Welcome to the Law Med Blog special Anesthesia Standard of Care Page. Here you will find an archive of all of our articles related to the standard of care in Anesthesia. Be sure to explore all 3 pages.

Hospital Policies Can Create a Standard of Care and Surprise Liability

Last modified on 2010-09-27 10:26:39 GMT. 0 comments. Top.

Many health care workers might read their hospital’s policy and procedure manual in bits and pieces as the need arises, relying on fellow staff members to provide guidance as to ‘how things are done’. They do so at their, and the hospital’s, peril. Institutional policies and procedures quite often create a ‘local’ standard of care which if violated allow claims of negligence which otherwise might not be valid. It does not matter if an individual is doing things the way they have ‘always’ been done and the same way that the rest of the staff does them. If the P & P manual says things are to be done another way, patients can hold you to it.

An excellent example of how a specific hospital policy can wreak havoc with the professional is contained in our series on Dr. Bernstein and the Maryland Board of Physicians. This article will  directly address the P & P issue, making it a much shorter read. The practice of anesthesia is very vulnerable to P & P issues so we’ll use it as an example.

Ohio, 2001. Joanne Luettke is diagnosed with a paraesophageal hernia and scheduled for laparoscopic surgical repair at St. Vincent Mercy Medical Center in Toledo, Ohio.In the pre-op area Student Nurse Anesthetist Sherrie Lynn introduces herself as a registered nurse from the anesthesia department, and informs the patient she will be working with nurse anesthetist Joan Eischen and anesthesiologist Dr. Dooner, and that they comprise her anesthesia team.

After induction Dr. Dooner instructed Lynn to perform the induction and intubation of Luettke, according to court documents. After this Dr. Dooner left the operating room. He did not return until he was called back approximately an hour and a half later. During the procedure a series of esophageal dilators are inserted through the mouth and down into the esophagus. It is typical that the anesthesia provider at the head of the bead inserts the dilators at the request of the surgeon. Once Luettke was under anesthesia, the surgeon, Dr. Sferra, requested that the anesthesia team pass the first dilator into the esophagus. Under the supervision of CRNA Eischen, Lynn successfully passed a size 40 dilator. Dr. Sferra determined the device was within the esophagus and told Lynn to remove it and insert a larger, size 44 dilator. Incrementally larger dilators are passed to gradually expand the diameter of the esophagus. Lynn inserted the 44 and indicated that it should be seen or felt in the esophagus by the surgeon. Dr. Sferra, however, could not perceive the dilator. Lynn then withdrew the dilator and attempted to pass it a second time. Again, Dr. Sferra was unable to see it.

CRNA Eischen then attempted to insert the device, but it was still not perceptible in the operative field. Dr. Sferra then suggested that Dr. Dooner be called back into the operating room and he was paged. A ruptured esophagus was suspected. Sterra asked Dooner to attempt to pass the dilator and the result was the same. Further investigation revealed the dilator had perforated the esophagus. The procedure was converted to an ‘open’ procedure with an incision into the abdomen. A cardiothoracic surgeon was consulted and the esophagus was surgically repaired, requiring the insertion of a feeding tube and the inducement of a ‘coma like’ state for 4 days during which Luettke had a number of complications including a build up of fluid in the lungs and blood clots in her arms.

Once awake and off the ventilator she experienced severe pain, gagging, nausea, loss of appetite, poor esophageal motility, and depression. Two months after the procedure, Luettke was still unable to take food by mouth and was
continuously nourished through feeding tubes. As a result of her complications she was admitted to the University of Michigan Hospital where she was diagnosed with no esophageal motility, severe anxiety and depression which required electro-convulsive therapy.

Luettke filed a medical malpractice and informed consent claims against CRNA Eischen, SRNA Lynn, anesthesiologist Dr. Dooner and his practice group, and St. Vincent Hospital. Prior to trial, the trial court granted, in part, defendant’s motion in limine (motion to exclude or limit evidence), which excluded all evidence and/or testimony with respect to the policies, provisions, and standards concerning the supervision of anesthesia procedures performed by students, informed consent for student participation, and patient rights, as set forth within St. Vincent’s Resident Manual (“Manual”) and Rules and Regulations of the Medical Staff (“Regulations”). The trial proceeded without this evidence, despite plaintiff attempting to introduce it and objecting to its exclusion, and a verdict was returned in favor of the defendants. Luettke appealed complaining that the court erred in excluding the policy and procedure evidence.

