February 2007

Study Says Hospital Patients Regard 'Errors' as Including More Than Traditional Definition

Study Says Hospital Patients Regard 'Errors' as Including More Than Traditional Definition

CHICAGO --Hospital patients define medical errors mu ch more broadly than traditional clinical definitions by including communication problems, responsiveness, and falls, according to a new study published Jan. 7 in the Joint Commission Journal on Quality and Patient Safety.

The study of more than 1,600 patients at 12 Midwestern hospitals also shows the importance of explaining exactly what is meant by the term "medical error" if patients are to be effectively engaged in programs to prevent them.

The study, "Patients' Concerns About Medical Errors During Hospitalization," concludes that most patients felt a high level of medical safety, but 39 percent experienced concern about at least a single type of medical error during their hospitalization.

Certain groups, such as middle-aged patients, parents of pediatric patients, and blacks, were more likely to be concerned about medical errors, the study found. Also, patients who experienced longer periods of stay, more severe illnesses, or were admitted through the emergency department were likely to experience more concerns.

However, patients who received care in small and rural hospitals reported the fewest types of concerns, regardless of the severity of illness, according to the study.

Need to Educate Patients

As a result, programs to educate patients to play a more active role in preventing errors may need to be tailored to address the fears and concerns of each patient, the study's lead author, Thomas E. Burroughs of St. Louis University, noted in a Dec. 18, 2006, statement.

"The study underscores that patients and clinicians can have different views of the things that constitute a medical error," Burroughs said. "For patients, clear communication and responsiveness are particularly important. If these are lacking, patients may view this as a medical error. It is important that clinicians recognize these differences, and the importance of communication and responsiveness."

The study recommends that hospitals consider routine measurement of patient concerns about medical errors as part of patient satisfaction efforts, and calls for additional research into the factors that generate concerns among patients about medical errors, how best to encourage patients to express these concerns, and what strategies effectively reassure patients about their medical safety.

The journal is published monthly by Joint Commission Resources, an affiliate of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

Additional information is available at http://www.jcrinc.com on the Web.

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Growing Availability of Quality Data May Spur New Type of Enforcement Actions

LAS VEGAS --Enforcement actions targeting institutions' failure to provide adequate care, whether civil or criminal, are increasingly being built on the growing amount of quality-of-care data and information culled from a growing array of sources, according to a Feb. 6 presentation to a gathering of health care attorneys.

James G. Sheehan, associate U.S. attorney for the Eastern District of Pennsylvania, said his office is continuing its focus on ensuring that health care providers receiving federal health care dollars give patients high quality care, as they adjust to the "Medicare revolution" that is changing the federal reimbursement system from one based on payment for procedures performed to one based on outcomes.

As this revolution moves ahead, he said, new enforcement cases targeting lapses in delivery of quality care will be developed from data-mining activities conducted by a range of regulatory and oversight entities, as well from information from regulators, whistleblowers, media, and others. Discrepancies in the information from multiple sources on one provider or facility may serve as the "red flag" that gets prosecutors' attention, he said.

"We are reviewing assorted sources of quality information on your facility to see what it says and if it is consistent. You should be doing the same," he said. The fact that the data may be flawed or missing will not itself give rise to a claim of fraud or false statement, he added, but it does bring attention to and raises concerns about the facility.

"We are certainly going to look further at institutions where the data just doesn't make sense," he said. Sheehan made his remarks at the American Health Lawyers Association Hospitals and Health Systems Law Institute.

Egregious Cases

Sheehan, who said he was not speaking in an official capacity, said his office will continue to focus criminal investigations only on the most egregious failure of care cases and that the general approach is to give voluntary compliance efforts a chance to work. He noted that his office has received complaints from some whistleblowers who were asked whether they had attempted to avail themselves of internal remedies. That should be done first, but if voluntary compliance and corrective action efforts do not solve the problem, his office is prepared to act, he said.

Sheehan said his office would continue to ask the same underlying questions to determine whether prosecution is appropriate:

• Was there a systemic failure by the institution's management and the board to address quality issues?
• Did the institution make false reports about quality or fail to file mandated reports?
• Has the institution profited from ignoring poor quality or ignoring providers of poor quality?
• Have patients been harmed by poor quality care or been given false information about it?

