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Risk Management Essentials: A Self-Study Course for Medical Office Staff

This activity is designed to provide risk management education to all members of the medical office staff. Implementing the strategies and techniques outlined in this self-study course can minimize liability in the ambulatory health care setting.

Date of release: March 2009

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Participant Instructions for Risk Management Essentials:

A Self-Study Course for Medical Office Staff

Instructions for Completion of Self-Study Course:

Read the Physicians Insurance publication entitled 1. Risk Management Essentials: A Self-Study Course for Medical Office Staff.

Answer the questions in the quiz by filling in the appropriate circles on the An-2. swer Sheet provided by the Facility Test Administrator.

Return your completed Answer Sheet to the Facility Test Administrator.3.

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Section 1

Communication and Rapport

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Whom Do Patients Trust?Amidst the bad news in the health care community—falling reimbursement rates, costly and complex government regulations, endless lawsuits, and soaring malpractice premiums—it is easy to overlook items of encouraging news that emerge from time to time.

An American Bar Association survey

A consumer survey conducted by the American Bar Association Section of Litigation showed that Americans trust physicians and the medical profession more than any other profession or institution. The polling data, obtained by Leo J. Shapiro & Associates, posed the following ques-tion to a national sample of 300 heads of household—half male, half female: “Here is a list of [ten] American institutions. As far as the people running these institutions are concerned, how confident do you feel about each institution?”

Heading the list were physicians, with 50 percent of the respondents indicating they are “ex-tremely” confident or “very” confident in physicians and the medical profession.

The federal executive branch of government and the U.S. Supreme Court tied for second at 46 percent; on the lower end of the scale were state and local courts (31 percent), federal Congress (22 percent), and lawyers and the legal profession with a less than robust 19 percent. Sparing lawyers the ignominy of finishing absolutely last in the ABA survey was the media, at 16 percent.

Despite the managed care revolution, and the countless other stresses and strains impacting medicine today, the poll findings reaffirm that physicians are held in uniquely high regard.

Promoting trust in your practice

How can a physician build upon the trust patients have for them? And how can a physician prevent a patient’s trust from crumbling? Here are three key areas to focus on with patients:

Informed consent

Busier practices and shorter medical appointments often mean the informed-consent process is hasty, and a patient can feel confused, rushed, and out of control. To encourage a patient’s trust, a physician can do the following:

Take time to explain the various kinds of treatment available, including the option of no •

treatment

Take time to explain basic procedures in lay terms•

List the most frequent complications and discuss the likelihood of detrimental effects•

Never make guarantees about outcomes•

Explain the most frequent side effects of any prescribed medications•

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Encourage the patient to ask questions •

By taking time with the patient, and by being open to questions, a physician can make great strides in encouraging trust.

Working with other physicians

Some patients may trust an individual practitioner but feel wary about getting lost in the medi-cal system. To encourage trust in a medical group, or even the medical profession as a whole, avoid criticizing other physicians. In addition, for serious or complicated cases, talk to the pa-tient’s other physicians regularly to establish roles, and be sure a physician talks with the patient and family members each day. Call very ill patients at the end of the day, and ask about their progress and concerns. For hospital patients, call their spouses or family members after morning rounds. As so many physicians know, phone calls to patients and family members can improve patient care and reinforce the patient-physician bond.

Telling patients about mistakes

It is important to acknowledge a medical error to the patient. Many lawsuits are initiated because a patient feels the truth has been hidden. Juries are more understanding of physicians who have been honest from the start and less understanding of those whose conduct suggests a concealment of error. Please read the article Apology: The Right Thing to Do for informa-tion regarding state law and tips to enhance physician communication with patients and family members following an adverse event. As always, if you are concerned about how to talk with your patient about a mistake, feel free to call our Claims Department for assistance. We are here to help you work with your patients and prevent claims.

Conclusion

The ABA survey results may carry broader significance than simply serving to remind physicians that their efforts are appreciated. The poll results suggest that it may be the medical community that holds the ultimate high card—the hard-earned trust of Americans. This is one claim the plaintiff bar, despite huge successes in and out of the courtroom, cannot make. Patients who trust their physicians are better patients and are less likely to file a claim. To strengthen your patient’s trust, take the time to be attentive, be respectful, be honest, use lay terms, and express empathy. Taking the time to elicit a patient’s trust can do much to further your practice and keep the medical profession strong during these difficult times.

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Beware the Literacy GapA young internist had bad news to relate to his patient, an elderly farmer who sat directly across from him in the exam room. “Jim,” began the doctor, “I’ve just received the pathology report from the lab, and it’s positive for cancer.” Pausing for a second to assess Jim’s reaction, the doctor was surprised when the patient announced, “Well, I guess I won’t be needing to see you anymore,” shook the doctor’s hand, and abruptly exited the office. The doctor was puzzled by the reaction until he later learned, so the story goes, that Jim had understood “positive” to mean “cancer-free.”

While the tale is probably apocryphal, it is a reminder that communication mishaps between clinician and patient have no doubt always existed. In the 1960s and 1970s, effective commu-nication assumed increased legal significance with the recognition, state by state, of the in-formed-consent doctrine.

The early days

This new cause of action made it possible to sue health care providers for not adequately disclosing information to patients concerning significant risks and complications, benefits, and alternatives relating to a proposed treatment or procedure. Failure to give the patient enough information to make a reasonably informed decision could subject the clinician to liability for harm or injury—even though the treatment or procedure was clinically appropriate and per-formed properly.

In essence, informed-consent laws meant that clinicians had a legal obligation to act as effec-tive patient educators. In 1972, in an often quoted and influential opinion, a federal judge wrote that only an “exceptional” patient cannot comprehend a nontechnical explanation of therapy alternatives, goals, and risks, adding (quite presumptuously, it might be said) that “so informing the patient hardly taxes the physician.”1

Though the imposed informed-consent responsibilities may not have been unduly taxing in 1972, today’s task of adequately informing and advising patients is not so easy. National illit-eracy is a communication obstacle that should not be overlooked.

According to the National Institute for Literacy (NIFL), year 2000 statistics indicate that 45 percent of the adult population, or 90 million people, perform at Levels 1 or 2 (8th grade or below reading level).

Almost all adults in Level 1 can read a little but not well enough to fill out an application, read a food label, or read a simple story to a child. Adults in Level 2 usually can perform more com-plex tasks such as comparing, contrasting, or integrating pieces of information, but usually not higher-level reading and problem-solving skills. Literacy experts believe that adults with skills at Levels 1 and 2 lack a sufficient foundation of basic skills to function successfully in our society.

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A new way to communicate

The implications for clinicians are important. Clinicians are well advised to:

Ensure that any patient-educational materials—including handouts, discharge instruc-•

tions, and consent forms—are free of unnecessary medical jargon. Necessary medical terms should be defined in simple, ordinary language. For example, “hypertension” should be “high blood pressure,” a “suture” should be a “stitch,” and so on. Remind yourself and your staff that even highly educated patients may be totally unfamiliar with medical terms.

Use plain language when explaining clinical issues to patients. If a patient displays a •

sophisticated medical vocabulary or understanding, you can instantly adjust the level of discourse.

Use pictures, diagrams, and anatomical models whenever possible to assist a patient’s •

understanding. Many patients pretend to understand more than they do, perhaps be-cause they are embarrassed to admit they don’t know what a stent is. Use the teach back method giving the information, then ask the patient to explain it back to you.

Conclusion

Numerous studies indicate that patients who have a genuine understanding of a procedure or treatment—including its risks—are much more accepting of the truth that complications can and do occur even with the best of medical care. Taking extra care to explain medical concepts using basic, everyday language is not being condescending. Rather, this is effective and efficient communication, something greatly valued by patients—whether they say so or not.

1. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

2. Kirsch, I., Jungeblut, A., Jenkins, L., Kolstad, A. 1993. Adult illiteracy in America: A first look at the results of the national adult literacy survey. Washington, D.C.: U.S. Department of Education.

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Communicating Office PoliciesSetting the stage

All practices want to minimize unwanted, disruptive behavior by patients. To help avoid this problem, practices should communicate office policies and expectations about the clinician-pa-tient relationship early on. Following are some ideas that might help establish a positive, healthy relationship from the start.

Educate patients

Consider providing all patients with an information brochure to include some or all of the items below:

A short biography of professional staff.•

Basic services provided by the practice.•

Office address and hours of operation.•

Phone numbers, including main number and appointment line (if different).•

Instructions regarding after-hours care and prescription refills.•

When to call for an appointment and when to call 911.•

Patient rights and responsibilities, including missed appointments, tardiness, and billing.•

Basic rules of behavior including child supervision in the reception area.•

Guidelines addressing the use of e-mail for communicating with clinicians and staff, •

including the expected response time.

A map locating the practice.•

If you have a Web site, consider including the above information there as well. Take time to talk with new patients about basic expectations and allow them an opportunity to ask questions.

Educate staff

In addition to making sure patients understand expectations, it is important to make sure that everyone in the practice is on the same page.

Encourage staff to participate in creating a safe patient-care and work environment.•

Make sure that everyone in the practice is familiar with information provided to the •

patient in brochures and other documentation regularly given to patients.

Define inappropriate behavior so that everyone can identify what is acceptable or not. •

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Inappropriate behavior might include:

•Manipulation. •Demeaninglanguageoractions. •Swearing. •Threateninglanguageoractions. •Makingsexualadvancesorusingsuggestive/vulgarlanguage.

Provide staff with training and strategies for dealing with inappropriate behavior when •

confronted with a difficult situation.

Utilize a system or chain of command to handle difficult patients.•

Staff should understand that they should refer the situation to the person who is •

equipped to address the problem.

Document behaviors objectively.•

Assure your staff that they will be listened to, situations addressed, and that staff will be •

supported when appropriate.

Use conflict resolution strategies to help prevent escalation.•

Practice saying “No”

Finally, recognize and accept that there are limits to what can be done for patients. It is perfectly appropriate to say “no” to a patient who is asking you to do something that is outside your limits of expertise or level of authority. Beware of patients who insist on receiving care from you that is medically inappropriate or beyond your expertise.

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Dealing with Noncompliant BehaviorAll health care providers, regardless of specialty, encounter patients who are noncompliant with medical advice or treatment recommendations. In many cases, the patients are not being delib-erately noncompliant, and their providers can help them become more compliant.

Good communication skills, including active listening, are essential for good patient care and compliant behavior. A provider’s choice of words, body language, and even silence all play a role in how a patient receives the provider’s information and advice. A provider who appears rushed and doesn’t allow a patient time to fully explain symptoms or ask questions may be setting the patient up for failure. Other factors that can lead to patient noncompliance include the follow-ing:

Misunderstandings due to medical terminology•

Misunderstandings due to language, a hearing disability, or mental barriers•

Patient not realizing the seriousness of the condition or urgency of the situation•

Patient not having insurance coverage or money to pay for the recommended medica-•

tions, tests, or treatment

Patient believing the treatment will be embarrassing or uncomfortable•

Patient deciding to go elsewhere for treatment•

Patient simply forgetting•

It is important to provide patients with enough information regarding their condition and your treatment recommendations, and to provide it in a format that is easy to understand. Stressing the significance of the condition and the need for timely follow-up should help with patient compliance.

A patient certainly has the right to refuse recommended treatment or tests. You are responsible for informing the patient of any risks associated with a refusal of care and documenting this discussion in the patient’s chart.

You may choose to dismiss a habitually noncompliant patient. Allowing a patient to continue noncompliant behavior can not only be detrimental to the patient’s health but can also increase your professional liability exposure. Any dismissal letter to the patient should include a reitera-tion of your treatment recommendations and the risks associated with not receiving the recom-mended treatment.

Generally, you can terminate your relationship with a patient at any time and for any reason. The exceptions are that you may not stop treating a hospital inpatient, a patient in unstable con-dition, or a number of patients from any specially protected population or socioeconomic group. In addition, federal and state law protecting the disabled may prevent you from discharging a

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patient whose noncompliance is the result of a physical or psychological disorder.

Risk management strategies for combating patient noncompliance

Educate patients regarding the recommended treatment or test and why it is necessary. •

Inform patients regarding any alternatives, benefits, risks, and complications associated •

with the proposed treatment or test.

Provide clear oral and written instructions to patients, using• interpreters as necessary.

Emphasize the seriousness of the condition and the urgency of the recommended •

treatment or test.

Schedule referral and follow-up appointments before the patient leaves. •

Place reminder calls to patients regarding upcoming appointments. •

Follow up on failed appointments. •

Document all noncompliant behavior including no-shows, cancellations without reap-•

pointments, and failure to follow recommendations regarding treatment, diagnostic studies, referrals to specialists, medication use, etc.

It is reasonable to expect a patient to share responsibility for compliance with your follow-up recommendations. However, court decisions nationwide have placed significant responsibility for patient follow-up with the health care provider. In the event of a lawsuit, the most crucial element in your defense is documentation in the medical record indicating your instructions and advice to the patient regarding treatment recommendations, referrals, and follow-up care.

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Understanding the Difficult PatientIn the delivery of high-quality medical care, physicians are challenged by time demands, busi-ness and financial demands, maintaining clinical competence, the erosion of autonomy, and pa-tient demands and expectations. While all of these can be difficult to manage, few challenges are more frustrating than dealing with a difficult patient. Difficult patients may be routinely angry, demanding, manipulative, controlling, noncompliant, or constantly complaining. Unfortunately, these behaviors are not always reserved for private, behind-closed-doors meetings but are often displayed in your busy reception area to the dismay of your other patients. Difficult patients can have a negative impact on the physician, office staff, and other patients. Moreover, they can lead to a breakdown in the physician-patient relationship—resulting in mistrust, poor communica-tion, and perhaps even a malpractice claim. This article will explore what makes some patients difficult, why they act the way they do, and how to prevent conflicts.

Why not terminate?

When faced with a troublesome patient, you may want to simply terminate the patient from the practice. However, while termination may be the action that is ultimately necessary, it should not be the automatic response. We strongly encourage you to take some time to work with the unhappy patient. Your goal will be to resolve the immediate issues, communicate your expecta-tions of patient behavior, and discuss how you and your patient will address future problems. If successful, you will have reduced the likelihood that this angry patient will become a plaintiff in a malpractice action, and the patient will see that his or her unacceptable behavior is self-de-structive and unlikely to bring about the desired results.

When is a patient considered “difficult”?

From a physician’s point of view, difficult patients are those who:

Fail to follow directions•

Generally ignore the rules of the practice•

Ignore their health or fail to listen to advice•

Utilize more time than necessary•

Become demanding•

Use inappropriate language with the staff•

Threaten staff or physicians•

The abusive or threatening patient needs to learn early on in the relationship that these be-haviors must not continue. If not addressed immediately, these behaviors often escalate. The verbally abusive patient should improve his or her behavior immediately or be discharged from the practice.

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For the patient who threatens, ask yourself: Did the patient physically threaten a member of the health care team, or was it simply a threat to “file a complaint with a supervisor”?

Threats of violence should never be tolerated; immediate dismissal is an appropriate response. If necessary, do not hesitate to notify law enforcement and warn those within your group that may come into contact with this patient.

Why is the patient being so difficult?

Several surveys conclude that patient dissatisfaction commonly stems from patients’ percep-tions that they are being rushed through the office visit, that their concerns are not being ad-dressed, and that the provider has little interest in their problems. Another common source of dissatisfaction is the lack of information regarding treatment, tests, or prognosis. This feeling of being “unimportant” or “discounted” is often exacerbated by a long wait in the reception area followed by a long wait in the examination room before the provider ever appears. In addi-tion, patients often report that staff rudeness and “billing issues” have been the catalysts for an unpleasant exchange.

Other patients may become difficult patients because of overwhelming fear, high stress, con-fusion, depression, or unrealistic expectations. Even more difficult to manage are the patients afflicted with a personality disorder such as the dependent personality, the antisocial personality, the borderline personality, and the addicted personality. For these patients, appropriate referral to mental health professionals or behavioral health specialists may be required to assist you in delivery of care.

How can I prevent a patient from becoming difficult?

One very effective tool to prevent good patients from becoming difficult is patient education—at the beginning of the physician-patient relationship—regarding office policies and expecta-tions. Efforts to educate patients can dramatically reduce the many misunderstandings that typically occur when expectations, protocols, and office policies are not adequately communi-cated to patients. One way to communicate to new patients is through a patient-information brochure. This can be used to inform patients about services offered and office policies regarding hours of operation, phone numbers, no-shows and tardiness, after-hours care, prescription-refill protocol, billing, and patient rights and responsibilities. In addition, a brief biography of the professional staff creates an instant familiarity that reduces patient anxiety and assists in build-ing rapport. A Web site can also communicate these policies. Finally, it is always a good idea to allow additional time for a new patient during the first visit; with more time you can familiarize the patient with your practice and answer any questions.

To promote consistency in the information provided to your patients, be sure that all of your of-fice staff fully understands your office policies, expectations, and protocols.

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How to Work with a Difficult PatientIn the middle of a very busy day, you find yourself in the exam room face to face with a very angry patient who complains about the “attitude” of your front office staff, how difficult it is to see you, and how your last treatment was unsuccessful. You have not had any bad experiences with this patient in the past, but it is clear the patient is now agitated and aggressive. Caught off guard, you may feel a bit confused and defensive at first, but as the patient continues complain-ing, you become angry. What is your plan to deal with this situation? To simply fold your arms, stare at the floor, and listen in silence? To aggressively challenge the patient point by point and defend yourself and your staff? To ask the patient to leave your office and never return?

