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 lists of sections from the three sample tools, below ).

QAPI survey tool

Pre-Decisional Surveyor Worksheet
Assessing Hospital Compliance With the Condition of Participation for Quality Assessment & Performance Improvement (QAPI)

Pilot Program Draft Version

Part 1 – Hospital Characteristics

Part 2 - New Hospital Worksheet Section - Purposely Omitted From Pilot

Part 3– Data Collection And Analysis - Quality Indicator Tracers

Part 4 – Applying Quality Indicator Information - Activities And Projects

Part 5 – Patient Safety – Adverse Events And Medical Errors

Part 6 – Broad QAPI Requirements And Leadership Responsibilities

Discharge planning survey tool

Pre-Decisional Surveyor Worksheet
Assessing Hospital Compliance with the Condition of Participation for Discharge Planning

Pilot Program Draft Version

Section 1 – Hospital Characteristics

Section 2 – Discharge Planning – Policies and Procedures

Section 3 – Discharge Planning – Reassessment and QAPI

Section 4 – Discharge Planning Tracers

Infection control survey tool

Pre-Decisional Surveyor Worksheet

Assessing Hospital Compliance with the Condition of Participation for Infection Control Pilot Program Draft Version

Section 1 – Hospital Characteristics

Module 1 – Infection Control/Prevention Program

Section 1. A. Infection control/prevention program and resources

Section 1. B. Hospital QAPI systems related to Infection Prevention and Control

Section 1. C. Systems to prevent transmission of MDROs and promote antibiotic stewardship, Surveillance

Section 1. D Personnel Education System / Infection Control Training

Module 2:General Infection Control Elements - to be applied to all locations (e.g., general wards, critical care units, labor and delivery, emergency department, endoscopy suites, radiology)

Section 2. A. Hand Hygiene

Section 2. B. Injection Practices and Sharps Safety (Medications, Saline, Other Infusates)

Section 2. C. Personal Protective Equipment/Standard Precautions

Section 2. D. Environmental Services

Module 3 – Equipment Reprocessing

Section 3.A. Reprocessing of Semi-Critical Equipment

Section 3. B. Reprocessing of Critical Equipment

Sterilization of Reusable Instruments and Devices

Section 3. C. Single-Use Devices (SUDs)

Module 4: Patient Tracers

Section 4. A. Urinary Catheter Tracer

Section 4. B. Central Venous Catheter Tracer

Section 4. C. Ventilator/Respiratory Therapy Tracer

Section 4. D. Spinal Injection Procedures

Section 4. E. Point of Care Devices (e.g. Blood Glucose Meter, INR Monitor)

Section 4. F. Isolation: Contact Precautions

Section 4. G. Isolation: Droplet Precautions

Section 4. H. Isolation: Airborne Precautions

Section 4. I. Surgical Procedure Tracer

Section 5. A. Protective Environment (e.g. Bone Marrow patients)

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

For more information on this topic, contact Marilyn Dahl, Director, Division of Acute Care Services, and Daniel L. Schwartz, MD, MBA, Chief Medical Officer, Survey and Certification Group, Centers for Medicare and Medicaid Services. Washington, DC. Telephone: (202) 690-7183.