In Part 1 of this two-part series on the ESRD Core Survey developed by the Centers for Medicare and Medicaid Services, I concentrated on collaboration, facility-based program preparation, control of environmental hazards, and culture of safety. Part two of this series will review how the surveyors participate in direct observation of treatment prescription delivery, infection control practices, water safety, and performance improvement through unit-wide action plan strategies.

Direct observation

Dialysis treatments consist of many moving parts: assessment, treatment prescription verification, vascular access care, treatment initiation, monitoring, medication administration, discontinuation of treatment, and post assessment. Dialysis staff must remain vigilant in delivery of safe care based on the policies and protocols of their particular organization. The surveyors will focus on delivery of prescribed care, prevention of infections, and the safe operation of technical systems and dialysis equipment.

Since infections are one of the leading causes of death for patients on dialysis, observing procedures for infection control practices will be done for all patients, including any patients in isolation. Surveyors will also review the facility’s immunization programs, infection control logs/trends/actions plans, review of Hepatitis B positive (HBV+) patient charts, and how staff is assigned to HBV+ patients for the delivery of care. Infection control and isolation practices directly affect the patient survival outcomes.

Here is a list of some of the most frequently cited V-tags for the CMS FY 2012 (Oct. 1, 2011-Sept. 30, 2012) period. Again, V113 (hand and hygiene and glove compliance), tops the chart.

V122 (clean disinfect surfaces and equipment) is the second most frequently cited tag when there is a risk of cross contamination. The chart below illustrates how long various organisms remain viable on surfaces.

The surveyors will also want to verify that home therapy patients/caregivers received adequate training and safe supportive care from the interdisciplinary team. They will interview the home training nurse, and observe care if a patient is training or making a clinic visit during the survey. If a home therapy patient is not present, the surveyor may conduct an interview with the patient or family by phone. One of the questions that may be asked is, “What does this facility do for infection control and prevention?”  Will the patient or family member be able to answer that question adequately, demonstrating that your facility is effectively teaching infection control and prevention?

Water treatment/dialysate

The provision of water and dialysate safe for use in dialysis is critical to the health and safety of the dialysis patient. Understanding the quality of the source water, and of the treatment components needed to ensure the source water is safe for use for dialysis is vital. In recent years many natural disasters have resulted in the need for emergency sources of water to be found for dialysis. Responsible staff members, including the medical director, nurse manager, charge nurses, patient care technicians, and biomedical staff all play a role in ensuring water and dialysate quality and safety.

The article, “Water treatment for hemodialysis: An update,” 1 is an excellent resource for clinic staff and, along with the core surveyor laminates on the critical water treatment components, will assist you in performing your facility self-inspection.

The Core Survey process will review or observe a total chlorine test and interview staff on “breakthrough” procedures, the reverse osmosis (RO) unit, the water quality monitor and alarms, chemical and microbiological monitoring, and deionization (DI) system, if present. The key is understanding the purpose and function of these portions of the water treatment and testing systems, and documentation. A focused interview will be done with both the biomedical technician and/or the Medical Director. Here are some of the key questions you may hear.

  • Can the staff interpret the daily RO readings?
  • Do they know what to do when a reading is outside the limits?
  • Is the medical director knowledgeable of the water treatment systems and directly involved with the training of the staff?
  • What is the emergency preparedness plan if the water source is interrupted or contaminated?
  • Are all staff members trained annually in water treatment and dialysate preparation to include safety testing and quality monitoring?

Reprocessing/reuse

If your facility reprocesses dialyzers, the surveyor will observe dialyzer reprocessing and set-up for use of a reprocessed dialyzer. Review of the program will include verification; if there is quality oversight, including the required audits; and ongoing patient protection. The following are the focus areas:

1.     Reuse technician training program, including annual updates

2.     Patient consent process: How is the patient informed about reprocessing and what role does the patient take in the safety steps? 

3.     Transportation of used/dirty dialyzers

4.     Pre-cleaning procedures

5.     Reprocessing and labeling procedures

6.     Reprocessing equipment preventative maintenance

7.     Germicide mixing, storage, and spill management

8.     Patient safety/pre-checks before treatment

9.     Event reporting system

Observation and interview tools are available under Tab 9 in the Core Survey Field Manual, which is available online.

