Opening Up Your ASC
Could your surgery center pass an unannounced Conditions for Coverage inspection?
By Wayne F. Bizer, DO
President Ronald Reagan once famously claimed, “The nine most terrifying words in the English language are, ‘I'm from the government, and I'm here to help.’” Many of us in medicine might be inclined to agree with the late president—between Medicare and the recent healthcare reform legislation, physicians are perhaps more familiar than most of our fellow citizens with just how much an impediment our government's idea of “help” can be.
That sentiment may well be heightened by a recent development in state inspections of ambulatory surgery centers. ASCs across the country are being deluged by unannounced state inspection teams. What is the purpose of these unpleasant surprises? Backed by $40 million in federal stimulus funds, they are part of an endeavor to determine if the nation's ASCs are in compliance with the ASC Conditions for Coverage issued by the Centers for Medicare and Medicaid Services in 2009.
Typically, three to five inspectors spend one to three days evaluating every aspect of ASC activity and interviewing at length every employee in the facility. Additionally, the inspectors track at least one patient along every step of his or her ASC experience from registration to discharge, including observation of the surgical procedure. Many ASCs have been found to have serious violations of these CMS-mandated Conditions for Coverage (CfC) issues. Many non-compliant ASCs have submitted an acceptable Plan of Correction (POC) to remedy each of their deficiencies, while other ASCs have had their certification revoked.
About now you are probably asking yourself how these inspections help you and your ASC! It may be hard to believe after my description, but the inspections are probably more beneficial than you think. Here is what you need to know.
The Realities of Infection Control
One of the most devastating events in ophthalmic practice is discovering endophthalmitis in a patient whose operation appeared to have gone perfectly. The heartache and anguish takes a bitter toll on the doctor as well as the patient. Infection control is not our only worry. As surgeons, we need to know and understand all of the details concerning these CfC and embrace these efforts for what they can do to protect our patients and ourselves.
In January 2008, a cluster of Hepatitis C caused by serious breaches in the infection control processes was identified at a Nevada ASC. More than 50,000 patients had to be notified of their potential exposure to this terrible disease.
Soon after, surveys were conducted in 100% of the ASCs in Nevada; almost two thirds of these were found to have serious deficiencies. Five of the Nevada ASCs were terminated from the Medicare program.
Prompted by this experience, CMS initiated a pilot study to survey ASCs in Maryland, North Carolina and Oklahoma. About two-thirds of the 68 ASCs examined were found to have at least one serious breach in infection control and almost 20% were found to have failed in three or more of the categories of the inspection.
The Result
In November 2008, Medicare proposed modifications to their CfC (42 CFR 416.2-416.52), making them much more rigorous and inclusive; this represented the first change in Medicare ASC certification rules since the advent of the program in 1982. The final rule was published in January 2008. The document, with interpretive guidelines, was expanded from 20 pages to 167 pages and the new CfC became effective on May 18, 2009. I urge you to go to http://www.cms.gov/manuals/downloads/som107ap_l_ambulatory.pdf or to http://www.ascassociation.org/cfcredline.pdf to read the expanded documentation. The words in red ink represent additions/revisions to the previous CfC. You will quickly notice that most of this document is in red ink.
The Obama administration initially allocated nearly $10 million from the $787 billion American Recovery and Reinvestment Act of 2009 to provide CMS the resources to send to the states to conduct CfC inspections of ASCs. Millions more dollars have been added to the program since.
A very interesting feature of the CfC guidelines is that the government did not attempt to set forth its own directives as to what constitutes proper care in an ASC, but rather has instructed that all ASCs must adopt and rigorously adhere to a nationally accepted standard.
One of the commonly-accepted sets of standards is the 800-page “Perioperative Standards and Recommended Practices” publication by the Association of Operating Room Nurses (AORN). This book (also available on CD) is re-released every January and can be purchased from AORN (www.aorn.org). It is almost three inches thick and provides guidance and standards in almost every condition and policy situation that might occur in a surgical setting. Other sources of nationally recognized standards include the Association for Professionals in Infection Control, the American College of Surgeons, the American Society of Anesthesiologists, the Centers for Disease Control and Prevention, and the National Patient Safety Goals.
CfC inspections ensure that every ASC has formally adopted a nationally accepted standard and rigorously follows the directives in that standard. Among other things, the inspectors will search for instances in which the ASC has failed to fulfill the requirements and directives of the standard that it has adopted.
Prominent categories among the CfC are the following: (1) state licensure, (2) governing body management, (3) surgical services, (4) QA/PI, (5) environment, (6) medical staff, (7) nursing staff, (8) medical records, (9) pharmaceutical services, (10) lab/radiology/anesthesia services, (11) patient rights, (12) infection control, and (13) patient admission, assessment and discharge.
