What should I do after a serious adverse event?

When a serious adverse event occurs, sincere sympathy and compassion expressed to the patient and/or family is often the most important response to help diffuse a potentially volatile situation. Rather than taking a defensive stance against accusations of substandard care, the health care team should refrain from castigation or infighting and immediately begin the following positive measures: Assess the situation and communicate with the patient and family Determine who from the health care team will discuss the event, with whom (the patient and/or responsible family member), and when. Achieve consensus among team members as to the factual details and sequence of what occurred and what needs to be done in response. Discuss how the details of the event, the outcome, and the treatment plan will be explained. Maintain contact with each other and the patient/family for questions. Repeated requests for an explanation of the event is a common reaction of angry or anxious patients and family members. Organize a family meeting if several relatives are involved in the patient’s care or if treatment decisions are complicated. Contact the institutional risk manager and complete any institutional reporting requirements (potential claim, medical device failure, etc.) if indicated. Empathize with the patient and family; offer emotional support. If appropriate, apologize for the patient's distress,without admitting liability. Attempt to reconcile opposing perceptions of what has occurred. Accept responsibility for follow up of serious complaints, but do not accept or assign blame, or criticize the care or response of other providers. The Medical Record Assign the most involved and knowledgeable staff member(s) to record factual statements of the event in the patient’s record and any follow-up needed or done as a result of the incident Avoid writing in the record any information unrelated to the care of the patient (e.g., incident report filed , legal office notified ). Additional Resources Guidelines for Disclosure After an Adverse Event

What are the pros and cons of using an addendum in a medical record after an adverse event?

While information in the medical record should never be deleted, obliterated, or altered after the fact, the judicious use of an addendum in a medical record is reasonable, as long as the addendum is designated as such and dated. Accepted rationale for including an addendum would be for the correction of facts (i.e., persons involved, time of event, sequence of events) and for the addition of facts or clarifying information. Individuals who participated in the care, but were unable to access the record until a later date, may also provide added information. Addenda should not be used to state opinions, perceptions, or defenses. Arguments Supporting Addenda Accuracy: The witness to the event may not be the person who documents it. Inaccuracies, even those that appear minor, should be corrected by someone who did witness the event. Recall: Recording everything that is happening during an emergency situation is often impossible. Witnesses to an event may recall details at a later time, in which case, an addendum is appropriate. Clarification: Information previously thought irrelevant may be deemed pertinent upon review of the case by an objective clinician. In this case, clarifying comments should be added to the record if they are pertinent to future care. Arguments Against Addenda Perception: The major argument against writing addenda is the potential that they may be perceived as attempts to falsify or change the record of fact. Inappropriately phrased, an addendum may appear to be self-serving rather than providing information important in the course of a patient's recovery. For example, following an adverse event, individuals may attempt to explain their own particular role (or lack of one) in addenda. This appears defensive, does not contribute to the care of the patient, and should be avoided. Vulnerability: An addendum will be interpreted by plaintiff counsel as an attempt to alter the medical record and, if at all possible, used to support his or her client's claim. Seemingly insignificant record details are often magnified and used effectively to emphasize a plaintiff's point.

Is an apology after an adverse event treated as an admission of negligence?

No. In Massachusetts, any statements, writings, or benevolent gestures relating to the suffering of patients involved in an unexpected outcome are inadmissible as evidence of liability. Even so, some types of apologies are better than others. An apology that includes such words as I am so sorry that my treatment caused you harm is inappropriate. A sincere expression of regret following a poor outcome or upsetting experience, such as I am sorry this happened coupled with a discussion about future treatment options can demonstrate an empathetic and caring attitude. Apologies can help to mitigate any anger the patient may feel, and communicate that you will work with the patient to improve the outcome.

Is free servicing accounts to try to avoid claims a good idea?

Yes, in some cases. The majority of patients who experience an adverse event or an unexpectedly bad outcome do not sue the institution or their physicians, or even lodge a complaint. In those cases where a patient or family member does express anger, dissatisfaction with care, or even their intent to seek legal advice, questions about the bill often arise. One reasonable approach to resolving patient dissatisfaction on a case-by-case basis is to consider free servicing or writing off all or a portion of the patient’s bill. However, no one guarantees that this practice prevents or avoids future claims. Supporters of this approach say it promotes good will and improves customer satisfaction, and may thereby avert a claim. Others believe that patients who are inclined to sue will do so regardless of this assistance. In court, adjustments to a patient's bill are not considered an admission of liability. Free servicing is not recommended if doing so is unlikely to satisfy the patient. The decision to not charge or to reimburse a patient when something goes wrong is based on a multitude of factors that change with every case. Is the adverse event or poor outcome due to an error? Is a provider at fault? Could the event have been prevented? What is the magnitude of the injury and amount of billings involved? Is this a one-time write off, or an open-ended clinical situation? In the opinion of the providers involved, the risk manager, and administrator, will the free care resolve the patient’s complaint, anger, and frustration with his or her care? A corollary to free servicing is the practice of providing reimbursement for lost personal articles, such as dentures and glasses, stolen or lost valuables, and repair of dental injury occurring during intubation. The ability to provide free service is an important tool in handling patient concerns at an administrative level. Involving caregivers in risk management decisions and communicating to them any action taken on behalf of a patient is also important.