Granted, it’s very difficult to fight our natural instincts when we feel we are being attacked. But it is important to remember that, more often than not, the real reasons for this patient’s behav-ior are often far removed from anything you or your staff did. Often the patient is reacting to a variety of stressors and you happened to be in the right place at the wrong time—a convenient target! Or maybe the patient is legitimately frustrated about your staff, your treatment, or your office policies. The manner in which you initially respond to this patient’s anger will have a great impact on the ultimate outcome of this situation. Regardless of the merit of the accusa-tions, the techniques you employ to deal with this incident are the same. Here is a list of time-tested techniques for managing conflict:

Remain calm in tone and posture. An angry patient will tend to mirror your demeanor. •

Be objective; do not take the anger personally. Expressing an angry or defensive tone will effectively end the communication. There is nothing to be gained by jousting with the patient.

Listen, listen, listen. It is very important that you try to identify the real issue that is •

frustrating your patient. Careful listening involves the use of appropriate body language that demonstrates you are focusing on the patient’s statements. Nodding, maintaining eye contact, and sitting at the same level as the patient demonstrate a caring attitude and help defuse anger.

Be patient. Avoid interruptions and do not tell the patient to “get to the point.” Some •

patients take a while to express themselves.

Paraphrase the patient’s statements back to him or her to confirm you understand. Peri-•

odically repeat back what you have heard until you are satisfied the patient is finished.

Confirm and validate. You can validate the patient’s feelings without admitting wrong-•

doing or agreeing with the patient. Statements such as “You sound upset about the slow healing of your infection” are fine and communicate your understanding. If it is clear the patient has a valid concern, acknowledge it. The facts are the facts.

Be honest. Tell the patient exactly what options are available, what you can do, and—•

importantly—what you cannot or will not do. If another member of your practice

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needs to be involved in a decision, let the patient know that you need to consult with that person before providing an answer.

Follow through. Do not forget promises you have made. The patient will not forget. If •

you agree to take action, take it.

Certainly, all staff should be familiar with these techniques. You may wish to designate key individuals within your practice to intervene when these situations develop. If you have one point person, be sure to designate an alternate.

Once a patient has created a problem, you need to decide whether this is a patient you wish to rehabilitate or terminate from care. If you choose to rehabilitate the patient, the point person should meet with the patient and explain the practice’s expectations. Here are guidelines for the meeting:

Clearly identify the inappropriate behavior or actions. Explain why the behavior is not •

acceptable.

Listen carefully to the patient’s response to identify any unresolved or previously un-•

identified issues.

Describe and document your expectations of the patient. Also document the patient’s •

acceptance or rejection of your expectations.

Communicate these expectations to the staff so that everyone is on the same page •

regarding this patient.

Consider limiting the patient’s staff contact to the designated point person to ensure •

compliance.

Consider using a • “patient contract” or “patient-care agreement” that memorializes the patient agreements. The contract should identify the consequences—such as termina-tion of care—for breaching the terms.

Addressing these issues is important for the overall health of your practice. The time you invest in dealing with these issues will provide many rewards, including office harmony and happier patients.

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Patient Care AgreementsWhile clear and early communication can prevent a lot of unwanted or inappropriate behavior, there may be times when you will be faced with the stress of a difficult patient-care situation. Frequent lateness, aggressive behavior, drug-seeking behavior, or nonadherence to medical ad-vice are among the challenges commonly faced in medical practices. Family members, too, may challenge every medical recommendation you make. These situations call for a well-planned response to avoid a drain on time and energy, as well as further erosion in the clinician-patient relationship.

Consideration should be given to whether to continue treating the patient. However, in some cases, terminating the patient relationship may not be a viable option. For example, the patient may have an acute condition that requires treatment—and no other provider in your area agrees to accept the care of the patient.

Effectively working with difficult patient-care situations requires a team effort. We recommend that clinicians consult with all members of the patient’s health care team to develop a manage-ment plan. It might be advisable to include consultation with specialists as appropriate (for example, it may be prudent to consult a social worker, behavioral specialist, or psychiatrist).

You might want to consider implementation of a patient-care agreement to strengthen your health care team’s efforts to maintain a professional and safe environment. Asking a patient to sign an agreement communicates to the patient that you and the rest of the health care team are serious about making the relationship work.

A patient-care agreement is a unique contract negotiated between the care provider and indi-vidual patient for the purpose of addressing issues specific to that relationship. It should define ground rules for continued care, expectations about future behavior, and consequences for failure to comply with the agreed terms.

Following are some additional strategies to consider when addressing these situations. These recommendations are geared toward helping the health care team manage the provider-patient relationship professionally.

Clearly identify and define the noncompliant or inappropriate behaviors.•

Develop a strategy for stopping or modifying the behavior.•

Clearly define the objectives of the strategy for later reference.•

Make sure that the patient receives a consistent message from everyone on the team, •

including front office staff.

As a part of the plan, identify a “point person”—someone who can oversee and coordi-•

nate communication and health care team efforts to work with the patient.

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Consider using a patient-care agreement to ensure patient understanding of expecta-•

tions, including what is acceptable and what is unacceptable.

After a period of time, evaluate whether implementation of the strategy is working. Are •

the goals and objectives previously identified being met? Is there improvement in the patient-care relationship?

Modify the strategy as necessary. •

Physicians Insurance risk management consultants are available to provide assistance regarding these issues, as each patient situation needs to be evaluated on a case-by-case basis.

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Your Patient Has an Adverse Outcome: What Now?

One certainty in the practice of medicine is that there will always be a percentage of cases where treatment does not result in the perfect outcome. Regardless of the clinical expertise of the pro-vider, adverse outcomes and unexpected results can and do occur. Most often, these events are not the result of substandard care or malpractice but are the known potential risks or complica-tions associated with the procedure, test, or treatment.

Patients have high expectations and are understandably disappointed when adverse outcomes are the result. However, a claim or lawsuit is not the predestined result of a complication with care. Experience has shown that how the provider responds to the event has the greatest impact on whether the matter will result in a claim. The following tips are offered to assist providers in dealing successfully with patients who have experienced a less-than-perfect result:

Communicate

As soon as possible, fully inform the patient of the complication using language the patient un-derstands. Provide a basic outline of what has occurred, avoiding overly technical medical termi-nology. Certainly, communicating this information to the patient is much easier if good informed consent was obtained prior to treatment. Good informed consent allows the physician to open the conversation with a statement such as “Well, unfortunately, one of the potential complica-tions we discussed did occur…. Now this is where we go from here….”

Be open and available

Do not avoid the patient or the patient’s family members. Avoiding difficult situations is a natu-ral human reaction, and sharing bad news about an adverse outcome or complication in treat-ment is difficult. It is equally true that the patient’s actual reaction is typically much better than the anticipated one. With an appropriate explanation, patients can understand and accept that bad outcomes do occur.

What they do not accept is poor communication. A physician who communicates poorly after a bad outcome is typically seen as uncaring, and it is the primary reason patients pursue the legal option. Patients want answers and often feel that litigation is their only recourse.

Express your concern

Demonstrate your empathy and concern for the patient. Where circumstances warrant, and after due reflection, an apology may be appropriate. In Washington State, apologies, to include an ad-mission of error, are not admissible evidence if made within 30 days of the bad outcome. Doing so is not an admission of liability. Your outward expressions of care and concern are extremely important to the patient and can actually strengthen the physician-patient relationship. Many patients have more confidence in their providers after working through such an event—because their providers demonstrated care and concern.

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Do not blame others

Do not point fingers at others involved in the patient’s care. Despite your concerns regarding another provider’s treatment, consider whether it is fair and professional to critique another’s treatment without knowing all the circumstances the provider faced. Follow established proce-dures for quality improvement and peer review when you have such concerns. Remember, it is never useful to place blame or incite the patient. Doing so usually results in a distrustful patient and a lawsuit rather than a patient ready and willing to focus on treatment for the complication.

Present a plan

Outline for the patient your plan for continued treatment in the near and long term. Let the patient know you have thoroughly considered all relevant options and have a detailed plan if additional treatment is necessary.

Does the patient understand?

After your presentation, question your patient on the key points. Be certain he or she has a clear understanding of what has occurred and what the future course of action entails.

Document

Clearly document your conversations with the patient and family members, their response to the information, and the agreed-upon (or proposed) plan of action.

Conclusion

Give us a call! If you are concerned about a particular situation, please contact the Risk Manage-ment Department to discuss it. We are here to help, and we appreciate the opportunity to assist you. Our risk management consultants are available for telephone or in-person consultations to review matters of concern and offer helpful suggestions.

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Apology: The Right Thing to DoIn this day and age, with physicians feeling besieged by malpractice claims and the fear of litigation, many physicians firmly believe that apologizing for a bad outcome in care is equivalent to an admis-sion of guilt or wrongdoing. The obvious concern is that well-intended expressions of empathy will later be used as evidence against the physicians by the very patients they were trying to console! These same physicians naturally assume that their insurance company would not want them apolo-gizing for a poor result or revealing information to a patient about what went wrong and why. Cer-tainly, when actual medical errors do occur, the appropriate response should always be “deny and defend,” right?

Actually, nothing could be further from the truth. In our view, it is always appropriate to be straight-forward with the patient regarding all aspects of care. This applies in all circumstances, whether you are dealing with a bad outcome or actual patient injury resulting from a medical error. The facts regarding your care are what they are. The facts will not change and they should be shared with the patient. In short, your patients have a right to all of the information you possess relevant to their medical condition.

Our experience at Physicians Insurance clearly demonstrates that an authentic and sincere apology or expression of caring and concern over the patient’s outcome has a tremendous influence in strength-ening the physician-patient relationship and promoting patient trust. Importantly, this enhanced trust greatly reduces the likelihood that the patient will seek answers through the financially and emotionally taxing legal system.

Most often, it is a lack of communication or a physician’s failure to commiserate that makes a patient believe the physician is unconcerned. Then the patient considers ways to take control of the situa-tion to get the physician’s attention. Typically, this involves hiring a plaintiff attorney to “get some answers”—and then the misery begins!

Fortunately, the State of Washington also believes that saying you are sorry is a good thing to do. HouseBill2292,acompromisemeasureenactedinthewakeoftheI-330/I-336stalemate,becameeffective June 7, 2006. While the complete bill contains several worthy provisions, it is arguably the hard-won apology section that promises to best serve physicians and patients in Washington State. Before the passage of the apology language in HB 2292 (now embodied into statutory law as RCW 5.64.010), existing law held that furnishing or offering to pay an injured patient’s medical expenses could not be used against a physician as evidence of liability. In 2002, the legislature extended similar protections to a physician’s expression of sympathy. A direct admission of fault, however, remained admissible against the physician to prove liability.

The new provisions

Now, as a result of the new law, this unwelcome legal hazard has been eliminated (subject to certain conditions). The newly enacted protections of RCW 5.64.010, slightly condensed, renumbered, and paraphrased for purposes of readability, provide that:

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In a civil action against a health care provider for personal injuries based upon alleged •

professional negligence, any statement, affirmation, gesture, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence, is not admissible as evidence if:

It was conveyed by a health care provider to the injured person, or to a person a. authorized to provide informed consent on behalf of an incompetent patient, within thirty days of the act or omission that is the basis for the allegation of professional negligence, or within thirty days of the time the health care provider discovered the act or omission that is the basis for the allegation of professional negligence, whichever period expires later; and

It relates to the discomfort, pain, suffering, injury, or death of the injured person b. as the result of the alleged professional negligence.

How the new law affects your practice

It is important to keep the following points in mind:

The language in the law’s first paragraph is sweeping and comprehensive. It is intended •

to enhance physician communication with patients and family members by remov-ing the burden of wondering whether words of apology will someday be recited in a courtroom.

Remember that even in the absence of special legal protection—where the thirty-day •

window has been exceeded, for example—the physician’s ethical duties to the patient remain supreme. If in doubt as to the correct course of action, get advice from risk man-agement and other appropriate sources, perhaps the hospital ethicist.

Thethirty-daytimelimitforapology/admissionprotectionshouldaffordampletime•

for action. If apologies are indicated, the sooner the better. Take due care, however, to first coordinate with other providers, confer with risk management, and, at all costs, avoid finger-pointing.

The thirty-day time period commences with either the bad outcome or when the •

physician discovers his or her involvement in a bad outcome, whichever is later. With regard to the latter scenario, in which the physician is not immediately aware there is a problem, the chart should reflect the date of notification. Here is an example of a good chart note:

Received call from Dr. Smith today, advising patient—now living in Portland—may have experienced complication relating to procedure I performed 4/12/05 . . . records on way, I’ll review and contact patient.

A chart entry like the above is likely to eliminate the need for otherwise unnecessary

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legal wrangling relating to the question “When did the clock start?” It also simplifies statute of limitation issues.

The apology itself

A physician’s sincere expression of regret following a poor outcome or distressing patient experience is a powerful means of enhancing trust. In a case where a mistake was clearly made, the patient should be told this forthrightly, with good eye contact. Here is an example of a good forthright apology:

I am very sorry this happened, that you’ve had to go through this ordeal. John, the medication you received was due to a prescription error on my part. It was my fault, and I feel terrible about it. Somehow I overlooked the information you had provided about your drug allergy. It shouldn’t have happened, and we’re reviewing the case to make sure something like this doesn’t happen again. You’re going to be just fine, but it looks like you’ll need to spend at least one more night in the hospital. John, do you have any questions for me?

A sincere apology and admission can prevent, rather than ignite, a lawsuit—a fact that plaintiff lawyers acknowledge. The facts do not change, and patients appreciate honesty and candor. Many lawsuits are filed because physician communication was lacking when it was needed most. Lawsuits aside, an apology is the right thing to do when things go awry, and this is true regardless of whether the apology happens within the thirty-day window.

Idaho and Oregon apology guidelines

On July 1, 2006, Idaho joined the two-dozen or so states which had recently enacted “apology” legislation. As a result, Idaho physicians, and other health care professionals, are able to offer apologies without fearing that well-intended words could be used against them in a medical malpractice lawsuit.

The new statute, IC (Idaho Code) 9-207, does not limit protection to only those apologies made within a thirty-day window, or other specified time-frame. IC 9-207 reads in part:

“…all statements…gestures or conduct expressing apology, sympathy, commiseration… or a gen-eral sense of benevolence, including any accompanying explanation… shall be inadmissible as evidence for any reason including… as an admission of liability…”

In Oregon, physicians may make an apology or an expression of regret regarding a bad outcome without it being used against the physician in any civil or administrative action. However, an admission of fault will be admissible.

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Section 2

Medical Records—Documentation and Release

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Medical Records: Definition, Organization, and Charting

The medical record is critical to good patient medical care and to the successful defense of malpractice lawsuits when they occur. As patient loads increase and medicine becomes more complex, both the patient and physician benefit from the complete, accurate, legible, and contemporaneous documentation of the medical care provided. From a patient care standpoint, medical records are the basis upon which the quality of patient care is judged by hospitals, pro-fessional review organizations, third-party payers, governmental agencies, and medical licensing boards. From a malpractice perspective, cases that appear defensible on clinical grounds be-come indefensible in court when inadequate records are introduced as evidence. Similarly, cases of severe damages have been won with comprehensive and meticulously documented records. Good charting is one of the most important patient care and medical risk management skills a physician can develop.

What is a complete medical record?

Laws at both the state and federal level define what constitutes a medical record. Essentially, a complete medical record, based on these laws, is a collection of information that is created by a health care provider or the patient, including information collected from multiple providers or other sources, and relates to:

The physical, mental, or behavioral health or condition of an individual whether in the •

past, present, or future

The provision of health care to an individual•

Any information used, in whole or in part, to make decisions about individuals•

Billing and payment information for the provision of health care to an individual•

Enrollment, payment, claims, education, and case or medical management by or for a •

health plan

The ideal office medical record contains the following:

Patient information sheet listing the patient’s name, date of birth, social security num-•

ber or patient identification number, address, insurance carrier, and financial and emer-gency contact data

Health history questionnair• e

Current problem list•

Current medication flowsheet listing past and present medications and indicating drug •

allergies, sensitivities, or adverse reactions

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Comprehensive medical, family, and psychosocial history•

Dictated or legibly written progress notes in the SOAP or other problem-oriented for-•

mat for each patient visit including references to patient education materials provided and informed consent discussions

Laboratory, imaging, or other diagnostic reports; •

Consultation requests and reports; •

Copies of hospital or other health care provider records; and •

Correspondence about the patient. •

You can judge the soundness of your medical record by asking yourself whether a colleague could provide immediate and appropriate medical care in your absence with only your chart for assistance.

Organization

To ensure easy review of a patient’s medical information, you should organize your medical records thoughtfully. Each patient should have a separate chart, as should each member of a family. Moreover, each patient file should have its own file jacket with fasteners to secure all papers. A commonly used filing system groups all progress notes on one side of the folder or jacket and all laboratory, consult, and other reports or records on the other. To further organize the chart, we suggest you use color-coding or dividers. In addition, each office or clinic should adopt a standard filing system for all charts so that the medical and office staff can quickly locate information in any given chart.

Charting

For most specialties, Physicians Insurance recommends adopting a medical record that can be dictated and transcribed within 48 hours. Because the average individual talks much faster than he or she writes, a dictated record is generally more comprehensive and can provide bet-ter documentation of patient visits. Furthermore, dictation eliminates a major impediment to patient care and malpractice defense: illegible handwriting. Lawsuits have been lost or settled for substantial amounts because a single chart entry was illegible or subject to several possible interpretations.

