Proposed conditions would take extra time

CMS: ASCs would need an extra 55 hours a year

Do you and your staff have an extra 55 hours a year? That's the amount of time the Centers for Medicare & Medicaid Services (CMS) estimates that you and your ambulatory surgery center (ASC) staff would spend complying with new and revised Conditions for Coverage (CfC) for ASCs.

The breakdown of the time estimate is as follows: four hours to develop a disaster preparedness plan, at least 40 hours to develop a Quality Assurance Performance Improvement (QAPI) plan, one hour to adhere to new patient rights requirements, and 12.5 hours to investigate patient complaints and develop and send out notices about the complaints to people in authority in the ASC, the state, and local bodies having jurisdiction, as well as the state survey agency if warranted.

CMS is proposed to update the ASC Conditions for Coverage (CfC) to reflect contemporary standards of practice in the ASC community, as well as recommendations from the inspector general. The new requirements will ensure quality services in ASC, according to CMS.

However, some leaders in the field think CMS has added requirements that won't improve outcomes or patient safety.

One example is a requirement that patients disrobe or wait in a private place, says Kathy Bryant, president of the Federated Ambulatory Surgery Association.

"I think common sense says, 'OK, it's not to improve patient outcomes or safety, but it's nice for patients,'" she says. "But I've never been to an ASC where patients disrobe in the middle of waiting room."

Much of the wording in the proposed changes, such as the term "private space," is subject to interpretation, Bryant says. "As long as CMS interprets that to mean that curtains around the area are fine, there may not be a problem," she says. If they say it must be soundproof and viewproof, that would be a problem, Bryant adds. "We want to make sure definitions aren't adding burdens."

Other industry leaders are more optimistic, such as Craig Jeffries, executive director of the American Association of Ambulatory Surgery Centers (AAASC). AAASC is "delighted" that CMS has proposed improvements in the CfC that reflect standards of practice that most ASCs, already address, Jeffries said in a prepared statement. "Establishing these new requirements in regulatory rules should eliminate many of the regulatory oversight concerns raised by those who opposed further expansion of the list of procedures that Medicare allows to be performed in an ASC," he said.

The proposed CfCs include three new conditions:

• Patient rights.

ASCs would be required to provide patients with verbal and written notices of their rights and responsibilities prior to providing care. Some ASCs already may have interpreters to be certain that patients who don't understand English fully understand their rights and responsibilities. For those who don't, telephone services can be purchased for about $2 per minute, according to CMS. The agency estimates that 3% of cases might need such services, and that an average of 15 minutes might be needed per patient.

Also, each ASC would be required to establish an advance directive policy. Generic advance directives forms in English and Spanish are available from state agency web sites and other sources, CMS says.

As part of the patent rights CfC, CMS emphasizes that access to patient information and clinical records is permitted only with the written consent of the patient or representatives, or as allowed by law. All ASCs would be required to comply with the Health Insurance Portability and Accountability Act (the HIPAA privacy rule).

The CfC would require ASCs to document and investigate written and verbal grievances made by patients or their representatives. These grievances may include mistreatment; neglect; theft of personal property; and verbal, mental, sexual, or physical abuse. The ASC would be required to report allegations to a person in the ASC, at the state level, and local bodies that have jurisdiction, and the state survey agency, if warranted. The grievance process should specify time frames for reviewing and responding to the grievance, CMS proposes. Also, certain information would have to be documented, including how it was addressed, the steps during the investigation, written notice to the patient or representative of the decision, including the name of an ASC contact person, the results of the grievance process, and the date the process was completed.

ASCs may have to investigate complaints from about 1% of patients due to allegations of mistreatment and neglect, for example, CMS estimates.

• Infection control.

ASCs would be required to prevent, control, and investigate infections and communicable diseases, and take action that results in improvements for problem areas. The sanitary environment standard would be expanded to include use of infection control standards of practice as guidelines in the ASC infection control program. While CMS would not dictate any specific set of infection control guidelines, officials "strongly encourage" ASCs to use guidelines published by the Centers for Disease Control and Infection (CDC), the Association of Practitioners in Infection Control (APIC), and The Joint Commission as references.

ASCs would be required to designate a qualified professional, such as a registered nurse, as the infection control officer. That officer would investigate and resolve incidents. That person would need continuing education in infection control on at least an annual basis, CMS says. CMS estimates that facilities would spend about $500 annually on infection control training for that person that would include an approximate four-hour course.

"I don't think having an infection control officer is harmful," Bryant says. ASCs often already have someone who deals with clinical issues, including infection control, she says. "Everyone knows who it is that does that," Bryant says. "If they have to have on a chart they are on an infection control officer, it's not a big deal."

The infection control program would be required to follow a plan of action to identify problems and correct and prevent them, when necessary. ASCs would be required to establish hand hygiene policies. These policies would include antiseptic agents used, scrubbing technique, duration of the scrub, condition of the hands, and techniques for drying and gloving.

ASCs would be required to create and implement policies and procedures for instrument cleaning and maintenance of sterilization equipment.

• Patient admission, assessment, and discharge.

CMS proposes that each patient have a history and physical not more than 30 days before the date of surgery by a physician or other qualified practitioners. The history and physical would be required to be in the patient's medical record before the procedure is started.

CMS proposes several items that must be included in the pre-surgical assessment, including an updated entry for examining any changes in the patient's condition since the most recent history and physical, documentation addressing the patient's physical and mental capacity to undergo the surgery, and documentation of any allergies. The post-surgical assessment would require that a through assessment of the patient's condition is documented, and that any post-surgical needs are addressed and included in the discharge notes.

The ASC would be required to provide each patient with written discharge instructions. The ASC would ensure all patients have the "best possible" transition to home and that all post-surgical needs would be met. The discharge instructions should include physician coverage information regarding emergency care for any postoperative adverse effects.

CMS proposes that each patient have a discharge order signed by the physician or practitioner who performed the procedure. The discharge order would indicate that the patient has been evaluated for anesthesia and medical recovery.

"We believe it is imperative . . . that a physician or the qualified practitioner who performed the surgery or procedure be available to provide assistance in the ASC if needed, until all patients have been given a signed discharge order by the aforementioned practitioner," CMS says. "We believe this would eliminate any confusion with respect to the level of care and the ability of the ASC to respond to a patient emergency before the patient is discharged."

CMS has not specifically required a physician to be on site while there are patients in the ASC. "However, when the discharge order is signed, the patient would be expected to be discharged, that is, physically leave the ASC facility within a reasonable amount of time," which CMS defined as 15-30 minutes. (See a list of proposed definition changes: See a list of proposed revisions to CfCs)

For those ASC managers who may be concerned about the proposed changes, keep in mind that CMS has been working on these proposals for more than a decade, and it's uncertain when the final rule will be published, Bryant says.

In the meantime, share your concerns with your associations, she advises. "We need to know how to comment," Bryant says.

Comments on the proposed rule will be accepted through Oct. 30. The proposed rule can be seen at A final rule will be issued later this year. In commenting, refer to file code CMS-3887-P. Comments may be submitted electronically at


For more information on proposed changes to the Conditions for Coverage, contact the following people in the Office of Clinical Standards and Quality at CMS:

  • Joan A. Brooks, Health Insurance Specialist, Clinical Standards Group. Phone: (410) 786-5526.
  • Steve Miller, Director of Non-Institutional Quality Standards. Phone: (410) 786-6656.
  • Jacqueline Morgan, Health Insurance Specialist, Clinical Standards Group. Phone: (410) 786-4282.
  • Rachael Weinstein, Director, Clinical Standards Group. Phone: (410) 786-6775.