What responsibilities does my office practice have for reporting medical device adverse events?

What responsibilities does my office practice have for reporting medical device adverse events? The Safe Medical Devices Act (SMDA) requires that any device user facility report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes: an ambulatory surgical facility, a nursing home, or an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency). The requirements do not apply to a physician’s office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients. All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.) Device user facilities are also required to have written procedures for identifying and evaluating events that might be reportable. These facilities must also comply with documentation requirements, and provide employees with training and education about their obligations under the institution’s program. Programs in all settings are subject to FDA auditing for compliance with the mandatory reporting requirements. Copies of the mandatory reporting form, instructions, and the coding manual can be obtained from the FDA by calling 1.800.638.2041. Or visit the FDA’s website .

What is the CRICO AMC PSO?s

AMC PSO stands for Academic Medical Center Patient Safety Organization. The AMC PSO is a national convener of clinicians and health care organizations striving to promote patient safety by focusing on specific quality and safety initiatives, including: Root Cause Analysis (RCA) Information Convening Sessions Adverse Event and Near-Miss Reporting This began in 2009 when the Patient Safety and Quality Improvement Act (PSQIA) was enacted to create a culture of safety by providing federal privilege and confidentiality protections for information that is assembled and reported to a PSO, or developed by a PSO, for the conduct of patient safety activities.

How can I join your PSO?

For information on joining the AMC PSO, please email Carol Ann Garcia , Program Administrator.

What can I learn about this work as a non-member?

AMC PSO makes patient safety learnings available to the public as part of CRICO’s ongoing commitment towards improving patient safety across the continuum of care. These learnings can be found in guidelines, papers and our Patient Safety Alerts, which can be downloaded. New editions are published regularly and are free and available on our AMC PSO Publications page .

What are the benefits of being part of the AMC PSO?

CRICO’s AMC PSO offers the following benefits to members: Access to the AMC PSO Secure Portal to share files and collaborate safely. Ability to access and use the Root Cause Analysis Information Exchange tool. Chance to be part of the closed secure in-person patient safety discussions and to influence the solutions.

What changes were made to the requirements during the pandemic?

Each state updated its CME requirements near the beginning of the global pandemic for COVID -19. Find your state’s information in this document: States Modifying Continuing Medical Education Requirements in Response to COVID-19

What types of Continuing Medical Education (CME) credit are available?

AMA PRA Category 1 credit ™ is issued by an accredited provider to physicians who participate in their certified activities and claim credit. Category 1 credit is provided for activities that meet all the requirements prescribed by the AMA. They are formal, pre-planned activities including live activities, and enduring materials. AMA PRA Category 2 credit ™ include activities that provide valuable learning for individual physicians that are not designated for Category 1 credit. They might include such activities as unstructured online searching, reading authoritative medical literature, or self-assessment activities. For more: a complete explanation, consult: AMA CME Provider Resources page CRICO content and activities available for credit, refer to: Education and CME Catalog Page The Board’s CME Pilot Program policy with details of the CME requirements in Massachusetts.

How do I obtain Risk Management Credits if I practice in Massachusetts?

In Massachusetts, a majority of CPD* credit must be directly related to the primary area(s) of a physician’s practice, and must include two hours studying the Board of Registration in Medicine’s regulations. Massachusetts Risk Management Study: Category 1 – Formal, pre-planned activities that focus on medical malpractice prevention such as risk identification, loss prevention, and patient safety. Those areas may include medical ethics, quality assurance, medical-legal issues, patient relations, utilization review, and non-economic aspects of practice management. Category 2 – Activities that that provide valuable learning and address medical malpractice prevention but are not designated as formal, pre-planned activities. Those might include participation on peer review committees in quality assurance or medical ethics. For a more complete explanation, you may consult: FAQs about Continuing Professional Development (CPD) *CPD was formerly known as Continuing Medical Education (CME)

What is risk management study?

