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DAILY UPDATE

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April 18, 2014   Download print version

Doctors, medical staff on drugs put patients at risk

BevMD introduces Clearfast, the first U.S. patented pre-operative beverage to end pre-op fasting from midnight prior to surgery

Meaningful use not correlated with quality in study

Misdiagnoses common among U.S. outpatients: Review

Class I Recall: ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare

Bringing the UDI Regulation & the Global UDI Database (GUDID) to Life!

AMA: Docs add $1.6 trillion to economy

A year after marathon bombs, Boston hospitals apply lessons learned


 

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Doctors, medical staff on drugs put patients at risk

America's prescription drug epidemic reaches deep into the medical community. Across the country, more than 100,000 doctors, nurses, technicians and other health professionals struggle with abuse or addiction, mostly involving narcotics such as oxycodone and fentanyl. Their knowledge and access make their problems especially hard to detect. Yet the risks they pose — to the public and to themselves — are enormous.

A single addicted healthcare worker who resorts to "drug diversion," the official term for stealing drugs, can endanger thousands. Nearly 8,000 people in eight states needed hepatitis tests after David Kwiatkowski, an itinerant hospital technician, was caught injecting himself with patients' pain medicine and refilling the syringes with saline. He infected at least 46, mostly in New Hampshire.

It was the third hepatitis outbreak since 2009 linked to a healthcare worker using patients' syringes (the others were in Denver and Jacksonville, FL). And for each of those worst-case scenarios, there are countless more practitioners whose drug-related errors are more isolated — a botched surgery, an incorrect dose of medication, a worrisome vital sign missed.

Much of the damage goes unnoticed or undocumented; oversight mechanisms to detect, report and address drug problems in health care settings are haphazard and limited. Still, a USA TODAY review of state and federal records identified hundreds of cases in recent years in which physicians and other healthcare practitioners were disciplined or prosecuted for drug diversion or other medical misconduct related to substance abuse.

The toll also can be brutal for the medical professionals who suffer with addiction — often in high-stress jobs with little help. Many struggle with guilt and despair, physical and mental health ills, and indifferent professional environments. Last year, New York's Supreme Court ruled that a hospital was not liable for the overdose death of a physician who, after returning from drug rehabilitation, was given operating room duty, where she had ready access to the propofol that killed her.

"Drug diversion affects so many people, and the systems for dealing with it are completely broken," says Lauren Lollini, 45, who was infected with hepatitis C in the Denver outbreak and now works with HONOReform, a patient safety group.

USA TODAY reviewed an array of government data and independent studies on drug use among healthcare practitioners, including records on hundreds of doctors, nurses and others caught diverting drugs. The newspaper also interviewed medical professionals, addiction specialists, regulators and law enforcement officials.

Findings:

·         Pervasive problem: The latest drug use data from the U.S. Substance Abuse and Mental Health Services Administration, released in 2007, indicated that an average of 103,000 doctors, nurses, medical technicians and healthcare aides a year were abusing or dependent on illicit drugs.

·         Easily hidden: Safeguards to detect and prevent drug abuse in other high-risk industries rarely are employed in healthcare. No state has universal drug testing requirements, and hospitals, nursing homes and other facilities almost never do so on their own.

·         Poorly policed: Many states lack rules to ensure that medical facilities alert law enforcement or regulatory agencies if they catch employees abusing or diverting drugs, so those staffers often are turned loose to find new jobs without treatment or supervision. Disciplinary action for drug abuse by healthcare providers is rare and often doesn't occur until a practitioner has committed multiple transgressions.

Only a sliver of the healthcare practitioners who use drugs get caught.

All but a few states have special rehabilitation program for healthcare practitioners, typically run under the auspices of state licensing boards or medical professional societies. Practitioners who enroll voluntarily often can keep practicing with supervision after treatment. And those who complete rehabilitation usually are not subject to disciplinary action, so there's no public record of their drug problem. The structure and success of the professional assistance programs vary, but they have one thing in common: They enroll only a fraction of the doctors, nurses and other healthcare providers who struggle with substance abuse.

Based on widely accepted estimates of substance abuse among medical professionals, the programs typically aim to enroll 1-3% of a state's healthcare practitioners. Even at 1%, that adds up to some 50,000 people nationwide: Nearly 9,000 of the nation's 878,000 licensed physicians, 27,000 of 2.7 million working nurses, and 15,000 or so medical technicians, nurse assistants and other clinical staff. And the programs aren't reaching anywhere near that many.

"The message we need out there is … we can treat these people and get them healthy," says Jon Shapiro, medical director for Pennsylvania's Physicians' Health Program.