The Manual contains “safety standards of care” promulgated by St. Vincent for the supervision and responsibilities of students in training. The Manual provides, in part, that “all anesthetic procedures, other than locals, shall be performed in the presence and under the supervision of a qualified anesthesiologist.” It goes on to say that “”Know the name and professional status of your health care providers, the reasons for any changes, and the relationship to any other health care or educational institution involved in your care.”

The Regulations define the hospital’s “standard of conduct and care” required of all medical providers. It provides for the rights and responsibilities of the patient, including the right to know the identity and training status of student caregivers, in addition to the rules governing consent for procedures and “other research/educational projects.” The Regulations provide that “Patients should be told of the identity and professional status of individuals providing
service to them, and which physicians or other practitioners are primarily responsible for their care. Patients should also be informed of the relationship between the medical center and other institutions involved in their care. Persons engaged in clinical training programs or in the gathering of data for research purposes should identify themselves.”

Regarding consent the Regulations state “”Patients have the right to make reasonably informed decisions involving their health care, and the right to the information necessary to make such decisions.” Also “”Patients should be informed about who is responsible for performing procedures or treatments.”

The court, in excluding the Manual and Regulations from being entered as evidence reasoned that that the documents were irrelevant in determining the standard of care. The court found in the alternative, that if the documents had relevance, admission would mislead or confuse the jury. The court supported its conclusion by stating that “expert testimony rather than documents or other evidence establish [sic] the proper standard of care in a medical setting.”

Defendants argued that neither document is relevant to provide evidence of a standard of care. They contend that the Manual pertains to “residents” and medical students only. Because Lynn was an SRNA and did not fall under either classification, they argued that it did not apply to her. However defendants failed to present any document that did pertain to Lynn or any other student nurse anesthetist. This left the appellate court dissatisfied that apparently no policy existed pertaining to SRNAs. They quipped “To argue that residents and medical students are required to perform all anesthetic procedures ‘in the presence and under the supervision of a qualified anesthesiologist,’ but a lesser trained student nurse anesthetist performing the exact same procedures is not, is illogical and offensive to one’s sensibilities.” Uh oh.

Defendants argued that both the Manual and Regulations were irrelevant because expert testimony, not documents, establishes the standard of care in a medical setting. To this the appeals court replied:

While appellees’ and the lower court’s contention is correct, the Ohio Supreme Court held that hospital rules and regulations are, at the discretion of the judge, also admissible to provide evidence of the standard of care. Berdyck v. Shinde (1993), 66 Ohio St.3d 573; Burks v. The Christ Hospital (1969), 19 Ohio St.2d 128, 131. See, generally, Gray v. Grandview Hospital (Jan. 22, 1979), 2d Dist. No. 5849; Siebe v. University of Cincinnati (Ct. Claims 2001), 117 Ohio Misc.2d 46. Therefore, the trial court’s stated basis for excluding both documents is contrary to established law. Moreover, if self-imposed policies, rules and regulations are not relevant to help determine a hospital’s standard of care, as appellees and the lower court would have one believe, then why would an organization create such policies in the first place? The whole purpose of promulgating documents, such as the ones at issue here, is to ensure that employees follow a consistent standard of care and quality at all levels of an organization.

Here we have a situation where a state supreme court has actually ruled that hospital policies and procedures may, at the discretion of the judge, be admissible as evidence to establish a standard of care. If that were not enough, the hospital policies and procedures supported the expert testimony of the Plaintiff’s witnesses. Plaintiff argued “because such evidence, if presented, would make the existence of appellees’ violation of the standard of care more probable than not, the documents are relevant and therefore should have been admitted.” The court agreed.