Deficiencies are cited as either being “condition level,” which is cause for termination of the ASC, or “standard level,” which would not necessarily result in such a drastic sanction. See below for 25 examples of issues that have resulted in citations by CfC inspection teams.
| 25 Ways to Get a CfC Citation |
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| According to CMS documentation, here are some examples of issues that have resulted in ASCs receiving citations by CfC inspection teams. The material comes from CMS's Exhibit 351 Infection Control Surveyor Worksheet, CMS's Conditions for Coverage (CfC) Guidelines, and the AORN Perioperative Standards and Recommended Practices 2010 Edition. For the full citation, see the parenthetical note at the end of each example. 1. Failure to formally adopt and properly follow a specific nationally accepted national standard of policies and procedures. This is a “condition level” infraction. (Exhibit #351 CMS Infection Control Surveyor Worksheet, page 3) 2. Failure to have and document proceedings of a properly working infection-control program and have a properly trained infection control officer in charge of the effort. This is a “condition level” infraction. (Exhibit #351 p. 3) 3. Failure to conduct and document a properly operating and ongoing education program, including infection control, for all professional and non-professional ASC staff. This can be a “condition level” infraction. (#351 p. 5) 4. Failure to follow manufacturer-designated specifications regarding “single-use” equipment, supplies, devices, injectables and medications. (#351 p. 11) 5. Failure to properly credential and re-credential physician, nursing, anesthesia and other ASC staff. (CfC 416.42) 6. Failure to safely maintain confidentiality of medical records. ASCs physically connected to clinics need to be aware that patient medical records may not be merged with clinic records in hard copy form or with electronic health record systems. (CfC 416.2) 7. Failure to have a proper and operational system to receive and properly respond to patient complaints and concerns. Federal Register. (CfC 416d) 8. Failure to have proper relationships with lab/radiology/ anesthesia services and that these relationships protect patient medical information. (CfC 416.49) 9. Failure to properly advise patients of their rights, ASC physician ownership (must be at least 24 hours prior to surgery except in special circumstances), and seek details concerning each patient's advanced directives prior to admission. (CfC 416.50) 10. Failure to secure an H&P within 30 days of the date of surgery, on all ASC patients including minimally invasive procedures such as laser peripheral iridotomy and YAG laser capsulotomy. Documentation of functional disability to justify the surgical intervention must be included in the record. (CfC 416.52) 11. Failures to utilize, clean, sterilize and maintain all surgical instruments and equipment in a manner consistent with the recommendations of the manufacturer. (#351 p. 14) 12. Failure to document the contact information of an adult responsible person who will accompany a discharged patient from the center, unless otherwise approved by the ASC surgeon. (CfC 416.52) 13. Failure to ban wearing artificial fingernails or allowing fingernails to be longer than ¼ inch in patient contact areas. (AORN, p. 69) 14. Failure to properly scrub or alcohol hands prior to putting on gloves and after removing gloves following their use in situations where possible contact with blood or other bodily fluids may have occurred. This means proper contact time with surgical scrub and alcohol-based products as defined by the manufacturer. It is just as important to wash or alcohol hands after the removal of sterile and non-sterile gloves as it is to do so prior to putting them on. (#351 p. 7) 15. Failure to ensure that surgical gowns and/or surgical masks used in surgery are not worn outside of the operating room. (AORN p. 69-70) 16. Failure to properly clean ORs between each case and to conduct a terminal cleaning at the end of each day. Documentation of cleaning staff education, training and performance must be maintained. (#351 p. 15) 17. Failure to follow proper sterilization procedures. Flash sterilization is unacceptable. Short-cycle steam sterilization may be acceptable if the materials are sterilized and transported inside an acceptable sealed and filtered container in such a way that the sterilized materials are not exposed to air that might not be filtered or is otherwise exposed to contaminants. (AORN p. 460) 18. Failure to ensure that non-disposable or cloth surgical head covers are not worn in the OR and failing to wear disposable head covers inadequate to cover all exposed head and facial hair, other than eye brows and lashes. (AORN p. 69) 19. Failure to launder all clothing worn in the OR and in patient contact areas properly. Home laundering of surgical attire worn in patient contact areas is a violation. (AORN p. 67. Additionally, a personal communication from the AmSurg Operations Director notified me that AORN will move home laundering from “discouraged” to “violation” status in the 2011 Edition of Standards, due in Jan. 2011.) 20. Failure to properly label every medication (even BSS syringes) used in the OR or in any area of patient contact is a violation. (#351 p. 8) 21. Failure to ensure that food is never placed in the same refrigerator as medications. 22. Failure to maintain a properly designed and functioning system to collect information about the postoperative course of all patients treated at the ASC and document how that information is collected. (CfC 416.47) 23. Failure to ensure that “multiple-use” medication vials are always entered with a new needle and a new syringe. (#351 p. 10-11) 24. Failure to carefully monitor and ensure that OR temperature and humidity are maintained within the accepted ranges. (AORN p. 221) 25. Failure to document all events that fail to meet the nationally accepted standards adopted by the ASC and demonstrate appropriate actions of education, remediation and follow up. (CfC 416.43) |
Keeping Out Of Mischief
Despite the daunting list of examples that can get a citation, staying out of trouble from CfC inspections might actually be easier than you imagine. Here's how.
