.6 months delay to early-stage breast cancer diagnosis, according to the research published this week in Health Affairs.
"The most likely reason that women delay these events along the path towards breast cancer diagnosis and treatment would be the barrier of high out-of-pocket costs that women face when they join high-deductible health plans," said study chief author J. Frank Wharam, MD, with the Harvard Pilgrim Health Care Institute.
Wharam says that cancer screenings, diagnosis, and treatment often go through stages, and this is where the delays mount.
"What we found was that in between the stages—from screenings to diagnostic tests to a biopsy to a diagnosis of cancer to chemotherapy—there were some delays and those delays added up to be quite substantial by the time you compared time to chemotherapy," he says.
"And again, this is likely related to fear of out-of-pocket costs," he says. "We do know that people tend to put off care towards the end of the year when there's a high-deductible health plan because their cost sharing goes down once they hit the deductible, so that's possibly another factor."
The researchers looked at the time to first breast cancer diagnostic testing, diagnosis, and chemotherapy among a group of women whose employers switched their insurance coverage from health plans with low deductibles ($500 or less) to plans with high deductibles ($1,000 or more) between 2004 and 2014.
The research group included 54,403 low-income and 76,776 high-income women who were continuously enrolled in low-deductible plans for a year and then up to four years in HDHPs.
Low-income women in HDHPs experienced relative delays of 1.6 months to first breast imaging, 2.7 months to first biopsy, 6.6 months to incident early-stage breast cancer diagnosis, and 8.7 months to first chemotherapy.
High-income HDHP members had shorter delays that did not differ significantly from those of their low-income counterparts.
HDHP members living in metropolitan, nonmetropolitan, predominantly white, and predominantly nonwhite areas also experienced delayed breast cancer care.
The researchers recommend developing policies to reduce out-of-pocket spending obligations to encourage prompt screening and treatment.
Wharam says further study is needed to determine if the treatment delays were detrimental.
"There's not great evidence about whether longer delays are associated with worse outcomes," he says. "There have been a few studies that indicate that delays of three to four months between diagnosis and surgery are associated with worse outcomes such as survival. But those studies are a bit challenging in the sense that the delays might be related to other illnesses."
"We're not completely sure, but if it was a two- or three-month delay to chemotherapy, I don't think there'd be as much great concern as if it were, say, a two-year delay," Wharam says. "We're in this in-between area where I'm not sure of the downstream impact on health outcomes like death and survival and progression to metastatic disease."
The health system served more than 2 million patients in 2018, the highest annual total in its history, but CEO Tom Mihaljevic says it has a 'moral obligation' to serve even more.
Cleveland Clinic CEO and President Tom Mihaljevic, MD, this week unveiled a strategic plan to double the number of patients served by the renowned health system over the next five years.
"We will stay true to who we are—working as a team with the patient at the center of everything we do," Mihaljevic said in a State of the Clinic address that wraps up his first year as CEO and president.
"We will care for patients and families across their lifetimes, with proactive care, supported with the very best of digital technology," he said. "And we will grow and double the number of patients we serve over the next five years."
Mihaljevic said Cleveland Clinic has a "moral obligation" to expand it services to as many patients as possible.
"Last year, we cared for over 2 million patients—more than ever before," he said. "Despite adding more facilities and more caregivers, we barely made a dent in demand for our services."
"We can't take this demand for granted. It's our moral obligation to open our doors as wide as possible for those in need," he said.
Among the successes in Mihaljevic's first year as CEO:
Cleveland Clinic cared for more than 2 million patients in 2018, the highest annual total in its history.
The 16-hospital health system saw operating revenue increased 6.2% to $8.9 billion.
Contributions to state and local economies—in the form of jobs, wages and taxes—totaled $17.8 billion, according to Cleveland Clinic estimates.
The heart and urology programs were ranked No. 1 in the nation by US News & World Report.
The Cleveland Clinic footprint expanded—in Northeast Ohio, with the addition of Union Hospital in Dover and the opening of Cleveland Clinic Children's new home; and in Florida, with the addition of four hospitals in 2019.
In 2019, Mihaljevic said Cleveland Clinic will continue to focus on care priorities it introduced last year for patients, caregivers, communities, and the health system itself.
Prosecutors allege that Vanguard SNFs and top executives submitted false claims to Medicare and Medicaid for "worthless" services.
Vanguard Healthcare LLC and two top executives will pay more than $18 million to resolve allegations that five of the company's skilled nursing facilities billed Medicare and Medicaid "for grossly substandard nursing home services," the Department of Justice said.
The settlement also resolves claims brought by DOJ against Vanguard's majority owner and CEO, William Orand, and Vanguard's former director of operations, Mark Miller, who agree to pay $250,000 as part of this settlement.
"Simply stated, our elderly and vulnerable citizens who can't care for themselves deserve far better treatment than what they were subjected to by Vanguard," U.S. Attorney Don Cochran for the Middle District of Tennessee said in a media release.
"The substandard care that many of these facilities' residents endured while the companies were raiding the public coffers is deplorable," he said. "This settlement holds them accountable and the ensuing Corporate Integrity Agreement should ensure that this conduct is not repeated going forward."
DOJ and Tennessee filed suit against several Vanguard companies, Miller, and Orand, alleging that they were responsible for five Vanguard-owned skilled nursing facilities submitting false claims to Medicare and Medicaid for nursing home services that were "grossly substandard or worthless."
In particular, the state and federal prosecutors allege that the five Vanguard nursing facilities:
Failed to administer medications as prescribed;
Failed to provide standard infection control, resulting in urinary tract infections and wound infections;
Failed to provide wound care as ordered;
Failed to take prophylactic measures to prevent pressure ulcers, such as turning and repositioning;
Used unnecessary physical restraints on residents;
Failed to meet basic nutrition and hygiene requirements of residents.
