The center is more likely to encounter violations during the re-inspection process, at which point it has been operating for several years, he says. "It's one thing to talk about conducting an infection control meeting when you first start, for example, but over a three-year time period, have you been doing it every quarter like you said you would?"
2. Inspectors classify non-compliance into three categories. A Medicare accreditation inspector identifies three levels of non-compliance/deficient practice when examining an ASC:
- Immediate jeopardy. A deficient practice that falls under this category would likely cause the surgery center to close immediately, says Dr. Watts. "An extreme example would be if a surgeon was operating and eating a sandwich at the same time", he says. "Another example would be if the surgery center didn't have a crash cart, or if all the medications in the cart were expired. CMS would say to shut them down."
- Condition level deficiencies. These deficiencies are typically related to infection control, such as when a surgery center does not have a hand washing or sterilization policy in place, says Dr. Watts. There is no set number of condition level deficiencies that must occur in order for an ASC to be closed — the deficiencies are noted and the ASCs Plan of Correction is reviewed by a committee following the inspection.
- Standard level deficiencies. The most minor of the three categories, a standard level deficiency is an error that does not immediately jeopardize patient safety but that must nonetheless be corrected. A tear in an OR table, a lack of eye wash at a sink or an unsigned patient bill of rights all constitute potential standard level deficiencies, says Dr. Watts. As with condition level deficiencies, these deficiencies are noted and reviewed by the accreditation committee at the AAASF office. An excessive amount of standard level deficiencies in one area such as O.R. environment can cause the ASC to be cited for condition level deficiencies, says Dr. Watts.
3. A sufficient number of deficiencies will prompt a re-inspection. AAAASF must inform the ASC of any areas of non-compliance found within 10 business days of an inspection. From that point, the ASC has 10 calendar days to develop a plan of correction to address its deficiencies and an additional 30 days to implement. Every ASC that has even minor deficiencies must develop a plan for correcting them, says Dr. Watts.
If an ASC was found to have only standard level deficiencies, sending a photo or a receipt proving that the problems are fixed may be sufficient, he says. However, if conditional level deficiencies are noted, a focused re-survey will occur for ASCs that are renewing their Medicare accreditation. "They will send the examiners back unannounced to see if the ASC has fixed the problems. New applicants that have condition level deficiencies will not be recommended for deeming and must send a letter of intent to continue the accreditation process once they have made the appropriate corrections if they want to continue to pursue Medicare deeming." says Dr. Watts.
4. The ASC must report bi-annually into an electronic peer review system. "You want to look at how you're logging in and tracking narcotics, handling disciplinary problems, the advanced directives looked at by patients, the bill of rights looked at by patients — this has to happen on a daily basis for every case," says Dr. Watts. "You want to make sure that documents like pathology reports and x-rays have to be signed off on by the physician doing the case. All of this has to be checked."
5. Unannounced quality reviews can happen at any time. Quality measures in the ASC are also closely reviewed, and an accreditation representative can visit at any time to inspect these measures, says Dr. Watts. "When you're moving patients, is it safe?" he says. "Is there any break in sterile techniques during a case? Is the staff wearing protective equipment like glasses and gloves? How are you sterilizing instruments when you wash them?" These quality and infection control protocols are all noted during the inspection and, depending on the severity, could be classified as condition level deficiencies.
Dr. Watts says he sees common errors and deficiencies when examining ASCs, but once they are noted and corrected, the surgery centers ultimately attain a higher level of patient safety and care. "The process requires incredible vigilance to make sure that everything gets done, but once you do it, you will have an incredibly safe facility," he says.
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