► The nationally recognized standard of care that your ASC adopts provides the guidance your center needs to demonstrate compliance with important issues. Additionally, the criteria used by the inspection teams are readily available online. Go to http://www.cms.gov/manuals/downloads/som107ap_l_ambulatory.pdf. You need to read this! It could make the inspections much like an “open-book test” (a very big but open book).
► Establishing an ongoing formal educational program regarding the CfCs is probably the most important single thing that can be done to protect your ASC, your patients and yourself. These efforts should be documented and a permanent record kept of the training. Be sure to designate a qualified person with this responsibility. As part of the change in mindset of your staff, it is important for all staff to recognize that they are not going to do things any longer simply because “it's the way that we've always done it.”
► Self-monitoring, auditing and properly complying with CfCs is critical. A process of educating, evaluating and corrective activities for individuals who fail to adhere to CfC policies needs to be documented and appropriate action taken by the ASC.
► Subscription to online and ongoing management tools and educational programs are available. Progressive eSupport is one such resource offered by Regina Boore, RN at Progressive Surgical Solutions. You can sign up for a no obligation web demo at www.progressivesurgicalsoluntions.com. It will be well worth your time.
► AORN and other similar agencies offer a variety of educational programs and meetings. A visit to the AORN Web site (aorn.org) is helpful. It is important that your infection control officer is sufficiently trained.
Possible Remedies
If your ASC is inspected and found to have deficiencies, there are several things you can do:
1. Know the appeals process and know your rights. Go to www.gpoaccess.gov/cfr/retrieve.html with the specific deficiency citations.
2. Understand that there are two levels of deficiencies. A “condition level” deficiency is a basis for decertification, while a “standard level” deficiency is less severe. Be receptive to the inspection team and respectful of their findings.
3. A Plan of Correction (POC) for each deficiency must be submitted within 10 days of notification of the deficiency. The POC will be reviewed and if it is accepted, you may continue to function. If your POC is denied, you may be given five more days to resubmit and secure approval of your revised POC to avoid termination. You can be certain that the inspectors will return within the next 30–45 days to determine that all of the POCs are being fully implemented.
4. Do not attempt to submit POCs that might be regarded as foot-dragging, as the inspection team may reject your corrective action and give notice that your ASC will be terminated in five days pending an acceptable POC. Termination notices are provided to the local news agencies.
5. You may need an attorney skilled in these CfC deficiency matters such as Allison Shuren, JD, of Washington, DC-based Arnold & Porter LLP. Ms. Shuren is an attorney who specializes in CMS issues, as well as a licensed nurse practitioner who understands the health care environment.
Deadlines to Know
HHS is developing additional expansions for patient protection and infection control efforts as seen in the following goals by the noted deadlines. Becker's ASC Review lists the following important deadlines:
December 31, 2013:
► ASCs must demonstrate 100% adherence to measures in the infection control worksheet.
December 31, 2015:
► All ambulatory surgical centers must report surveillance data in standardized formats to patient safety organizations and the National Healthcare Network.
► ASCs must demonstrate 100% adherence to the Surgical Care Improvement Project and National Quality Forum infection process measures, such as perioperative antibiotics, hair removal, postoperative glucose control and normothermia.
► ASCs must achieve zero incidence of “Never Ever Events” as defined by the National Quality forum. Never Ever Events are those surgical occurrences that should never occur, such as wrong patient, wrong site, wrong surgery and wrong device.
► All ASCs must have a certified infection preventionist on staff or contract with one for service.
“I'm From the Government and I'm Here to Help”
So what do you think of President Ronald Reagan's famous words now—are they true or false? We all would like think that we and our ASC practice at the very highest level of skill and care giving, with the greatest attention to all patient safety details. We would all like to think that problem ASCs are located somewhere else. And we would certainly like to think that these unannounced inspections are not necessary.
The reality is that all ASCs, as a group, will succeed or fail based on the perception of both the public and the surgeons who bring their patients to ASCs, that ASCs are as safe as or are safer than hospitals. Unsafe practices in any ASC are a threat to the viability of all ASCs. Any person, any group, and any governmental agency that assists all ASCs to practice at the very highest level of patient safety should be welcomed. How can we advocate for anything less than 100% compliance with nationally recognized standards and procedures? OM
Author's note: In addition to those mentioned above, I would also like to thank AmSurg, Inc.; American Society of Ophthalmic Administrators; Becker's ASC Review; Corcoran Consulting; Michael A. Romansky, JD, Washington Counsel, Outpatient Ophthalmic Surgery Society; Lou Sheffler Chief Operating Officer of American SurgiSite Centers, Inc.; and the center director of my ASC, Melanie Spagnoli, RN.
References
1. Exhibit #351 CMS Infection Control Surveyor Worksheet.
2. CMS's Conditions for Coverage (CfC) Guideline.
3. Paige L. ASC Groups Respond to HHS Proposal to Substantially Boost Infection Control Measures. Becker's ASC Review. Oct. 13, 2010.
| Dr. Bizer is medical director at the Foundation for Advanced Eye Care in Sunrise, Fla. Contact him via e-mail at wfbizer@bellsouth.net. |
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