Mar 11, 2009 | Laboratory Pathology, Management & Operations
Consumers raise the bar on expectations of error-free healthcare
Multiple cases of medical errors hit the headlines in recent months. Collectively, these headlines raise an interesting point. Patients and the public at large have changed expectations about the quality of healthcare. Consumers increasingly expect medical services to be error-free. When news surfaces that a provider committed a pattern of medical errors over an extended period of time, it becomes a major news story. (more…)
Jan 8, 2009 | Laboratory News, Laboratory Pathology
Just days after The Dark Report and Dark Daily alerted the laboratory industry to systemic problems with “home brew” mass spectrometry Vitamin D testing at Quest Diagnostics Incorporated (NYSE:DGX) during a period starting in early 2007 and lasting into mid-2008, the New York Times has confirmed the essential details of this extraordinary story.
In the Thursday, January 8, 2009, edition of the New York Times, reporter Andrew Pollack wrote a story titled “Lab Acknowledges Problem with Vitamin D Test.” In balanced coverage, Pollack provided information about Quest Diagnostics’ acknowledgement that it had reported inaccurate results for what appears to be about a year and a half. He also quoted physicians on the various clinical issues associated with Vitamin D testing, Vitamin D therapy, and the role Vitamin D plays in various diseases.
The exact magnitude of the problem remains unknown, because Quest Diagnostics has neither disclosed the number of physicians who received letters about erroneous Vitamin D results reported on their patients, nor the number of patients for whom inaccurate Vitamin 25(OH) D test results were reported by Quest Diagnostics during the 2007-2008 time period.
However, competing laboratories in the New York metropolitan area have told The Dark Report and Dark Daily that thousands of physicians in this region received Vitamin D recall/retest letters from Quest Diagnostics. Most of these letters were sent in October 2008. Each physician may have had as few as a handful of patients to retest, or as many as several hundred. Thus, just in the New York region, it would not be unreasonable to estimate that tens of thousands of patients are involved in this Vitamin D retest program.
One clue to the total number of inaccurate results was provided in The New York Times story, which wrote that “Dr. Salameh [Wael A. Salameh, M.D., Medical Director, Endocrinology at Quest Nichols Institute in San Juan Capistrano, California] said the inaccurate results represented fewer than 10% of all the vitamin D tests done by the Quest from early 2007 to mid 2008. And even many of the possibly inaccurate results were probably accurate, he said, because Quest sent letters even if there was only a remote chance that the test was erroneous.”
Take Salameh’s statement that “fewer than 10% of all the Vitamin D tests” were inaccurate, and assume a 9% rate of inaccurate tests. Next, combine that with a rough estimate that Quest Diagnostics performed between 5 million and 7 million Vitamin D results during 2007-2008, and one comes up a possible range of between 450,000 to 630,000 inaccurate Vitamin D test results.
That’s a lot of patients-and a lot of doctors! Assume 10 patients per doctor, and that means Quest Diagnostics may have reported inaccurate Vitamin D results to between 45,000 and 63,000 doctors! If the real numbers approach these estimates of affected patients and referring physicians, then this is a laboratory failure without precedent.
How could something this troubling happen at the nation’s largest laboratory company? According to the New York Times, Salameh stated that “some materials used to calibrate test results were faulty.” Salameh also admitted that “four of Quest’s seven testing laboratories around the country did not follow proper procedures for some period of time.”
The January 12 issue of The Dark Report will have additional intelligence briefings on this unfolding story. Dark Daily readers interested in becoming a subscribing member to The Dark Report can act immediately with this link (or copy this URL and paste in your browser: http://www.darkreport.com/dark/subscribe.htm).
The current issue of The Dark Report (dated December 22, 2008) was the first public news reporting on Quest Diagnostics’ problems with Vitamin D testing. This issue has been distributed to existing subscribing members. Dark Daily readers can see the individual intelligence briefings by using this link (or pasting this URL in your browser: http://www.darkreport.com/dark/past.htm) For more information on Charter Memberships go here.
Dark Daily asks that anyone with knowledge of this remarkable story about inaccurate Vitamin D results and willing to share insights can contact editor Robert L. Michel in complete confidence at rmichel@darkreport.com or by dialing 512-264-7103.
Related Information:
Dec 24, 2008 | Laboratory News, Laboratory Pathology
Hospitals, physicians, laboratories and others have until January 1, 2009, to provide comments on the proposal by the Centers for Medicare and Medicaid (CMS) on three National Coverage Determinations about preventable surgical errors, or “never events.”
Dark Daily readers know that, beginning October 1, CMS stopped paying hospitals for care or services associated with a list of eight “never events.” Other insurers, including Blue Cross and Blue Shield Association, Aetna, Cigna Corp and Wellpoint, have followed the CMS lead, implementing similar nonpayment policies for medical errors.
A never event is the industry term for a serious preventable medical incident occurring while the patient is under the care of a medical provider. The National Quality Forum (NQF) has developed a list of 28 never events, ranging from surgical and other procedural errors to sending an infant home with the wrong parents.
