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Hospitals have both state and federal regulations to follow. The state regulations they have to follow depend, of course, on the state in which they are located. Federal regulations are those they all must follow. Very often you will find states tend to adopt the federal regulations as their own?with some minor changes. This may or may not be a “good thing”. Some of the Federal regulations are so very vague you could drive a truck through them. This is true for some state regulations too.?Some regulations are very outdated.

One example is in California. The California Code of Regulations. at  70737(a) requires hospitals to report “Any occurrence such as epidemic outbreak, poisoning, fire, major accident, disaster, other catastrophe or unusual occurrence which threatens the welfare, safety or health of patients, personnel or visitors shall be reported as soon as reasonably practical, either by telephone or by telegraph to the local health officer and to the Department.”

Notice the telegraph – when was the last time you sent something to anyone, much less the state, via telegraph? There is no mention of faxes much less e-mail, both forms of communication which are becoming more acceptable. Can you imagine the day that you can text message a complaint into the state even as you see a situation happening?

You will find this same allowance about telegraphs for other types of health facilities at 71535(a); 72541, 73539, 75053, 75339, 76513(g), 76551(a), 76913(g), 76923(a)…. And I could go on and on, but I think you get the idea.

So the regulations (whether state or federal) don’t always keep up with the changing times and needs of the healthcare consumer.

Let’s talk a bit about those Federal regulations that all hospitals in the United States must follow. Well, let me take that back a bit, there are some exceptions. Not all hospitals have to follow the Federal regulations. So you are asking, which ones don’t?

Those hospitals that don’t receive Medicare or Medicaid payments don’t need to follow the Federal regulations. As you can imagine, most hospitals accept Medicare and Medicaid. That is often the lifeblood of the hospitals. Most insurance companies follow right along with Medicare and Medicaid, so the Federal requirements do apply in most cases. For those hospitals that are totally private pay – they would not have to follow the Federal regulations, but they would still have to follow their state’s licensing regulations.

Ahh, again, another piece in the puzzle….Did you know, Ohio is the only state that doesn’t license its hospitals. But, I digress…..

The Federal Regulations for hospitals are located in the Code of Federal Regulations, Title 22, Part 482.

Hospitals that do want to receive Medicare and Medicaid monies are required to be in compliance with the Medicare Conditions of Participation (COPs). In order to determine if the Hospital is in fact in compliance with the conditions of participation a survey is conducted. The surveys are unannounced and are conducted following protocols and guidelines set forth by CMS (The Centers for Medicare and Medicaid Services).

The survey protocols and Interpretive Guidelines (IGs) clarify and/or explain the intent of the regulations and all surveyors (some states may call them evaluators or investigators) are required to use them in assessing compliance with Federal requirements. They are there to help direct the surveyor’s attention to certain avenues for investigation while preparing for the survey, ?while conducting the survey, and while evaluating the findings of the survey.

The hospital survey is conducted to determine whether the facility is in compliance with the regulations. Deficiencies are based on a violation of the regulations, which, in turn, is to be based on observations of the hospital’s performance or practices.

We will discuss more about Interpretive Guidelines at another time. Suffice it to say for now there are interpretive guidelines for all the facility types. Some are more helpful than others, and CMS is revising many of them.

The COPs for hospitals are organized into the following general categories:

  • Compliance with Federal, State, and Local Laws
  • Governing Body
  • Patient’s Rights
  • Quality Assessment and Performance Improvement
  • Medical Staff
  • Nursing Services
  • Medical Record Services
  • Pharmaceutical Services
  • Radiologic Services
  • Laboratory Services
  • Food and Dietetic Services
  • Utilization Review
  • Physical Environment
  • Infection Control
  • Discharge Planning
  • Organ, Tissue, and Eye Procurement
  • Surgical Services
  • Anesthesia Services
  • Nuclear Medicine Services
  • Outpatient Services
  • Emergency Services
  • Rehabilitation Services
  • Respiratory Services

So there you have it, the COPs for the hospital. There is so much more to this, things that will help you be a better informed consumer – so come on back and keep learning. Be safe, know what you need to know!

JL

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For Federal surveys, hospitals and nursing homes have a different rating or grading system. In fact, nursing homes have a different system than all the other healthcare facility types. Nursing homes have a Severity and Scope level (from A through L). Hospitals and other healthcare provider types have standards and conditions of participation.

We will talk about Conditions of Participation and standards in the future. Today, let’s look at Severity and Scope, which is a system of rating the seriousness of deficiencies. A “deficiency” is a regulatory requirement that a facility fails to meet; or as it is officially put “is found not met” during the survey.

The Severity and Scope system is national and is used by all state survey agencies and the Centers for Medicare and Medicaid Services (CMS) when conducting nursing home Medicare and Medicaid certification surveys. For each deficiency, the survey team first determines the level of harm (severity) to the resident or resident(s) involved and then determines the scope of the problem within the nursing home. The team then assigns an alphabetical Severity and Scope value, A through L, to the deficiency. “A” is the least serious and “L” is one of the most serious ratings. It’s kind of like the grade on a report card except “A” doesn’t mean 100%; and “L” isn’t a grade any of us ever had on our report cards.

This is a visual representation:

Immediate jeopardy to resident health & safety

Level 4

J

K

L

Actual harm that is not immediate jeopardy

Level 3

G

H

I

No actual harm, with potential for more than minimal harm

Level 2

D

E

F

No actual harm, with potential for minimal harm

Level 1

A

B

C

Isolated

Pattern

Widespread

Here is how it is used.