But relying on healthcare workers to self-refer for treatment is risky and could put lives at risk. Many won't seek help voluntarily. And rooting them out is especially difficult in the medical world, which generally lacks the safeguards used to identify substance abusers in other high-risk jobs, such as flying planes or driving buses.

Drug use in the medical community "can't be treated just as an addiction and treatment problem," says U.S. Attorney John Kacavas, who prosecuted Kwiatkowski. "To protect the patient," he says, "there has to be a law enforcement component." Kacavas is part of a coalition of law enforcement and patient safety groups pushing for state laws to require that medical institutions alert authorities when a caregiver is caught stealing drugs or working impaired. Many also favor random drug testing, which is almost never used in the medical community.

When the University of Tennessee Medical Center in Knoxville cracked down on drug diversion with a series of new controls — video surveillance, medication accounting systems, and internal reporting rules — the problem proved larger than anyone expected.

"I was catching at least one health care provider every month stealing medication," says Kimberly New, until recently the hospital's manager of controlled substance surveillance.

New is president of the Tennessee Chapter of the National Association of Drug Diversion Investigators.

Other hospitals that take similar steps find the same, says New, a board member of the National Association of Drug Diversion Investigators. But practitioners who get caught rarely are prosecuted, either because institutions don't report them or because the cases aren't big enough.

USA TODAY reviewed more than 200 state and federal prosecutions completed since 2008 for drug diversion by health care providers; just 15% involved practitioners stealing drugs for personal use. Most involved doctors, nurses and others who diverted on a large scale for profit, often using prescription scams.

Disciplinary actions by medical boards and hospitals also are rare. From 2010 to 2013, only about 750 physicians nationwide lost hospital privileges or had their licenses revoked or restricted for being unable to practice safely because of drug or alcohol abuse, according to a USA TODAY analysis of the government's National Practitioner Data Bank public file.

Many addiction specialists and policy-makers believe the more immediate way to address the medical community's drug problem is to give practitioners better education on preventing addiction and spotting potential impairment in colleagues. Visit USA Today for the report.

 

 

BevMD introduces Clearfast, the first U.S. patented pre-operative beverage to end pre-op fasting from midnight prior to surgery

BevMD, a medical beverage company focused on optimizing patients’ pre surgical experience recently announced its first patented beverage. This unique drink can be safely consumed about two hours prior to surgery. It hydrates, nourishes, and assists in the recovery process and can improve postoperative outcomes. Clearfast, a carbohydrate-rich beverage designed and patented by anesthesiologist, M. Lou Marsh, M.D. of BevMD, is the first product available in the United States that is specifically formulated for consumption by pre-operative patients.

Clearfast was granted the American Society of Anesthesiologists’ seal of compliance with all of its fasting guidelines. Clearfast’s carbohydrate-rich polysaccharide formula can also reduce postoperative insulin resistance that causes hyperglycemia which leads to post-op infections.

“More than 80 million surgical and diagnostic procedures, requiring some form of anesthesia or sedation, are performed annually in the U.S. alone,” said Dr. Marsh. “Though the risk of death or disability from the aspiration of stomach contents is extremely low, a majority of patients are still subjected to traditional, rigorous preoperative fasting protocols. Patient noncompliance with fasting rules can lead to costly surgery delays, cancellations or, when undetected, can result in devastating regurgitation and aspiration. BevMD is leading the way to changing how millions of patients will be prepared for surgery every day across the Country.”

The cap on each Clearfast 12 ounce bottle a label upon which the patient is instructed to record and initial the time of completing the beverage. The cap is then given to the pre-operative nurse upon admission for validation of compliance with the fasting protocol. Clearfast ensures that patients are receiving the nutrition and hydration necessary to maintain the pre-op fast and to achieve enhanced recovery after surgery. Visit www.BevMD.com for more information.

 

 

Meaningful use not correlated with quality in study

Showing meaningful use (MU) of electronic health records (EHRs) was not correlated with performance on clinical quality measures, according to a new study published in JAMA Internal Medicine.

The study, one of the first of its kind, was performed at clinics affiliated with Brigham and Women's Hospital in Boston, MA. It compared the quality scores of 540 physicians who achieved MU with those of 318 physicians who did not. The healthcare organization computed quality scores on MU measures for all of the 858 physicians, but only some of these physicians met all of the criteria for the government incentive program during the 3-month study period.

Lipika Samal, MD, MPH, from the Division of General Medicine and Primary Care, Brigham and Women’s Hospital, and colleagues looked at 7 metrics for 5 conditions: hypertension, diabetes, coronary artery disease, asthma, and depression. "[MU] was associated with marginally better quality for 2 measures, worse quality for 2 measures, and not associated with better or worse quality for 3 measures," the authors state.