The actions taken by appellees and Lynn were in clear violation of St. Vincent’s policies, rules, and regulations. Thus, the Manual and Regulations, if admitted, would have made the existence of appellees’ violation of the standard of care, i.e. the duty to disclose training status and the required supervision of student nurse anesthetists, more probable than not. For that reason, both documents are relevant and admissible pursuant to Evid.R. 401.

A key finding of the court was that defendants “and their expert witness’s testimony directly conflicts with the aforementioned standard of care set forth by St. Vincent in the Manual and Regulations”. Yikes. The court directly, without the assistance of a jury, recognized that a ‘standard of care’ existed defined by the Manual and Regulations. This lead the court to determine that the exclusion of the Manual and Regulations was not harmless error and that it was an issue for the jury to decide whether the M & R were representative of the standard of care for St. Vincent’s and whether that standard was violated.

The judgment for the defendants was reversed and the plaintiff was entitled to a new trial with the policy and procedure evidence to be included.

No matter how small or how significant a provision in hospital policies and procedures, regardless of how many colleagues, if any, adhere to a particular policy, written regulations are controlling. If the medical practice bylaws state that a physician anesthesiologist must be present in the room when a labor epidural is placed, he/she better be there otherwise even a non-negligent complication may turn into a very successful malpractice lawsuit for a plaintiff. The first step for any health care provider is to sit down and READ the P & P, in detail. I guarantee you that there is SOMETHING in there you are unaware of which is a liability disaster waiting to happen. Likely the policy was created to AVOID liability. Surprise!

LUETTKE V ST. VINCENT MERCY MED CNTR OH 2006

NY Times: Anesthesia Risk Minuscule When CRNAs Give Anesthesia, Cost Effective

Last modified on 2010-09-12 06:13:31 GMT. 5 comments. Top.

Editorial

Who Should Provide Anesthesia Care?

Can a highly trained nurse deliver anesthetics as well as a physician who has specialized in anesthesiology, or does the nurse require close medical supervision? That issue emerges from two recent studies and from California’s decision last year to join 14 other states in freeing the nurses from a federal requirement that they be supervised by a physician. Colorado seems poised to join the group.

The issue is potentially important to patients and to health care reformers seeking to restrain costs and reduce reliance on high-priced medical specialists.

The two studies — hotly disputed by the American Society of Anesthesiologists — essentially concluded that there is no significant difference in the quality of care when the anesthetic is delivered by a certified registered nurse anesthetist or by an anesthesiologist. The studies were paid for by the professional association for the nurses, a potential conflict of interest, but were conducted by researchers at respected organizations.

Analysts at the Research Triangle Institute found that there was no evidence of increased deaths or complications in 14 states that had opted out of requiring that a physician (usually an anesthesiologist or the operating surgeon) supervise the nurse anesthetists. The analysts recommended that nurse anesthetists be allowed to work without supervision in all states. Researchers at the Lewin Group judged nurse anesthetists acting without supervision as the most cost-effective way to deliver anesthesia care.

Anesthesia has gotten remarkably safe in recent decades, with roughly one death occurring in every 200,000 to 300,000 cases in which anesthetics are administered during surgery, childbirth or other procedures.

There is not much difference between the two professions in the amount of training they get in administering and monitoring anesthetics. Where the anesthesiologists have a big advantage is in their much longer and broader medical training that, many doctors say, may better equip them to handle complex cases and the rare emergencies that can develop from anesthesia.

From a patient’s point of view, it would seem preferable to have a broadly trained anesthesiologist perform or supervise anesthesia services, but, in truth, the risk is minuscule either way.

Fifteen states have exempted the nurse anesthetists from a Medicare requirement that they be supervised by a physician. California’s move is being challenged in court by physician groups on procedural technicalities. The state’s reasoning, which appears sound, is that patients in areas short on anesthesiologists would lose access to surgery and childbirth services if no one else could deliver the anesthetic. The final decision ultimately rests with the hospitals on how best to serve their patients.

