Disclosure of Unanticipated Events

In July 2002, TJC released The Joint Commission Patient Safety Standards, which states, “Patients and, when appropriate, their families are to be informed about the outcomes of care, including unanticipated events.” There is no clear information from TJC or agreement among institutions about what is required to meet this standard. Controversy exists over the types of conditions and the severity of the outcomes that should trigger this requirement for disclosure to the patient or family. Some suggest that it should be managed as part of the sentinel event process required by TJC, encouraging the health care facility to conduct a root cause analysis. Many health care facilities have created policies that determine when disclosure is required based on when the patient is substantially harmed. However, what constitutes substantial harm remains an issue of debate. Harm may be viewed from a patient or family’s subjective view, or it may require a more concrete approach, such as the need for additional medical care or diagnosis of a patient’s injury.

This TJC standard has created much discussion and different views about what information must be shared with patients and their families. The debate is likely to continue and produce more regulations in the future. In Canada, the judiciary has declared that health care providers should disclose any and all substantive risks related to a procedure that any reasonable individual would wish to know to provide informed consent for surgery or anesthesia. Being honest about care is always good policy, but a policy mandating disclosure of unanticipated events can be fraught with legal peril. If an adverse event occurs, the practitioner should seek risk management or legal advice to determine what information should be disclosed and the mechanism by which the information should be conveyed to the family. In many cases, avoiding a misunderstanding is crucial and may determine whether a frivolous lawsuit results.

Managing Adverse Outcomes

An adverse event is an event that occurs during patient care that can cause an undesirable or unanticipated outcome. Adverse outcomes include the following:

Patient injuries are adverse outcomes. A patient’s care plan that is changed and requires an unanticipated escalation of care also is an adverse outcome. These situations may result in two types of discontent for patients and their families: disappointment in the medical outcome and disappointment with the way health care providers discuss the issues.

Preliminary research suggests that families and patients are much more distressed and disappointed when the health care providers who do not present straightforward, honest information or are perceived to be hiding the truth and facts. This has been the message of the Sorry Works movement, which advocates a proactive approach to patients and their families or legal guardians to fully disclose and discuss adverse events such as an untoward incident, therapeutic misadventure, iatrogenic injury, or undesirable outcome.

Communication must start with the medical or surgical team as they try to evaluate the unanticipated outcome, its cause, and its subsequent treatment. The entire team must fully comprehend the facts and come to a mutual understanding of the sequence and timing of the occurrence. Disclosures should be made after information has been gathered and analyzed and practitioners are comfortable with their position. Health care providers and risk management personnel should be consistently involved in the investigation and communication with the patient and family. Patients and their families desire and deserve a discussion of what transpired, an apology (e.g., Sorry Works program) that the unanticipated outcome occurred, and assurances that there will be ongoing dialogue to clarify the events and the future for the patient and family. Families also want reassurance that the event will not happen to other patients and that something good may come out of this experience through system improvements.

However, communication is often very difficult after such an event. Guilt, speculation based on incomplete information, and the need to blame something or someone can interfere with the investigative process and with communication with the patient and family.

In some centers, there is direct communication with the patient and family concerning an apology and settlement if it is determined there was an error by the hospital or the medical team. There is considerable support for apologizing for the unanticipated event, regardless of whether an error precipitated it. This process does not imply guilt, and most states have passed legislation to protect apologies from being used in litigation. However, a statement of fact that posits the cause of harm is not protected from discovery in a legal action. Rather, most legislation is intended to protect statements of empathy, such as, “I’m sorry you have experienced this unanticipated outcome.” Other types of statements, such as, “I’m sorry the nurse or doctor gave too much of the medication,” are not protected from discovery in a lawsuit.

In some cases, the cause of the unanticipated event cannot be ascertained in a timely manner to a reasonable degree of certainty (i.e., the legal standard that an expert must meet). When this occurs, a candid discussion of the situation should take place with the family members, and they should be informed that further investigation is anticipated, the results of which will be communicated to them. Families often seek legal assistance because an event occurred that resulted in questions that they think were not adequately addressed by the hospital or members of the medical team (e.g., an event occurred but no one followed up with the family to explain in lay terms what had transpired).

Who Should Anesthetize Children?

