This Just In

Infection Controversy Update
FDA Pseudomonas Outbreak Probe Continues; Steris Responds to Hospital Letter
As an FDA investigation continues, debate remains heated over who is at fault for a bacteria outbreak that killed one and sickened 16 in October at Pittsburgh's Allegheny General Hospital (AGH).

Outpatient Surgery has obtained a copy of the letter AGH submitted to the FDA Jan. 20. AGH Department of Medicine Chairman Richard P. Shannon, MD, writes that the hospital's internal investigation uncovered three variables that "may have led to either incomplete decontamination, or subsequent recontamination of the three bronchoscopes in question, including (A) user error; (B) bronchoscopic instrument defect; and (C) the Steris System I." AGH concludes that the Steris System I is the only plausible explanation.

• User error. According to the AGH letter, 11 of the 12 technicians in the pulmonary lab where the bronchoscopes were reprocessed had more than eight years' experience, and all had "demonstrated competency" in pre-cleaning and using the Steris System I.

Steris tells Outpatient Surgery that user error cannot be discounted. "Our records indicate we trained a large number of employees from various departments there last year, but the pulmonary lab chose not to participate," says Steris spokesman Kevin Marsh.

Steris also claims that, at the hospital's request, the company conducted an audit of the hospital's reprocessing needs. "The nurse's report showed there were breaks in technique and failure to follow our protocol," says Ric Rumble, vice president of global healthcare for Steris.

• Bronchoscope defect. Dr. Shannon's letter says that scope defect was unlikely. The bronchoscopes that were contaminated with Pseudomonas aeruginosa were produced by two manufacturers and constituted three models - an Olympus P20D (2002456), a Pentax 15X (A91296) and a Pentax 15X (A01561). AGH says a defect in one model would not account for all three's contamination.

Steris counters that the age and condition of the three scopes could also be a factor. "The scopes they were using were getting older. There appears to be evidence that these scopes may not have been in the best condition," says Mr. Rumble. "To clean [scopes], they must be in good physical condition."

Pentax and Olympus have cooperated with the FDA probe. According to Pentax's report to the FDA's Manufacturer and User Facility Device Experience Database (MAUDE), the contaminated Pentax scopes were 12 and 13 years old, respectively. Based on when the affected Olympus bronchoscope was marketed, according to the MAUDE report, the Olympus scope was between 10 and 14 years old. Neither company is aware of any defects in the three scopes.

• Sterilizer defect. AGH's investigation concludes that the Steris System I Sterilizer itself likely caused the outbreak. The hospital alleges defects with the Quick Connect Kit and the equipment's sterile water filter. According to AGH's letter to FDA, the hospital received an Aug. 19 letter from Steris in which Steris offered users a 40 percent package discount to change to a new Quick Connect Kit - but this offer did not indicate a recall or clinical need.

That's because the Quick Connects were not under recall, says Mr. Rumble. Furthermore, AGH was not using the proper Quick Connects with its System I. "If they were using the right connects, they would still be using them today," he says.

Dr. Shannon writes to the FDA that scientists at the Centers for Disease Control and Prevention raised the possibility the sterile water filters were at fault. But by that time, AGH had already called Steris in to change the filters, says Mr. Rumble. AGH claims Steris technicians invalidated the evaluation of the efficacy of the filters when they "removed the sterile water filters and tossed them in the sink."

"Our service technician was called and asked to do preventative maintenance," responds Mr. Rumble. "We were not notified that we were trying to find a cause-and-effect relationship ' [or] that they were looking at further clinical study."

Dr. Shannon says AGH officials then conducted an experiment using a sterile water filter from another Steris System I machine; the filter and a sample of rinse cycle water were sent to the CDC for analysis. Dr. Shannon alleges that results show breakdown in the biological filter is another potential source of contamination. Allegheny County Department of Health Director, Bruce Dixon, MD, confirms the CDC was involved, although he cannot confirm the extent of its participation.

According to Steris, company technicians found the System I was not being used according to validated test protocol. "Our techs found they created a gerry-rigged stand to put the sterilizer on, which did not allow it to sit flat and did not allow it to work properly," says Mr. Rumble.

- Stephanie Wasek

At Long Last, ASC Procedure List Expands
CMS Adds 288 CPT Codes, Subtracts 141

The eight-year wait for an updated ambulatory surgery center procedure list is over. On March 28, the Centers for Medicare and Medicaid Services (CMS) published a notice in the Federal Register finalizing an updated list of Medicare-reimbursed procedures in the ASC setting. The new procedure list takes effect July 1. In total, 288 new CPT codes from all surgical specialties have been added. CMS also will delete 141 procedures (generally for lower-reimbursed procedures that can be done in a doctor's office) from the list for a net increase of 147. The total of Medicare-reimbursable codes for ASCs will be about 2,400.

Medicare still won't pay for more than 100 relatively common ASC procedures, forcing Medicare beneficiaries to have those procedures done in hospital outpatient departments. On a brighter note, for the first time, CMS has made use of the ninth and highest ASC payment group ($1,339 before wage index adjustment). About 50 new codes have been assigned to the ninth payment group. Go to writeOutLink("www.outpatientsurgery.net/ASC_Procedure_Codes.pdf","1").

Fire Safety Codes
Get Ready for New LSC Compliance