When an ASC has a difficult survey with numerous deficiencies, receives an Immediate Jeopardy finding or a series of condition-level citations, suddenly loses its administrator or Director of Nursing, needs interim leadership, or receives a notice that places its license, Medicare certification or accreditation at risk, the response has to begin immediately.

These are different assignments with different time commitments. A leadership change may begin with a quick review of the center’s current status and continue through recruitment, transition and training. A serious survey requires a Plan of Correction that may be due very quickly, preparation for a revisit and continued monitoring that may last a year. A formal regulatory notice will have its own deadlines and required response.

The common first steps are to establish the facts, identify the deadlines and determine who has authority to make decisions. After that initial assessment, the work must be organized around the specific problem.

Begin with an experienced assessment

The first step is to determine the actual status of the organization and the size of the problem. That requires review of the source documents, discussions with the people who know how the center operates and an evaluation of the work that was being handled before the crisis occurred.

The assessment will be different for each situation. A leadership transition requires a review of the center’s administrative and clinical operations, outstanding regulatory work, current leadership coverage and the experience of the people who may assume additional responsibilities. A difficult survey requires a detailed analysis of the findings, the requirements cited, the center’s actual practice, the response deadlines, the evidence available and the likelihood of a revisit. A notice involving licensure, certification or accreditation requires a close review of the action being considered and the process available to the center.

This work requires knowledge of ASC operations, regulatory requirements and the survey process. The purpose is to determine what needs immediate attention, what can be addressed over time, what resources are required and who is qualified to perform the work. The resulting plan may include an urgent regulatory response, interim leadership, preparation for another survey, recruitment, staff development and long-term monitoring.

A difficult survey, Immediate Jeopardy or condition-level findings

An ASC does not need to fail a survey to be facing a serious crisis. A more common situation is a survey with numerous deficiencies, an Immediate Jeopardy finding, or a series of condition-level citations that will require a revisit. The volume and severity of the findings may affect certification or accreditation and can place substantial demands on the center’s leadership and staff.

Review each finding against the exact requirement cited and the facts stated in the report. Then compare the finding with the center’s policies, records and actual practice.

For each finding, decide which of the following applies:

  • An actual compliance problem that needs correction
  • A process that occurred but was not documented
  • Documentation that existed but was not reviewed during the survey
  • A misunderstanding of the center’s process or scope of services
  • A possible misapplication or interpretation of the requirement

Challenge only those findings that can be addressed through the available objection, reconsideration or appeal process and supported by the requirement, the facts and the center’s records. An unsupported objection wastes time and may weaken the center’s position on other findings. An inaccurate finding should receive the same careful review as a finding that requires correction.

When correction is required, the Plan of Correction should identify what will be changed, who is responsible, when the correction will be completed and how the center will monitor the change. Education may be part of the correction, but a single in-service does not demonstrate that a process has been corrected. Policies, daily practice, documentation, monitoring and Governing Body oversight need to agree.

The work continues after the Plan of Correction is submitted. The center must prepare for the revisit, organize the evidence showing that each correction was implemented and make sure employees can explain the revised process. Monitoring will usually continue for approximately a year so the Governing Body can confirm that the correction remains in place and that the same problem has not returned. A serious survey therefore begins with an urgent response but may require a long period of follow-up.

In some cases, survey findings, enforcement actions or related documents may become publicly available. If that possibility exists, the ASC should determine what may be disclosed and prepare an accurate explanation of what happened, what has been corrected and how the correction is being monitored. Communications about serious findings should be coordinated with legal counsel and the organization’s regulatory advisors.

A change in leadership

The unexpected departure of an administrator, Director of Nursing or other key leader can interrupt the work that keeps the ASC operating and compliant. In many small ASCs, one individual may have managed regulatory correspondence, credentialing files, QAPI reports, infection control records, policy updates, renewals and Governing Body materials. Leadership may not realize how much information was held by that person until another employee needs it.

This situation requires a rapid review of the organization’s current status. The Governing Body needs to know what is complete, what is overdue, what deadlines are approaching and which responsibilities were understood or performed only by the departing leader. The result should be a gap analysis that identifies the work requiring immediate attention and gives the next leader an accurate starting point.

The Governing Body should also determine who has authority to make administrative and clinical decisions and if interim leadership is required. The review should include:

  • Open survey findings and Plans of Correction
  • Pending license, accreditation and certification renewals
  • Required state and federal reports
  • Credentialing and privileging files that are awaiting action
  • QAPI, infection control and peer review activities in progress
  • Policy, personnel and committee records
  • Passwords, portal access and contact information for regulators and accrediting organizations
  • Scheduled Governing Body and medical staff actions

The individual covering the position needs defined authority, the information needed to make decisions and access to the center’s records and reporting systems. A temporary appointment on the organizational chart does not address those operational requirements by itself.

Once the immediate risks are controlled, the center must decide how leadership will be restored. That may involve bringing in a new administrator or Director of Nursing, promoting a current employee, or dividing responsibilities while an internal candidate is trained. Each choice has a different schedule and level of support. Ambulatory Healthcare Strategies can assist with the initial organizational review, preparation of the gap analysis, interim leadership, the transition to a newly hired leader, and the training and support of an employee promoted from within.