Occasionally, when a child who has a significant medical problem presents for elective surgery at a location that does not routinely provide care for a child with a complex medical problem, an adverse outcome may result. The resulting lawsuit may be difficult to defend. The nature of the anesthesia services that are appropriate to perform in a particular location and the qualifications of those who provide the services must be addressed in the policies and procedures of the facility to avoid such an event, although guidelines in this area typically are arbitrary. Children in certain age groups with certain medical conditions and in certain types of emergencies should be designated for referral to a center that is more appropriately equipped or staffed to deliver expert care.

Issues of Consent and Assent

Consent is a process that provides patients and families with sufficient information to allow them to make an informed decision about whether to proceed. The anesthesiologist must provide sufficient information in terms that are understandable by adults with a grade 5 or equivalent education. In most instances, the patient must be an adult (18 years of age or older) to consent to a procedure. However, in some states, minors are allowed to make decisions independently, without the participation of a parent or guardian. In some circumstances, the court has the authority to override the parent’s rights based on the best interests of the patient. An example is providing lifesaving blood transfusions for children of parents who are Jehovah’s Witnesses. Knowledge of these special provisions for minor consent in the state’s laws is important. Virginia addressed the issue of pediatric assent and adult neglect in 2007 (VA code §63.2-100 et seq.). Assent may be given when a 14-year-old with a life-threatening condition or elective surgical issue is sufficiently mature to agree to the proposed treatment (see later for a complete definition). Dissent is when the child refuses. A judge threatened to remove a 14-year-old boy from his parents because they refused chemotherapy for lymphoma and instead trusted in prayer and herbal remedies.¹¹ These discussions and decisions are influenced by the severity of the issues and whether the procedure is elective or necessary to treat a life-threatening problem.

A common difficulty that arises with consent for minors is identifying the adult who is legally responsible to provide consent. State law governs who makes health care decisions for minors, and these laws vary from state to state. As an example, when the parents of a child are divorced, the custodial parent is most often the health care decision maker. However, this designation may vary based on the parents’ custody agreement and according to state law. Reviewing the custody agreement is not feasible, and most often, the arbiter must rely on what a parent says. If questions or concerns remain regarding the appropriate decision maker, a facility administrator, risk manager, or legal advisor should be consulted. Lack of consent from the appropriate decision maker is the same as no consent, which can lead to liability.

The issue of assent deserves special consideration. Assent is defined as agreeing to something after thoughtful consideration. Children may not be able to assent to a procedure because they are unqualified to have thoughtful consideration. At what age and under what circumstances the minor’s wishes should be followed because they mature enough to engage in thoughtful consideration is unclear. Unless there is a specific state law that grants decision-making authority to a minor in the current circumstances, the issue of a minor’s assent is an ethical one, rather than a legal matter. Knowing whether the issue is ethical or legal is important in minimizing liability risks. If an older minor patient does not want a surgical procedure, a discussion should be held with the legally responsible adult, and any differences should be resolved before surgery. Even if the parents or guardians wish to proceed and the child does not, it is usually best to delay surgery and have a focused discussion to ensure that the wishes and thoughts of the minor patient have been considered and respected. Knowledge of state law and a low threshold for seeking consultation with the hospital lawyer are indicated in this situation.¹¹

Communication with Patients and Families

The preoperative visit is an opportunity to develop rapport with the child and the family. It is important to establish a shared relationship, because children and families who feel they have communicated well preoperatively with their health care provider usually do not sue if there is an adverse outcome. Unfortunately, the time for preoperative evaluation and discussion is greatly limited. The physician should review the record before interviewing the child to focus the discussion and be aware of any underlying issues so that they can be directly addressed during the interview session. One technique for developing rapid communication with the child and the family is to recognize that they have major concerns about the surgical procedure, such as pain management, severe anxiety, nausea and vomiting, and safety issues. The anesthesiologist should clarify how he or she will address these issues preemptively so that the child and family understand that they have an advocate who can ensure safety and comfort throughout surgery (see also Chapter 4). The next step is to determine whether the child and family have specific concerns or suggestions. If the child has had multiple operations, the anesthesiologist should inquire whether any anesthetic technique has proved superior to others and incorporate it when possible. If the lines of communication have been opened before an unanticipated outcome occurs, it will be easier to maintain rapport, which reduces the likelihood of a lawsuit being filed.

