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New NYS Law to Improve Infection Control

January 24, 2008

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A new law is aimed at preventing the Hepatitis C transmission that occurred in Dr. Harvey Finkelstein's office. In New York, more stringent accreditation and reporting guidelines are now required by certain medical practices to enforce good infection control practices.

Law enacts tough new guidelines for NYS outpatient facilities

BY RIDEGLY OCHS | ridgely.ochs@newsday.com
12:39 PM EST, January 14, 2008

www.newsday.com

With a new law going into effect Monday, New York's oversight of outpatient facilities -- including pain-management practices such as Dr. Harvey Finkelstein's -- will be among the toughest in the nation, advocates and health officials said.

But some said the law fails to address ways to ensure good infection control in all outpatient settings, an issue for Long Islanders in light of the state's recent notification of more than 10,000 of Finkelstein's patients after the Dix Hills doctor's re-use of syringes led to a transmission of hepatitis C in 2004.

Experts estimate that more than half of medical procedures, including surgeries and invasive procedures such as colonoscopies, take place in offices and clinics. The state has about 2,000 of these facilities, which, unlike hospitals, have not been required to be accredited.

The result has been little hard data on how well the practices operate as well as reports of botched surgeries and disease outbreaks like those among some of Finkelstein's former patients.

The new state law now requires any ambulatory surgery center that uses moderate or heavy sedation to be accredited by one of three national groups or the doctor will lose his or her license. The centers also will be obligated to report adverse events, including patient deaths, within 30 days or any other serious or life-threatening occurrence.

The reporting requirement begins Monday; practices have until July 14, 2009, to become accredited. Podiatrists and dentists, regulated by the state education department, are not included. Neither are medical offices that use only light sedation, such as Valium.

John Morley, the state health department's medical director of the office of health systems management, said he believed the law will "make a major difference" in office-based surgery practices.

Others agreed.

"We probably have the best legislation for this kind of thing nationwide," said Bernard Rosof, senior vice president for corporate relations and health affairs at North Shore-LIJ Health System.

In 1997, Rosof chaired a committee that developed guidelines on office-based surgery. Eight years later he chaired the committee whose recommendations led to the law signed by Gov. Eliot Spitzer in July.

Twenty-six states have some legislation on outpatient surgery, and New York's is the toughest, said Alan Gold, a Great Neck plastic surgeon. Gold is also president of the American Association for Accreditation of Ambulatory Surgery, one of the groups approved to accredit these facilities.\

"This is the law with the most significant degree of enforcement attached to it," he said.

To be accredited every three years by Gold's group, which has 1,100 members nationwide, the applicant must comply with a booklet full of requirements -- ranging from anesthesia to safety equipment to the office layout. In an announced visit, an inspector reviews procedures. A perfect score is required before accreditation is given, Gold said. After that, the group may periodically send in unannounced inspectors.

Arthur Levin, director of the Manhattan-based Center for Medical Consumers, called the law a "huge breakthrough." But Levin and others concede the law, based on sedation levels, may not be broad enough to include all outpatient facilities where invasive and potentially dangerous procedures are done.

Tom McKnight, a doctor from Fremont, Neb., whose wife, Evelyn, was one of 99 people to contract hepatitis C in 2002 at a nearby outpatient cancer treatment clinic -- the largest such outbreak ever -- called the New York law "a step toward reform." But because sedation wasn't used in the clinic where his wife was treated, "the legislation would not have helped Evelyn or any other victims," he said.

And although accreditation would make a doctor like Finkelstein show he understands good infection control, it is not clear under the law whether his infecting a patient with hepatitis C would have been reported as an adverse event, said health department spokeswoman Claudia Hutton. That's because, she said, Finkelstein didn't realize what was happening at the time.

So far, 11 of Finkelstein's former patients have tested positive for hepatitis B and nine for hepatitis C, according to the Nassau County Department of Health. The state health department has said it is impossible to tell whether Finkelstein's office was the source.

Sen. Kemp Hannon (R-Garden City), chairman of the Senate Health Committee, said he and Health Commissioner Richard Daines have discussed trying to find ways to ensure good infection control.

"The current [law] utilizes major accrediting agencies to ensure good practices," he said. "The next question is: Can we use something akin to that for sanitary practices, short of having to inspect 20,000 private offices?"

Copyright © 2008, Newsday Inc.

Posted by Editors at January 24, 2008 5:07 PM