First the team decides what “Level” the deficiency falls in.

Level 1 (the green row) means there was no actual harm but there was a potential for minimal harm. In other words there was no more than minor negative impact.

Level 2 (the yellow row) means there was no actual harm, but there was a potential for more than minimal harm that is not an immediate jeopardy. In other words there was no more than minimal physical, mental, and/or psychosocial discomfort as a result of the deficient practice. There is a potential to compromise the resident’s ability to maintain and/or reach his/her highest practicable physical, mental and/or psychosocial well being.

Level 3 (the orange row) means there was actual harm that is not immediate jeopardy. In other words there was a negative or bad outcome. The resident ended up being clinically compromised, or experienced deterioration or harm, or his/her ability to maintain &/or reach greatest practicable well-being was compromised.

Level 4 (the red row) means the facility’s deficient practice has caused or is likely to cause serious injury, harm, impairment, or death and therefore requires immediate action/correction. In this case the pattern of the facility’s practice establishes a reasonable degree of predictability of similar actions, situation, practices, or incidents occurring in the future if they don’t fix it right now. Anything in this row is called Immediate Jeopardy.

Once the team has made a determination of the severity they must then determine the scope. That means how many people, staff, or areas it affected, i.e. how prevalent or widespread the problem is.

Isolated (the first column) means:

  • One or a very limited number of residents are affected
  • One or a very limited number of staff are involved,
  • The situation had occurred only occasionally or in a very limited number of locations

 Pattern (the second column) means

  • More than a very limited number of residents are affected,
  • More than a very limited number of staff are involved,
  • Situation has occurred in several locations,
  • The same resident(s) have been affected by repeated occurrences of the same deficient practice.

Widespread (the third column) means

  • The problems causing the deficiencies are pervasive in the facility or
  • There is a systemic failure that has the potential to affect a large portion or all of the facility’s residents.

So taking all this together here is how you explain the scores (grades)

  • A – Isolated/Potential for minimal harm – Least serious rating and is isolated to the fewest number of residents, staff, or occurrences. This deficiency has the potential for causing no more than a minor impact on the resident(s).
  • B– Pattern/Potential for minimal harm – Least serious deficiency but affects more than a limited number of residents, staff, or occurrences. This deficiency has the potential for causing no more than minor negative impact on the resident(s) and was not found to be throughout the facility.
  • C– Widespread/Potential for minimal harm – Least serious deficiency but was found to be widespread throughout the facility and/or has the potential to affect a large portion or all of the residents. This deficiency has the potential to affect a large portion or all of the residents, but has the potential for causing no more than a minor negative impact on the resident(s).
  • D– Isolated/Minimal harm or potential for actual harm – This is a less serious (but not lowest level) deficiency and is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential to negatively affect the resident’s ability to achieve his/her highest functional status.
  • E– Pattern/Minimal harm or potential for actual harm – This is a less serious (but not lowest level) deficiency and affects more than a limited number of residents, staff, or occurrences. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the resident’s ability to achieve his/her highest functional status. This deficiency was not found to be throughout the facility.
  • F– Widespread/Minimal harm or potential for actual harm – This is a less serious (but not lowest level) deficiency but was found to be widespread throughout the facility and/or has the potential to affect a large portion or all the residents. This deficiency is one that results in minimal discomfort to the resident or has the potential (not yet realized) to negatively affect the residents’ ability to achieve his/her highest functional status.
  • G– Isolated/Actual harm – This is a more serious deficiency but is isolated to the fewest number of residents, staff, or occurrences. This deficiency results in a negative outcome that has negatively affected the resident’s ability to achieve his/her highest functional status.
  • H– Pattern/Actual harm – This is a more serious deficiency and affects more than a limited number of residents, staff, or occurrences. This deficiency results in a negative outcome that has negatively affected the resident’s ability to achieve his/her highest functional status. This deficiency was not found to be throughout this facility.
  • I– Widespread/Actual harm – This is a more serious deficiency that was found to be widespread throughout the facility and/or has the potential to affect a large portion or all the residents. This deficiency results in a negative outcome that has negatively affected the residents’ ability to achieve his/her highest functional status.
  • J– Isolated/Immediate Jeopardy – This is the most serious deficiency although it is isolated to the fewest number of residents, staff, or occurrences. This deficiency is one which places the residents in immediate jeopardy as it has caused (or is likely to cause) serious injury, harm, impairment, or death to a resident receiving care in the facility. Immediate corrective action is necessary when this deficiency is identified.
  • K– Pattern/Immediate Jeopardy – This is the most serious deficiency and affects more than a limited number of residents, staff, or occurrences. This deficiency is one which places the residents in immediate jeopardy as it has caused (or is likely to cause) serious injury, harm, impairment, or death to a resident receiving care in the facility. Immediate corrective action is necessary when this deficiency is identified. This deficiency was not found to be throughout the facility.
  • L– Widespread/Immediate Jeopardy – This is the most serious deficiency and was found to be widespread throughout the facility and/or has the potential to affect a large portion or all the residents. This deficiency is one which places the residents in immediate jeopardy as it has caused (or is likely to cause) serious injury, harm, impairment, or death to a resident receiving care in the facility. Immediate corrective action is necessary when this deficiency is identified.

There you go, a quick explanation of what those “grades” you see mean. Let me know if you have any questions and leave your comments. They will help me develop posts to answer questions you have.

JL

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