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

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