If your office cannot use a dictated medical record, all chart entries should be legibly printed in black ink to provide an easily read chart that will photocopy successfully. Each time you docu-ment a patient’s chart, keep in mind that photocopies of your records will be sent to other health care providers, governmental agencies, or lawyers.

A progress note, which should be dictated or written as soon as possible after seeing a patient, must be a complete record of a patient visit. Each note should be filed in chronological order, and each page should include the patient’s name or clinic identification number. Additionally,

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each chart entry should display the complete date (month, day, and year). The chart should document all general and limited examinations, as well as all positive and negative findings relat-ing to the patient’s complaint or condition.

Record and initial in the chart all substantive telephone contacts, patient instructions, medica-tion refills, missed appointments, and failures to follow medical advice. Develop guidelines stat-ing which medications can be refilled by office staff, which medication refills require physician intervention, and which patient calls or problems should be brought to the physician’s immedi-ate attention. You may also wish to design written instructions for specific illnesses, injuries, or procedures.

Devise a system to ensure that physicians initial all laboratory, imaging, correspondence, con-sults, and other reports prior to filing. Lawsuits have been lost or settled for substantial amounts because the physician never saw a test result. If stat tests are ordered, the physician should receive the results as soon as possible for immediate follow-up.

The medical record should always be an objective record of facts, impressions, clinical judg-ment, and treatment. To prevent a lawsuit for libel, you should avoid any subjective or pejorative remarks about a patient or about other providers.

Use commonly accepted and understood abbreviations and acronyms. Be meticulous in chart-ing by printing drug names, doses, and regimens. As you can imagine, a misplaced decimal point or illegible prescription can have tragic consequences for a patient.

If you need to make a correction on your chart, you should draw a single line through the er-ror, add the correct information, and date and initial the change. If you find you have omitted information, you should make an addendum after the last chart entry. Identify this as an ad-dendum and date and initial it. You should never obliterate, cut out, erase, or overwrite an entry, nor should you squeeze words into an existing chart entry. If litigation were to ensue, improper record changes, corrections, or alterations could destroy the defensibility of your case.

Electronic medical records

As the use of electronic medical records (EMR) becomes more widespread, questions may arise about how a record comprised of so many individual data fields differs from a paper chart. The fact is that a well-designed EMR will collect all of the information required to meet the defini-tion of a complete record. There are a few considerations to be made, however, when working with an EMR.

Some systems will allow for lab results to be electronically submitted and reported from within the EMR. Since the provider won’t be able to sign off on the lab or report as in a paper system, be sure to have protocols in place that will effectively communicate receipt of all results to all appropriate personnel in a manner that will reflect the urgency of the information as well as al-low for quick response and documentation of decisions and actions taken. It is likely that some reports or studies will still be in a hard-copy format. In order to make sure that findings are

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communicated consistently regardless of whether they are submitted in electronic or hard-copy format, develop a policy and procedure to ensure that clinicians are notified of the hard-copy results in a timely manner, that they sign off on the report or consults, and that the original is ei-ther imaged or stored in such a manner that will preserve the quality and integrity of the record.

Just as with a paper system, sometimes corrections will need to be made. How this is done electronically will vary depending on the EMR you are using. However, in order for the record to remain credible, there are some things that need to be addressed by the EMR configuration. Make sure that entries cannot be altered without an audit trail that identifies the modification made, by whom, and the time of alteration. If possible, the reason for the need to modify should also be documented. Restrict the ability to alter any entry to essential personnel only. If chart information needs to be appended, create a new entry and reference the original chart entry to avoid the appearance of inappropriate alteration.

Remember that many EMRs have built-in tools not available in a paper record such as point-of-care decision aids or prompts, reminder messages, or warnings. These tools can be very helpful. However, be aware that how a user responds to or uses these messages will also become a part of the electronic record. If your practice chooses to use these tools, be sure to activate only those features that will be used consistently. Have policies and procedures in place regarding how clinical decisions to override or ignore reminders, warnings, or restrictions should be document-ed.

Conclusion

Having a well organized, up-to-date, and consistent chart is essential for quality patient care and effective defensibility against malpractice claims. Physicians Insurance has developed a list of guidelines to help health care professionals document effectively. Consider the following when developing documentation guidelines for your organization:

Document facts, impressions, clinical judgment, and treatment objectively. Be specific •

and avoid general statements such as “Patient doing well.”

Use commonly accepted and understood medical terms, abbreviations, and acronyms. •

Chart so that any medical professional can read the medical record.

Use a standard charting format, such as the SOAP format, when documenting progress •

notes.

Avoid using sticky notes and half sheets of paper to document information in the medi-•

cal record.

Include a suggested return date and information about referrals to other health care •

providers when documenting progress notes.

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Document in the chart when patients are notified regarding test results and consultant •

opinions. Include the date the patient was notified, the method of reporting (e.g., in person, by telephone, or by letter), the information reported, and the person reporting.

Chart drug names, doses, routes, and regimens meticulously.•

Correct errors in the chart by drawing a single line through the error and dating and •

signing the correction.

Add omitted information by identifying the entry as an addendum or late entry, and •

date and sign the entry.

Chart all clinical interventions, advice given, and patients’ responses.•

Avoid using the medical record as a battleground to criticize other professionals. Re-•

spect the opinion of peers. Never blame an adverse occurrence on another provider.

Never, ever use humor in the medical record. What may seem funny at the time may not •

seem funny to a jury.

Eliminate bias from the written description of a patient. Avoid words such as “lazy” or •

“sloppy.” A jury may infer that patient care was substandard because the provider did not like the patient.

Chart relevant patient acts. A jury may not be sympathetic to a patient who does not •

comply with a provider’s instructions (e.g., the patient on strict bed rest who refuses to stay in bed).

Avoid gaps or omissions in the record. The old adage “If you didn’t chart it, you didn’t •

do it” still holds true today.

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Electronic Medical Records: Litigation Experience and Risk Management Tips

By Elizabeth A. Leedom, JD, Bennett Bigelow & Leedom, PS

Elizabeth Leedom, JD, is a trial lawyer with over 20 years of experience representing hospitals, physicians, and other providers in medical malpractice cases. Educated at the University of Wash-ington, she is past president of the Washington Chapter of the American Board of Trial Advocates.

The electronic medical record (EMR) has only recently started to appear in litigated medical malpractice cases. This article will discuss the positive effects of an EMR in defending claims, point out the ways we have seen EMR used by opposing counsel, and offer some risk manage-ment tips for using EMR.

The benefits of EMR

One of the positive effects of EMR has been more detailed and complete documentation. The templates used for various chief complaints provide a handy and thorough checklist to facilitate history taking and docu mentation. For example, the template for chest pain sets forth a series of important descriptors such as associated symptoms, location, quality, radiation, duration, tim-ing, context, and modifying factors. The typed-in history taken by the physician can then ad-dress these issues. The templates also offer a helpful section for the review of systems in which the physician can ask about related symptoms and simply type in a “no” if the patient’s history is negative. This provides accurate documentation of what previously may not have been written down due to a presumed negative response by the patient. Such EMR-facilitated documenta-tion of a negative history has recently been helpful in a case where the patient later died and the physician could point to actual documentation of what turned out to be a very pertinent nega-tive in the review of systems. Had this not been affirmatively documented through the EMR, the evidentiary rules excluding verbal statements by a decedent would likely have prevented the physician from defending herself with this key point.

Another positive aspect of EMR has been its ability to prompt the physician to follow up on abnormal lab values, results of oth er diagnostic tests, and overdue preventive-medicine screen-ing tests. The EMR can flag abnormal test results in the physician’s e-mail and can even signal scheduling personnel to follow up by calling the patient for an appointment. The EMR can also keep track of preventive-medicine screenings and generate a reminder letter to the patient and a trigger to the physician when he or she next sees the patient. Because of the good use of EMR capabilities, we are now seeing a near elimination of specific allegations of failure to follow up appropriately on abnormal tests or needed screening.

How EMR can hurt a physician’s case

However, we are also starting to see the EMR used against the defendant physician in several important ways. First, we are beginning to see requests for the EMR’s underlying metadata—

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that is, the information about the data that describes, for example, how, when, and by whom the data was received, created, accessed, and modified. Many, many data fields are not printed or regularly viewed in the EMR as it is used daily by physicians. For example, the EMR’s audit trail feature tracks individual access to the EMR, and we have had to produce EMR audit trails in the litigation context. The audit trail tracks certain portals in the EMR, causing a tripwire-type notation in the audit log when those portals are accessed. The audit trail thus provides a permanent record of each time the patient’s EMR is accessed, and by whom, even if no entry is made. It is important to keep in mind that each time you access a patient’s EMR, an electronic “footprint” of that access may be permanently created.

Second, plaintiff attorneys are suggesting that the defendant physician is so preoccupied with typing in the EMR that he or she isn’t paying adequate attention to the real live patient in the exam room. We have heard plaintiff patients testify at deposition that their physicians were typing throughout the interviews, making their patients uncomfortable and unsure if the physi-cians were really listening. You can reduce such a perception in your practice by explaining why the EMR is used instead of hand writing—and then listening intently and typing separately.

Third, plaintiff attorneys have been placing an overemphasis on the EMR’s “date and time stamp” feature. The EMR creates a date and time stamp for nearly all entries—from the docu-mentation of vital signs by the medical assistant to the physician’s review of diagnostic test results. Plaintiff attorneys are using the date and time stamps to try to show the actual length of the visit at issue and the amount of time spent between physician and patient.

The risk of date and time stamps

Be aware of the “date and time stamp” feature in the EMR. Plaintiff attorneys try to use this as proof of when the physician first reviewed an abnormal lab result. In reality, the date and time stamp is trig gered when the physician formally opens and reviews the lab result, test, or other report. Depending on the EMR, date stamp ing a lab result or report might be accomplished by clicking on a button, check box, or other feature. The physician may well have seen and acted upon the result earlier when accessing the EMR for another reason that did not trigger the date and time stamp. That is, the physician may have seen a lab result through an auto-preview feature on his or her e-mail but did not activate the date-stamping feature in the record indicat-ing his or her review because there were still outstanding lab results to receive. It is important for physicians to “mark” the record with the date and time stamp when they first review results, tests, or reports. This practice documents the physician’s prompt review of patient tests and supports an accurate chronicle of clinical care.

The risk of automatic text

Pay attention to the automatic text that is placed into the EMR when certain actions are taken. The automatic text may be different from what is intended and may not fit the clinical situa-tion. For example, when the medications list is reviewed and updated, the EMR may insert an automatic text stating “Medications discontinued at this visit.” In a recent case involving an alleged failure to diagnose an aortic dissection, the patient had been seen 18 months earlier and

31

had reported during the visit that he had not been taking the anti-hypertensive medication prescribed a year earlier but had been taking an herbal supplement instead. When the physician cleaned up the medication record, he took the prior prescriptions for anti-hypertensives off the patient’s list. Therefore, in the EMR, the notation “Medications discontinued at this visit” automatically appeared, giving the impression that the physician, rather than the patient, had decided to stop this treat ment for high blood pressure.

Conclusion

For risk management purposes, the “e” in electronic medical records stands for “eternal.” Any and all access, changes, edits, or modifications to the patient’s record are preserved and may even be date and time stamped. Despite the eternal and omnipresent nature of the electronic eye of the patient’s electronic chart, careful and attentive use of the EMR with these risk management tips in mind will generally help the defense if the patient’s care is subsequently litigated.

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Retention of Medical RecordsIf you are ever in the position of defending your treatment decisions in court, it is essential that you possess the relevant medical records. Without them it is very difficult to prepare an ad-equate defense. How long, then, do you need to keep medical records, including X-rays on your patients?

Pursuant to the privacy rules under HIPAA, some documented requests for and disclosures of medical records must be maintained for at least six (6) years. Consequently, you will be required to maintain patient health care records for a minimum 6-year period.

The statute of limitations, or the period of time after treatment during which a patient may bring suit against you, provides some guidance. An 8-year statute of repose became effective June 6, 2006. A civil action for injury from health care must be commenced:

Within three years of the act causing injury, or•

Within one year of the time that the patient discovered the injury or should have dis-•

covered the injury, whichever is later, but

No more than eight years after the act causing the injury•

The knowledge of the custodian parent is imputed to a minor child under the age of 18 for pur-poses of the statute of limitations.

To best serve you in the event of a claim, however, we continue to advise that if you cannot retain medical records indefinitely, you should retain them for a minimum of:

6 years from the date of patient’s death•

10 years from the date of patient’s last medical service•

21 years from the date of a child’s birth for pediatric records and for the obstetric pa-•

tient’s prenatal records

Appointment books and computer scheduling should be retained for at least 10 years. They are frequently the only source of information about cancelled appointments, no-shows, or other pertinent information about a physician’s schedule.

If you want to be absolutely safe, you should never destroy medical records. Certainly, if you are aware of problems with a patient’s care or have reason to believe you may be sued, you should retain all relevant medical records indefinitely.

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The Washington State Uniform Health Care Information Act (UHCIA)

Background

The Washington State Legislature enacted the Uniform Health Care Information Act (UH-CIA) in 1991. Since then, the UHCIA has governed the use and disclosure of health care infor-mation in Washington State. In 2003, the federal Health Insurance Portability and Account-ability Act (HIPAA) took effect, providing additional regulation of health care information. Because both state and federal laws govern health care information, there has been concern over inconsistent standards and the potential for lowering the quality of care.

Current status

In 2005, the Washington State Legislature amended the UHCIA to make state law more consis-tent with HIPAA. These amendments became effective on July 24, 2005. The amendments pri-marily addressed authorizations for disclosing health information and accounting for disclosures.

Summary of amendments

A sample Authorization to Use or Disclose Health Care Information form is available on our Web site at www.phyins.com.

The UHCIA’s general 90-day limit on the length of validity for a health care informa-tion disclosure authorization has been removed.

Before the amendment, Washington law permitted a patient to authorize disclosure of his or her information relating to future health care that the patient received for up to 90 days after the authorization was signed. The 90-day limit has now been removed. The UHCIA has been brought in line with HIPAA regulations by requiring that an authorization include an expira-tion date or event that relates to the patient or the purpose of the use or disclosure. A 90-day limit does, however, apply to an authorization for disclosure to a financial institution or an em-ployer for purposes other than payment unless the patient renews the authorization.

The authorization may specify a particular class of persons to whom information may be dis-closed. As amended, the UHCIA permits a patient to designate a particular class of person to whom information may be disclosed instead of being limited to designating particular indi-viduals. A patient may authorize the disclosure of health care information to a class of persons, including researchers who have obtained the patient’s informed consent and third-party payers if the information is disclosed only for payment purposes. Moreover, the UHCIA now permits the authorization to identify a class of providers who are to make the disclosure.

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Today, a disclosure authorization must:

Be in writing, dated, and signed by the patient.•

Identify the nature of the information to be disclosed.•

Identify the name and institutional affiliation of the person or class of persons to whom •

the information is to be disclosed.

Identify the provider or class of providers who are to make the disclosure.•

Identify the patient.•

Contain an expiration date or an expiration event that relates to the patient or the pur-•

pose of the use or disclosure.

There are three new instances when disclosures can be made without patient authori-zation. To further align the UHCIA with HIPAA, state law is clarified to permit health care providers or health care facilities to disclose information without patient authorization to:

Law enforcement authorities if the health care provider or facility believes in good faith •

that the information disclosed constitutes evidence of criminal conduct that occurred on the premises.

Another health care provider, facility, or third-party payor who has a relationship with •

the patient and is for the purpose of quality assessment and improvement activities, provider credentialing and related activities.

Those carrying out payment.•

Accounting For Disclosures. Prior to amendment, the UHCIA required health care provid-ers or facilities to account for every disclosure of health care information, except to third-party payers. Now, the UHCIA accounting requirements mimic the HIPAA requirements. Thus, health care providers and facilities now do not need to account for disclosures:

To carry out treatment, payment, and health care operations.•

To the patient of health care information about him or her.•

Incident to a use or disclosure that is otherwise permitted or required.•

Pursuant to the authorization where the patient authorized the disclosure of health •

care information about himself or herself.

Of directory information. •

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To persons involved in the patient’s care.•

For national security or intelligence purposes if an accounting of disclosures is not per-•

mitted by law.

To correctional institutions or law enforcement officials if an accounting of disclosures is •

not permitted by law.

Of a limited data set that excludes direct identifiers of the patient or of relatives, em-•

ployers, or household members of the patient.

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Disclosing Health Care Information in Washington—Q and A

How long is a records release authorization valid?1.

Except for permission to provide information to third-party health care payers, an au-thorization to release records can be valid for varying lengths of time. The authoriza-tion to release records must specify one of the following: an expiration date (a specific date—e.g., January 1, 2010) OR a specified number of days from the date signed OR when the following event occurs (e.g., “when adoption of our child is final”). The law has no time limit on the validity of releases to health care payers.

Does a patient have a right to be informed of disclosures of health care information?2.

Yes. A patient has a right to receive an accounting of disclosures of health care infor-mation made by a health care provider or a health care facility in the six years before the date on which the accounting is requested, except for disclosures:

To carry out treatment, payment and health care operations.•

To the patient, of his or her own health care information.•

Incident to a use or disclosure that is otherwise permitted.•

Pursuant to a valid authorization where the patient authorized the disclosure of •

health care information about himself of herself.

