A Q&A with CMS: Getting up to speed on inspection reports

The Centers for Medicare and Medicaid Services answers questions about the inspection process and the 2567 forms used to complete the inspections. Quick links to answers below:

These reports have always been available to the public, right? Until now, how could someone get a copy of a hospital’s inspection report?

Correct. Until now, a request for an inspection report (or, in federal parlance, a survey) conducted on behalf of the Centers for Medicare and Medicaid Services (CMS) could be made to the state agency that conducts inspections on behalf of CMS, which we refer to as a local state survey agency, or CMS regional office.

This process is described in a CMS memo entitled “Release of Form CMS-2567 (Statement of Deficiencies) by State Survey Agencies (SAs),” available here.

See also 42 Code of Federal Regulations § 401.133, available here.

These reports, as we understand it, are called 2567 forms. How did they get this name?

A number is typically assigned to the official forms a federal agency uses. The “official” name for this document is “Form CMS-2567, Statement of Deficiencies and Plans of Correction.”

How are the 2567 forms derived?

When state survey agencies conduct surveys of acute hospitals, critical access hospitals (CAHs) or psychiatric hospitals on behalf of CMS, they are assessing compliance with Medicare health and safety regulations for those hospitals, the “Conditions of Participation (CoPs).” The surveyors prepare their survey report on an electronic version of the Form CMS-2567 available in a CMS data system that supports survey work. This system contains the text of the regulations, broken down by surveyors into smaller sections called “tags” to facilitate the work of the surveyors to identify regulatory deficiencies and choose the applicable tag. The system generates a Form CMS-2567 with the regulatory text associated with that tag, and then surveyors enter a summary of the evidence for the noncompliance they observed. The survey report is released to the hospital which, depending on the survey findings, may be required to return the Form CMS-2567 with a plan of correction for each area of deficiency.

When are Plans of Correction (POCs) Required?

Non-deemed hospitals always have to do plans of correction.

Deemed hospitals generally do them only when they have condition-level deficiencies.

However, some deemed hospitals choose to do a POC even when not required, because they are aware the 2567 can be released and they want their POC released as well.

Does CMS inspect all hospitals in the U.S.? If not, please explain.

No. Only hospitals that choose to participate in Medicare and/or Medicaid are subject to federal surveys to assess compliance with the CMS Conditions of Participation (CoPs). Medicaid regulations require hospitals to comply with the Medicare CoPs. Veterans Administration, military and prison hospitals may not participate in Medicare or Medicaid, and therefore are also not inspected by CMS.

In addition, federal law permits participating hospitals that are accredited by a CMS- approved Medicare accreditation program to be “deemed” to be in compliance with the CMS CoPs. Eighty- five percent of acute hospitals and 32 percent of critical access hospitals participate in this manner. They are surveyed by their accrediting organization at regular intervals.

Generally surveys of non-accredited hospitals to assess compliance with the Medicare CoPs are performed by a state survey agency on CMS’s behalf. CMS may also direct the state survey agency to conduct a survey in an accredited hospital in certain situations, such as when complaints allege serious deficiencies.

Since most hospitals have deemed status on the basis of their accreditation, the vast majority of the survey reports being made available were generated from focused surveys responding to serious complaints.

By law, reports generated by accrediting organizations are not considered public records.

How often are hospitals inspected?

On average hospitals are reassessed every three to four years for their compliance with all of the CoPs.

Focused surveys to investigate complaints may occur at any time.

Is there any variation by state? If so, please explain.

There are uniform national policies in place for surveys conducted to assess compliance with the CoPs. CMS conducts training and other activities on an ongoing basis to improve consistency and reduce local or regional variation in how these federal policies are implemented.

It should be noted that many of the state survey agencies that conduct surveys on behalf of CMS under federal law are also responsible for enforcing their individual state licensure laws, which vary. States may use the same survey to assess both federal and state regulatory compliance. However, they must report their federal survey findings separately.

What types of problems do you look for in hospitals?

On the periodic surveys, compliance with all of the hospitals’ CoPs are to be assessed. The CoPs address areas such as nursing services, infection control, medical staff requirements, emergency services, pharmaceutical services, physical plant safety and maintenance, etc. In a survey done to investigate a complaint, the areas assessed depend on the nature of the complaint.

Are there differences in the level of seriousness or a rating system akin to what is used for nursing home violations?

For hospitals the statutory and regulatory requirements are that they be in “substantial” compliance with each Condition of Participation (CoP). There are two different types of citations that CMS can issue. The more serious, known as “condition-level” mean that a hospital is not in substantial compliance with the CoP. A “standard-level” deficiency means that the hospital may be out of compliance with one aspect of the regulations, but is considered less severe than condition-level. There is an additional level of non compliance called “immediate jeopardy” that arises when surveyors determine that the hospital’s deviation from regulatory standards constitutes an immediate threat to patients’ health and safety. An immediate jeopardy determination forces a hospital to correct the underlying problems quickly. Termination from participation in Medicare and Medicaid can result in 23 days if the hospital fails to correct the problems.