Unanticipated Event Resulting in Patient Injury or Death

When a medical error in providing anesthesia results in injury or death, an anesthesia caregiver’s worst nightmare has come true. One example of an unanticipated event is a perioperative allergic reaction such as latex anaphylaxis.¹² This event may be avoided by a careful preoperative history, and anticipation and preparation for this possibility can aid treatment. Little has been done to develop an algorithm for management of an adverse outcome that results in injury or death. An algorithm published by the Anesthesia Patient Safety Foundation emphasizes the need for an incident manager, who is the person who takes charge of the administrative aspects of the situation while the anesthesia caregivers continue to manage the patient’s problems.¹³

Step 1 in this algorithm is taking care of the patient. Step 2 is making plans for dealing with the family, which can be done with the help of the surgical team, the anesthesia team, and/or the risk management team. Most anesthesia caregivers have an enormous emotional jolt of depression and guilt over the bad outcome because the American system of teaching through negative reinforcement suggests that they must have done something wrong. This likely response needs to be recognized by the anesthesia caregiver, so that when the issues are discussed with the family, the caregiver can avoid his or her own emotions taking over and instead focus on known facts while offering appropriate empathy to the family. Full disclosure (previously discussed) remains a critical issue, along with complete and accurate charting and discussion of the child’s care with other key providers to ensure that there is a mutual understanding of what transpired and that the documentation is consistent.¹⁴ The family will understandably be very emotional and angry. A note should be entered into the child’s chart providing a summary of these family discussions.

Involved physicians should notify their medical malpractice insurance carrier in the event of a medical error or when there is a significant adverse outcome without error, but the family is very angry and threatening. The insurance carrier will conduct its own investigation of the event. If the carrier thinks there is a significant likelihood of a claim being filed, it may assign an attorney to represent the physician before a lawsuit is filed. The attorney can discuss the matter with confidentiality and offer advice as the facility’s quality review takes place. Regardless of whether legal action will occur, it behooves the physician to record the precise sequence of events that occurred and then to sign, date, and file the narrative with his or her risk management office and insurance carrier.

Emotional support should be available for the involved care providers. The facility may have a mechanism to provide for this, but at the very least, the anesthesia department should have a plan. Sometimes, the anesthesia caregiver may need to seek professional help from psychologists or psychiatrists to help him or her cope with the emotional impact of the event. Doing so is important for the individual’s well-being and professional career. These issues are well recognized, and assistance should be readily accessible for health care providers.¹⁵

Anesthesia Record and Charting

Poor anesthesia records and charting often lead to verdicts in favor of the plaintiff in lawsuits. A key strategy to avoid lawsuits is to ensure that documentation is complete, understandable, timely, and legible.^16,17 The use of automated anesthesia records (i.e., automated information management systems) is helpful in most cases.¹⁶ We think that many malpractice cases that resulted in plaintiff verdicts could have been defended if greater attention had been paid to accurate documentation in the medical records. In the middle of a difficult or complicated case, it often is impossible to ensure thorough documentation of the events. However, many modern anesthesia monitors retain recent data (until they are powered off), allowing the anesthesia caregiver to retrieve information that is missing from the medical record and to document the details in a timely manner. When completed, a note that includes the date and time and the reason that the documentation was completed after the fact should be added to the child’s record. Completing a record can only help as long as the entries added are accurate and properly identified.

The second area of record keeping is the anesthesia note about the incident. After some preparation, it is written in the chart and can be compared with what the other health care professionals state in their notes. The anesthesia note should be brief, factual, and without unsubstantiated conjecture regarding what occurred. Before writing the note, the anesthesia care provider should discuss the event with the nurses and the surgeons to clarify the sequence of events and any other pertinent information to ensure that there is a consistent understanding of what transpired. Occasionally, there is a difference of opinion regarding the events that occurred. It is preferable to clarify any discrepancies immediately rather than after inconsistent documentation has been entered into the child’s chart and discussed with the parents. It is important to review notes written by other caregivers at the time of the event; for example drugs administered by the anesthesia care team that are entered in the anesthesia record must also be listed on the arrest log.