Of directory information.•

To persons involved in the patient’s care.•

To authorized federal officers for certain national security or intelligence purposes.•

To correctional institutions or law enforcement officials having lawful custody of •

the person in necessary for certain purposes.

Of a limited data set that excludes direct identifiers of the patient or of relatives, •

employers, or household members of the patient when done so for certain limited purposes.

How long do I have to respond to a request to copy records?3.

You should comply as soon as is reasonably practical, but the law allows up to 15 work-ing days to make the information available. If special or unusual circumstances cause a delay beyond 15 working days, you must inform the patient in writing of the reasons for the delay and specify a date no later than 21 working days after receiving the autho-rization when the information will be made available. This discussion does not apply

37

in the context of a subpoena or request for discovery.

What do I do if a patient asks to see his or her record?4.

The patient does have the right to personally inspect his or her medical record as promptly as required under the circumstances, but no later than 15 or 21 working days after the patient’s request as described in question 3 above. A staff member should accompany the patient to provide assistance, answer questions, and guard against tam-pering with the chart.

How much can I charge for copies of the records?5.

For Washington practitioners and facilities:

HIPAA and Washington State law limit the amount that may be charged for duplica-tion and searching services to a reasonable cost-based fee. HIPAA prohibits charging patients for handling fees, chart-pulling fees, or per-page fees in excess of the direct cost of materials. The interaction between these two laws may arguably permit the inclusion of a clerical or labor fee only under certain circumstances.

When editing of the record is required by statute and is done by the provider per-sonally, Washington State law allows the provider to charge the usual and customary charge for a basic office visit. However, because of the HIPAA Privacy Rule, individu-als must agree to these charges in advance. A typical example of where editing would be required is a records request that does not specifically authorize disclosure of infor-mationrelatedtoHIV/AIDS,sexuallytransmitteddiseases(STDs),substanceabuse,or mental health, which would require that information be removed from the chart copy.

The Washington State Department of Health discourages charging a fee in cases of financial hardship. Refusing to provide copies of records for treatment purposes is unethical. In other situations, Washington State and federal law does provide that a “reasonable” or “cost-based” fee may be charged. In Washington State, these fees may not exceed the following:

Copying $0.96/pageforthefirst30pagesplus$0.73/pagethereafter (HIPAA prohibits charging patients or their representative handling fees, chart-pulling fees or per-page fees in excess of the direct cost of materials)

Clerical/labor Upto$22.00(HIPAAprovidesthatthisfeecannotbecharged to patients or their representatives)

Certification $2.00

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Differing opinions exist concerning how the language contained with the HIPAA privacy regulations interacts with the copy charges allowed by Washington State law. HIPAA regulations may limit permissible copy charges assessed to patients by al-lowing labor and supply costs only, and specifically excluding charges for “retrieving or handling.” Therefore, we currently believe that the $22 “clerical fee for searching and handling” allowed under Washington law cannot be charged to patients request-ing copies of their records. For nonpatient requestors, excluding third-party payers, HIPAA contains no provisions governing or limiting such fees. Therefore, it is debat-able as to whether or not it is permissible to charge nonpatient requestors the $22 clerical fee for searching and handling. The bottom line is that you cannot charge the patient, or third-party payers, the $22 fee. The “per page” charges allowed under Washington law can still be charged to patients up to the statutory maximum pro-vided that these fees do not exceed the direct cost of materials.

References: RCW 70.02.010, RCW 70.02.080, WAC 246-08-400, 45 CFR 164.524, Washington State HIPAA Preemp-tion Analysis (2002 WHSA)

DoIstillneedaspecialformtoreleaseinformationaboutHIV/AIDS,sexuallytrans-6. mitted diseases, drug abuse, and mental health treatment?

The patient must sign an authorization that specifically mentions these conditions before the records can be released. Please refer to our sample Authorization to Use or Disclose Health Care Information for the recommended language.

Can anyone other than the patient sign a records release authorization?7.

If the patient is alive but does not have the capacity to sign a records release autho-rization, a person authorized to make health care decisions on behalf of the patient can sign the records release authorization. A person authorized to make health care decisions is a member of one of the following classes of persons in the following order of priority:

The appointed guardian of the patient, if any.1.

The individual, if any, to whom the patient has given a durable power of 2. attorney for health care.

The patient’s spouse.3.

Children of the patient who are at least eighteen years old.4.

Parents of the patient.5.

Adult brothers and sisters of the patient.6.

If the patient is deceased, the personal representative of the patient (executor of the patient’s estate) can sign a records release authorization. If there is no personal rep-

39

resentative, then a person authorized to make health care decisions for the patient as listed above can sign the release.

Can parents sign releases for their minor children?8.

Parents may sign releases for their minor children in most cases. However, if the minor is emancipated, married, or authorized to consent to health care without parental consent according to federal and state law, only the minor may authorize the release of health care information pertaining to his or her care. Minors may consent at age 14 for treatmentrelatedtoHIV/AIDSorsexuallytransmitteddiseases;atage13foroutpa-tient mental health care or outpatient substance abuse treatment; and at any age for birth control or pregnancy-related care.

What if the parents are divorced?9.

If the parent represents to the health care provider that he or she is authorized to consent to treatment for the minor, the parent can sign the records authorization. This applies regardless of whether the parents are married, unmarried, or separated at the time of the request; the consenting parent is or is not the custodial parent; and the giv-ing of consent by the parent is or is not in compliance with a divorce order or decree.

What do I do when I receive a discovery request or subpoena for records, 10. deposition, or trial from a lawyer?

Before a discovery request or subpoena is served, the health care provider must be given at least 14 days’ advance written notice by the attorney issuing the request or subpoena. A copy of the advance notice also is sent to the patient or patient’s attorney.

The notice must indicate from what provider the information is sought, what informa-tion is sought, and the date by which a protective order must be obtained to prevent the provider from complying with the discovery request or subpoena. The health care provider may not, without the patient’s consent, disclose the information sought if the requestor has not complied with the notice requirements.

If the notice requirements have been met, the provider must disclose the requested information in response to the discovery request or subpoena unless a protective order is issued by the court or the information is otherwise protected by law as described in the next paragraph. The discovery request or subpoena must be placed into the patient’s record.

The fact that notice requirements have been met and that the release is pursuant to a discovery request or subpoena for records does not modify the terms and condi-tions of disclosure under laws forbidding the compelled disclosure of information aboutHIV/AIDS,STDs,mentalhealth,orsubstanceabuse.Youcannotdisclosesuchinformation unless the patient specifically consents in writing or the party requesting disclosure obtains a specific court order. A general subpoena or request for discovery is

40

not enough. If you receive an advance notice of a subpoena or discovery request with-outthepatient’ssignedauthorizationforthereleaseofinformationaboutHIV/AIDS,STDs, mental health, or substance abuse, we recommend you send the parties a letter that explains your dilemma. It should include language similar to this:

“I will comply with the (subpoena) (discovery request) to the extent allowed by law. If the patient’s record contains any information which requires the patient’s specific consent for disclosure, I will need the patient’s specific written consent or a specific court order before I can release such information.”

If you delete information from the record, advise the requestor that information has been deleted as required by law, but do not specify the nature of the information.

Of course, if you are involved in the litigation as a party, you should consult with your counsel about the appropriate response to a request for records.

Can I disclose health care information without the patient’s authorization?11.

Yes. There are a variety of situations whereby information may be disclosed without authorization by the patient.

Following is a partial list of such circumstances. This list is not intended to be all in-clusive and each organization’s policy regarding privacy practices should be consulted before disclosures are made without a patient’s authorization. Privacy regulations now in effect are designed to improve the privacy and security of health care information but they are not intended to be a barrier to quality health care.

Tofuneraldirectors/coronersconsistentwithapplicablelawtoallowthemtocarry•

out their duties.

To organ procurement organizations (tissue donation and transplant) or persons •

who obtain, store, or transplant organs.

To the Food and Drug Administration (FDA) relating to problems with food, •

supplements, and products.

To comply with workers’ compensation laws—if a workers’ compensation claim is •

made.

For public health and safety purposes as allowed or required by law:•

To prevent or reduce a serious, immediate threat to the health or safety of a •

person or the public.

To public health or legal authorities:•

To protect public health and safety.•

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To prevent or control disease, injury, or disability.•

To report vital statistics such as births or deaths.•

To report suspected abuse or neglect to public authorities.•

To correctional institutions if the patient is in jail or prison, as necessary for the •

patient’s health and the health and safety of others.

For law enforcement purposes such as when a subpoena, court order, or other legal •

process requires disclosure, or if the patient is a victim of a crime.

For health and safety oversight activities. For example, health information may be •

shared with the Department of Health.

For disaster relief purposes. For example, health information may be shared with •

disaster relief agencies to assist in notification of a patient’s condition to family or others.

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Section 3

Medical-Legal Issues

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Interpreters: Working with Patients with Limited English Proficiency

All patients are entitled to confidential, effective communication, and fully informed consent. For many healthcare providers, this means having to develop strategies for working with pa-tients for whom English can be a challenge.

The DHHS Office of Civil Rights has concluded that inadequate interpretation for patients with Limited English Proficiency (LEP) is a form of prohibited discrimination on the basis of national origin under Title VI of the Civil Rights Act of 1964. Over the past few years, the Civil Rights Division of the U.S. Department of Justice has been charged with coordinating, reviewing, and enforcing rules established to ensure that LEP individuals have access to essential services. In addition to the Civil Rights Act, there are a variety of state and local laws that apply to LEP individuals including the Washington Law Against Discrimination.1

One or more of these laws will require you to provide a qualified interpreter or auxiliary aids to ensure effective communication at no cost to the patient. Additionally, your ability to continue receiving federal or state reimbursement may be affected by your compliance with these laws.

In Washington State, people with LEP are defined as individuals with “limited ability or an inability to speak, read, or write English well enough to understand and communicate effec-tivelyinnormaldailyactivities.Theclientdecideswhetherhe/sheislimitedinhis/herabilityto speak, read, or write English.”2 This includes people whose primary language is not English as well as those who may have hearing, sight, and speech limitations.

LEP Q and A:

Who decides what aid is necessary?1.

While the patient decides whether he or she is limited in his or her ability to speak, read, or write English, the provider, in consultation with the patient or patient’s repre-sentative, determines what strategies are necessary to communicate effectively.

If an interpreter is not immediately available, can I ask that the appointment be re-2. scheduled?

In many cases, yes. However, if the patient would suffer because of the delay, you will want to have an alternative strategy available. The laws require “timeliness.” Though there is no specific definition of “timeliness,” the nature of the consultation and the ur-gency for treatment are factors that must be taken into consideration. A delay should not take place if the delay would reasonably deny the patient access to quality care.

For emergent needs, when it is not possible to have an interpreter assist in person, there are resources available, such as Language Line Services, which have interpreters available on a 24-hour basis.

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Can we ask the patient or their representative to bring in a family member? 3.

Family members or friends should not be used unless the patient so chooses, and only after you advise the patient of your obligation to provide an interpreter at no cost to the patient. While patients may be comfortable with family members, it is important to remember that the family member may not have the appropriate skills necessary to convey complicated health care information. There may also be situations in which the family member could have a conflict of interest.

Are we obligated to use an interpreter selected by the patient?4.

No. You are not required to utilize an interpreter designated by the patient. You can require the patient use a qualified interpreter selected by you.

Who pays for the interpreter?5.

The provider or practice cannot charge the patient for interpreter services. Patients must be fully informed of the availability of a qualified interpreter at no cost to the patient. Some providers who care for DSHS patients do qualify for reimbursement. However, coverage varies and you should not rely on reimbursement without first contacting the DSHS Medical Assistance Administration.

How do I identify a qualified interpreter?6.

Washington State has established procedures for identifying qualified interpreters and translators, in both foreign languages and American Sign Language. Through a certifi-cation process, interpreters and translators are tested to demonstrate a proficiency in and ability to communicate in both English and the other language. Good sources of referrals may be found in hospitals and at local public health offices. Develop a contact list of services in your area.

Where can I learn more about LEP?7.

We have put together a list of Web sites to help you identify resources and develop policies for working with LEP patients.

Washington State Web sites

Washington State Language Testing and Certification (LTC) Home Page http://www.dshs.wa.gov/msa/ltc/

DSHS MAA Interpreter Service Providers for Spoken Language http://fortress.wa.gov/dshs/maa/InterpreterServices/SpokenLanguageVendor.htm

American Sign Language Providers http://fortress.wa.gov/dshs/maa/InterpreterServices/ASLproviders.htm

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United States Federal Government Web sites

Interagency Working Group on Limited English Proficiency www.lep.gov

Links to Medical Translator and Interpretation Services http://www.lep.gov/medtrans.html

US Department of Justice http://www.usdoj.gov/crt/cor/13166.htm A collection of federal legislation related to LEP

http://www.usdoj.gov/crt/cor/Pubs/ISpeakCards.pdf A printable flashcard that can help providers identify which language a patient speaks

Federal Citizen Information Center http://www.pueblo.gsa.gov/multilanguage/multilang.htm

US FDA Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/~mow/language.html Some documents available for download about basic nutrition and health information in many foreign languages

Office of Women’s Health http://www.fda.gov/womens/taketimetocare/mymeds.html Patient information document available in many languages

Other resources

Language Line Services www.languageline.com

National Council on Interpreting in Health Care http://www.ncihc.org/

Diversity Rx http://www.diversityrx.org/HTML/MORES_SMI.htm Resources on cross-cultural healthcare including translation, interpretation, and other issues

1 RCW 49.60

2 WAC 388-555-1000

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Health Care Assistants: the BasicsMore and more medical practices are hiring health care assistants as a cost-effective way to obtain valuable medical assistance. Many physicians call the Risk Management Department with questions about a health care assistant’s authorized duties, the certification process, the required level of supervision, and what new risks health care assistants can bring to a practice. Fortunately, the law in Washington State provides clear guidance. This article will answer some of the com-mon questions we receive about health care assistants in light of current Washington State law.

What is a health care assistant?

As defined by RCW 18.135.020, a health care assistant is an unlicensed person who assists a licensed health care practitioner in providing health care to patients. Health care practitioner is:

A physician licensed under chapter 18.71 RCW, and a physician assistant licensed under 1. chapter 18.71A RCW.

An osteopathic physician or surgeon licensed under chapter 18.57 RCW, and osteopath-2. ic physician assistant licensed under chapter 18.57A RCW.

A podiatric physician and surgeon licensed under chapter 18.22 RCW, acting within the 3. scope of their licensure.

A registered nurse or advance registered nurse practitioner licensed under chapter 18.79 4. RCW.

A naturopath licensed under chapter 18.36A RCW.5.

What are health care assistants authorized to do?

The health care practices authorized by Washington law are limited to administering skin tests and subcutaneous, intradermal, intramuscular, and intravenous injections, minor invasive pro-cedures to withdraw blood, hemodialysis, as well as FDA-approved vaccines by injection, orally or topically, including nasal administration. Authority to perform such procedures may only be delegated by a delegator (e.g., a licensed health care practitioner) who is authorized to perform these procedures within the scope of his or her license. Health care assistants may perform only thoseproceduresthatareauthorizedundertheircurrentcertification/delegationformsonfilewith the Department of Health.

What is certification and who certifies the health care assistant?

Any health care facility may certify a health care assistant to perform authorized functions in that facility, and any health care practitioner may certify a health care assistant capable of per-forming such services in any health care facility, or in his or her office, under a health care practi-tioner’s supervision. Before certifying the health care assistant, the facility or health care practi-tioner must verify that the health care assistant has met the minimum requirements applicable to the health care assistant’s classification. Training and supervision in this same capacity is allowed to continue after the trainee has submitted the application for certification and up to the time

47

the certification is issued. However, persons trained by a federally approved end-stage renal-disease facility who perform end-stage renal dialysis in the home setting are exempt from certifi-cation.

What are the different levels of certification for a health care assistant?

There are seven levels of certification; each level allows for specified activities and has certain specific training and educational requirements. Certification is valid for two years, and the delegating practitioner or health care facility is responsible for certifying and recertifying health care assistants. Any change in health care facility, health care practitioner, or category requires a new application. As a general outline, the activities authorized under each certification level are as follows:

Category A: may perform venous and capillary invasive procedures for blood withdrawal

Category B: may perform arterial invasive procedures for blood withdrawal

Category C: may perform intradermal (including skin tests), subcutaneous, and intramuscular injections for diagnostic agents

Category D: may perform intravenous injections for diagnostic agents

Category E: may perform intradermal (including skin tests), subcutaneous, and intramuscular injections for therapeutic agents

Category F: may perform intravenous injections for therapeutic agents

Category G: may perform hemodialysis

Note that intra-arterial injections are not authorized for health care assistants.

Remember, each certification level has individual training and educational requirements. WAC 246-826-130 through WAC 246-826-180 identifies the training and educational requirements for each level. WAC 246-826-300 through WAC 246-826-303 identifies the minimum require-ments, training, standards of practice, and core competencies of hemodialysis technicians. It is essential to familiarize yourself with the training and educational requirements before preparing and submitting an application with the Department of Health.

Which medications can a health care assistant administer?

The medications or diagnostic agents and the route of administration of each that a delegator authorizes for injection must be produced on a list and submitted to the Department of Health in conjunction with the assistant’s initial certification application and upon recertification. Any changes in this list must be provided to the Department of Health within 30 days following the change. Health care assistants are prohibited from administering any controlled substance as de-fined in RCW 69.50.101(d), any experimental drug, and any cancer chemotherapy agent unless a

48

delegator is physically present in the immediate area where the drug is administered.

