This Just In

Infection Controversy
Hospital, Sterilizer Manufacturer Debate Responsibility for Deadly Bacteria Outbreak
The Steris System 1 sterilizer is at the center of a public battle between Pittsburgh's Allegheny General Hospital and Steris Corp. Both parties are blaming the other for the deadly bacteria outbreak that infected 16 patients who underwent bronchoscopy at the hospital last year. One person died. (Eight other infected patients also died, but their deaths were not attributed to Pseudomonas aeruginosa, according to numerous published reports.) According to published reports, Allegheny General claims the sterilizing systems were defective. Steris claims the hospital didn't follow proper sterilizing procedures. The FDA says it is investigating.

An Allegheny General spokesperson declined comment, but the hospital blames the Pseudomonas infections on two serious potential equipment defects that prevented the sterilizers from properly sterilizing the bronchoscopes, according to published reports:

• A potentially faulty sterile water filter, which removes bacteria from rinse water. The filter malfunctioned over time and allowed instruments to be infected with waterborne bacteria. In the published reports, the hospital claims that the FDA sent a letter to Steris in April 2001, outlining the problem and noting several cases of infection during endoscopy in which the System 1 was used to clean the scopes.
• A potentially faulty tube designed to direct the flow of sterilant from the Steris System 1 Processor through the device's internal channels. In a warning letter FDA sent to Steris in December 1999, FDA said that the company had failed to fully validate the performance of the tube and questioned whether the tube could be responsible for six infections involving Staph., Pseudomonas and tuberculosis. Since then, Steris says that it has voluntarily recalled a limited number of these devices.

Steris, which has made more than 16,000 sterilizers used by 5,000 healthcare facilities across the United States, "categorically rejects" the hospital's findings. In a statement released to Outpatient Surgery, Steris says it is cooperating fully with an FDA investigation and calls the hospital's claims "false, misleading and not reflecting an appropriate investigation."

Regarding the filter, Steris's Kevin Marsh says in an interview that the letter Steris received was a request for information, not a warning letter. He says, "we responded [to the FDA] with technical data supporting the safety and efficacy of the System 1 filtration system, and we answered the agency in full." According to Steris, "technical studies performed by third-party experts have demonstrated ' [the] bacterial retentive filter reliably produces sterile water for processing." Outpatient Surgery could not obtain copies of the data. Mr. Marsh adds that the System 1 has a built-in diagnostic cycle that notifies the user when to change the filter.

Regarding the tube, Mr. Marsh says that the hospital did not purchase the accessory in question.

Steris says the hospital's internal investigation is inconsistent with the preliminary FDA findings. The company says an FDA spokesperson stated, "the proper cleaning and disinfecting procedure may not have been followed. It looks like that may have been the problem, not the unit itself."

ASCs in Britain
UK Looking to Emulate U.S. ASC Model
Britain's National Healthcare Service (NHS) is looking to the U.S. outpatient surgery model to help alleviate some of the strain on the country's backlogged hospitals. In December 2002, delegates from the NHS led by Thomas Mann, MD, visited Nashville, Tenn., in search of healthcare companies interested in building outpatient surgery centers in the UK. According to Dr. Mann, the NHS is looking for U.S. companies to partner with British companies and U.S. companies who want to run facilities themselves. Says Dr. Mann, "We are just looking for good quality businesses at a value."

With Britain's nationalized healthcare system backed up with ailing patients, some patients wait more than a year for treatment, according to Dr. Mann. The NHS would like to see more ASC-like "diagnosis and treatment centers" (DTCs) up and running in the next two years with the hope that patients will only have to wait six months for surgery.

While in Nashville, home to more than 220 healthcare companies, Dr. Mann pitched his ideas to a number of interested healthcare companies at a luncheon forum hosted by the Nashville Health Care Council.

Florida Patient Tragedy
CRNA Pleads Guilty to Negligence in Patient's Death
Admitting she failed to monitor the vital signs of a 75-year-old woman who went into cardiopulmonary arrest three minutes into routine laser retinal surgery and died six days later, Tina Mays, CRNA, pleaded guilty last month to a misdemeanor negligence charge, officials say.

