Covering Compliance with The Joint Commission, AAAHC, and Medicare Standards
Minor surgery can equal major infection control woes
EXECUTIVE SUMMARY
A report from the Pennsylvania Patient Safety Authority showed that 84% of the 733 events related to infection-control that were reported from ambulatory facilities from March 2004 through July 2012 were healthcare-associated surgical site infections (SSIs) that were a "complication of a procedure/treatment/test."
• Perform a risk assessment that includes training and experience of your s staff members and the procedures that are performed at your facility.
• Look to the manufacturers' instructions and sales reps for information, especially when devices change.
• Educate staff at hire, annually, and as needed.
• Ensure your inventory of equipment and devices is large enough.
A patient in Pennsylvania developed an infection six days after cataract removal, and the result was complete loss of vision. Another Pennsylvania patient underwent a bunionectomy, and 10 days later tested positive for osteomyelitis with a resistant organism. The patient's big toe had to be amputated.
These actual cases at ambulatory facilities, reported to the Pennsylvania Patient Safety Authority, show how seemingly minor surgical procedures can have major infection control problems. In fact, 84% of the 733 events related to infection-control that were reported from ambulatory facilities from March 2004 through July 2012 were healthcare-associated surgical site infections (SSIs) that were a "complication of a procedure/treatment/test." (To access the authority's free report, "Strategies to Fully Implement Infection Control Practices in Pennsylvania Ambulatory Surgical Facilities," go to http://bit.ly/19ja094.)
There has been no standardized surveillance definition for many higher-volume procedures performed in ambulatory facilities, the authority says. The current standard for some definitions is the National Healthcare Safety Network (NHSN). Expect federal action on this front shortly. By Dec. 31, the Department of Health and Human Services (HHS) will develop a set of ASC procedures for which SSI definitions and methods should be developed for ambulatory surgery centers (ASCs).
Another challenge for ambulatory surgery programs is meeting infection control standards. For the first half of 2013, 47% of hospitals, 37% of ambulatory care facilities, and 26% of office-based surgery facilities were out of compliance with The Joint Commission standard IC.02.02.01, which requires the facility to reduce the risk of infections associated with medical equipment, devices, and supplies. Additionally, 28% of ambulatory facilities were out of compliance with IC.01.03.01, which requires the organization to identify risks for acquiring and transmitting infections. To improve compliance and reduce infections at your facility, consider these suggestions:
• Perform a risk assessment before you create a written targeted infection prevention program.
Risk assessment includes items such as the training and experience of your staff members and the procedures that are performed at your facility, says Marsha Wallander, RN, associate director of the Accreditation Association for Ambulatory Health Care (AAAHC).
"You can hire a nurse who has an excellent background in infection prevention, but if she doesn't have a background in high-level disinfection and sterilization, you can't put her in charge of those processes until she's been educated," she says.
Every facility's risks are different, Wallander says. "It's hard to have a canned infection control program," she says. "It doesn't take into account the uniqueness of each patient population and staff training level."
• Adhere to the manufacturers' practice instructions.
The engineering and design of equipment changes over time, Wallander says. For example, an endoscope manufacturer might add a lumen to a scope, she says.
"If you don't take the time to read the instructions, this version of the same company's piece of equipment may need a different cleaning process, a different push in teaching," Wallander says. "If you try to do to a new piece of equipment what you did to the old piece of equipment, you might not end up with a piece of sterile equipment."
Take the time to read the instructions, Wallander advises. Also, make sure you have a resource for questions and concerns, such as the manufacturer's sales rep, she says.
• Educate your staff.
Ensure the staff member assigned to perform cleaning or disinfection process is competent.
"The staff has to be educated," Wallander says. "That takes time."
The manufacturer's rep or technical staff can be a good resource for documented inservices, sources say.
AAAAHC standards require infection control prevention and training during initial orientation, at least annually, and as needed, Wallander says. "As an example, if you're hired as an employee today, I'll see you have that infection prevention and safety training tomorrow or this week, then I'll see you have pertinent refresher training on an annual basis," she says. "If I buy a new piece of equipment in three months or six months, I also have to train the staff on that."
Employees can demonstrate their competence at least annually, Wallander says. For example, a sterile processing tech can demonstrate the step-by-step process needed to clean a specific high-risk piece of equipment according to written policy and manufacturer instructions, she says.
• Ensure appropriate inventory of surgical tools and instruments.
"If an organization doesn't have an appropriate inventory, it's very difficult for sterile processing to keep up with the reprocessing turnaround time," Wallander says.