The international trend toward using automated medical information systems to create an anesthesia record has been encouraged by the provision of generous financial incentives. Whatever method is used, having a full, accurate, and timely record is essential for a successful defense. Correcting errors or making additions to the record should follow the policies and procedures of the department and hospital; on paper, errors should be indicated by using a single line through the text followed by the initials of the signer and the date. Errors should never be removed with whiteout or by removing the page. Late entries should be so indicated and initialed.

Monitoring

The ASA has set standards for basic anesthesia monitoring (Table 52-1). Specific monitors must be used with all patients who are undergoing general anesthesia, regional anesthesia, or monitored anesthesia care. The anesthesia caregiver may waive certain monitoring requirements under extenuating circumstances. However, when this is done, the reasons should be stated in the anesthesia record. The second standard for basic anesthesia monitoring states, “during all anesthesia, the patient’s oxygenation, ventilation, circulation, and temperature shall be continually evaluated.” The ASA standards further state, “When the pulse oximeter is used, the variable-pitch pulse tone and the low-threshold alarm shall be audible to the anesthesiologist or the anesthesia care team personnel.” The section on temperature monitoring provides this standard: “Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated, or suspected.” This can be interpreted to mean that brief procedures and certain anesthesia locations may make temperature monitoring unnecessary or impractical or potentially dangerous because of burns. It is essential to document when and why standard monitoring procedures are not followed. If this is not done, it increases the risk of a decision against the defendant in a malpractice claim. Physicians also must be aware of changes in these standards. For example, expired carbon dioxide monitoring becomes a requirement for the updated ASA standard in 2012 for all patients receiving moderate or deep sedation by an anesthesiologist.^17a

TABLE 52-1 Standards for Basic Anesthesia Monitoring

Delay in the recognition of ventilatory or circulatory difficulties is frequently caused by the anesthesia caregiver not believing that the monitor accurately reflects the child’s condition. An example of this is the pulse oximeter. Movement and mechanical problems frequently interfere with pulse oximetry readings, suggesting that an erroneous reading is not a patient-related but rather an equipment-related problem. A basic premise of monitoring is that when there are changes in the monitor, the patient must be evaluated first and the monitor evaluated second. If the accuracy of the pulse oximeter is in doubt, the other monitors should be scanned to determine whether they show consistent changes. The most useful monitor for cross-checking the pulse oximeter is the capnograph. A decrease in the child’s perfusion (i.e., cardiac output) reduces oxygen saturation and end-tidal carbon dioxide (ETco₂). Another useful method is checking that the heart rates displayed on the pulse oximeter and the electrocardiogram are identical. If there is any question about the accuracy of the pulse oximeter after the child and the monitor readings have been carefully checked, the pulse oximeter sensor should be applied to the anesthesia caregiver to verify its function. Changes in ETco₂ usually are caused by hyperventilation, hypoventilation, or decreased cardiac output.

Tracheal intubation may be problematic. When the breathing circuit is connected to the tracheal tube, the absence of the carbon dioxide waveform should immediately raise concerns that the tracheal tube is not in the trachea. If the functionality of the capnogram is in question, the caregiver can breathe into the sampling line for the capnogram, providing the child’s oxygen saturation remains within normal limits. If the capnogram is functioning properly, laryngoscopy should be performed to confirm that the tracheal tube has passed through the vocal cords.

Another potential problem with monitoring systems is that the default alarms are set for adults, not children. This has resulted in the alarms sounding despite normal readings for children, prompting some clinicians to inappropriately disable the alarms. As irritating as these alarms may be, they should not be disabled but should be reset for the appropriate values. Alarms should only be temporarily silenced when the anesthesia caregiver knows the reason for the alarm and is taking steps to correct it. The alarms are set for the anesthesia caregiver and for the whole surgical team. If the anesthesia caregiver is having difficulty with the child’s vital signs, the other members of the surgical team should be informed so that they can assist in correcting the problem. If the alarms are disabled, other members of the care team may not be aware that a problem is developing. If monitor alarms are ignored or turned off, the risk of a finding in favor of a plaintiff in a medical malpractice case increases dramatically.

Resuscitation

If a child develops bradycardia and hypotension, the classic interventional sequence of airway, breathing, and circulation as taught by the American Heart Association should be followed. A common finding is that repeated doses of atropine are administered before epinephrine; the latter is the first drug of choice for symptomatic bradycardia (see Chapter 39). A nurse or other assistant should accurately record the timing and doses of medications administered during these events, the names of the health care providers who were present, the timing of the call for additional help, and the name of the person who directed the resuscitation. In facilities without automated anesthesia records, the anesthesia record can often be filled in after the event if the monitor stores recent vital signs that can be interrogated later, and a note should be made in the record that this is how the data were retrieved.

