New survey tools for patient safety COPs

Nationwide pilot under way

For years, the Centers for Medicare & Medicaid Services (CMS) state operations manual has had guidelines for surveyors to assess issues related to patient safety at hospitals. But there is such a wide range in size and scope of hospitals, says Marilyn Dahl, CMS director of the division of acute care services, that the organization decided it would be a good idea to create some sort of prompt for surveyors to use.

The organization began a process a couple of years ago to create the new tools after picking three areas — infection control, quality assurance and performance improvement, and discharge planning. Expert panels helped create the guidance and tools. They included patient safety experts from a variety of organizations, and for the infection control tool, there was assistance from the Centers for Disease Control and Prevention, she says. They also used the much simpler ambulatory surgery center infection control tool as a starting point, says Dahl (See list of sections from the discharge planning tool, below).

Piloted initially in 11 states, Dahl says, surveyors tested the tool beginning in the fall of last year. Not every state tested every tool, and all did varying numbers of surveys with them. "We have them test the tools in isolation on hospitals they identify to run them," she says. The tests are non-punitive, although statements of deficiencies were issued. But barring any findings so serious that patients were in imminent danger, no enforcement actions occurred.

Last December, with feedback from the states that did the pretests, they made some simple revisions — mostly typographical errors and changes in wording, Dahl says.

The infection control tool had the most work done, says Daniel L. Schwartz, MD, MBA, chief medical officer for the survey and certification group. While most of the changes were related to how the tool was organized, Schwartz says that there were some questions added, and some issues that users felt needed work. One example was that the section on hand hygiene didn't include guidance for surveyors to look for staff with long or false fingernails.

By the spring of this year, CMS was doing training with hospital accreditation organizations and providing detailed instructions to the states on doing pilot tests, says Dahl. By the end of September, every state is expected during the pilot phase to do at least one survey using each tool. They can volunteer to do more. After that, and for the next several months, CMS may ask that some test all three of the tools in a single survey.

"As surveyors become more familiar with the tools — they are very comprehensive — there is a lot of review to do," Dahl says. "If we combine all three together, is there any efficiency we can realize? Or will it be simply additive?"

The pilot will last through January, she says, and will continue to be non-punitive — again, barring any findings that show patients are in immediate danger. Examples of that would be egregious breaches in infection control, or dropping surgical instruments on the floor, picking them up and using them, Dahl explains. A facility that had a number of wrong-site surgeries but didn't have a program in place to analyze what happened or do a time out —that would be considered immediate jeopardy and a serious enough threat to patients to require punitive action.

After a last round of user feedback, the tools will be finalized, Dahl notes. "At that point, they will become a standard part of the survey process."

Hospitals that are part of the pilot program are welcome to provide feedback, too, she adds.

National associations related to hospitals have been involved from the start in updating this guidance, and Dahl says they are very supportive of the efforts. "There is a lot that hospitals are expected to do, but these tools are assessing current regulations," she says. "In the past, we haven't been so explicit in our expectations. So while this may look like a change, it isn't. We are just outlining expectations for regulations that are already there."

Creating the tools wasn't easy. The Quality Assurance and Performance Improvement (QAPI) tool was particularly difficult. But the level of work required to create it won't preclude CMS from developing further tools. After these three have had their initial outings and been "digested," Dahl says others will be considered.

Schwartz says he would encourage hospitals to look at these tools now and use them as a guide for self assessment. He says the infection control one, in particular, is great for such activities.

They all are, Dahl says. "We want people to understand them and use them internally," she says. "It will help them do well in future surveys."

All three pilot tools are available in their entirety at