Must the health care assistant be supervised?

The answer is “yes” if the health care assistant is performing a delegated function. The assistant may be supervised by either the practitioner who delegated the act or by a practitioner who can order the act under his or her license. The supervising practitioner must be physically present and immediately available in the facility during the administration of injections or vaccines. The supervising practitioner does not need to be present during procedures to withdraw blood.

It is important for physician employers to remember that they can be held accountable for any errors made by health care assistants that they employ. As such, it is imperative that employers make sure their staff members are properly trained, supervised, and certified for their delegated duties within the practice. A health care provider’s failure to comply with these state-mandated certification requirements could expose them to disciplinary action by the Department of Health under the Uniform Disciplinary Act RCW 18.130. Further, health care assistants who are not certified or who perform tasks outside the scope of their certification place patients at risk of harm and also place the health care provider and supervising health care provider at risk in the event of patient harm.

The key to successful employment of these valued employees is to make sure that each receives quality training for the activities delegated and that appropriate supervision is taking place. Make sure all of your health care assistants are currently certified with the State of Washington and all assistants are providing only those services authorized within their current certification. In addition, it is useful to familiarize yourself with the state laws that pertain to health care assis-tants. Indeed, all health care assistant applicants for certification are required to read these laws. They include the Revised Code of Washington, Chapter 18.135, Washington Administrative Code, Chapter 246-826, and Revised Code of Washington, 18.130.170 and 180 of the Uniform Disciplinary Act.

For additional information or technical assistance in filling out the health care assistant applica-tion form or clarification of the statute, rules, requirements, and processes for health care certifi-cation, contact the Department of Health’s Customer Service Center at (360) 236-4700.

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Health Care Directives An advance medical directive, commonly referred to as a “living will,” “health care directive,” or “directive to physicians,” is a legal device intended to ensure that a patient’s wishes concerning medical treatment will prevail if the patient is terminally ill or permanently unconscious. Most physicians will encounter a patient-executed advance directive. Of course, this article does not provide specific legal advice, and it is not intended as such. When specific questions arise, we suggest you seek legal counsel.

Federal law

In 1990 Congress passed the Patient Self-Determination Act (PSDA), which requires hospi-tals, hospices, home health agencies, nursing homes, personal care providers, and Medicare- or Medicaid-participating prepaid health plans to inform patients of their right to execute an advance directive. Facilities and prepaid health plans subject to the PSDA must:

Upon admission or enrollment, provide written information to all adult patients •

describing their rights under state law to accept or refuse treatment and prepare an advance directive.

Include in the written information a description of the provider’s policies concerning •

implementation of these rights.

Adopt a policy of nondiscrimination against patients that have executed an advance •

directive.

Document in the patient’s chart whether or not an advance directive has been execut-•

ed.

Follow any state law requirements pertaining to advance directives.•

Provide (individually or with others) for education of the staff and the community at •

large about advance directives.

Physicians practicing in a traditional office or clinic setting have no obligation to comply with any of the above federal requirements. However, the quality-improvement programs of some managed care plans obligate physicians to inform patients of their right to execute an advance directive. Physicians are also typically obligated to ensure that the patient’s chart reflects the dialogue and contains a copy of any advance directive.

State laws

Washington State’s Natural Death Act (NDA), which is reasonably representative of much state legislation, provides protections and guidelines for physicians. The NDA specifically rec-ognizes advance directives and durable powers-of-attorney as means of effecting patient wishes

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concerning the withholding or withdrawal of life-sustaining treatment in the event of a terminal condition or permanent unconscious condition.

Questions and answers about the Natural Death Act:

Does the statute tell us what an advance directive should look like?1.

Yes. The NDA has created a suggested form. Directives available from the Washington State Medical Association and other health care-related organizations are closely mod-eled on this form.

When does an advance directive become operative?2.

When the patient has been diagnosed, in writing, to be in either:

A terminal condition (where death from injury, illness, or disease is expected •

within a reasonable period of time, and where the application of life-sustain-ing treatment—to include nutrition and hydration—would serve only to prolong the process of dying), or

A permanent unconscious condition (an incurable and irreversible condition •

with no reasonable probability of recovery from an irreversible coma or persis-tent vegetative state).

Can a physician act as one of the required two witnesses?3.

The NDA specifically prohibits the attending physician, employee of the attending physician, or any employee of the hospital or other health facility caring for the patient from acting as a witness. Attending physician is defined as the physician having pri-mary responsibility for the treatment and care of the patient. As a practical matter, a physician with any involvement in the patient’s care should avoid acting as a witness.

What responsibilities does the physician have in determining a directive’s legal validity?4.

A reasonable “good faith” effort is sufficient before a physician withdraws or withholds life-sustaining treatment. Be sure you read the directive and verify that it is signed by the patient and two witnesses. Keep in mind that the patient can use an advance direc-tive to either refuse or request specific measures. Unless otherwise negligent, the following are immune from civil and criminal liability and professional conduct sanctions when acting in good faith on a directive’s instruc-tions: physicians, health care providers acting under the direction of a physician, certain health care facilities (hospitals, hospice agencies, nursing homes, home health agencies, and boarding homes), and their personnel.

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Does a physician have to comply with a “no-treatment” directive?5.

No physician or other health care practitioner is required by law or contract to partici-pate in the withholding or withdrawal of life-sustaining treatment if he or she objects. However, if a physician is aware of a patient’s directive, and has no intention of follow-ing it, he or she must inform the patient. If the patient does not elect to be treated elsewhere, the physician must file a writ-ten plan in the patient record indicating what actions will or will not be taken if the patient becomes terminal or permanently unconscious. After the physician advises the patient and prepares and complies with the written plan, he or she is protected from liability and professional conduct sanctions for not carrying out the directive.

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Informed ConsentNational data indicates that more than one-third of all malpractice claims and lawsuits allege a failure to obtain informed consent.

Actions based solely on issues of informed consent are rare; commonly, informed-consent claims are coupled with allegations of negligence. As an entirely distinct legal theory, failure to obtain informed consent can result in physician liability regardless of whether the standard of care is met.

Case study

A 26-year-old female athlete was hospitalized for a severe staph infection involving her left foot. HerattendingphysicianorderedIVadministrationofgentamicin(apotentantibiotic),5mg/kg every eight hours, with close monitoring of serum levels to avoid toxicity. The physician was aware that the drug had potential serious adverse effects, including nephrotoxicity, otoxicity, and vestibular toxicity—the latter of which can result in ataxia (unsteady gait) and oscillopsia (“bouncing” vision).

On the eleventh day of hospitalization, the patient had improved markedly. Discharge within 24-48 hours was anticipated. However, later that evening, the patient experienced difficulty walking, reporting a sense of “feeling uncoordinated.” A nursing assistant had to assist her back to her bed. The physician was notified.

The following morning, the patient had similar difficulties attempting to walk. Her physician immediately suspected gentamicin-related toxicity, though serum levels had remained within, or very close to, the desired therapeutic range. The physician immediately ordered a change of antibiotic, discontinuing gentamicin.

The patient’s problems with muscle coordination persisted. It was later determined that gentamicin toxicity had resulted in irreversible damage to the vestibular labyrinth. When dis-charged from the hospital, the patient required a cane to steady her gait. There were no signs of infection, nor any indication of permanent damage to the structures of the foot.

Case evaluation

One year after discharge, the patient named the physician in a lawsuit. On issues of standard of care, the suit alleged that gentamicin dosages were excessive and blood monitoring inadequate. The defense conceded that gentamicin had caused the harm to the plaintiff but vigorously contested the notion that negligence had been involved. Despite the patient outcome, plaintiff experts floundered in their efforts to provide convincing evidence that the defendant had devi-ated from acceptable standards of practice.

The plaintiff’s second legal theory was that the defendant had failed to obtain informed con-sent. She testified that her physician had told her nothing of the risks of gentamicin therapy, nor had he mentioned any alternatives. She recalled that he had told her that gentamicin was a

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“heavy-duty” antibiotic, necessary because of the severity and type of the infection. However, “heavy-duty” did not suggest to her that the drug carried any special risks. The plaintiff said she trusted her doctor, and it had never occurred to her to ask questions about the antibiotic. She merely asked the defendant if her foot would be OK and how long she would have to stay in the hospital. Her physician offered general reassurance, which she appreciated at the time, but no specific information. She said he seemed “very caring.” She had felt that if there were something she needed to know, her doctor or the nurses would have told her. The plaintiff testified that she “devoutly” wished the defendant had told her that there were “less risky” antibiotics that might have worked. She said she would have told her doctor to try something other than gentamicin.

Plaintiff experts agreed, under cross-examination, that gentamicin was not contraindicated or inappropriate—“it worked”—but were firm on the point that it was not the sole antibiotic suitable to combat this infection. “There are other weapons in the arsenal,” they said, and the patient should have been told. These same experts told the jury that, in their opinion, the de-fendant had a “clear duty” to tell the patient “up front” about the “considerable risks” of kidney damage, hearing loss, and ataxia. If the defendant had done this, a “decent discussion” about alternatives might have followed.

Medical experts on both sides provided testimony concerning the statistical probability of the harm that had befallen the patient and information about the likely severity of such injuries.

The defendant physician recalled mentioning to the patient that he had selected gentamicin be-cause it was a potent antibiotic with a proven record against staph infections. He was uncertain if he had mentioned possible side effects, but “might well have.” He was forced to admit there was nothing in the medical records that indicated the patient was told anything specific about gentamicin. When the questioning turned to therapeutic alternatives, the physician acknowl-edged that he “probably didn’t go into that …” He would have had a discussion with the patient about other antibiotics had it appeared that gentamicin was proving ineffective, but that was not the case.

After weeks of testimony and lengthy deliberation, the jury returned its verdict: The defen-dant had not violated the standard of care, but the defendant had failed to obtain the plaintiff’s informed consent. The jury found that:

Information concerning risks of gentamicin and treatment alternatives was “material” •

and should have been disclosed.

If the required disclosure had taken place, a reasonable patient would have, more prob-•

ably than not, elected one of the options.

Had one of the testified-to alternative antibiotics been chosen, the plaintiff would have •

avoided the damage to her vestibular system and would not have suffered from ataxia.

The plaintiff had proven each element of her informed-consent case. That the jury found the standard of care had been met was of little consolation to the physician. The damage award was

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substantial.

Post-trial, jurors mentioned their sympathy not only for the injured plaintiff, but also for the physician. They agreed he had tried to do what he thought was best for the young woman.

The jurors also said they believed gentamicin was not an unreasonable choice. The problem, however, was that this choice was made solely by the doctor. He did not give the patient a chance to participate in the decision. The jurors agreed that the plaintiff could not be faulted for not asking more questions. She was not a doctor, so she had no way of knowing there were questions to ask.

Analysis

This above case did not involve a medical emergency under circumstances where consent is implied by law. Although the patient was dangerously ill upon presentation to the hospital, she was conscious and able to participate in decision making. There was no evidence that the plaintiff exercised her right to refuse informed consent. She did not tell her physician anything along these lines:

“Hold on, Doctor, I don’t want to hear anything about those risks—that kind of stuff scares the hell out of me. I want you to make the decision.”

A conversation such as this would have relieved the defendant of the obligation to obtain informed consent and possibly avoided a lawsuit—assuming thorough documentation of the patient’s refusal.

The plaintiff verdict resulted from a well-intentioned physician falling into the old snare of medical paternalism, acting in the perceived best interests of the patient, to be sure, but effec-tively excluding the patient from the decision-making process. The defendant, wholly focused on the challenging clinical issues confronting him, forgot that the paternalistic approach to medicine was discarded decades ago, a casualty of the consumer-oriented informed-consent movement that emerged in the 1960s.

Guidance

As always, the devil is in the details: How is the time-deprived physician to know what informa-tion must be offered a patient? Recognizing that it is impossible to require that physicians in-form patients of every conceivable risk, complication, or treatment alternative, Washington law (fundamentally similar to that of Oregon and Idaho) requires health care providers to disclose only material information. Material is defined as what a reasonably prudent patient would want to know before consenting to the proposed procedure or treatment.

Physicians would be wise to consider: “Would this information, if disclosed, be likely to change a patient’s decision?” If so, the patient should, with few exceptions, be told. When in doubt, it is better to give the patient more information, not less.

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Documenting informed consent

An adequate informed-consent process includes not only the dialogue with the patient or other decision maker but also the documentation of the discloser and the patient’s understanding of the information imparted. It is advisable to document the informed-consent discussion in hospital and office progress notes as well as employ a procedure-specific, patient-signed consent form.

A properly developed, patient-signed consent form is compelling evidence that a patient was adequately informed before a medical procedure. It can deter litigation or at least help the phy-sician prevail in the courtroom setting. Informed consent also encourages a patient to be more responsive to advice and is associated with a patient’s ability to recuperate more quickly, require fewer analgesics, and feel less anxiety—while experiencing fewer complications and days in the hospital. Physicians Insurance now offers our insureds two informed-consent templates, acces-sibleathttp://www.phyins.com/pi/publicationslist.html.Boththeabbreviatedformandthelonger, patient-teaching form can facilitate clinicians’ development of procedure-specific forms.

We believe strongly that the specific information called for by the templates, such as risks and complications, is best provided by the clinician. Vendor-provided, procedure-specific forms may not accurately or completely reflect the views of the physician who provides the form to the patient. It is important that the right procedure-specific form—one reflecting the views of the particular clinician—be utilized. Comprehensive documentation often deters potential litigation.

What’s this about new CMS guidelines?

In January 2005, the Centers for Medicare and Medicaid Services (CMS) devised new interpre-tive guidelines for CMS surveyors pertaining to the informed-consent process in the hospital. Though directed at hospitals, pursuant to Medicare Conditions of Participation, these new hospital informed-consent requirements threatened to place unwelcome new administrative burdens on physicians. Specifically, the 2005 CMS guidelines mandated that hospital informed-consent forms include (in addition to the customary elements) the following:

In addition to the names of primary physicians or surgeons, the names of other prac-•

titioners and the specific, significant surgical tasks to be performed by them. Specific surgical tasks included opening and closing; harvesting grafts; dissecting, removing, or altering tissue; and implanting devices.

Signature of a “professional person” witnessing the patient’s consent. •

Various medical organizations expressed great concern relating to the novel requirements, and uncertainties, inherent in the new form. For example, nowhere did the guidelines define the qualifications of the “professional person,” the required “witness.” Also criticized was the re-quirement that all persons anticipated to be involved in the procedure be identified on the form by name. Because the identity of “other practitioners” will, as a matter of necessity, sometimes change shortly before surgery or other procedure, this requirement would be difficult or impos-

56

sible to meet, especially in hospitals with resident training programs. In the face of these and other criticisms, CMS suggested that adjustments and clarification would be released at some point.

Relief: the 2007 CMS revised interpretive guidelines

On April 13, 2007, CMS released substantial revisions to the 2005 guidelines:

The “professional witness” requirement is abandoned.•

Hospital forms need not list specific risks of a procedure, specific alternative procedures, •

or specific risks of no treatment.

The names of all practitioners involved in a procedure—except for the primary surgeon •

or physician— need not be listed on the consent form.

The new guidelines emphasize well-designed policies, procedures, and forms, citing new mini-mum requirements for hospital informed-consent forms:

Name of the hospital•

Name of specific procedure•

Name of physician performing the procedure•

Statement that the procedure, anticipated benefits, material risks, and alternatives were •

explained

Signature of patient or legal representative •

The date, time, and signature of a person witnessing the patient’s signature on the form is en-couraged, but not required, as are other elements of the 2005 requirements.

The reach of the CMS guidelines does not extend to procedures or treatment performed in a non-hospital setting. Nonetheless, we recommend that ambulatory surgery centers and office practices use a form that incorporates the revised CMS requirements to ensure consistency in the informed-consent process for both the patient and the physician. With respect to mal-practice liability issues, the fundamental informed-consent responsibilities of physicians are set forth, and consent forms addressed, within the Revised Code of Washington. Oregon and Idaho physicians have similar responsibilities, as set forth in the Oregon revised statutes and in the Idaho statutes. The CMS guidelines are more exacting.

Conclusion

Though physicians’ ultimate legal duty is still controlled by state law, physicians will be re-quired to cooperate as hospitals work to implement the CMS requirements. Our two informed-consent templates will accommodate the 2005 CMS informed-consent guidelines—which, although ultimately rejected as overly ambitious, nonetheless incorporate ideas worthy of your consideration—as well as the more modest April 2007 revised CMS guidelines.

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DEA Rule Addresses Schedule II Controlled Substance Prescriptions

Background.

Prescribing Schedule II controlled substances has become an increasingly difficult issue

in patient management. In August 2005, the U.S. Drug Enforcement Administration

(DEA) published guidance on prescribing Schedule II controlled substances that

essentially eliminated the practice of a physician writing multiple prescriptions on the

same day with instructions to fill on different days. The DEA guidance of 2005 provided

that writing multiple Schedule II prescriptions on the same day was illegal because it was

equivalent to the illegal practice of writing a prescription authorizing refills of a Schedule

II controlled substance.

The result of this guidance was that providers had to establish refill and medication

management protocols to assure timely delivery of newly written prescriptions for

patients whom the physicians determined had a legitimate clinical need to continue to

take the Schedule II substance. Depending on patient population, or individual patient

needs, physicians were left with the options of mailing prescriptions to patients or

requiring that patients pick up prescriptions in person. Each prescription needed to be

dated on the day it was written and signed.