After this type of event, the anesthesia machine should be quarantined and the monitors left on so that the stored data can be retrieved at a later time or date to better reconstruct the sequence of the events. If there is a problem retrieving data, a technician should be called to download the information to a permanent record. This should then be handed over to risk management for preservation. Any time discrepancy between the monitors and the operating room clock used to record events should be noted.

Service of Process

A defendant physician in a medical malpractice case usually is served by an official of the court (often a local sheriff) with a copy of a medical malpractice lawsuit. The heading on the lawsuit indicates the location of the court where the lawsuit has been filed and the name of the person (i.e., plaintiff) who is filing the litigation, along with the names of any other defendants.

Service of process may be accepted by anyone, but the person accepting service must sign the suit papers as accepting them on behalf of the defendant. Others at the office and those at home must immediately notify the defendant of having received a lawsuit. The defendant should then immediately notify his or her medical malpractice insurance carrier that a lawsuit has been served, and then fax a copy of the suit papers to the insurance company. If an attorney has not already been assigned, one will be soon. The insurer undertakes its own investigation and requests a copy of the medical record if it does not already have it. The hospital administration should also be informed because the hospital also may become a defendant.

Court Pleadings

Different states use different names for a civil claim filed in court (as is the case for most medical malpractice insurance claims). It may be called a complaint, motion for judgment, or another name. The attorney must file a responsive pleading within the time specified by state law, usually 21 days. If a defendant does not file a response in the required time frame, a default judgment may be entered. After a lawsuit is filed, all further interactions between plaintiffs and defendants must be through their respective attorneys. It is inappropriate for a defendant to call a plaintiff or vice versa.

Discovery

The next step in the legal process is called the discovery process. It can continue for years. Discovery provides an opportunity to investigate the plaintiff’s claim and the defendant’s responses. The initial step in discovery is to file interrogatories, which are written questions answered under oath. The attorney sends them to the defendant with a deadline for returning them. The defendant’s answers are reviewed by his or her attorney, who may discuss them further. The final answers must be signed by the defendant and notarized. If needed, the answers may be amended later. However, if they are not amended and the answers are different from those given in a deposition at a later date or at trial, the interrogatory responses may be used to attack the defendant’s credibility. It is vitally important to answer the interrogatories as accurately as possible. The defense also is asked to identify all witnesses they will use, including experts and their expected opinions to be testified to at trial. The number and detail of questions vary from case to case and attorney to attorney. The attorney may instruct the defendant not to answer some questions based on a legal objection. The defense attorney also poses interrogatories to the plaintiff.

In addition to interrogatories, the attorneys may request the defendant to produce certain documents. The attorney works with the defendant to determine if there are objections to these documents and will make any needed objections.

Dispositions constitute the most important tool in the discovery process. All witnesses, whether experts or general witnesses, may be deposed, in addition to all parties to the lawsuit. In a deposition, questions usually come only from the attorney on the opposing side. The defendant’s attorney does not want to reveal information or strategy for your defense, so his or her questions will be reserved for trial. Objections to questions are usually made but reserved for argument later if the matter goes to trial. These objections are a distraction to the defendant but are a part of the legal process. Occasionally, the issue is so important that the matter may be taken to the judge during or shortly after the deposition. However, during a deposition, the attorney makes his or her objection and then instructs the client to answer the question.

The importance of the deposition in developing a defense cannot be underestimated. The physician must know the chart, his or her entries, and the medical issues of the case. Several points should be remembered during a deposition. The defendant should give short, concise answers, not try to educate the lawyers or impress them with a superb record as a health care practitioner. Persons being deposed should be prepared to avoid traps. For example, the attorney may ask, “Do you have an independent recollection of the case?” The lawyer does not want to know if the person generally remembers the tragedy of the event but instead wants specific details of the case. Because depositions usually occur 2 to 5 years after the event, it is often difficult to remember the details of a case, and the person being deposed should rely primarily on the patient’s chart. Offering a best guess is never a good idea, and if a certain detail cannot be recalled, the person should answer, “I do not recall.”