Ms. Mays, who was assisting an anesthesiologist, did not monitor the vital signs of Nealia Cunningham during an April 2001 case at the Northpoint Surgery Laser Center in West Palm Beach, Fla. A blood pressure monitor and heart rate alarm that would have sounded if Ms. Cunningham's vital signs fluctuated were switched off, court documents state. It was not until another nurse attempted to wake Ms. Cunningham after the surgery that resuscitation attempts began.

Ms. Mays, 65, a nurse for more than 40 years, subsequently falsified medical records and repeatedly lied to other medical workers about when Cunningham's heart stopped beating, according to court records. As part of her plea arrangement, Ms. Mays has agreed to serve six months of probation and surrender her nursing license.

Hospital Reimbursement Cuts
MedPAC Recommends Less-Than-Inflation Updates For Hospitals
The Medicare Payment Advisory Commission (MedPAC) next month will recommend that Congress pass legislation to reduce the annual cost-of-living Medicare adjustment for hospital reimbursements, effective in 2004. Federal law requires a Medicare update equivalent to the Consumer Price Index (CPI). Hospitals received a 3.5% adjustment for outpatient services in 2003.

MedPAC proposes a reduction of hospital outpatient updates to the CPI minus 0.9%. Inpatient rates would be reduced to 0.4% below full inflation. MedPAC estimates that hospitals will receive $1 billion to $5 billion fewer over the next five years if Congress enacts the legislation this year. MedPAC says hospitals already receive reimbursement from Medicare to address rising technology costs, thus offsetting the need for full inflationary increases. MedPAC cites hospital new technology APCs and so-called Medicare "pass-through" payments as two ways rising costs are offset.

• CMS has finalized its ASC procedure list update, says AAASC executive director Craig Jeffries. The list could be published in the Federal Register in the next 60 days...
• A patient is suing a surgeon for using a cautery pencil to brand "UK" (short for University of Kentucky, the surgeon's alma mater) on her uterus before performing a hysterectomy. The surgeon maintains that cauterizing an internal surgical site marking of an asymmetrical symbol recognizable to the surgeon is a routine patient safety precaution. He says that he informed the patient prior to surgery that there would be a need to mark the uterus, but the specific mark was not discussed...
• Under CMS's recently published final rule on healthcare facility fire safety standards, most ASCs will not, as previously feared, have to pay to retrofit a Type I Essential Electrical System (EES) or upgrade its medical gas capabilities. ASCs in compliance with earlier editions of the Life Safety Code's (LSC) EES and medical gas standards will not be required to upgrade to the 2000 edition, provided the ASC continues to meet the LSC requirements applicable to when it was constructed. However, new ASCs will be required to meet the 2000 LSC, as will facilities for which the EES or medical gas system are renovated, altered or modernized. Additionally, the final rule does not change the requirements for vertical openings and fire-rated wall standards applicable to ASCs. ASCs will be required to upgrade emergency lighting consistent with the 2000 edition of the LSC, but they have until March 13, 2006, to do so...
• Tennessee Republican William Frist, MD, has been named the new majority leader of the United States Senate. Dr. Frist, a heart and lung surgeon, still operates periodically...
• The Office of Inspector General is considering allowing ASCs to require physician owners who fail to refer a prescribed percentage of cases to the facility to divest their ownership interest as part of safe harbor compliance. If your facility is owned by physicians from different specialties, one of the criteria for attaining safe harbor protection from the federal kickback statute is meeting the contribution margin of each owner. Safe harbor regulations require at least one-third of the procedures performed by each physician investor to be performed at the ASC...
• Patient deaths and injuries resulting from nosocomial infections should be considered sentinel events, says JCAHO in a recent alert. When such events occur, an investigation of the root causes of the incident should follow. JCAHO urges facilities to voluntarily report these events to the commission. JCAHO says it has received only 10 infection-related reports since the commission adopted its sentinel event standards...
• The number and the value of ASC merger and acquisition transactions more than doubled in 2002 compared with 2001, says ASC Inc.'s Jon Vick. Still, of the more than 3,600 Medicare-certified freestanding surgery centers in the United States, about 70% are independently owned by physicians.