The study found that MU was correlated with better control of cholesterol in patients with diabetes and of blood pressure in hypertensive patients. The MU group provided worse treatment of asthma and depression than the non-MU group did.

Dr. Samal told Medscape Medical News that the integrity of the data "wasn't much of an issue for us. The issue of not having structured data doesn't apply to our health system as much as to other health systems. You can trust the data we have." The bigger challenge, in her view, is that the MU quality metrics are so specific that they exclude a lot of patients with a particular condition. "The problem is not that the data is suspect, but there's so little data that matches specific questions."

The study showed the numbers of physicians in 3 groups of specialties who had achieved MU. Seventy-eight percent of primary care physicians, 62% of medical specialists, and 43% of surgeons had met all of the MU criteria. However, the researchers did not break down the percentages of physicians in these categories who had scored higher than non-MU on the quality measures.

Dr. Samal said she and her colleagues had decided not to do that because the government's regulations for quality reporting apply equally to all specialties. However, she acknowledged that the MU metrics are skewed toward primary care.

Eric C. Schneider, MD, chair in healthcare quality for the RAND Corporation and director of its Boston office, commented, "We don't have good [MU] metrics for specialists, other than cardiologists and endocrinologists. For the vast majority of specialists, we're looking at the primary care aspects of the care they're delivering."

The MU quality metrics are "fairly crude" in understanding nuances of clinical care, he noted. Moreover, not enough structured data are being entered into EHRs yet to do good quality measurement. Visit Medscape for the study.

 

 

Misdiagnoses common among U.S. outpatients: Review

At least 5 percent of American adults -- 12 million people -- are misdiagnosed in outpatient settings every year, and half of these errors could be harmful, a new study indicates. The findings, from an analysis of data from several published studies, should lead to greater efforts to monitor and reduce the number of misdiagnoses that occur in primary care, said Dr. Hardeep Singh, at Baylor College of Medicine, and colleagues.

Primary care is given outside the hospital, such as in doctors' offices and outpatient clinics.

The researchers noted that most efforts to improve patient safety have focused on hospitalized patients and on issues such as medication errors, infections and falls. However, the researchers added, most diagnoses are made in outpatient facilities.

There have been no reliable estimates of how often misdiagnoses occur in outpatient settings, making it difficult to develop methods of reducing such errors, according to the authors of the study published in the journal BMJ Quality & Safety.

The researchers' review of the published studies involving U.S. adults showed that outpatient facilities have a misdiagnosis rate of just over 5 percent, or about one in 20 patients. Applied to the U.S. population, that means that 12 million adults are misdiagnosed in outpatient settings each year, according to a journal news release.

The results should be used by patient advocates, healthcare organizations, policymaker and researchers to seek ways to reduce the number of such misdiagnoses, the study authors concluded. (HealthDay) Visit NIH for the study.

 

 

Class I Recall: ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare

Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may cause the system to stop working.

This defect may cause serious adverse health consequences, including hypoxemia and death. Spacelabs Healthcare received one report related to the software defect. Affected products were manufactured and distributed from March 18, 2013 through June 17, 2013. Sixteen units were distributed to hospitals in North Carolina and South Carolina.

The Spacelabs ARKON Anesthesia Delivery System is used in hospital operating rooms. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The primary users of this device are qualified physicians. Read the MedWatch Safety Alert, including links to the Recall Notice at http://go.usa.gov/k8JA.

 

 

Bringing the UDI Regulation & the Global UDI Database (GUDID) to Life!

HPN is helping to sponsor a UDI Implementation Workshop May 20-22, 2014 in Baltimore, MD. The UDI Implementation Workshop is for Class III Medical Device Manufacturers who are in immediate need of information and guidance to meet the September 24, 2014 compliance deadline, or those that need to jumpstart their UDI adoption effort!

The FDA UDI Team will be at the meeting for a roll-up-your sleeves / deep-dive Workshop covering all components of the UDI Regulation and the GUDID Guidance. This Workshop is strictly focused on critical information exchange, expanded interaction, and heightened networking designed to deliver immediate and actual results in your UDI implementation initiative.

Attend the Workshop to:

·         Hear a summary of the FAQ’s processed by the UDI Help Desk to date

·         Establish a GUDID Account

·         Walk-through the Data Identifier (DI) Record

·         Discuss the GUDID HL7 SPL Submission Options

·         Learn about the FDA Data Quality Program & Specifications

·         Understand the requirements for your automatic identification systems

·         Gain insight into the Supply Chain and Healthcare Provider’s use of UDI data

·         Create your plan for UDI implementation to help guide your organization

Healthcare Purchasing News subscribers receive a $100 Discount. Seating will be limited and will be assigned on a first-come, first-served basis. Go to http://udiconference.com/register.html and enter “HPN” in the promotional code field line during online registration to receive $100 off of the rate. Register by April 30th for the best rate.