Sheehan noted that some of the sources of data that will be "mined" and considered in initiating or pursuing such an investigation include information from the reporting hospital quality data for annual payment update (RHQDAPU), information from JCAHO, state reporting, mandated reporting of errors and near misses, mandated apologies required under some state laws, quality improvement organizations, pay-for-performance contracts in the private sector, and whistleblowers.

With respect to this last group, Sheehan noted provisions of the Patient Safety and Quality Improvement Act of 2005 that gave quality-of-care whistleblowers most of the same protections afforded whistleblowers under the False Claims Act. "I expect an increase in the number of mixed cases in which whistleblowers allege both quality lapses and false claims in one action," he said.

The wider threat of enforcement actions against providers makes the development of programs designed to assess and maintain compliance in the quality of care arena paramount, Sheehan said .

More information about the meeting is available at http://www.healthlawyers.org/Content/ContentGroups/Programs3/2007/Br-LTC07.pdf.

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An allegation that a gastroenterologist's removal from the staff of a hospital "was [an] injury to the competitive market in that it reduced the public's choice of providers who could effectively treat them" does not sufficiently allege harm to competition to state a Sherman Act claim, according to an unpublished opinion by the U.S. Court of Appeals for the Fifth Circuit (Taylor v. Christus St. Joseph Health Systems, 5th Cir., No. 06-40775, 2/6/07).

In a per curiam opinion affirming dismissal of the complaint, the Fifth Circuit also found no abuse of discretion in the district court's decision to dismiss the case with prejudice, especially since the plaintiff had been afforded the opportunity to file an amended complaint.

David Taylor, a gastroenterologist, alleged that, in 1998, he joined the medical staff of Christus St. Joseph Medical Center in Paris, Texas, as well as the private practice of Drs. Daryl Dickey and David Stewart. St. Joseph allegedly recruited Taylor to maintain its competitiveness with another local hospital, McCuistion Regional Medical Center, in the area of gastroenterology.

In 1999, St. Joseph's was acquired by McCuistion. Thereafter, St. Joseph allegedly had no need to support Taylor's practice and began conspiring with Dickey and Stewart to drive the plaintiff out of the Paris market.

During this time, two malpractice suits were filed against Taylor. The filings led St. Joseph to begin a review of his charts. During the review process, St. Joseph learned that a federally funded health insurer had rejected Taylor as an "approved physician," and it disqualified Taylor from its staff and removed his hospital admission privileges as a result of the discovery. Taylor further alleged that, during this time, Dickey and Stewart made comments that he was a "bad doctor" and a "problem doctor."

Taylor 's suit, filed in June 2004, included a claim under the Sherman Act. The antitrust claim was dismissed for failure to allege harm to competition. Upon refiling in a March 31, 2005 amended complaint, the claim suffered the same disposition.

Analysis

The Fifth Circuit, affirming, said that Taylor's Sherman Act claim actually alleged only one fact--that he was removed from practice at St. Joseph. This fact, the court stated, only showed harm to Taylor, not to competition as required to allege a Sherman Act claim.

To adequately allege harm to competition, the Fifth Circuit observed, Taylor would have had to allege "that there was a rise in the price of gastroenterology services above a competitive level, a decrease in the supply of gastroenterologists in the relevant market, or a decrease in the quality of gastroenterology service provided" (Miller v. Indiana Hosp., 814 F. Supp. 1254, 1265 (W.D. Pa. 1992).

Taylor 's complaint does not allege any of these injuries, the court observed. Taylor claimed "only that he was ejected from working at St. Joseph's, not that he was somehow prevented from serving patients in the Paris, Texas area. He alleged only that his ejection might have 'allowed the remaining doctors ... to engage in monopoly pricing.' He also stated that 'the remaining market providers could now easily reduce services.' "

None of these statements, the Fifth Circuit held, "amounts to a factual allegation sufficient to withstand a [Rule] 12(b)(6) motion."

The opinion is available at http://www.ca5.uscourts.gov/opinions/unpub/06/06-40775.0.wpd.pdf