Health care's wake-up call: consumer safety and fraud
by Isabel Fawcett, SPHR
Summer 2010: The Heat is On
There are 3 high-profile news stories this summer (2010) that have captivated my attention in terms of what each potentially represents to healthcare consumers and industry executives. The stories are:
- As reported by the New York Times and other media sources, a prestigious New York City university has now suspended psychiatric-related research at its brain-imaging center on the heels of findings stemming from a federal investigation. Among other serious findings, brain-imaging center staff allegedly administered potentially dangerous drugs to patients over a 4-year period. Dating back to 2008, there may have been findings of lax internal quality control related to the injections. An internal investigation by the university reportedly determined there had been "no harm to patients."
- A major pharmaceutical company has faced legal claims that its Avandia drug for diabetes treatment may have caused increased risk of heart attacks to some patients who were treated with Avandia. As in the university research case, the Food and Drug Administration (FDA) is involved in reviewing all such reports. Not unlike the university case, Avandia's manufacturer is conducting additional internal reviews.
As of July 17, 2010, Avandia has not been recalled by the FDA. A panel of expert advisers to the FDA rendered a split decision regarding whether Avandia should remain on the market. Twelve members of the panel reportedly voted to remove Avandia, while 10 expert panelists voted to leave Avandia on the market with added warnings and restrictions on the drug's use.
- The federal government announced the *arrest of 94+/- doctors, health care owners, and executives in a nationwide crackdown on fraudulent Medicare billing, also dubbed "schemes" by the incumbent U.S. Attorney General.
*An arrest does not denote guilt. Individuals who are arrested are presumed innocent unless and until proven guilty in a court of law.
Perceptions and Reality are Invaluable Lessons
In each of the news stories, the verdict may be out regarding some of the allegations. Still, there are major lessons to be derived whenever things go wrong in business, even if such breakdowns are limited exclusively to appearances of impropriety and not actual wrongdoing on anyone's part. As a healthcare consumer, former human resources management professional and internal investigator, I've learned that there are recurring themes that surface in similar circumstances, including:
- Insufficient, lacking, or out-of-date policies, practices and procedures in business. In some workplaces, policies and procedures become an after-thought instead of being integral to the organization's unified vision, strategic direction and daily operations.
- Insufficient or lacking staff training on policies, procedures and/or regulatory standards. Having updated policies and procedures is an exercise in futility if all workers are not regularly trained on such protocols and held accountable for sustained compliance.
- Inadequate management oversight and supervision of daily operations. Sometimes senior managers and executives who make operations assumptions overlook the realities of front-line workers.
- Internal investigations are sometimes delayed due to management or executive interference or coercion. Some internal investigations are a day late and more than a dollar short and only allowed to begin after external complaints have been filed.
- Poor internal communication. Some jobs are highly specialized, more so in technical industries such as healthcare. It is possible for one specialty area to never interact with other areas of team specialization. Even skilled specialist and technician positions require management direction, oversight and transparent internal controls.
- Ineffective or insufficient audit controls and/or delegated authority including to internal investigators. Although by legal definition internal auditors function independently, there still may be undue influence or management interference in some situations. Non-audit internal investigators are seldom afforded functional independence by virtue of being buried at low levels in the organization's reporting lines of authority.
- Fear of retaliation for reporting suspected fraud or irregularities. It is reasonable in some instances when some workers fear retaliation in employment even though retaliation for reporting some forms of misconduct in the workplace is strictly prohibited under federal laws.
- Lack of specific and recurring mandatory ethics training for workers. Ethics can be a dry topic for training due to its overlap with highly complex laws and lack of trainer creativity. Regardless, ethics road-maps are a must in business, more so in training of healthcare workers and all other organizational representatives. Ethics starts and quickly makes its way back to the top of any organization, including when lacking.
- Insufficient, inadequate and/or lacking executive involvement in meaningful strategic planning and organizational direction. This one speaks for itself. Sometimes lacking executive involvement is a career-ending mistake.
Acute care, long-term care, pharmaceutical companies and higher education research institutions have consumers who are also customers. Not unlike the airline industry, consumer confidence is easily shaken to the core even with limited incidents. Perception sometimes morphs into reality.
It was reported that "the lab" failed to check "…the purity…of each active ingredient…prior to release…." The brain-imaging lab (or any other clinical laboratory) is an inanimate object. People- as in workers - at every level of an institution need to be held fully accountable for individual and team performance excellence and failures. In healthcare, let's not lose sight of patient safety and regulatory compliance.
I have reason to care. Not only am I a caregiver to an elder. I'm also an occasional patient. "The lab" has never caused me any heartburn. It never will, either.