Risk management study consists of learning that includes information regarding the prevention of medical malpractice. Some examples are activities that include loss prevention, risk identification, and patient safety instruction. Risk management study must include instruction in medical malpractice prevention, such as risk identification, patient safety and loss prevention, and may include instruction in any of the following areas: medical ethics; quality assurance; medical-legal issues; patient relations; utilization review that directly relates to quality assurance; or non-economic aspects of practice management. Note that at least some of the instruction should focus on medical malpractice prevention, and all instruction should be in one or more of the areas described above. A course designed to improve clinical skills by increasing technical knowledge may qualify for AMA PRA Category 1 credit ™, but typically will not constitute risk management study. Note : CPD was formerly known as Continuing Medical Education (CME).

How do I claim risk management credit?

Risk management study is a self-claimed activity. This means you should maintain a record of the activities you complete that meet the requirement for risk management study.

Who needs to receive risk management credit?

Any physician licensed in Massachusetts must earn risk management credit during each licensing cycle.

I’ve completed a CRICO online module, how do I receive credit?

After completion of an on-line activity, such as a test or questions on a recorded webinar, a certificate is sent to your email address on file. If you believe you should have received a certificate, and did not, contact the Patient Safety Department to inquire further.

I’m a nurse; do you offer Continuing Education credits?

At this time CRICO offers AMA PRA Category 1 credits ™. The Massachusetts Board of Nursing website describes how you may use participation in an activity that provides CME credit for license renewal in their frequently asked questions .

What are a physician’s responsibilities when working with a nurse practicing in an expanded role?

In Massachusetts, nurses practicing in an expanded role include: nurse midwives, nurse practitioners, psychiatric nurses, mental health clinical specialists, and nurse anesthetists. Massachusetts is one of several states in which the Boards of Registration in Nursing and Medicine jointly govern the practice of nursing in the expanded role. Nurses practicing in the expanded role must practice in accordance with written guidelines which are developed in collaboration with and mutually acceptable to the individual physician or the appropriate medical and nursing administrative staff. Important issues of concern in collaborative relationships include responsibility, quality of care, communication, scope of practice, delegation of authority, patient satisfaction, and conflict resolution. Nurses practicing in an expanded role are responsible for their own actions. If such actions result in a claim, the supervising physician may be named. The best protection is to formulate or adapt written guidelines and practices which address the questions on how best to serve patients under the combined care of physicians and nurses emphasizing a team approach. Regular review of these guidelines and a regular conference/chart review time to review clinical care is an important part of maintaining quality patient care in a collaborative practice. Clinicians outside Massachusetts should check with their state medical boards regarding the rules for collaborative practice.

What is a physician’s responsibility when supervising nurses with prescriptive authority?

In Massachusetts, nurses’ prescriptive privileges are governed generally by the regulations of the Boards of Registration in Nursing and Medicine, and specifically by the guidelines developed with a supervising physician. Such guidelines must state the nature and scope of the nurse's practice, any specific limitations on prescriptive powers, and the mechanism for physician supervision. The supervising physician must review the nurse’s prescriptive practice at least every three months and provide ongoing direction. Physicians deciding whether and how to supervise a nurse with prescriptive authority should consider the geographical proximity, practice setting, volume, and complexity of the patient population for each nurse being supervised, as well as the nurse's and physician's levels of expertise. New Hampshire does not require physician supervisors for prescribing nurses. In Rhode Island, nurse practitioners’ prescribing privileges are defined by formularies written in collaboration with the medical directors or physician consultants of individual entities. These cannot exceed the scope of the formularies promulgated annually by the Rhode Island Department of Health. Physician consultants reviewing these formularies need to keep up to date with any statewide changes. As nurses gain increased authority, physicians are advised to keep track of regulatory changes.

What are my risks from an informal "curbside consult"?

Historically, the courts have looked for a formal physician-patient relationship as the basis for risk exposure. Court decisions have given increased consideration to factors such as whether: A contractual agreement created a relationship, Actions by your employees implied your willingness to establish a physician-patient relationship, or Treatment or diagnostic decisions by your consulting colleague indicate substantial reliance on your advice. If your curbside consult takes on any of these characteristics, follow up on the patient’s care as you would for a formal consult. Additional Resources Curbside Consultations [PDF]

How do I reduce the risks associated with an increased patient load?

Clinicians seeing an increasing volume of patients might consider: Reducing paperwork with electronic clinical information systems. Available systems automate processing of health insurance claims, produce medical outcomes information needed by managed care organizations, generate patient education materials, and generate reminders for routine and follow-up care for your patients Meeting regularly with office personnel to assess existing office systems and develop protocols for streamlining routine activities such as follow-up on missed appointments and referrals, telephone call documentation, and scheduling of diagnostic tests. Employing continuous quality improvement and patient safety concepts that involve and educate office staff in changing requirements and procedures.

