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Spring is the season for conferences and live events, which can go a very long way toward revitalizing your outlook....
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By: Bill Meltzer
Published: 10/10/2007
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.
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.
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.
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
A Type 1 EES is required in your ASC if any patients are on non-emergency electrical life-support or if general anesthesia is used. A Type 1 EES is a hospital-type system that maintains life safety systems and continuous activity, including ventilation systems, elevators and heating. Its emergency power is provided by a generator (no batteries with enough power exist), which must have a minimum of four circuit breaker panels (one for normal and at least three for emergency power).
The regulations do not permit "grandfathering" of existing non-conforming facilities.
- Stephanie Wasek
New OR Technology
Hospital-to-Hospital Robotic Telesurgery
Dr. Anvari controlled the endoscopic camera and surgical instruments with the Zeus surgical robot (top). Meanwhile, 300 miles away in North Bay, general surgeon Craig McKinley, MD, positioned the robotically controlled instruments and controlled the electrocautery energy source (bottom).
ASC Medicare Reimbursement Cuts?
OIG Recommends Eliminating 72 ASC Procedures
The Office of Inspector General has asked Congress to eliminate 72 CPT codes for ASC-reimbursable procedures that are more commonly performed in an office. Six of these have been deleted in the new ASC list of covered procedures (see page 9). For now, the remaining 66 CPT codes targeted by OIG are safe. However, they may not be in the near future, when Congress and CMS tackle the larger issue of ASC payment rates in general as part of the Medicare package.
The recommended deletions fall into 12 categories, including five ophthalmic codes, three pain management codes (such as single intercostal nerve injections and follow-up care for programmable pain pumps), seven dermatologic lesion excision codes and many closed orthopedic treatments for bone fractures. See writeOutLink("www.outpatientsurgery.net/newsletter/03-10-03.htm","1").
While you needn't worry about losing these reimbursements within the next year or two, coding and billing consultant Lolita M. Jones suggests that you gauge the potential impact of losing these procedures in future updates. She recommends generating a report to identify all cases your facility reported to payors involving one or more of the targeted codes.
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