Current law.

Effective December 19, 2007, the DEA finalized a rule change that allows physicians to

write up to three 30-day prescriptions for the same Schedule II controlled substance on

the same day. However, the law remains clear that Schedule II prescriptions may not be

refilled and prescriptions cannot be postdated.

Risk management recommendation.

It is now a legal practice to provide multiple prescriptions to patients on Schedule II

controlled substances, but

the prescriptions must be dated on the day they are written and signed, and •

the earliest fill date must be specified on the prescription.•

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The rule makes administration of Schedule II controlled substances less burdensome, particularly for physicians with patients on chronic prescriptions—such as those with chronic pain or attention deficit hyperactivity disorder. Of course, authorizing a pre-scription to be refilled for 90 days may not be appropriate for all patients. Care for these patients can be enhanced with a properly designed and executed protocol incorporating these guidelines and a well-documented chart regarding patient-specific considerations.

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Termination of CareIf you have a patient who does not comply with your recommended treatment, who does not pay medical bills, or who becomes in some way a “problem patient,” you can terminate your therapeutic relationship with that patient. However, this action should be taken only in ex-treme or unusual circumstances. If you decide to terminate the physician-patient relationship, ethically and legally you should write the patient saying you will no longer be his or her doctor, and you should provide adequate time to find a new doctor. You will also need to transfer the patient’s medical records to the new doctor.

Generally, you can terminate your relationship with a patient at any time and for any reason. The exceptions are that you may not stop treating a hospital inpatient, a patient in unstable condition, or a number of patients from any special population or socioeconomic group. This will protect you from charges of abandonment or discrimination. In addition, federal and state law protecting the disabled may prevent you from discharging a patient whose noncompliance is the result of a physical or psychological disorder.

If you decide to terminate the physician-patient relationship, these guidelines should be fol-lowed:

Notify the patient in writing that you intend to terminate the relationship. You do not •

have to reveal the reason for the termination.

Be sure to state in the letter that you will continue to provide medical care to the pa-•

tient for 30 days while he or she looks for another doctor.

Include in your letter the name and number of a local physician referral service and •

county medical society whenever possible.

Explain in the letter that you will send a copy of the patient’s medical records to the •

new doctor.

Send the letter by certified mail, return receipt requested.•

Put a copy of the letter and the delivery receipt into the patient’s medical chart.•

If letter is returned as undeliverable, file unopened letter in patient’s chart, send another •

copy of the letter through the normal mail route, and document the patient’s chart.

Under some circumstances, a verbal notice may be sufficient, but always document the discus-sion in the chart. An example might be a patient who frequently moves or has no permanent address.

A sample termination of care letter can be found on our Web site at www.phyins.com.

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Risk Management Education MandateThe law in Washington State

Under the Health Services Act of 1993 the Washington State Legislature enacted a law mandat-ing that once every three years, a physician licensed and practicing in Washington complete a health care liability risk management training program provided by the physician’s professional liability insurer (RCW 48.22.080). Under this statute, every physician must complete the re-quired training in order to renew his or her professional liability insurance policy.

The role of Physicians Insurance

Physicians Insurance offers numerous seminars throughout the state and self-study courses so our members can fulfill the mandate. In addition to fulfilling the education mandate, many of our seminars and self-study courses also provide members with AMA Category 1 continuing medical education credits.

Our seminars offer personalized recommendations and a chance to meet informally with col-leagues over a meal. All courses are presented free of charge to insured members and their office staff.

It is important to remember that by law Physicians Insurance is not permitted to renew profes-sional liability insurance policies for physicians who have not completed the education require-ment. Physicians who fail to complete the requirement put their policies in jeopardy.

How we help members comply with the law

Our Risk Management Department tracks member attendance at seminars and participation in self-study courses. We also monitor the compliance status of each Washington physician member. In January of each year, notices are mailed to physician members who need to meet the mandate by year-end. This written notification process continues at nine months out, six months out, three months out, and then as necessary until the mandate is met.

To some, this notification process may be an imposition. However, our intent is to ensure that no physician member faces nonrenewal of a professional liability policy for failure to meet this education mandate.

Recent changes to the insurance laws in Washington State (RCW 48.18.2901) require us to pro-vide 90 days’ advance written notice for nonrenewal of a professional liability policy. Therefore, although mandate periods end on December 31, members who have not met the mandate by the end of September will receive notice by October 1, of a nonrenewal effective January 1. We will be able to rescind such nonrenewals and renew the policies of those members who com-plete the education mandate requirement by December 31.

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Registration brochures for seminars are mailed to insured members on an ongoing basis. To view a list of upcoming events, register for one of our risk management courses, or request the self-study course, please visit www.phyins.com or call our Risk Management Department at 1-800-962-1399 (Seattle) or 1-800-962-1398 (Spokane).

As a physician-owned company, we are committed to working with you to improve the quality of patient care and reduce the frequency and severity of malpractice claims. We welcome your ideas to improve our educational program, and we look forward to seeing you at an upcoming seminar.

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Section 4

Patient Care Issues

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Medication RecordsMany medical malpractice claims are due to alleged medication errors. Properly maintained medi-cation records can help reduce errors and can be crucial to the defense of a malpractice claim. The following suggestions will help prevent medication errors and significantly decrease risk:

Use a medication flowsheet to document every medication a patient takes. Include the •

date of the prescription, the name of the medication, the dose, route, amount, duration, number of refills, and the signature of every refill provider. Place the flowsheet in the front of the chart where it will be easily accessible.

Post patient allergies and prior adverse reactions to medication on the flowsheet and on •

the front cover of the file jacket. Do not give any medication without first checking the list of allergies or adverse reactions.

Question your patients periodically about their use of prescription and over-the-counter •

drugs, especially if you know they are seeing other physicians or getting medication from more than one source. Update the flowsheet accordingly. Many patients cannot give an accurate statement of all current medications. A good practice is to ask such patients to bring in all prescriptions and over-the-counter medicines.

Tell your patients about the contraindications, drug interactions, warnings, and side ef-•

fects of every medication you prescribe. Document in the chart that you have done this and include all patient reports of side effects or adverse reactions, as well as all actions taken to relieve them. Note on the flowsheet any drug you prescribe that requires blood level assays or laboratory screening.

Take these simple steps to avoid common pitfalls:

Be absolutely clear with verbal medication orders. Articulate the name of the medication, •

the dose, and the regimen, and spell out any words that could be misunderstood.

Many abbreviations can be easily confused, such as “O.D.” and “Q.D.” or “mg” and “mcg,” •

so print or write all prescriptions legibly.

Never put a zero after a decimal point, because whoever administers it could overlook the •

decimal point and increase the dose tenfold.

Keep all medications and samples in your office properly secured and labeled. If you dis-•

cover an unlabeled container, discard it immediately.

Double-check each container’s label before dispensing its contents.•

Discard all medications before the expiration date.•

Use a medication flowsheet• . A medication flowsheet on thicker stock is available at no charge to policyholders who want to order it from Physicians Insurance.

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Failure to Monitor Diagnostic TestsCase study

Our insured physician, a family practitioner at a walk-in clinic, evaluated a new patient whose painless breast mass had persisted for eight months. The patient, a 48-year-old Caucasian woman with a medical history significant for fibrocystic breast disease, was unsure whether the mass fluctuated in concert with her menstrual cycle. The ensuing examination showed only an ir-regular firm mass in the upper left quadrant of the breast. The physician’s differential diagnosis included breast cyst versus breast cancer. A fine needle aspiration biopsy of the mass revealed a small amount of reddish fluid, which was sent out for pathological evaluation. Palpation of the mass after aspiration showed a minimal decrease in size.

The pathology lab never received the patient’s specimen, which was unwittingly lost in the clinic. The clinic did not have a way of tracking diagnostic tests to guarantee receiving reports, and it did not have a tickler system to ensure that patients were brought back in for follow-up treat-ment. Fourteen months later, the patient returned on her own with symptomatic complaints and weight loss. After the subsequent diagnosis of stage III infiltrating ductal carcinoma, she un-derwent a partial mastectomy, an axillary node dissection, and radiation therapy. At the time of settlement the patient was disease-free but had a questionable long-term prognosis.

Because of the difficulty in obtaining expert support for the defendant physician, who lost the biopsy specimen and failed to follow up with the patient, a substantial settlement was made.

Risk management guidelines

Diagnostic tracking system: Many practices use a log book to track diagnostic tests performed outside the office—including radiology studies (such as mammography and chest films), pathol-ogy studies, prenatal lab work, or other tests. The log book displays the name of the patient, the date of the outgoing requisition, the date the report is returned, and the date the patient is noti-fied. With such a system, physicians and staff members can tell at a glance if a test result has not been received. For your convenience, the sample Diagnostic Test Tracking Log can be found on our Web site at www.phyins.com.

Appointment scheduling and patient reminder systems: A patient reminder or tickler system can help physicians and staff remind patients about periodic exams, routine follow-up visits, and patient recalls. Such a system could have prevented the delayed diagnosis described in this case. Patient recall systems are also effective practice marketing tools.

Conclusion

Administrative errors are an increasing problem in medical practice. Each office must develop systems to ensure that diagnostic studies are not lost and that patients are seen in follow-up visits when necessary.

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Avoiding Drug ScamsMany factors drive the increasing abuse of prescription drugs: fear of contracting AIDS, predict-ability of action of prescription drugs, prescription reimbursement through medical assistance programs, and lighter criminal penalties for prescription drug fraud than for illicit drug traffick-ing.

Abusers of prescription drugs come from the entire socioeconomic and psychosocial spectrum. Most drug-abusing patients seek drugs for personal use, but there are also many “professional” drug-seeking individuals and organized groups who sell drugs obtained by prescription. A drug abuser’s prime drug supplier is a gullible health care provider. Some possible behavioral signs of a drug-seeking patient may include:

Patient makes an urgent or walk-in visit for pain complaints.•

Patient schedules an appointment for late afternoon, particularly on Friday.•

Patient is from out of town and claims to be just passing through.•

Patient from out of town requests maintenance narcotic analgesics for a chronic condi-•

tion.

Patient calls in after hours with pain complaints, yet does not wish to be evaluated in the •

emergency department.

Patient requests a specific • controlled substance by name.

Patient claims that non-controlled drugs do not work, produce an allergy, or are other-•

wise contraindicated.

Patient claims that the original prescription was lost or stolen.•

Patient refuses a diagnostic workup.•

Patient reports complaints of subjective pain such as facial, migraine, or back pain.•

Patient gives evasive or vague answers to questions about medical history.•

Patient asks an on-call or covering physician for a specific controlled drug and claims •

that his or her attending physician, who happens to be unavailable, always gives a pre-scription for the requested drug.

Patient presents to the emergency department with pain complaints during the busiest •

times.

Blank prescription pads are missing from the exam room or office after a patient de-•

parts.

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Risk management guidelines

There are several steps physicians can take to minimize the chance of being victimized by drug scams:

Drug monitoring

Record all medications taken by or prescribed for a patient on a medication flowsheet kept in front of the patient’s chart. This enables the clinician to easily monitor drug usage and avoid providing excessive refills.

Refill protocols

Practices should carefully consider how to best handle refill requests. Your patient brochures should include your policy on refills, including both noncontrolled and controlled drugs. Many drug-seeking patients count on busy practices with office staffs who give automatic approval to refill requests. If your practice allows medications to be refilled by someone other than the clini-cian with prescriptive authority, a written protocol should be adopted. This should include a list of medications suitable for refills by nonphysicians, guidelines for questioning the patient to determine the patient’s present medical status, and a decision tree determining whether or not the patient should be seen before a refill is authorized.

Pain clinic/mental health referrals

Patients on chronic analgesic or psychotropic therapy must be periodically reevaluated on the indications and efficacy of continued therapy. These patients may also be appropriate candi-dates for a pain clinic or a mental health referral for non-drug management.

Charting

The best defense against claims of inappropriate prescribing is documenting the indications and rationale for treatment. Any signs of medication dependence or drug-seeking behavior should be charted objectively.

Prescription pads

Make your prescriptions forgery-proof by writing out quantities in figures as well as numbers. For instance, since “12” can easily be changed to “42,” it is better to write “#12 (twelve)” on the script. Some health care payers may require that handwritten prescriptions be written on tamper-resistant pads. Additionally, clinicians should never pre-sign blank prescription pads. To prevent theft, remove any blank prescription pads from exam rooms and public access areas. The safest locations for prescription pads are in the clinician’s coat pocket, the clinician’s office, and a drawer at the nurses’ station or front desk.

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Coordination with other providers

Drug-abusing patients count on physicians and pharmacists being too busy or reluctant to talk with each other. Under state law, the patient’s consent is not required to disclose health care information to the patient’s other providers. In addition, information given to a provider for the unlawful procurement of a legend drug is not a privileged communication. Therefore, you and other health care providers caring for the patient may discuss suspected or actual prescription drug fraud, diversion, and forgery. Since pharmacists detect the majority of such cases, physi-cians should always respond quickly to a pharmacist’s telephone inquiries.

Telephone diagnosis and treatment

When it is practical, clinicians should avoid making diagnoses and prescribing controlled sub-stances by telephone without examining the patient. If the situation is urgent, patients should be directed to the hospital emergency department.

Transient, emergency department, and weekend, on-call, or coverage patients

Treating physicians should prescribe or dispense only minimal amounts of controlled substances until the patient’s attending physician can be contacted, particularly for patients with subjective pain complaints. Attending clinicians should be told of any prescriptions or refills authorized by covering colleagues.

Conclusion

Prescription drug fraud, forgery, and diversion are common occurrences. Close attention to pre-ventive measures will help reduce the number of inappropriate prescriptions written.

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Sample MedicationsWhen your office dispenses sample medications to a patient, you are acting as a pharmacist. Be sure that your office complies with all state statutes, federal laws, and federal regulations.

Below is a list of suggestions your office may want to follow when dispensing sample medica-tions to a patient:

Ask the patient if he or she has any known drug allergies, and be sure to document this •

information in the patient’s medical record.

Give the patient written instructions on how to take the medication.•

Patients will not remember oral instructions on how to take the medication.•

Include the doctor’s name on the written instructions.•

Include the patient’s name on the written instructions.•

Include the date the samples were dispensed on the written instructions.•

Include the name, strength, and route of administration of the medication on the writ-•

ten instructions.

Include the office’s phone number, in case of an allergic reaction, on the written instruc-•

tions.

Place a copy of the written instructions in the patient’s medical record.•

A sample medication form can be found on our Web site at www.phyins.com.

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Risk Management for Telephone Health CareIn many cases, a staff member performs a telephone assessment on which the clinician and the patient rely. What happens or does not happen over the telephone can serve as a basis for a malpractice action.

The issues:

Consider the limits of your expertise.1.

Standard of care—always ask yourself what a reasonably prudent person would 2. do in this situation.

Essential elements of documentation:3.

Clear statement of problem.a.

Symptom analysis as related to current health problem.b.

Prescription or over-the-counter medications or herbs being used.c.

Allergy status if medications are involved.d.

Pregnancy status.e.

Assessment.f.

Plan of care.g.

Medications prescribed or recommended.h.

Advice/instructionsforfurtheraccesstohealthcare.i.

Guidelines on when to chart telephone calls:4.

Change/orderingofmedications.a.

Significant medical advice including all significant changes in health status.b.

Significant patient anxiety.c.

Administrative advice or directions, e.g., stay at home, call an ambulance, d. return to work, or come to the clinician’s office.

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Section 5

Practice Management Issues

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Risk Management for Office Personnel Office staff can play a major role in reducing the risk of a malpractice claim. We offer

these guidelines for office personnel to help reduce the risk of a malpractice claim.

Do not play doctor. Although most staff members know that only licensed physi-1. cians and mid-level providers can diagnose illnesses and treat patients, many do not know that well-intentioned remarks can be interpreted as medical advice. Since patients tend to take seriously anything they are told in a physician’s office, the staff should not volunteer medical opinions or comment on treatment.

Stay within the limits of delegation. All delegated duties should be performed 2. under the physician’s supervision by an individual qualified to carry them out. A protocol should be established if feasible and practical.

Respect patient privacy. Information about a patient should never be given on 3. the telephone unless the caller has appropriate authorization or need to know the information. If you are unsure of the caller’s identity, you may want to obtain a phone number and return the call. There will be instances where a written autho-rization to release information is not practical or necessary. An example would be to another provider that has treated, is treating, or will be treating the patient. Use your best judgment. Patient care is almost always of higher priority than patient confidentiality.

Cooperate with law enforcement and CPS. Law enforcement officers and CPS 4. workers are entitled to obtain relevant medical record information that pertains specifically to an investigation of alleged child abuse or neglect. They do not have to have a signed authorization or a subpoena to obtain the child’s records. The clinician and the staff are immune from breach of patient confidentiality if the information released is relevant to protect the child. We recommend you verify the identity of the CPS representative or law enforcement officer and thoroughly document in the child’s chart the information released, to whom it was released, and the reason it was released. You may not release information pertaining to the parent(s) without authorization or court order.

Use these guidelines for release of records. Clinicians should comply with record 5. requests from attorneys and insurance companies on a timely basis. There is a need to be sensitive about sending only records that are authorized and requested. The release of records to parties other than those providing care to the patient relating toHIV/AIDS,STDs,mentalhealthtreatment,orsubstanceabuseisauthorizedonly upon receipt of specific patient consent. To satisfy these requirements, you may provide requesting parties with the Authorization to Use or Disclose Health Care Information form developed by Physicians Insurance. When responding to a proper request for a complete copy of the medical record, the records produced

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by a medical office should include copies of medical records received from other practitioners.