Don't use shortcuts, she emphasizes. "Cutting corners compromises the safety of the patient and the staff," Wallander says. "I don't want to work with a sharp instrument that hasn't been sterilized."
Advance directives can 'trip up' ASCs
Ambulatory surgery centers are being cited for including a blanket statement in their policies that the facility doesn't honor advance directives, said Kara Newbury, JD, assistant director of health policy at the Ambulatory Surgery Center Association (ASCA). Instead, you can decline to implement "elements" of advance directives, Newbury said. Newbury spoke at an Ambulatory Surgery Center Association webinar on "CMS' Interpretive Guidelines: How to Comply with Recent Changes."
"We know that many centers currently use a blanket statement of refusal," Newbury said. "CMS makes it clear in the revised interpretive guidelines that this is not acceptable."
Gina Throneberry, RN, MBA, CASC, CNOR, director of education and clinical affairs at the ASCA, concurred. "Many have in their policy, as part of the consent verbage, that we do not honor advance directives but will transfer a patient to a higher level of care if needed," Throneberry said. "Delete it. It probably will be cited by a surveyor."
The interpretive guidelines for advance directives from the Centers of Medicare and Medicaid Services (CMS) have been amended. It still says, "Each ASC patient has the right to formulate an advance directive consistent with applicable State law and to have ASC staff implement and comply with the advance directive;" however, a newly added section adds "subject to the ASC's limitations on the basis of conscience. To the degree permitted by State law, and to the maximum extent practicable, the ASC must respect the patient's wishes and follow that process."
The new wording also states that the surgery center can decline to implement elements of an advance directive based on conscience or any other reason allowed by state law, if that limitation is stated clearly in the advance directives policies.
Information on advance directives doesn't necessarily have to be given to the patient in advance of the day of surgery, but it does have to be in advance of the procedure, Newbury said. "You must include a clear and precise statement of limitation if you can't implement any element of an advance directive on the basis of conscience or other reason," she said.
A statement of limitations must do the following, she said:
• Clarify the difference between ASC-wide conscience objections and those that might be raised by individual ASC staff member,
• Identify the state legal authority allowing such an objection.
• Describe the range of medical conditions and procedures affected by the objection.
Newbury said that language that should be included in the ASC's notice of limitation could indicate, if permitted by state law, that the facility would "always attempt to resuscitate a patient and transfer that patient to a hospital in the event of deterioration." Include such language in your policy and in your statement to patients, she said.
Often advance directives are handled in the physicians' offices, Newbury acknowledged, "but it's still the ASC's responsibility to make sure an informed consent process is in place, and each patient has been educated."
Based on these changes, Newbury and Throneberry advised the following:
• Become familiar with your state requirements.
Before you develop policies on advance directives, know what your state permits, Newbury advised.
"It gives us some leeway," she says. "It's not practical to honor, for example, a DNR [do-not-resuscitate] clause in an ASC setting," she said.
The more strict regulation (state vs. Medicare) is the one that needs to be followed. State regulations are particularly important in terms of limitations for advance directives, Throneberry said. "If it's allowed under state law, state that the center will always attempt to resuscitate and transfer," she said. Have the governing body approve the new language of limitations, and document that action in the meeting minutes, Throneberry said.
Also, keep in mind that laws are state-specific, she said. "What works for one state might not be the best for another state," Throneberry said. You should be able to pull the information you need about advance directives from your state government's web site, she said.
• Educate your staff.
Educate your staff about your advance directives policies and procedures, Throneberry said. Include the business office staff, as well as part-time and PRN staff, she added.
Throneberry said, "A surveyor will walk around and may ask anyone, 'What is your policy on advance directives?' Once you decide how to work in a statement of limitations, educate everyone on that change."
• Address the advance directive preoperatively.
When your staff members make preadmission calls before surgery, ask the patients if they have advance directives, and document this information in the medical record, Throneberry said. "If they do, ask them to bring it with them the day of surgery," she said. "If not, ask the patient if they would like more information."
• Steps for the day of the procedure.
If a patient brings an advance directive to the center, a copy should be made and placed in the ASC medical record, Throneberry advised. "If they forget, you need to document that you have made an attempt to get the document for the patient," she said. For example, "you told them to bring it in on the preadmit phone call, and they forgot."
Understand that the responsibilities for advance directives don't necessarily end when your patient leaves the facility, Newbury pointed out. "If the patient is transferred, a copy of the advance directives must be provided with the medical record," she said.
