Loose lips? Chicago transplant unit garners unwanted scrutiny

Internal QA documents: Take care they don’t grow legs

An intensive review of clinical standards at one of the nation’s most active heart transplant centers raises difficult questions about the confidentiality of quality assurance documents. National media attention resulting from a breach of security of QA documents also puts the spotlight on how the media covers perceived quality problems, and on the appropriate function of the Joint Commission on Accreditation of Health Care Organizations.

On Dec. 10, Rush-Presbyterian-St. Luke’s Medical Center in Chicago was approved for Medicare payments for heart transplants. Two days later, the Wall Street Journal ran a front-page story accusing the hospital’s heart transplant team of "unwise procedures" and questioning the quality of patient care before and after surgery. Hospital officials defended their facility and have announced plans to file a defamation suit against the newspaper. In an open letter to physicians, friends, and employees of the medical center, Leo M. Henikoff, MD, president and CEO of Rush, cited what he called a number of inaccuracies in the article (see related story, p. 18).

Days after the media coverage, the Joint Commission’s vice president for accreditation services and his senior staff determined a sentinel event had taken place at Rush. Henikoff was told on Dec. 18, 1996, that a physician surveyor was coming to review what happened. Based on the surveyor’s findings, the Joint Commission will decide whether accreditation status should be affected.

Internal QA document cited

In his Dec. 16 letter to the editor of the Wall Street Journal, Henikoff pointed out the source for much of the published article was a draft internal Quality Assurance review document from Rush. "In the Quality Assurance processes, physicians are encouraged to be highly critical of themselves and their colleagues in order to advance patient care," the letter explained.

"To ensure complete candor, the utmost confidentiality is accorded such documents. Often initial impressions are revised as a result of a comprehensive review of all relevant data. It is a crime in Illinois to disclose such Quality Assurance documents. This unprecedented action of the Wall Street Journal is not only reckless but undermines the very process of quality assurance that is so vital to the public interest." The letter continued, "In heart failure patients, the proper therapeutic approach is keenly debated by physicians because there is no right answer as to the proper balance between conservative and aggressive therapies. The use of hyperbolic statements based on Quality Assurance documents, when taken out of context, deserves public condemnation."

What can be learned from Rush’s nightmare? Quality managers in several hospitals note many things you may take for granted could be time bombs. For example, committee meeting minutes can be devastating when taken out of context. Some advise that minutes reflect only the topics of discussion and any action taken.

A scathing comment that did not result in action or was shown to be unfounded should not be in your minutes, warns Patti Higginbotham, RN, CPHQ, director of quality improvement at Arkansas Children’s Hospital in Little Rock.

"We have to be careful what and how we document incidents and where that information goes. I’d recommend that QI personnel turn to their staff attorneys or risk-management experts as to how to handle sensitive internal documents."

Higginbotham points to her facility’s minutes policy as an example of one action you can take to protect yourself and your facility.

"They should be lean and mean. Only write the essentials — the issue, the follow-up, and the action taken."

At Arkansas Children’s Hospital, QA and QI documents are clearly marked as such to remind employees of confidentiality. The hospital also takes tremendous pains to protect patient- identifiable data.

"We have a specific plan for aggregating the data. A part of that plan is knowing who’s going to get that report, who’s responsible for analyzing it, and how we’ll report it out. We’re also starting to set up mechanisms for when to get rid of patient-identifiable documents. Once the aggregate report has gone on its way, the individual data collection tools should be shredded or otherwise destroyed." (See related story, p. 21.)

A process defined is a document secured

How can you secure sensitive QA documents? "Define your process," answers Deborah Hare, RN, CPHQ, director of quality management and risk management at White County Medical Center in Searcy, AR. "And never deviate from those steps. If your process says that a particular party is the one who keeps the peer review minutes, that person should, with no exceptions, keep the minutes."

"Also, control copies of everything. They should be numbered, and individuals should be responsible for their copy."

Hare also reminds you to prepare for the worst. If a document is leaked, the hospital should respond. "No comment" makes the public think there’s something to hide, Hare explains. If there is a real problem, the hospital should let the public know quality improvement staff will solve the problem quickly.

Of course, quality managers ideally shouldn’t feel constraints on what they discuss. Staff members probably would be less candid in probing hospital practices if they thought unauthorized eyes might see the questioning process.

"We have to feel free to gather data and document our findings so we’re able to look back and draw constructive conclusions. This all improves patient care," says Higginbotham.

State laws also can help protect documents in some cases.

"All our reports are taken to a medical staff committee," says Higginbotham. Arkansas state laws that protect peer review information as long as it goes through the medical staff can help keep such documents from being forced into the public eye during court battles, she notes.

Be aware — but wary — of protections that come from your state laws. Even though quality documents, when handled correctly, may be protected by your state’s laws, meeting minutes or other documents can be subpoenaed during related litigation. Hare recalls being forced to turn over documents from a peer review meeting during litigation.

"When they were recognized to be a part of quality assessment, they were sequestered, but we had an uncomfortable few moments."

At Rush, many unanswered questions remain now the document cat is out of the bag. Why didn’t the Joint Commission discover any problems at Rush one month earlier when the initial accreditation was done? If there had been a problem, why was it not identified during the initial survey? Did the initial surveyors miss something crucial? Is the Joint Commission merely making an internal check on its first team in returning to the organization?

"But," says Hare, "the media should draw a line too as to what they should release. Patients entering that program at Rush from now on may find themselves trying to second-guess the professionals. Confidential, sensitive information that only medical people can possibly understand was placed in the hands of a reporter."