If a hospital is not in substantial compliance, the only enforcement remedy, if the facility fails to make timely correction, is termination of its participation in Medicare and Medicaid. There is no authority to issue civil monetary penalties based on a detailed rating of the scope and severity of deficiencies, as exists for nursing homes.

What is the difference between a standard-level deficiency and one that is labeled as condition-level?

As indicated above, a condition-level deficiency means that for that particular CoP the hospital is not in substantial compliance. There can be noncompliance with a CoP regulatory standard that does not rise to the level of substantial noncompliance with the condition. The manner and degree of the noncompliance is considered to determine whether there is substantial compliance or not.

What is an immediate jeopardy?

42 CFR §489.3 defines immediate jeopardy as “a situation in which the provider’s non-compliance with one or more of the requirements of participation has caused or is likely to cause, serious injury, harm, impairment, or death ...” When investigating a potential immediate jeopardy situation, surveyors must find that serious harm has occurred or has the potential to occur, that the threat of future harm is immediate, and that there is facility culpability that resulted in the situation.

As we understand it, deficiencies can be identified during regular inspections (known as surveys), as well as complaint visits. What’s the difference between the two? And are both included in the data being released by CMS?

To clarify, any on-site inspection is considered a survey. A complaint survey is a more focused survey to investigate compliance with CoPs related to the nature of the complaint. As stated above, surveys of compliance with all CoPs occur on average every three to four years for non-deemed hospitals. Each year, CMS also directs the state survey agencies to conduct full surveys of a sample of accredited hospitals as part of its assessment of performance of hospitals accreditation organization.

Currently CMS has plans only to release deficiencies cited on complaint surveys.

Does CMS have a team of inspectors that visit hospitals? If not, who does the agency rely on to conduct inspections on its behalf?

CMS has an agreement with each state to conduct federal surveys in that state, and the majority of federal surveys are performed by state survey agencies. In some situations, staff from a CMS regional office or contractors are assigned to conduct survey activities.

If a state conducts an inspection on behalf of CMS, is it still considered a federal inspection?

Yes.

What constitutes a complaint? Does a person have to fill out a form to complain?

A complaint is an allegation of noncompliance with federal and/or state requirements. Complaints regarding the care, treatment and services provided to patients can come from a variety of sources, including the patients themselves, family members, staff in hospitals, other hospitals, concerned citizens, other public agencies, or media reports. Complaints may be submitted by phone or in writing anonymously.

While some state survey agencies may have developed their own forms to document complaints, federal complaints need not be in writing and no form is required.

If a patient files a complaint with an accrediting group, i.e. The Joint Commission, will the reports you’re releasing include information on that? If not, why not?

No. By law, with the exception of Home Health Agencies, CMS may not release the results of an accreditation organization survey unless it is using those results in order to take enforcement action against the hospital. CMS generally takes enforcement action based on state survey agency surveys. If an accreditation organization informs CMS of serious quality of care issues in a hospital, CMS directs the state survey agency to conduct a survey and takes enforcement action if needed on the basis of that survey.

When an inspection is complete, is a hospital given a chance to respond? If so, how long?

The hospital must submit a plan of correction for any identified deficiencies within 10 calendar days of receiving the Form CMS-2567 report.

If a hospital believes a finding is in error, how would it challenge the finding?

If a hospital believes a survey finding was factually inaccurate, it may include supporting documentation for its claim in its plan of correction. CMS may revise the Form CMS-2567 if it agrees the original finding was not factually supported.

Are hospitals’ plans of correction included in the data you’ve released? If not, how should a reporter or member of the public get them?

Hospitals’ plans of correction are not currently included. Those plans can be obtained from the hospitals or from the state survey agencies.

What is the approval process for a plan of correction?

The hospital submits its plan of correction for review. If it is not acceptable, it is asked to submit a revised plan. Note that an accredited hospital is not required to submit a plan of correction in response to a survey with only standard-level findings, although it may voluntarily do so. Such voluntary plans are not reviewed for acceptability.

What’s the process for inspection findings to go from a state agency to the feds?

For non-accredited hospitals the state survey agency’s findings are final; for an accredited hospital where the state survey agency finds condition-level deficiencies, the CMS regional office must review the report and make the determination whether or not there is substantial noncompliance. The state agency enters these findings into the federal database.

Are there federal fines against hospitals that violate CMS Conditions of Participation?

No. CMS has the legal authority to terminate a hospital’s Medicare agreement if it does not comply with one of more of the CoPs, but there is no statutory authority to levy civil monetary penalties.