A request for records from a patient or an attorney can mean there is a loss of rap-port, so the clinician should be alerted to review such requests and take appropri-ate action.

The medical records law in Washington State allows you to charge no more than $0.96 per page for the first 30 pages plus $0.73 per page thereafter. A $22 clerical feel for searching and handling may be charged under state law, but federal law prohibits charging this fee to the patient or the patient’s representative. This fee schedule is subject to change every two years and the fees listed above became ef-fective July 1, 2007. Clinicians must not delay complying with a properly autho-rized medical records request merely because of an unpaid medical bill.

Be respectful of patients. Some staff members believe that being casual and call-6. ing a patient by his or her first name puts the patient at ease, which it may do in some cases. However, some people resent such familiarity. Be sensitive to the patient’s preference.

Avoid lengthy waiting time. If you anticipate the patient will have a long wait, ad-7. vise the patient and indicate how long you expect the wait to be. The back office staff should always inform the front office staff of waiting times. Let the recep-tionist know if the physician is running late. Some people may prefer to resched-ule an appointment—please give them that option.

Make sure the patients in your office understand how to obtain care after hours. A 8. practice information brochure can help in this area, as well as information pro-vided through your answering service.

Call day-surgery patients within 24 hours following the procedure. It is advisable 9. (as well as helpful in continuing rapport) to initiate a call to these patients after the procedure. Document the follow-up call in the patient’s chart.

Tell the clinician when a patient complains. Some patients are reluctant to com-10. plain directly to the clinician and instead vent their feelings to the office staff. Suchcomplaintsshouldbereportedimmediatelytotheclinicianand/orthepractice administrator, who can decide whether or not to talk to the patient to prevent minor matters from becoming major ones.

Before sending a patient’s bill to collection, consult with the clinician. In some 11. instances, it might not be appropriate to send the bill of a dissatisfied patient to collection.

Put it in the record. When a patient fails to come in for an appointment or cancels 12. a scheduled test or follow-up visit, it should be noted in the patient’s chart and in

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the appointment log. No-shows should be flagged for the clinician’s attention for further follow-up as indicated.

Using a patient-completed 13. health history questionnaire reduces your risk. With some exceptions, we recommend that all new patients complete a health history questionnaire to supplement the comprehensive history taken by the clinician. This information can often be combined with the patient registration form that most clinicians use. At the very least, the health history questionnaire should cover allergies, diseases, and medications. Depending on the clinician’s specialty, questions can vary as to type and number.

Documentation of medications reduces your risk. Without exception, all medica-14. tion samples, prescriptions, and refills should be documented in the chart. Ideally, documentation should be on a medication flowsheet so that the medication his-tory can be easily identified. It is acceptable for the staff to refill certain medica-tions without checking immediately with the clinician with prescriptive author-ity as long as a prescription refill policy has been established.

Use a dictated record. With few exceptions, the dictated record has become the 15. standard. We find that malpractice cases are easier to defend with the use of a dic-tated record, since the quality of documentation is usually better. Although there are increased costs for a dictated record, we are convinced that this record format not only reduces malpractice exposure but also lends a higher degree of produc-tivity to medical offices. Typical time for dictation, transcription, and filing is 24 to 48 hours from the time of service.

Document the chart when a patient is contacted about test results or follow-up 16. treatment. An individual responsible for contacting a patient about test results or follow-up treatment should document the contact in the patient’s chart. The failure to report the results of diagnostic tests and X-rays in a timely fashion to a patient can make a malpractice case difficult to defend. Do not file any clinical documents in the patient’s chart unless the clinician has “signed off” on them.

Always retain original records and X-rays. You can make copies, but retain all 17. originals. If you have to release original X-rays, document in the chart when, where, and why the originals were released.

Use these recommendations for records retention. Our basic guideline is “6-10-18. 21 years.” Clinicians should keep records at least six years from the date of the patient’s death, at least ten years after the patient’s last visit, and, in the case of minors, pediatric, or obstetric care, 21 years from the date of birth. We believe this guideline will protect the clinician even though the statute of limitations is frequently changing and is subject to judicial interpretation. We recommend that appointment schedules be retained for at least 10 years. Records of a potentially litigious patient should be saved indefinitely.

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Written protocols reduce your risk. We recommend the establishment of written 19. protocols with staff concerning the more basic clinical aspects of medicine, such as prescription refills and telephone triaging. Although many clinicians have a good working relationship with their staff, written protocols can prevent mis-understandings about what the nurses or medical assistants can do without first confirming with the provider. Write protocols that can and will be followed. Ori-ent all new staff members to the written protocols, and periodically review them with the entire staff.

BeawareofthelawconcerningHIV/AIDStesting.Duetoepidemiologyand20. politics,thelawconcerningHIV/AIDSisconstantlyevolving.Asageneralrule,werecommendthatHIV/AIDScounselingandtestingbeprovidedbythepublic health department, which is well equipped for this process and generally hasknowledgeconcerningthecurrentlaw.IftheclinicianplanstotestforHIV/AIDS, we recommend the use of the Washington State Department of Health consent form or the consent forms and patient information developed by your local city or county health department.

Notify patients by mail when you are going to 21. terminate their care. A certified letter, return receipt requested, should be sent to the patient explaining that your office will no longer provide care for him or her, but that you will continue to provide routine and emergency care for a specified length of time. The length of time depends on the availability of other medical care, but should be no less than 30 days. The letter should provide a referral to another source of medical care. File the signed receipt and a copy of the letter in the patient’s chart. If the certified letter is returned unclaimed, place the unopened returned letter in the chart, send a copy of the letter through the normal mail route and document the same.

Fee reduction is not an admission of liability. It is important to remember that it is 22. not an admission of liability to discount a professional fee, and we do not believe patients perceive this to be an admission of liability.

Bringlegaldocumentsimmediatelytotheattentionoftheclinicianand/orprac-23. tice administrator.

These guidelines outline some of the measures to reduce liability risks in a medical practice. Ori-ent new staff members to these guidelines, and review them at regular intervals.

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Patient Billings and CollectionsOverdue and uncollectible patient accounts are common in medical practice. Every physician has the right to be compensated for services, but fee disputes or aggressive collection efforts can lead to malpractice lawsuits, especially if a patient believes the treatment was less than optimal.

To reduce misunderstandings, we recommend you train an appropriate staff person to provide all patients with information about your fees. If care will be expensive, we suggest you or a trained staff person discuss fees with your patients in advance and explain that complications may result in additional costs. Be sure to ask patients to check their insurance coverage for any exclusions, de-ductibles, or second-opinion requirements.

A patient’s complaints about billing can indicate dissatisfaction with the care provided. Any verbal or written fee dispute should immediately be brought to your attention. With early intervention and a bit of tact and diplomacy, you will not only increase your chances of being paid, but possibly avert patient anger and keep it from escalating into a malpractice suit. If a patient requests a full or partial refund because of an adverse outcome, you should contact the Claims Department for advice.

Many physicians are concerned that offering to waive a bill or pay part or all of a patient’s medical expenses might be interpreted as an admission of liability. While some patients may feel this way, most interpret such assistance as a compassionate gesture. Furthermore, state law provides that furnishing, offering, or promising to pay medical expenses is generally not admissible as proof of liability in a malpractice suit. (RCW 5.64.010)

When medical practices submit accounts to collection agencies without the knowledge and con-sent of the involved physician, they increase their chances of receiving surprise malpractice claims. If collection efforts by your office prove unsuccessful, we suggest that the physician decide whether to turn the account over to an agency. Before making the decision, the physician should carefully review the patient’s chart and consider any possible mitigating circumstances.

Be sure that any collection agency you employ has been instructed to obtain your permission in writing before filing a suit. If a patient is thinking about filing a malpractice suit because of your collection activities, he or she is most likely to take action if you threaten a collection lawsuit. Keep in mind that winning a collection judgment and actually getting the money owed are sometimes two different things. Unless the court allows you to garnish the patient’s wages, collecting on a judgment can be difficult. Since the average collection agency charges a 50% fee, the physician can usually recover no more than half the money owed. Many physicians reserve collection lawsuits for cases involving substantial professional fees.

Remember that a financial dispute with a patient is not grounds for refusing a request to provide copies of medical records. Both the American Medical Association and the Washington State Medical Association have decided that withholding medical records pending payment for services is unethical. It is appropriate, however, to require insurance companies and attorneys to prepay for medical record copies or medical reports. HIPAA privacy rules contain language that effectively prohibits denying a patient access to his or her records because of a financial dispute.

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Are You Prepared for an Office Emergency?Acute medical emergencies can occur in any medical office. A clinician’s ability to respond ef-fectively may mean the difference between life and death for a patient, a family member, or an employee. In an emergency, clinicians must be able to stabilize the patient and quickly arrange for further intervention. Effective emergency response in a medical office involves more than a crash cart; it requires equipment, training, and a plan.

Equipment

The first component of emergency response is equipment. As a minimum standard, every practice should have the capability of a basic life support (BLS) response to emergencies such ascardio/respiratoryarrestoranaphylacticshock.BLSequipmentincludesoxygen,anoxygenmask, a bag resuscitator, oral airways, IV epinephrine and diphenhydramine, and other essential equipment and drugs relevant to your special practice requirements. Additionally, if your prac-tice treats children, you must include pediatric-sized equipment.

Several factors affect the level of response an office should have: patient demographics, location, the availability of medical resources nearby, and the level of emergency medical services in the community. Though opinions differ about which practices should have advanced life sup-port (ALS) or advanced cardiac life support (ACLS) abilities, those that do commonly include multi-specialty, primary care, or cardiology practices; serve significant numbers of young, elderly, or medically fragile patients; operate in rural or isolated areas; or receive only basic emergency medical services response from the community.

ALS or ACLS equipment, which can vary from simple drug kits to full crash carts with defibril-lation and intubation capabilities, is only as good as the skills of the clinician using it. In fact, it is best not to have ALS or ACLS equipment, or to attempt ALS or ALCS resuscitation, if the clinicians’ life-support skills are not current. All practices should check their ALS or ACLS equipment at least quarterly on a log sheet to monitor the equipment’s accessibility and func-tionality and each medication’s expiration date.

Training

The second component of emergency response is training. Because BLS, ALS, or ACLS train-ing is available from numerous sources, including most hospitals, all medical office personnel should have at least BLS training. Many hospitals require physicians to have ACLS certification to maintain active privileges.

However, because relatively few medical offices experience acute medical emergencies, the skills of many clinicians are typically not current. Every medical practice should require peri-odic recertification of life-support skills.

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Emergency plan

The final component of emergency response is a written emergency plan. Specific responsibili-ties for each staff member should be detailed in the event of an emergency. Periodic emergency drills are the best way to test staff response and resuscitation capabilities. A true emergency is not the time to discover that the emergency drug kit has expired or the defibrillator has dis-charged.

Part of the emergency plan should provide for calling the local emergency medical service when necessary. While the appropriate clinicians begin basic or advanced life support, a designated person should call 911 as soon as possible. Because of equipment and liability issues, most hospi-tal code teams or emergency department providers will not respond to emergencies off hospital grounds. The typical aid unit is better trained, equipped, and experienced to deal with medical emergencies than the typical medical office and can take over for you upon their arrival.

Conclusion

An effective response to office emergencies requires the necessary equipment, training, and emergency plan. In an emergency, practices must be able to adequately stabilize the patient while arranging for transfer.

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Semiautomatic External DefibrillatorsAccording to the American Heart Association, heart disease is the number-one killer in the United States. Some 950,000 adult Americans die each year from cardiovascular disease, and ap-proximately 250,000 of these deaths occur from sudden cardiac arrest. One of the most frequent reasons for sudden cardiac arrest is ventricular fibrillation (VF). The most effective treatment for VF is defibrillation —the application of a measured electrical shock to the patient’s chest.

Why are AEDs getting so much attention?

While cardiopulmonary resuscitation is a critical step to provide temporary artificial breathing and circulation, the only effective way to fully resuscitate a victim of VF is defibrillation. Statis-tics indicate that for every minute a victim remains in VF, the chance for successful resuscitation drops by 10%, so that at 10 minutes without defibrillation, the chance for a successful resuscita-tion is roughly zero. Studies also reveal that survival rates from VF cardiac arrest are as high as 74% when defibrillation is used within three minutes, compared to a 5% survival rate when defibrillation is not immediately available. The bottom line is this: the sooner defibrillation is started, the more likely the victim will survive. Automatic external defibrillator (AED) technol-ogy is a safe, effective, and easily implemented tool for treating victims of VF.

Is there really a risk for physicians?

In response to the alarming statistics regarding the prevalence of sudden cardiac arrest and the encouraging data for successful resuscitation with AED technology, there are now many efforts, both nationally and statewide, to encourage the distribution and availability of AEDs. As the distribution and use of AEDs has increased in public areas such as shopping malls, schools, pro-fessional sport arenas, airports, airliners, and other public settings, many medical practices have considered making this effective lifesaving technology available within their own practices.

However, some providers are concerned that having an AED within their practices might increase their liability exposure. This is not the case. In fact, Physicians Insurance claim data and national claim trends show no increase in liability exposure. Further, the user of an AED is afforded clear protection from civil liability under Washington state law—as long as the AED acquirer meets certain fundamental requirements including prescription, training, maintenance, notification, and contact with emergency services following AED use. The requirements and subsequent protection are outlined in RCW 70.54.310 as follows:

RCW 70.54.310

Semiautomatic external defibrillator–Duty of acquirer–Immunity from civil liability.

(1) As used in this section, “defibrillator” means a semiautomatic external defibrillator as pre-scribed by a physician licensed under chapter 18.71 RCW or an osteopath licensed under chap-ter 18.57 RCW.

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(2) A person or entity who acquires a defibrillator shall ensure that:

(a) Expected defibrillator users receive reasonable instruction in defibrillator use and car-diopulmonary resuscitation by a course approved by the department of health;

(b) The defibrillator is maintained and tested by the acquirer according to the manufac-turer’s operational guidelines;

(c) Upon acquiring a defibrillator, medical direction is enlisted by the acquirer from a licensed physician in the use of the defibrillator and cardiopulmonary resuscitation;

(d) The person or entity who acquires a defibrillator shall notify the local emergency medi-cal services organization about the existence and the location of the defibrillator; and

(e) The defibrillator user shall call 911 or its local equivalent as soon as possible after the emergency use of the defibrillator and shall assure that appropriate follow-up data is made available as requested by emergency medical service or other health care provid-ers.

(3) A person who uses a defibrillator at the scene of an emergency and all other persons and enti-ties providing services under this section are immune from civil liability for any personal injury that results from any act or omission in the use of the defibrillator in an emergency setting.

(4) The immunity from civil liability does not apply if the acts or omissions amount to gross neg-ligence or willful or wanton misconduct.

(5) The requirements of subsection (2) of this section shall not apply to any individual using a defibrillator in an emergency setting if that individual is acting as a good samaritan under RCW 4.24.300.

[1998 c 150 § 1.]

Conclusion

The acquisition of an AED for your medical practice adds a valuable tool to your emergency response capability whether the emergency involves a patient, staff member, or the general public. With appropriate staff training and satisfaction of the other basic requirements of RCW 70.54.310, you can feel confident that this technology can be utilized, without hesitation, in responding to a medical emergency. Remember, the documented incidence of patient injury arising out of the use of AED technology is virtually zero, and the worst that can happen is that you may save a life!

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Section 6

Treatment of Minors

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Treatment of Minors and the Handling of Their PHI

Washington State law allows minors under the age of 18 to consent to medical care and treat-ment under certain conditions that are described below. State law allows minors to make decisions about the handling of their Protected Health Information (PHI) when the law allows them to consent for their own treatment. The HIPAA Privacy Rule does not preempt state law in this regard.

A person under the age of 18 cannot consent to medical care unless one or more of the following exceptions apply:

If the minor is emancipated (legally independent) or married to someone at or above •

age 18. (RCW 26.28.020)

In the event emergency care is necessary. (When impractical to get parental consent •

first)

For birth control and pregnancy-related care at any age. (See State v. Koome)•

For outpatient drug- and alcohol-abuse treatment beginning at age 13. (RCW •

70.96A.095)

For outpatient mental health treatment beginning at age 13. (RCW 71.34.500 and •

71.34.530)

Forsexuallytransmitteddiseases,includingHIV/AIDS,beginningatage14.(RCW•

70.24.110)

Documentation

The underlying facts for the application of any of these exceptions should be documented in the medical record at the time of treatment. When consent forms are applicable to these excep-tions, such as pregnancy termination, the minor may sign these forms. Due to the minor pa-tient’s relative immaturity and lack of sophistication, adequate time needs to be spent concern-ing these consent issues.

Emancipation

A person under the age of 18 who is either emancipated or married to a spouse 18 years of age or older can consent to his or her own medical care. An emancipated minor is an individual who is free from parental control and is self-supporting.