An example of such a case was provided in the deposition of a nurse anesthetist defendant, who gave excellent answers. She said that she remembered the tragedy of the event but that she did not remember any details. She was asked many times about her independent recollection of the case. Her answer was always the same: “The record speaks for itself. The times may be off a little bit, but the sequence of events is [recorded] as they occurred.” The total time of her deposition was 1.5 hours. The anesthesiologist defendant in the case said that he did have an independent recollection, and he tried to remember details of the events. By the end of his deposition, which took 5.5 hours, he had tied himself completely in knots. The nurse anesthetist’s deposition also demonstrates the importance of having an accurate chart that is complete.

During depositions, the defendant may become angry or frustrated with the plaintiff’s attorney and the legal process. When anger becomes part of the defendant’s answers, the deposition often becomes protracted and confrontational. This can lead to answers that are not well thought out and consistent with records and sometimes result in angry outbursts by the defendant.

The discovery process may take place over several years. After it is complete, a case may proceed to trial. The purpose of discovery is to avoid any surprises at trial by revealing as much of the evidence as possible in advance of trial. This extensive discovery process leads to most medical malpractice cases being withdrawn or settled before trial.

Trial

At trial, the plaintiff has the burden of proving his or her case by the preponderance of the evidence. The jury will decide if this burden is met, which means that the jury members must find that it is more than 50% likely that negligence occurred.

A trial begins with selection of the jury. In civil cases, there are seven jurors. The trial begins with the opening statement of the attorney for the plaintiff, followed by the opening statement of the lawyer for the defendant. These statements are not evidence but preview for the jury what evidence the attorneys expect to present.

The plaintiff’s case is presented first, which often means that the defendant is called by the plaintiff as an adverse witness. If so, the defendant should give short, concise answers that respond only to the question asked to avoid being boxed into an opinion or unintended admission. All witnesses called by the plaintiff are first questioned by the plaintiff’s counsel. Defense’s counsel may then cross-examine a plaintiff’s witness. After that, the plaintiff’s attorney may have a redirect examination. On cross-examination, leading questions may be used, such as, “Isn’t it true that….” At this time, the attorney can go back to the prior answers to interrogatories and deposition testimony to make the defendant appear that he is contradicting himself or changing his story, which is why it is vital to keep the answers to all questions precise and concise.

At the completion of the plaintiff’s case, the defendant’s lawyer may move (i.e., make a motion to strike) the court to dismiss the plaintiff’s case if all the elements of the claim made have not been established. A motion to strike is rarely granted by a court. Trial usually proceeds to the defendant’s evidence, which seeks to rebut the evidence introduced by the plaintiff. New evidence may also be introduced in an effort to provide an alternative theory of what occurred.

At the close of the defendant’s evidence, the plaintiff has one last opportunity to put on evidence that rebuts the defendant’s case. The testimony by these rebuttal witnesses must be confined to contradicting evidence of the defendant.

Before a case goes to a jury, the defendant’s attorney has another opportunity to ask the court to dismiss the case on the basis of the plaintiff’s failure to establish his or her case. The attorneys also submit jury instructions to the judge, who selects from those submitted as he or she deems appropriate. These instructions are read to the jury by the judge before they enter into deliberations.

The last information provided to the jury is the closing statement of attorneys. These statements are not evidence but rather summations of what the attorneys think their cases showed. Jury deliberations may last minutes, hours, or days. At this point, all the defendant can do is wait because the verdict rests with the jurors or judges, depending on the jurisdiction.

Appeal

The plaintiff or defendant may appeal a case, although appeals are rare. There must be a legal basis for the appeal rather than an appeal based on the merits of the case. Rarely, an appeal may be granted because there is reasonable question that the evidence did not support the jury’s decision. Because the courts give extreme deference to the jury, overturning the decision solely on this basis is unlikely. Most often, appeal is based on a mistake of law by the trial judge.

If the appeal is granted, an appellate judge usually hears oral arguments by the attorneys. No witnesses are presented. The arguments are based on evidence and events in the trial court. The appellate court may decide that there is no basis for appeal, remand the case for retrial in the lower court with instructions on the applicable law, or dismiss the case altogether. How many levels of appeal there are depends on the particular state in which the case is being heard or whether it is heard in federal court.