Patient/staff interviews

In the past, surveys have found that patients did not feel that they had a voice in their care. Now with the new “Culture of Safety” emphasis, both patients and staff will need to be educated on how to voice their concerns or make suggestions without fear of retribution. The surveyors must feel that the culture within the facility promotes respect of staff and patients, and a comfortable and safe atmosphere.

There are interview guides for both patients and various staff members under Tabs 12 and 14 in the Core Survey Field Manual (referenced above) to assist the facility in ensuring they are building a “culture of safety.”

Medical record review

Part One of this series 2 encouraged the facility to be proactive in completing the data tool including in the Core Survey Field Manual. If you followed that suggestion, you are half way to your focused medical record review. Use the information that identified patients who did not meet one or more of the expected goals to choose clinical records to review. The review will focus on the dialysis prescription, treatment records, medication orders, and evidence of what the interdisciplinary team is doing to improve the outcome in the area identified as below goal. The surveyors will look at 2-3 consecutive weeks of hemodialysis treatment records for delivery of safe care. They will review the patient’s outcome trends, and see where the interdisciplinary team intervened with actions toward improvement or resolution of the poor outcome.

Other records which may be chosen for focus reviews include unstable patients, newly admitted patients (< 90 days), home patients, patients who live in long term care facilities, and involuntarily discharged patients. In the Core Survey Field Manual under Tab 13, there are record review tools that can be used to guide your record audits.

QAPI review

The Quality Assessment Performance Improvement (QAPI) program section should really be listed first in the Core Survey Field Manual. Why?  Because an effective, robust QAPI program is key to all of the Core survey requirements. This includes developing effective policies and procedures, monitoring all operations/services, and taking action when needed to achieve and sustain improvements.

CMS’ purpose for QAPI review is: “To verify that the facility’s QAPI program is sufficiently comprehensive and robust to monitor all facility operations/services, recognize when performance improvement is indicated, take action to attain and sustain improvements, and support a facility-wide 'Culture of Safety' that assures optimum patient safety.”

The Core Survey for QAPI review is divided into three general segments:

Segment I: Review of the systems in place to monitor care and facility operations. The surveyor will review clinical and operational indicators and oversight of technical operations and include the facility’s audits of practice of infection control, water testing, dialysate preparation, and reprocessing.

Segment II: Review of how the facility proactively monitors patient outcomes and recognizes issues and prioritizes and addresses problematic areas, trends in patient deaths, infections, and medical errors/adverse occurrences. Included in this segment is a review to determine if the facility has taken action to follow up on the areas identified during the survey activities as data-driven focus areas that are problems/risks.

When prioritizing performance improvement action plans, remember these steps: 1) look at the impact on patient safety, 2) consider the severity of the problem, 3) consider the prevalence of the problem, and 4) consider the impact on clinical outcomes.

Segment III: Culture of Safety review: Ensure that a robust facility-wide culture of safety is present through interviews with staff and patients. This means that patients and staff are engaged in the systems of care delivery and that all feel safe reporting any problem or concern, with no fear of retribution.

There are survey QAPI worksheets available for your use in the Core Survey Field Manual under Tab 16, pgs 1-10 to assist with self-inspection of this critical area.

Exit conference

This meeting is to facilitate communication and collaboration with both the surveyors and the facility team. The ultimate goal is to provide a safe and open environment for both patients and staff.

Summary

My experience with facilities that have been through a Core Survey is that if an issue or concern arises during a survey, the surveyor will ask to see the QAPI meeting minutes. If in the QAPI minutes, the interdisciplinary team has identified the concern, developed an action plan, and is working toward a remedy for that concern, the concern may not be cited as a deficient practice. Identifying your own problems is better than a “get out of jail free” card, because it allows you to proactively take actions and keep patients safe. The Core Survey process supports collaboration with CMS in identifying our own areas of concern and working toward safe and quality solutions.

I am optimistic about the future of dialysis and the delivery of care. One way to embrace these concepts is to sit down at the chair side and ask each patient, “How can we do better?” Listening, and taking action will drive care forward by using a strategic and collaborative approach.

References

1.     Layman-Amato R, Curtis J, Payne GM. Water treatment for hemodialysis: An update, Neph Nurs Jrnl, 40 (5) September-October, 2013

2.     Punch D. Collaboration key aspect of new ESRD Core Survey. Neph News Iss. 28 (4), 2014.