In the long run, there also could be savings to the health care system if nurses delivered more of the care. It costs more than six times as much to train an anesthesiologist as a nurse anesthetist, and anesthesiologists earn twice as much a year, on average, as the nurses do ($150,000 for nurse anesthetists and $337,000 for anesthesiologists, according to a Rand Corporation analysis). Those costs are absorbed by various institutions and public programs within the health care system. As health reformers seek ways to curb medical spending, they need to consider whether this is a safe place to do it.

Supervision of a CRNA: A Concept Without a Reliable Definition

Last modified on 2010-09-22 14:42:45 GMT. 2 comments. Top.

Physician supervision of Certified Registered Nurse Anesthetists has been a hot topic lately. But just what IS physician supervision exactly? Good luck in answering that one without a manual answering the following questions, and good luck finding one of those:

• Does a Certified Registered Nurse Anesthetist (CRNA) have to be supervised by an anesthesiologist?

• Does a CRNA have to be supervised by any physician? If so, what kind?

• What is that option available to states (the opt-out) to pass laws so that CRNAs do not have to be supervised? Isn’t that just a Medicare/Medicaid billing issue?

• Don’t anesthesiologists say that CRNAs should be supervised by an anesthesiologist?

• Isn’t there a law that requires CRNAs be supervised?

• I am a surgeon and if a CRNA is giving anesthesia to my patient without an anesthesiologist supervising, am I liable if there is a problem related to the anesthesia procedures? If I have an anesthesiologist I am not liable right?

• What does “supervision” mean? What about “medical direction?” What about “collaboration” or “cooperation” or “consultation”?

• I hear terms like “physically available”, “immediately available” and plain old “available”….what the heck is the difference?

• How did this become so confusing, and who decides the definitions of all these words, and creates the rules?

Similar to our first article about the Standard of Care in anesthesia, the answers to many of these questions depends entirely on who is asking and for what reason. You likely will receive different answers based on the profession, personal agenda, or personal experience of the individual you ask. To even begin to answer any of them you have to split yourself in two. Self #1 (Insurance Self) asks each question followed by the phrase “when billing an insurance company for anesthesia services”. Self #2 (Law Self) follows each question with “and don’t talk to me about billing insurance companies, just give me a straight legal answer.”

Unfortunately, Insurance Self and Law Self also then have to ask additional questions. Insurance Self needs to know what insurance company is being billed and in what state, and what terms listed above are used, if any, and how each individual insurance company defines them. Law Self needs to know what state you are practicing in, what the state law says specifically and which of the various terms mentioned above are used in state law, if any, and whether the state law goes on to define the term.

Both may find that there are actually no definitive answers, especially when it comes to definitions of terms…..which affects, and confuses even, anesthesia providers.

And all of this is rather important, since it directly affects if, and how much, an anesthesia provider will get paid for their services from an insurance company, whether or not a state licensing board will discipline them, the validity and outcome of a medical malpractice lawsuit, the cost of health care for us all, the cost to a hospital in provision of surgical and anesthesia services (passed on to the patient), and finally because it is tiresome and mentally exhausting to have to try and answer these questions over and over.  VERY tiresome and cerebral intensive if you are actually trying to answer correctly.

If you have any hope of this article making sense as you read it, you are going to have to pretend that you have never heard the words ‘supervision’ or ‘direction’ and abandon whatever definitions of these words you have stored in your brain. In exchange you will only be given reasons why there is no one single correct answer to most of the questions, since that is the most appropriate way of answering them without state specific and insurance carrier specific information.

INSURANCE COMPANIES AND THE RAPE OF THE ENGLISH LANGUAGE

From the Meriam Webster Online Dictionary:

SUPERVISION (which leads to defining DIRECTION):

Date: 1640 : the action, process, or occupation of supervising; especially : a critical watching and directing (as of activities or a course of action). Supervising: to Superintend, whose definition is: to have or exercise the charge and oversight of, or DIRECT, whose definition is: a : to regulate the activities or course of, b : to carry out the organizing, energizing, and supervising of.

Whoever can now explain the meaningful difference between supervision and direction functionality in the English language, please leave a comment. No need if you want to discuss Latin and Middle English origins and their time periods. I read all that and was very bored. Also, I was rather inconsiderate in first asking you to forget you ever heard these terms and then giving you their common English definitions, but the good news is these definitions are meaningless for the rest of the discussion.