EXECUTIVE SUMMARY
Under recent changes from the Centers for Medicare and Medicaid Services (CMS), you cannot have a blanket statement in your advance directive policies saying that your facility doesn't honor them but that the facility will transfer a patient to a higher level of care if needed.
• You can decline to implement elements of an advance directive on the basis of conscience, if permitted by state law.
• Any limitations to following advance directives must be stated clearly in your advance directives policies.
CMS grants waivers to areas of Life Safety Code
The Centers for Medicare & Medicaid Services (CMS) has granted a series of categorical waivers (CMS S&C 13-58-LSC) for several requirements in the 2000 edition of the "Life Safety Code" (LSC) published by the National Fire Protection Association (NFPA), according to The Joint Commission (TJC).
CMS issues waivers for hospitals, critical access hospitals, ambulatory surgical centers, long-term care facilities, and inpatient hospices when the requirements, if rigidly applied, result in unreasonable hardship for the organization, but only if the waiver does not adversely affect the health and safety of patients or residents, TJC said. Joint Commission staff petitioned CMS to approve the waivers to reduce the financial burden on healthcare organizations and to take advantage of provisions found in later editions of the LSC. Waivers are available for several requirements in the following categories:
• clean waste and patient record recycling containers;
• doors;
• emergency generators and standby power systems;
• extinguishing requirements;
• medical gas master alarms;
• openings in exit enclosures;
• suites.
Healthcare organizations immediately can take advantage of the waivers without seeking formal approval from CMS, TJC said. However, organizations are expected to have written documentation that they have elected to use a waiver, the agency said. This documentation can be done by noting it in the "additional comments" field of the statement of conditions (SOC) in the basic building information (BBI) for those categorical waivers associated with the Life Safety Code. For the requirements in the Environment of Care (EC) chapter, organizations should document the decision in the EC committee minutes (or an equivalent place), according to TJC.
Organizations also should notify the surveyor at the beginning of a survey that they have chosen the waiver, the agency said. It is not acceptable for an organization to first notify surveyors of waiver election after an LSC citation has been issued, according to TJC.
The Joint Commission will not be revising the elements of performance (EP) language in the standards manual because organizations are not required to choose the categorical waivers. However, they will be referenced in the Life Safety chapter introduction in the standards manual. At press time, a complete listing of the waivers was to be published in the November 2013 issues of "Joint Commission Perspectives" and "Environment of Care News."
The Accreditation Association for Ambulatory Health Care (AAAHC) will follow methodology similar to what The Joint Commission is planning when encountering these areas during a Life Safety Code survey where waivers are being applied, says Jack Egnatinsky, MD, medical director at AAAHC.
"It is nice to see CMS using common sense and logic in granting these waivers," Egnatinsky says. (For more information, go to http://go.cms.gov/18UYXmi.)
New tools available for AAAHC accreditation
The Accreditation Association for Ambulatory Health Care (AAAHC) has reached an agreement with Basha, a software company, and PowerDMS, a document management solution company, to license the AAAHC standards for use in their software tools.
The tools allow surgery center administrators to do the following:
• electronically store appropriate policies, procedures, and maintenance records adjacent to relevant standards;
• search for specific standards by keyword;
• better monitor where their surgery center stands in meeting regulatory compliance requirements, including accreditation standards and federal and state rules.
John Burke, PhD, president and CEO of AAAHC, said, "These two systems offer organizations seeking their first accreditation, or preparing to reaccredit, a new tool to help them simplify the process." (Editor's note: For more information on Basha's ASCpro software system, go to http://www.ascpro.com. For more information on the PowerDMS cloud-based application, go to http://www.powerdms.com/index.aspx.)
Helping you understand anesthesia standards
Do you have time to sort through the interpretive guidelines from the Centers for Medicare and Medicaid Services (CMS) for the Conditions of Participation (CoPs) regarding anesthesia and sedation? The manual is hundreds of pages. Do you know what documents surveyors are looking for when they come to your facility, and do you know what questions they will ask? Most of the most recent changes are effective immediately.
Help is on the way. AHC Media, publisher of Same-Day Surgery, has published "Cracking the Code: Understanding the CMS Hospital CoP Standards on Anesthesia," which explains the anesthesia standards and PACU standards. The chapters are organized in the order in which the anesthesia standards are contained in the hospital CoP manual. Our book covers anesthesia services, organization and staffing, preanesthesia evaluations, the intraoperative anesthesia record and required policies and procedures, and post-anesthesia assessments. We include hundreds of pages of policies and procedures and other informative practical material you can start using immediately.
For more information on this book, go to http://bit.ly/Ze16Xm.