A license, certification or accreditation problem

A notice involving state licensure, Medicare certification, accreditation or deemed status must be read closely because the notice establishes the response process and the time available. The first assignment may involve an immediate submission, conference, objection, Plan of Correction or preparation for another survey. The center may also need legal counsel, particularly when the notice could affect its authority to operate or receive payment.

The compliance work will depend on the findings and the action being considered by the agency or accrediting organization. Managing the response requires coordination of the deadlines, required submissions, corrective work, responsible individuals and evidence. The Governing Body should receive frequent reports until the immediate risk has been addressed and should continue oversight for as long as the correction remains under review.

If your ASC is already facing a response deadline or needs immediate leadership support, request urgent assistance at ah-strategies.com/sos or call 585-594-1167.

The Governing Body must remain involved

Under 42 CFR §416.41, the ASC must have a Governing Body that assumes full legal responsibility for determining, implementing and monitoring the policies governing the center’s operation. A serious survey, leadership or regulatory problem therefore requires a formal Governing Body response and documented oversight.

The Governing Body should understand what happened, the deadlines that apply, who is managing the response, what resources are needed and how completion will be verified. Depending on the problem, the center may also need assistance from legal counsel, its accrediting organization, state regulators, insurance representatives or other specialists. The regulatory consultant’s work should be coordinated with those resources.

Be careful with quick corrections

Under deadline pressure, it is tempting to issue a new policy, conduct an in-service and consider the matter closed. That approach often creates a response on paper without changing the process that caused the finding.

A complete correction generally includes an accurate policy, education for the people responsible for the process, documentation showing that the new process was implemented, monitoring to confirm that it continues to work and review by the Governing Body when required. The evidence should be organized while the correction is being completed. Waiting until the response is due to assemble the evidence creates unnecessary risk.

When outside assistance is appropriate

An ASC may need outside help when the response requires experience the center does not have, when key leaders are no longer available or when the workload cannot be managed without pulling staff away from patient care. An independent review can also help the Governing Body determine how serious the problem is and which items need attention first.

Consider requesting help if the center has received numerous deficiencies, Immediate Jeopardy or multiple condition-level citations, a response deadline is approaching, a revisit is expected, interim leadership is needed, or licensure, Medicare certification, accreditation or deemed status may be at risk. The initial review should define the type of help required and the expected time commitment. Some centers will need a short period of intensive work. Others will need interim leadership, preparation for another survey or monitoring and consultation for the following year.

The consultant should be able to work with the center on the actual correction, documentation and follow-up. A report that identifies problems but leaves the ASC to resolve all of them alone has limited value in an urgent situation. These assignments may require several types of expertise at the same time, particularly when survey findings involve administration, nursing, infection control, life safety, credentialing, QAPI and Governing Body oversight.

About the ASC SOS program

We added ASC SOS to the Ambulatory Healthcare Strategies website for ASCs dealing with serious, time-sensitive situations. The request form asks what happened, how soon help is needed and what the center wants to change. The request goes directly to my inbox with an urgent flag, and I review it personally.

The first discussion is used to understand the situation, the deadlines and the type of support required. ASC SOS is not one standard package. The assignment is organized around the specific problem and may range from an urgent review and response to a longer engagement involving leadership transition, survey preparation and ongoing monitoring.

ASC SOS is supported by the full resource base of Ambulatory Healthcare Strategies. We are a 25-person organization, not a single consultant or a small group trying to cover every subject. Our staff includes five surveyors and some of the nation’s leading experts in ambulatory surgery center regulation and operations. The team also includes experienced professionals in administration, nursing, infection control, life safety, finance, business-office operations, education and regulatory compliance.

Ambulatory Healthcare Strategies is independently owned. We are not owned by private equity or a publicly held company. Our organization is large enough to bring specialized resources into an assignment, but we remain a tight-knit group whose decisions are made by the people working directly with the ASC. Our priority is solving the center’s problem, not maximizing returns for outside investors.

We assign the people needed for the situation. A difficult survey with serious findings may require survey interpretation, clinical review, infection control, life safety, policy work, staff education, assistance with the Plan of Correction, preparation for the revisit and long-term monitoring. A leadership change may require administrative and clinical gap assessments, interim coverage, financial review, recruitment support and training for the person taking the position. Those resources are available within the same organization and can work from one plan.

Ambulatory Healthcare Strategies is known to surveyors as an organization that solves problems. Our work addresses the policies, operating processes, education, documentation, monitoring and Governing Body oversight that caused or allowed the problem. The job is not finished when a response is submitted or a Plan of Correction is accepted. The correction must be operating in the center, supported by evidence and monitored long enough to show that it continues to work. We fix the problem; we do not apply a temporary bandage to get the ASC through the next survey.

We cannot promise immediate availability. If our team cannot meet the center’s timeframe, we will say so. When we accept an assignment, we bring the appropriate resources into the work and remain involved for the period the situation requires.

The program is intended for ASCs that want to correct the problem and establish a process that will continue after the immediate deadline has passed.

Request urgent support: ah-strategies.com/sos

If you need to speak with us, call 585-594-1167.

John J. Goehle, MBA, CASC
Ambulatory Healthcare Strategies

This article provides general operational information and does not replace advice from legal counsel, regulators, CMS or an accrediting organization.