Supervision and medical direction are common, everyday terms used by the insurance industry in determining how much they will pay for anesthesia services, and to whom. Even then rules vary from state to state and insurance company to insurance company, but the definitions they invented and use remain similar in their affront to the English language. ONLY in the insurance industry will the terms mean the same thing somewhat consistently. BUT, they still do not have common sense definitions and you have to still must suspend everything you have learned about the words supervision and direction if you hope to understand any of this.

Billing:

It is also important to realize there is a distinct reimbursement difference between “supervision” and “medical direction.” While the terms are often used interchangeably by physicians, nurses, and office staff, they have two entirely different meanings.  Medical Direction ([when] the physician has met all the requirements, if applicable) effectively pays 100% of the claim.  Supervision, a claim that is filed with an “AD” modifier, indicates that the anesthesiologist was either involved with more than four concurrent rooms or cases (regardless of type of insurance) or failed to meet the medical direction steps in some states.  Medicare penalizes supervised claims by paying a maximum of four (4) units per case, providing the anesthesiologist was present for induction.  No time is allowed for any of the concurrent cases.    You may be surprised to learn that some carriers pay absolutely nothing when an AD modifier is reported.

OK…now you should be confused

STATE LAWS REGULATING NURSE ANESTHESIA PRACTICE

Supervision or medical direction, collaboration, consultation, etc. are also terms used in various state nurse and medical practice act regulations….and there is no rhyme or reason as to when they are used or what they mean.

Independent CRNA practice has existed for over 100 years. Only 12 states require by law that a physician ‘supervise’ a CRNA’s practice of anesthesia as a matter of law.

40 states do not have any physician “supervision” requirement for CRNAs in their nursing practice or medical practice laws or regulations. If one includes clinical “direction” requirements in addition to “supervision,” 32 states do not have a physician supervision or clinical direction requirement for CRNAs. Including state hospital licensing laws or regulations, 33 states do not require physician supervision. Including state hospital licensing laws or regulations, 24 states do not require physician supervision or direction. No state requires a CRNA be supervised or clinically directed by an anesthesiologist.

In states which do require physician supervision, the supervising physician is not required to have any training in the practice of anesthesia or additional qualifications with the exception of  New Jersey and Washington D.C. (exception applies in D.C. only when a general anesthesia is given). What constitutes ‘supervision’ or ‘direction’ is generally poorly defined or not defined at all. Usually the term hangs in the air without any reference as to what it should mean.

INSURANCE IS ONE THING……LICENSE REGULATIONS ARE ANOTHER

Well, most of the time anyway. WI recently passed an Anesthesia Assistant law which requires they be licensed, which for the past 20 some odd years they did not have to be. The legislature however placed language into the law which says that AAs will be supervised by an anesthesiologist at the ratio determined by Medicare (currently no more than 1:4). This bill was heavily lobbied by the WI Association of Anesthesiologists. So if  you happen to hear one of their members saying “supervision” is a practice issue dictated by quality of care and patient safety, feel free to point out that they are being less than earnest and their own actions have shown, without room for argument, that it is all about $$$$$. Supervise at 1:5 or more = no payment for anesthesia services, stick to the Medicare ratio = get paid.

Insurance reimbursement practices, terms and policies have no business being considered when creating state  medical or nurse practice acts. These acts are supposed to be about the standard of care under which the public health, safety and welfare is  upheld and protected. Science, not the amount of money an insurance company wants to spend, ought dictate medical and nursing practice…no? I know, I know, I live in a fantasy land, but professional organizations and legislatures should at least make the most basic attempts to hide their true agendas if they expect not to be challenged as self aggrandizing hypocrites.

THE TURFF WAR IS NOTHING NEW

The American Society of Anesthesiologists has been fighting the ever present independent practice of CRNAs for decades. In a blast from the past, here is a Parade Magazine article from July 17, 1988 headlining “Doctors and nurses are fighting it out over who should administer anesthesia”.

Anesthesia Battle Royale: Parade Magazine 1988

    Continued on page 2

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