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The Road to Compliance Starts with a Gap Analysis

On June 29, 2022, the Centers for Medicare and Medicaid Services (CMS) released updates to the surveyor guidance in Appendix PP of the State Operations Manual. Some are minor technical updates, while others introduce entirely new guidance. Given the enormity of the updates, along with the other challenges facility leaders face, finding the path to compliance may seem difficult. This article will provide an overview of how gap analyses can give facility leaders critical information, comparing current conditions to what compliance must be by the October 24, 2022, deadline. By charting out the impediments along the way, nurse leaders can guide their teams to the right road and drive the facility toward compliance.

Gap Analysis Defined

A gap analysis, when focused on regulatory compliance, is a method of assessing current performance against regulatory requirements. The aim is to discover any weaknesses or gaps in compliance and identify actions necessary to achieve compliance. This information will help facility leaders prioritize the issues that require an owner and an action plan.

Steps of the Gap Analysis

Become Informed

To begin a gap analysis focused on compliance, it is necessary to know the regulatory updates. With broad changes in the guidance and limited time to comply, facility leaders must designate enough time in their schedule to complete training, understand the updates, and develop the action plan. While the administrator must be knowledgeable on all the updates, other facility leaders can focus on learning the updates most relevant to their positions.

In addition to learning the updates to the guidance, facility leaders may also need to research sources of expert information, such as clinical practice guidelines or guidance from other federal agencies like the Food and Drug Administration or the Centers for Disease Control and Prevention. Because the guidance frequently comments that facilities should follow standards of care and evidence-based care, such research is necessary to gather the expert information.

The AAPACN October 2022 webpage offers many resources to guide facility leaders through the regulatory changes. For example, the AAPACN Survey Solutions on Demand Series provides an overview of processes in need of revision, and an article, Appendix PP Revisions in the State Operations Manual: Breaking Down Key Changes, synthesizes F-tag changes.

Compare the Current State to the Desired Future State

After the leadership team completes training and research to gain knowledge, they must compare the facility’s current state of performance and operations to the desired future state that complies with the requirements. There are methods to organize this analysis. For example, effective October 24, 2022, facilities must clean and disinfect equipment used for foot care after each use according to CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities. To determine if this is currently happening, facility leaders might observe care and note any gaps between current practice and the coming standards. The table below provides descriptions of additional methods.

MethodDescription
ObservationObserve staff performing various tasks, including providing bedside care. Compare what is happening to what the updates require.
Audit and reviewExamine or inspect records, including employee files, policies and procedures, and medical records. Compare current content to what the updates require.
Probes, key elements of noncompliance, and critical element pathwaysApply the same tools and guidance surveyors use to investigate compliance with regulations.

After determining what gaps are separating the current and future states of compliance, summarize the findings. This will assist facility leaders to proceed to the next step of the gap analysis.

Actions to Gain Compliance

Next, facility leaders will need to determine what actions are necessary to comply with the updates. For example, the updated guidance requires facilities to conduct a pressure injury risk assessment upon admission, weekly for the first four weeks, and then quarterly, or when a change in condition occurs. This is a significant departure from the current accepted standard of practice of monthly pressure injury risk assessments. If the current policy and procedure does not reflect this timeline, they will need to be revised. Nurses must be educated about the change, and process revisions will need to be implemented. To comply with the updates, facility leaders may need to implement:

Education – Teaching staff new information they need to work or provide care differently

Policy and procedure – Revisions that provide staff new rules to practice by and the guidance to follow those rules

Process – Changes to a series of repeatable steps that must be altered to produce a new outcome

Establish Priorities

Depending upon the gap between the current state and the desired state, and the availability of resources to implement the actions to achieve compliance, it may be necessary to prioritize certain F-tags. Address first the high risk, high volume, and problem-prone areas of noncompliance. High risk would include issues such as noncompliance with abuse and neglect or other non-compliance that could result in substandard care. Although the Prioritization Worksheet for Performance Improvement Projects is intended to assist QAA Committees to prioritize which performance improvement project they will charter, it can also be used to prioritize the F-tags that the facility will focus on first.

Assign an Owner

Each F-tag will need a facility leader as the owner, or person responsible for ensuring the action is executed and achieving compliance. The owner will likely need to coordinate with others to implement actions. For example, if a policy and procedure need revision, the owner may need to consult an attorney, a corporate risk manager, and/or the medical director. Consider that Appendix PP now states that F607 will require facilities to:

Develop written policies and procedures that define how staff will communicate and coordinate situations of abuse, neglect, misappropriation of resident property, and exploitation with the QAPI program under §483.75. Cases of physical or sexual abuse, for example by facility staff or other residents, always require corrective action and tracking by the QAA Committee, at §483.75(g)(2).

This is a substantial change if a facility does not currently have such a policy and procedure in place, given the gravity of confirmed or suspected abuse, neglect, and exploitation. The owner for this may be the Administrator, but he or she must collaborate with other stakeholders. Changes will require coordination with the QAA Committee as well as anyone else designated with responsible for policy and procedure development and implementation, as well as consultation with QAPI governance.

Template of a Gap Analysis

Below is a basic template of a gap analysis with one example. Nurse leaders can replicate this template and use it to guide and capture a facility’s gap analysis for regulatory compliance.

F tagGaps in complianceActions to gain compliance: education, policy and procedure revisions, process changesPriority level: high, medium, lowOwner
F812Policy and procedure for food handling do not require CNAs to use gloves when touching food.
CNAs are not using gloves to handle food when preparing plates.
Policy and procedure revision for food handling
Education for all staff responsible for preparing plates and handling food
Process changes – CNAs applying gloves when touching food and housekeeping stocking more gloves in dining room
MediumDietary Manager

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