The lawsuit further alleged that the defendants were responsible for the submission of hundreds of preadmission forms by these facilities to TennCare, Tennessee’s Medicaid Program, which contained forged nurse or physician signatures.
Vanguard and several of its companies that have reorganized in bankruptcy will pay more than $5.1 million, and two bankrupt Vanguard companies will pay $13.5 million.
Vanguard's SNFs include Boulevard Terrace Rehabilitation and Nursing Center in Murfreesboro, Tennessee; Glen Oaks Health and Rehabilitation in Shelbyville, Tennessee; and Manchester Health Care Center in Manchester, Tennessee.
Vanguard previously operated three other SNFs in Tennessee, including Crestview Health and Rehabilitation in Nashville; Imperial Gardens Health and Rehabilitation in Madison; and Poplar Point Health and Rehabilitation in Memphis.
In addition, Vanguard Healthcare owned Elderscript Services, LLC, in Tupelo, Mississippi, which provided pharmacy services to the Vanguard SNFs.
Due to the bankruptcy of Vanguard, federal prosecutors anticipate the total government recovery will exceed $6 million.
The Iowa Republican has asked the IRS for data on how many of the nation's approximately 3,000 tax-exempt hospitals are in compliance with charity care requirements.
Senate Finance Committee Chairman Chuck Grassley has renewed efforts to ensure that nonprofit hospitals are earning their tax-exempt status by providing enough services for low-income people.
In a letter to Internal Revenue Service Commissioner Charles Rettig, the Iowa Republican asked for data on how many hospitals are in compliance with the requirements for tax-exempt status and the status of IRS examinations of those not in compliance.
"Making sure that tax-exempt hospitals abide by their community benefit standards is a very important issue for me," Grassley said in his letter.
"As chairman of the Senate Judiciary Committee, I oversaw an investigation into the billing practices of the Mosaic Life Care hospital. That investigation resulted in debt relief of almost $17 million for thousands of low-income patients. This issue is still just as important to me now that I am chairman of the Senate Finance Committee," Grassley wrote.
The Mosaic Life inquiry examined the billing and debt collection practices at the health system after news reports indicated it had sued low-income patients who should have qualified for charity care.
Grassley told Rettig that he was renewing his probe of tax-exempt hospitals after hearing "reports" that "at least some of these tax-exempt hospitals have cut charity care, despite increased revenue, calling into question their compliance with the standards set by Congress."
He asked Rettig for information about whether tax-exempt hospitals are meeting the statutory requirements laid out insection 501 of the Internal Revenue Code, and he cited in his letter an article in Politico that suggested nonprofit hospitals were profiting from the Affordable Care Act while simultaneously cutting their charity care.
In February 2018, Grassley sent a letter to the IRS to inquire about how the agency reviews nonprofit hospital compliance.
Acting Commissioner David J. Kautter responded in April 2018 that the IRS reviews the status of about 1,000 U.S. tax-exempt hospitals each year by reviewing Forms 990, hospital websites, and other information in order to identify the hospitals with the highest likelihood of noncompliance.
Kautter said the IRS assigns either a compliance check or examination to those hospitals that appear to be most at risk of noncompliance.
Melinda Hatton, general counsel for the American Hospital Association, said her organization was confident that nonprofit hospitals are meeting their mission.
“In 2015, an AHA analysis of Schedule H filings reported that 13.3% of tax-exempt hospitals and health systems total expenses were devoted to community benefits programs, and that half of that spending was attributable to expenditures for providing financial assistance to needy patients and absorbing losses from Medicaid and other means-tested government program underpayments," she said.
Hatton said an analysis by Ernst & Young for the AHA found that hospitals' and health systems' community benefit activities outweigh the value of their federal tax exemption by a factor of 11 to one. "According to the report, non-profit hospitals in 2013 were exempt from an estimated $6 billion in federal taxes and provided an estimated $67.4 billion in community benefits," Hatton said.
The fraudsters peddled weight-loss shots on Groupon, but subjected patients to unneeded tests, and billed for hospital services to get higher reimbursements.
A federal jury in Texas convicted an internist and hospital owner for their roles in a $3.2 million fraud scheme that billed commercial payers for bogus and inflated claims, the Department of Justice said.
Harcharan Narang, MD, 50, who owned and practiced at North Cypress Clinical Associates in Cypress, and Dayakar Moparty, 47, who managed and operated Red Oak Hospital in Houston, were each found guilty of one count of conspiracy to commit healthcare fraud, 17 counts of healthcare fraud and three counts of money laundering.
Sentencing is set for June 20.
Evidence during the two-week trial showed that Narang and Moparty submitted false claims for unneeded and bogus medical tests, and billed those services at Red Oak Hospital to get a higher reimbursement.
Additionally, prosecutors said Narang and his co-conspirators falsified home health patient assessments to make the beneficiaries appear sicker than they were, to get higher reimbursements from Blue Cross Blue Shield, Cigna, Aetna and other payers.
Moparty also told his employees to falsely bill the medical services at Red Oak, even though the patients never received services there.
During the trial, patients testified that they bought a Groupon for weight loss shots with Narang, but that he gave them all a battery of medical tests that were not needed or provided.
As a result of the scheme, Red Oak received at least $3.2 million from payers, and Moparty covertly paid $3 million to shell companies owned by Narang.
A co-conspirator, Gurnaib Sidhu, MD, 67, of Houston, previously pleaded to conspiracy to commit healthcare fraud and is awaiting sentencing.
Attempts by HealthLeaders to contact Red Oak Hospital and North Cypress Clinical Associates were not successful.