For the complete Workshop agenda and the most up-to-date information, please visit www.UDIconference.com.

For information on the FDA UDI Regulation, visit www.FDA.gov/UDI.

 

 

AMA: Docs add $1.6 trillion to economy

U.S. physicians produced $1.6 trillion in direct and indirect economic activity in 2012 and supported an average of more than 13 jobs apiece, according to an economic impact analysis released by the American Medical Association.

But some outside observers say the AMA's analysis -- meant to put a dollar figure on doctors' real-world impact -- may be making unrealistic assumptions and be based on unreliable information.

On average, each physician supported nearly $2.2 million in economic output and supported more than $1 million in wages and benefits, according to the report, which was written by IMS Health in Alexandria, VA, and commissioned by the AMA. Furthermore, America's doctors combined to support more than 9.9 million jobs and paid more than $65 billion in local and state taxes.

"This report provides key data which may be used by policymakers, legislators, and thought leaders in medicine to demonstrate how patient care physicians critically support local economies and enable jobs, growth, and prosperity in addition to ensuring the health of the community," the report stated.

For the study, IMS used data from the AMA's master file, which accounts for more than 720,000 practicing physicians, and the 2012 Medical Group Management Association (MGMA) cost survey, which included the revenue, costs, and staffing of physician practices. IMS combined the data to estimate physicians' impact on output, jobs, and wages.

To figure the indirect impact, IMS multiplied direct impact by a conversion factor to measure influences generated by industries physicians support. The analysis estimated that $1.62 of indirect output was generated for every $1 in direct output.

Stephen Parente, PhD, of the University of Minnesota, called the analysis "unconventional, but novel and logical." He said the AMA likely contracted with IMS Health for the study because of the conflict of interest in publishing it in its Journal of the American Medical Association.

Also of note, the AMA said 29.0% of physicians were either directly employed by a hospital or were employed by a hospital-owned practice in 2012 -- up from 16.3% in the same 2007/2008 survey. Visit MedPage Today for the study.

 

 

A year after marathon bombs, Boston hospitals apply lessons learned

The homemade bombs that ripped through the crowd at the finish line of last year's Boston Marathon, killing three people and injuring 264, showcased the city's medical talent but also taught valuable lessons in responding to a mass disaster. By all accounts, Boston's hospitals performed well after the attacks on April 15, 2013. While many of the wounded lost limbs and a large amount of blood, all who made it to a hospital survived.

Looking back, a year after their hospitals were packed with blast victims, Boston officials have tweaked how they prepare for a disaster, now requiring city emergency medical personnel to carry tourniquets and developing a standard method for one city agency to track disaster victims in hospitals.

The new techniques will be in place by this year's race, set for April 21, with 36,000 runners taking part and tens of thousands of spectators expected to line the 26.2 mile course.

"This was worth more than 1,000 drills," said Dr. Eric Goralnick, medical director of emergency preparedness at Brigham and Women's Hospital, which received more than two dozen bombing victims. "A real event highlights real shortfalls and real successes like no other. And, after the marathon, every healthcare provider became a champion of emergency preparedness."

A variety of factors contributed to the survival rate last year. Hundreds of police and medical personnel were working the race, allowing for a quick response. Hospitals hold disaster scenario drills dozens of times a year, making sure teams are able to work quickly and fluidly in a crisis.

The city's compact size made for speedy transport to its six level-one trauma centers, where doctors and nurses stabilized victims, set bones, and performed necessary amputations. A key element, experts said, was the use of tourniquets, sometimes improvised from clothing. They stopped excessive bleeding from wounds to victims' feet and lower legs caused when the nail-filled pressure-cooker bombs exploded at ground level.

The wars in Iraq and Afghanistan, where U.S. soldiers have often encountered improvised explosive devices, illustrate the value of tourniquets. City officials are applying that knowledge more widely as tourniquets become standard equipment for Emergency Medical Services staff.

The throngs of patients who arrived with no identification underscored flaws in electronic tracking systems where the victims' strings of identifying numbers started to look alike. On the day of the bombing, the biggest weakness, however was in pushing information to one central agency responsible for tracking all data from all hospitals to help reunite families.

Staff from Boston's hospitals have since created a new single-page disaster record, including a checklist to capture specific aspects of care that might be missed in a disaster and record identifying features like hair color, tattoos and piercings.

"It is important that we ID people better and push that to the next level quickly," said Maureen McMahon, director of emergency management at Boston Medical Center. "It was hard to look people in the eye and say we don't know where your loved one is."

Visit the Chicago Tribune for the story.