CMS is proposing to add these three categories of errors to its “no pay” list:
- Wrong surgical or other invasive procedures performed on a patient
- Surgical or other invasive procedures performed on the wrong body part; and,
- Surgical or other invasive procedures performed on the wrong patient.
The CMS proposal to expand the number of “never events” on the no pay list is not without controversy. So far, the American Medical Association (AMA) and AHA have voiced disagreement with the proposal. The AMA opposes CMS using its National Coverage Determination process, which dictates procedures Medicare will or will not pay for, to fight surgical errors. Instead, the AMA suggests that the agency “develop a clear payment policy outlining the circumstances under which surgery would not be payable by Medicare.” The AHA also wants CMS to provide a clear definition of what costs or services would not be covered, but also wants the agency to describe how it would assign accountability for an error.
Meanwhile, there is support for the CMS “never event” policy from other sectors of healthcare. Researchers determined that, since CMS announced implementation of the first “never event” policy for eight conditions in August 2007, 23 state hospital associations had adopted policies forbidding or discouraging billing for serious preventable medical errors.
Large insurance companies quickly responded to the CMS announcement on “never events” by instituting their own no-pay policies for “never events. Aetna was first to publicize its policy. WellPoint and CIGNA soon announced similar policies.
Hospital laboratories are already experiencing the impact of the first round of the CMS “never event” policy that took effect on October 1, 2008. Among the eight conditions were nosocomial infections and administering incompatible blood products to a patient. In both cases, laboratory test services play a key role in providing clinicians with information to properly diagnose the patient and chose the appropriate course of treatment.
Related Information:
CMS Proposes Three National Coverage Determinations to Protect Patients from Preventable Surgical Errors
What Are Never Events and Why Do They Matter?
Sep 8, 2008 | Laboratory Management and Operations, Laboratory Pathology
It’s big news when the nation’s largest medical specialty organization shifts its policy on physician use of electronic medical record (EMR) systems and e-health services. The American College of Physicians (ACP), in Philadelphia, Pennsylvania, issued a new position paper.
ACP says that physicians, patients, technology companies, and policymakers must collaborate to foster e-health activities and electronic communication among physicians and patients. ACP further states that e-health activities-including remote monitoring of patients, personal and electronic health records, and patients seeking health information on-line-have the potential to transform health care in the United States!
“E-health activities have great potential to improve the quality of patient care, reduce medical errors, increase efficiency and access to care, and achieve substantial cost savings,” said ACP President David C. Dale, MD, FACP. “Furthermore, e-health is a critical part of the patient-centered medical home model of care, which in coordination with the other components, is the future of the U.S. health care delivery system.”
The new positions adopted by the ACP are useful for those pathologists and laboratory directors tracking acceptance of new technologies by physicians. Laboratories that establish electronic links with their physician clients end to enjoy a more productive relationship with those physicians.
The ACP’s new position paper is significant for two more reasons. First, it is a statement by ACP that its 125,000 physician-members are ready to embrace and adopt these new technologies. That’s a change from past years, when healthcare lagged other industries in its adoption of information systems and new technology. Second, physicians have been criticized for their collective reticence to adopt electronic medical record systems. The ACP’s position paper specifically calls for physicians and other stakeholders to recognize the potential that information technology holds for transforming healthcare.
“A recent report from the Robert Wood Johnson Foundation estimates electronic medical record (EMR) use in the ambulatory (physician) setting at 24% and in the inpatient (hospital) setting at 61%,” stated the ACP in its position paper. “According to a 2006 ACP member survey, adoption also varies by practice size; smaller practices (five or fewer physicians) have an adoption rate of 18%, while larger groups, (20 or more physicians) have an adoption rate of 58%. Those practices that have implemented EMRs may also include such services as online appointment self-scheduling and secure patient-physician messaging. This interaction between patients and their physicians through the use of electronic tools for health-related purposes has been broadly defined as e-health.”
In addition to citing the potential the IT holds for healthcare, the ACP position paper also acknowledges the barriers to more widespread adoption of information systems in healthcare. For physicians, the challenges of implementing e-health systems can be substantial in part because IT is expensive and the return on investment is not always certain. “For physicians, the financial costs of purchasing systems and incorporating e-health offerings can be considerable,” ACP said.
ACP also recommended investment in demonstration projects to assess how e-health activities can support the relatively new concept of the patient-centered medical home. A patient-centered medical home is an approach to providing comprehensive primary care for patients of all ages and medical conditions. Dark Daily has already alerted its clients and subscribers to the growing support behind the medical home concept (See Dark Daily, August 8, 2008, Doctors Promote “Medical Homes” as Way to Take Us Back to the Future ).
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Jun 27, 2008 | Laboratory Management and Operations, Laboratory Pathology
Patient-centric e-health services, including personal and electronic health records, remote monitoring of patients, electronic physician-patient communication, and patients seeking health information on-line, represent a new vision of healthcare’s future according to a recent position paper from the American College of Physicians (ACP), in Philadelphia, Pennsylvania. (more…)