Emergencies

State law provides that no clinician or hospital is liable for failing to secure consent when ren-dering emergency medical, surgical, hospital, or health services to any individual, regardless of

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age, where the patient is unable to provide consent for any reason and where there is no other person reasonably available who is legally authorized to give such consent. Emergency care should not be unduly delayed pending attempts to obtain any such consent. If the child’s condi-tion could deteriorate, treatment should begin at once and permission to treat should be sought concurrently. Although “emergency” can be defined either broadly or narrowly, we believe the interpretation should be considered as broader than “life threatening.” For example, in the instance of an upper respiratory infection in a child, we believe that treatment should be started even if consent is not readily available. Although it could be argued that in most cases a delay in treatment of an upper respiratory infection will not cause sequelae, clearly a delay in treatment increases a child’s suffering, and we can’t conceive of an instance where a parent would refuse this care and a court would support such a decision. As in most cases, the issue of determining when to treat without parental or guardian consent requires good judgment and common sense. In cases involving minors, clinicians or hospital personnel should thoroughly chart their efforts to contact the parent or guardian for consent for emergency care. If parental consent is obtained by phone, document it in the chart.

Sexual activity, substance abuse, and mental health

Courts and legislatures have granted minors the right to consent to medical care in a number of situations where forced consultation would most likely deter the minor from seeking needed treatment. A minor may consent to medical care relating to birth control, medical conditions relating to pregnancy, and pregnancy terminations. Persons 14 years of age or older may give theirownconsentformedicalcarerelatingtoHIV/AIDSorsexuallytransmitteddiseases.Persons 13 years of age or older may give their own consent for outpatient mental health care or the outpatient treatment of substance abuse. However, minors cannot be admitted for inpatient treatment of substance abuse or mental health without parental consent or a commitment order.

Cost of care

For other than emergency care, parents or guardians are not liable for the cost of care provided without their consent when the minor has the right to consent without consulting the parents. In these instances, each minor needs to be informed that he or she will be responsible for paying for services, and appropriate arrangements should be made.

Divorced or separated parents

For health care of a minor that does require parental consent, the parent or guardian who brings the child to the medical office can provide consent for the child’s care. A parent or guardian can provide consent for the treatment of a minor child regardless of whether the parents are mar-ried, unmarried, or separated at the time of the treatment. This applies whether the parent is the custodial parent or not, and whether or not there is a court order affecting the parent’s right to consent to the minor’s medical care. You may treat a minor when one parent provides consent to care even if the other parent demands you not treat the minor, although there may be occa-sional circumstances where, in your judgment, you choose not to provide care when the parents disagree.

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Conclusion

The law concerning treatment of minors has numerous exceptions and nuances, and this article attempts to focus on the most common issues. It does not address the more case-specific prob-lems related to extremely immature minors who may lack mental competence to consent, the court-ordered treatment of minors, or the right of minors to refuse medical care. If health care providers use their common sense and their best judgment, with an emphasis on what is best for the patient, the liability risk will be minimized. Whenever difficult case-specific consent issues arise, please call the Risk Management Department at 206-343-6526 or 1-800-962-1399 (Western Washington) or 509-456-5868 or 1-800-962-1398 (Eastern Washington).

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Important Information to Parents and Guardians of Minor Children (Washington State)

The providers and staff of (insert your clinic name here) place great emphasis on the health and well being of each and every patient in our clinic and we appreciate that you have entrusted us to provide health care services to your minor child. We look forward to working with you to ensure that your child receives the best health care possible.

As a general rule, we require the consent of a parent or legal guardian in order to provide health care services to a minor child (an unmarried person under the age of 18). With so many parents working outside the home or with other commitments, we realize that you may not be able to accompany your child on every visit to the clinic. If your minor child presents to the clinic unaccompanied or in the company of an adult other than a parent or legal guardian, we will do our best to attempt to contact you for consent. Depending upon the reason for the visit, if we are unable to contact you for consent, we may need to reschedule the appointment.

In an effort to provide the care needed and avoid having to reschedule your child’s appointment, we have developed an Advance Consent to Treat Minors form that, once completed by a parent or legal guardian, will be placed in your child’s medical record for use as necessary. This form will allow us to provide routine and emergency medical treatment for your minor child when deemed necessary by qualified medical personnel. This consent form will remain in effect until revoked in writing. You may request this form from any member of our clinic staff.

Under Washington State law, minors have the right to consent to certain health care without a par-ent or guardian’s consent. A minor may consent to medical care:

If the minor is emancipated (legally independent) or married to someone at or above age 18. •

(RCW 26.28.020)

In the event emergency care is necessary. (When impractical to get parental consent first)•

For birth control and pregnancy-related care at any age. (See State v. Koome)•

For outpatient drug- and alcohol-abuse treatment beginning at age 13. (RCW 70.96A.095)•

For outpatient mental health treatment beginning at age 13.(RCW 71.34.500 and 71.34.530)•

Forsexuallytransmitteddiseases,includingHIV/AIDS,beginningatage14.(RCW•

70.24.110)

If a minor consents to care as allowed by law, he or she can request confidentiality for that aspect of care which would prohibit us from releasing this information to anyone, including a parent or guard-ian, without the minor’s express written permission.

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It is the philosophy of this clinic to encourage minor patients to include a parent, guardian, or other trusted adult in all aspects of their health care including those areas noted above. For legal and other reasons, parent or guardian involvement may not always be possible. Rest assured that we would continue to provide health care services that are in the best interests of your minor child.

If you have questions regarding any of this information, please contact your child’s primary care provider.

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Section 7

Sample Forms and Letters

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Agreement for Use of Medication in Pain Management

Patient Name Date of Birth (Please Print)

Clinician Name Date

Effective pain management requires that the patient and the physician work together. This agreement is designed to make sure that you understand the rules we will use in your care. If you do not understand any part of this agreement, please discuss it again with your clinician. It is important that you understand that if you do not fulfill your obligations in your care, we will be less effective in helping you and might have to stop treating you altogether.

Please read and follow this agreement carefully. Help us to help you.

You must have a primary care physician (PCP). The name of the PCP is 1.

You may fill your initial prescription at the pharmacy of your choice. However, all refills 2. must be made with the same pharmacy.

Pharmacy Name

Phone Number

You must take your medication as prescribed. If you choose to change the way you are tak-3. ing your medication, please discuss it with your doctor beforehand.

You agree to take only your own medication. Do not take someone else’s medication even 4. if you think it is the same medication. Do not share your medication with anyone else.

You agree that we will be the only clinicians prescribing pain medication and other con-5. trolled substances (narcotics, tranquilizers, muscle relaxants, or sedatives) for you. You must let us know about any medications prescribed for you by other physicians or any other health care providers.

You must agree not to take any street or recreational drugs during the course of treatment.6.

You agree to advise us of any over-the-counter drugs, vitamin supplements, and herbal 7. remedies you are taking.

You give consent for on-demand, unscheduled toxicology screening (drug testing).8.

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Usually, we will prescribe enough medication to last until your next visit or next 9. scheduled medication refill date. We will not provide additional refills before that. You are responsible for notifying us at least three (3) days before your nar-cotic medication runs out. You must call during regular office hours for your refills. Refills for medications are not given on an emergency basis. Refills are not given after hours, on weekends, or on holidays.

Prescriptions are like money. If you lose your medication or the written prescrip-10. tion, it will not be replaced. You will have to wait until your next visit or sched-uled refill date.

You are required to attend all follow-up appointments scheduled for you. If you 11. must reschedule the appointment, you must call 24 hours in advance.

By signing below, you are agreeing with these rules and agreeing that you have read and under-stood them. In addition, you are indicating that your questions have been answered to your satisfaction. If you feel you will not be able to honor the commitments made in this agreement, you may notify us now or at any time. If you are not able to live by the agreement, we may need to terminate your care with us. If this occurs, we will attempt to notify you either in person or at your last known address or phone number.

Also by signing below, you are giving us permission to share this agreement with your primary care provider and pharmacy.

Patient/legallyauthorizedrepresentativesignature Date

Health care provider signature Date

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Employee Confidentiality StatementAll patient protected health information (PHI – which includes patient medical and financial informa-tion),employeerecords,financialandoperatingdataof[insertnameofpractice/healthcarefacility],andany other information of a private or sensitive nature are considered confidential. Confidential information should not be read or discussed by any employee unless pertaining to his or her specific job requirements. Examples of inappropriate disclosures include:

Employees discussing or revealing PHI or other confidential information to friends or family mem-•

bers

Employees discussing or revealing PHI or other confidential information to other employees with-•

out a legitimate need to know

The disclosure of a patient’s presence in the office, hospital, or other medical facility, without the •

patient’s consent, to an unauthorized party without a legitimate need to know, and that may indi-cate the nature of the illness and jeopardize confidentiality

The unauthorized disclosure of PHI or other confidential information by employees can subject each individual employee and the practice to civil and criminal liability. Disclosure of PHI or other confidential information to unauthorized persons, or unauthorized access to, or misuse, theft, destruction, alteration, or sabotage of such information, is grounds for immediate disciplinary action up to and including termina-tion.

Employee confidentiality agreement

I hereby acknowledge, by my signature below, that I understand that the PHI, other confidential records, and data to which I have knowledge and access to in the course of my employment with [insert name of practice/healthcarefacility]istobekeptconfidential,andthisconfidentialityisaconditionofmyemploy-ment. This information shall not be disclosed to anyone under any circumstances, except to the extent necessary to fulfill my job requirements. I understand that my duty to maintain confidentiality continues even after I am no longer employed.

Iamfamiliarwiththeguidelinesinplaceat[insertnameofpractice/healthcarefacility]pertainingtotheuse and disclosure of patient PHI or other confidential information. Approval should first be obtained before any disclosure of PHI or other confidential information not addressed in the guidelines and policies andproceduresof[insertnameofpractice/healthcarefacility]ismade.Ialsounderstandthattheunau-thorized disclosure of patient PHI and other confidential or proprietary information of [insert name of practice/healthcarefacility]isgroundsfordisciplinaryaction,uptoandincludingimmediatedismissal.

Date

Printed name of employee Signature of employee

Printed name of supervisor Signature of supervisor

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Notice of Privacy PracticesThis notice describes how medical information about you may be used and disclosed, and how you can get access to this information. Please review it carefully.

[Insertnameofpractice/healthcarefacility]respectsyourprivacy.Weunderstandthatyourper-sonal health information is very sensitive. We will not disclose your information to others unless you tell us to do so, or unless the law authorizes or requires us to do so.

The law protects the privacy of the health information we create and obtain in providing our care and services to you. For example, your protected health information includes your symptoms, test results, diagnoses, treatment, health information from other providers, and billing and payment information relating to these services. Federal and state law allows us to use and disclose your protected health information for purposes of treatment, payment, and health care operations.

Examples of uses and disclosures of protected health information for treatment, payment, and health care operations:

For treatment:

Information obtained by a nurse, physician, or other member of our health care team will •

be recorded in your medical record and used to help decide what care may be right for you.

We may also provide information to others providing you care. This will help them stay •

informed about your care.

For payment:

We request payment from your health insurance plan. Health plans need information •

from us about your medical care. Information provided to health plans may include your diagnoses, procedures performed, or recommended care.

For health care operations:

We may use your medical records to assess quality and improve services.•

We may use and disclose medical records to review the qualifications and performance of •

our health care providers and to train our staff.

We may contact you to remind you about appointments and give you information about •

treatment alternatives or other health-related benefits and services.

We may contact you to raise funds.•

We may use and disclose your information to conduct or arrange for services, including:•

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Medical quality review by your health plan;•

Accounting, legal, risk management, and insurance services; and•

Audit functions, including fraud and abuse detection and compliance programs.•

Your health information rights

Thehealthandbillingrecordswecreateandstorearethepropertyof[insertnameofpractice/health care facility]. The protected health information in it, however, generally belongs to you. You have a right to:

Receive, read, and ask questions about this Notice.•

Ask us to restrict certain uses and disclosures. You must deliver this request in writing •

to us. We are not required to grant the request. But we will comply with any request granted.

Request and receive from us a paper copy of the most current Notice of Privacy Prac-•

tices for Protected Health Information (“Notice”).

Request that you be allowed to see and get a copy of your protected health information. •

You may make this request in writing. We have a form available for this type of request.

Have us review a denial of access to your health information—except in certain cir-•

cumstances.

Ask us to change your health information. You may give us this request in writing. You •

may write a statement of disagreement if your request is denied. It will be stored in your medical record, and included with any release of your records.

When you request, we will give you a list of disclosures of your health information. The •

list will not include disclosures to third-party payers. You may receive this information without charge once every 12 months. We will notify you of the cost involved if you request this information more than once in 12 months.

Ask that your health information be given to you by another means or at another loca-•

tion. Please sign, date, and give us your request in writing.

Cancel prior authorizations to use or disclose health information by giving us a written •

revocation. Your revocation does not affect information that has already been released. It also does not affect any action taken before we have it. Sometimes, you cannot cancel an authorization if its purpose was to obtain insurance.

For help with these rights during normal business hours, please contact:

[Insert name or title of designated staff member]

[Insert phone number or address]

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Our responsibilities

We are required to:

Keep your protected health information private.•

Give you this Notice.•

Follow the terms of this Notice.•

We have the right to change our practices regarding the protected health information we main-tain. If we make changes, we will update this Notice. You may receive the most recent copy of thisNoticebycallingandaskingforitorbyvisitingour[office/medicalrecordsdepartment]topick one up.

To ask for help or complain

If you have questions, want more information, or want to report a problem about the handling of your protected health information, you may contact:

[Insert name or title of designated staff member]

[Insert phone number or address]

If you believe your privacy rights have been violated, you may discuss your concerns with any staff member. You may also deliver a written complaint to [insert name or title of person] at [in-sertnameofpractice/healthcarefacility].YoumayalsofileacomplaintwiththeU.S.Secretaryof Health and Human Services.

We respect your right to file a complaint with us or with the U.S. Secretary of Health and Hu-man Services. If you complain, we will not retaliate against you.

Other disclosures and uses of protected health information

Notification of family and others

Unless you object, we may release health information about you to a friend or family •

member who is involved in your medical care. We may also give information to someone who helps pay for your care. We may tell your family or friends your condition and that you are in a hospital. In addition, we may disclose health information about you to assist in disaster relief efforts.

[Hospitals] Information may be provided to people who ask for you by name. We may •

use and disclose the following information in a hospital directory:

Your name•

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Location•

General condition•

Religion (only to clergy)•

You have the right to object to this use or disclosure of your information. If you object, we will not use or disclose it.

Some of the ways that we may use and disclose your protected health information with-out your authorization are as follows:

With medical researchers—if the research has been approved and has policies to pro-•

tect the privacy of your health information. We may also share information with medi-cal researchers preparing to conduct a research project.

Tofuneraldirectors/coronersconsistentwithapplicablelawtoallowthemtocarryout•

their duties.

To organ procurement organizations (tissue donation and transplant) or persons who •

obtain, store, or transplant organs.

To the Food and Drug Administration (FDA) relating to problems with food, supple-•

ments, and products.

To comply with workers’ compensation laws—if you make a workers’ compensation •

claim.

For public health and safety purposes as allowed or required by law:•

To prevent or reduce a serious, immediate threat to the health or safety of a person •

or the public.

To public health or legal authorities:•

To protect public health and safety.•

To prevent or control disease, injury, or disability.•

To report vital statistics such as births or deaths.•

To report suspected abuse or neglect to public authorities.•

To correctional institutions if you are in jail or prison, as necessary for your health and •

the health and safety of others.

For law enforcement purposes such as when we receive a subpoena, court order, or •

other legal process, or you are the victim of a crime.

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For health and safety oversight activities for example, we may share health information •

with the Department of Health.

For disaster relief purposes for example, we may share health information with disaster •

relief agencies to assist in notification of your condition to family or others.

For work-related conditions that could affect employee health for example, an employ-•

er may ask us to assess health risks on a job site.

To the military authorities of U.S. and foreign military personnel for example, the law •

may require us to provide information necessary to a military mission.

Inthecourseofjudicial/administrativeproceedingsatyourrequest,orasdirectedbya•

subpoena or court order.

For specialized government functions for example, we may share information for na-•

tional security purposes.

Other uses and disclosures of protected health information

Uses and disclosures not in this Notice will be made only as allowed or required by law •

or with your written authorization.

Web site

We have a Web site that provides information about us. For your benefit, this Notice is •

on the Web site at the following address: [insert Web site address].

Effective date

[Insert effective date of the Notice]

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Prescription Refill PolicyThis is a sample policy only. Physicians Insurance provides this sample for use as an idea spring-board for offices developing or reviewing their own forms and policies.

POLICY:

Renewing prescriptions for patients on chronic medical therapy provides an opportunity to evaluate patient compliance with prescribed therapy, monitor therapeutic blood levels, and assess the need for follow-up office visits.

PROCEDURES:

We ask 24-48 hours notice for prescription refills to be completed.1.

After receiving a refill request from a patient or pharmacy, pull the patient’s chart.2.

Determine the date of the patient’s last office visit. Patients on chronic medical therapy 3. need to be evaluated by their health care provider on a yearly basis.

All narcotics and benzodiazepines require provider authorization.4.

Note the last therapeutic blood level or laboratory screening for patients requesting 5. refills of medications requiring the same.

Renew medications for six months if the patient is routinely coming to the office, blood 6. levels are therapeutic, the patient is compliant with laboratory screening as required, and/orthereisnochartnoteindicatingtheneedforotherinterimfollow-upcare.

Renew a one-month supply of medication if the patient is lacking one of the above. 7. Informthepatientand/orpharmacythatthepatientneedstobeevaluatedbytheirhealth care provider before further refills will be authorized.

Documenttheprescriptionrefillonthemedicationflowsheetand/orinaprogressnote8. entry if indicated.

Always consult the attending or covering provider if you have any questions regarding a 9. refill request.

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