What patient safety issues may arise when a specialist assumes a primary care role or vice versa?

Specialists assuming primary care duties run the risk of overlooking problems outside their specialty. Physicians accustomed to treating only one aspect of a patient's needs must be especially vigilant about maintaining responsibility for the whole patient, both in preventive care and in following up on referrals to specialists. Clinicians whose roles and patient bases are changing might consider continuing medical education programs targeting those changes. Primary care providers may find they are doing things that were previously done only by specialists. Clinicians whose roles and patient bases are changing need clear guidelines (systemwide or personal) for when to refer. For those new practices that are being assumed, continuing medical education programs targeting those areas is also recommended.

What are my responsibilities if care I recommend is disapproved by a third-party payor?

Insurance coverage does not dictate clinical needs or decisions. You must advocate for the care or treatment warranted by your patients' conditions. Be direct with patients and their managed care organizations (MCOs). Become familiar with the MCO’s appeals and grievance process. If necessary, make an appeal, or prompt an appeal by the patient or employer. Move up within the MCO as necessary to reach a key decision maker. Ask to speak to a physician reviewer within the MCO, ideally one trained in the specialty in which treatment is sought. If treatment is still not approved, dispassionately make your case to the MCO’ medical director in a letter. Do not “cc” state agencies, medical societies, or others as a technique of intimidation. Based on the outcomes of those advocacy efforts, you then need to obtain your patient's informed consent to, or refusal of, treatment. You may need to assist patients with alternative payment options. Include patients (and family members wherever possible and appropriate) in the decision process. Consider reasonable alternatives to a rejected treatment plan. Additional Resources Health screening test is not covered by the patient's MCO [PDF] Appealing an MCO's denial of coverage for recommended treatment [PDF] An MCO recommends that you observe specific practice guidelines [PDF]

What are my responsibilities if I'm called regarding an unfamiliar patient in the ED?

If you receive a call from an Emergency Department regarding an unfamiliar patient and this patient is new to your practice, the patient is someone listed on your managed care panel but whom you have not yet seen, or you are on that day's ED on-call list, your responsibilities are, basically, the same. When you are called, you are required to make and document appropriate decisions about the care of the patient and convey those decisions to appropriate personnel. Find out as much about the patient's condition as possible. Under federal law, ED personnel must do a medical screening on all patients to determine whether an emergency condition exists before asking the patient about insurance coverage. Depending on the medical situation, you can then decide what would be the most appropriate course of treatment: Have the ED personnel treat the patient with your consultation and have the patient call your office for follow-up Ask the ED personnel to call in a specialist to treat the patient and have the patient call the specialist's office to schedule a follow-up appointment if necessary Decide to go to the emergency department to treat that patient.

Can I transfer a "difficult" managed care contract patient?

Check with the MCO before taking any action to terminate your relationship with a patient. Specific legal criteria must be applied before any determination is made for “disenrollment” of the member.

How do “econsults” come into play with legal liability?

Technological advances have transformed the concern about “curbside” consults to “econsult.” But the recommendations are mostly unchanged. As with any formal consultation, a clinician responding to a request for consultation on a specific patient via an electronic format (text, email, EHR notes, etc.) becomes part of that patient’s record and, thus, is subject to discovery in any legal pursuit regarding medical professional liability. Additional thoughts and recommendations from a medical malpractice defense attorney regarding the risks of consults are available in the article Curbside Consults in the Digital Age . In general, providers are discouraged from engaging in “informal” consults about a specific patient—either as the inquiring or the responding party. Given the permanence of electronic communication, there is no such thing as an informal “econsult,” as the date, time, and parties involved are captured, and subject to legal discovery.

Do I have coverage for international activities?

A: Medical Professional Liability (MPL) coverage is provided automatically to physicians for activities within their scope of professional responsibilities and employees for activities within their scope of duties.* Limits for international MPL are $2,000,000 per event and an annual physician maximum limit of $2,000,000. To confirm the requirements for any specific jurisdiction you should consult with the inviting organization for their local legal requirements, or contact your Insurance Manager and/or your Office of General Counsel. Some members have International Advisory/Consulting (Errors and Omission) coverage with CRICO. If your sponsor has this coverage, it may be available to you. Contracts for these activities must be executed with your sponsoring organization. Please contact the insurance managers or your Office of General Counsel at your institution to verify coverage. Please note that certain information is required to be reported to CRICO prior to coverage being extended. * Physicians employed by entities domiciled outside of Massachusetts may have different limits and coverages. Please contact your employer regarding your coverage.

I will no longer be working at a CRICO institution. Can I still maintain my CRICO insurance?

CRICO is not a commercial carrier and as such can only offer insurance to individuals who meet certain eligibility criteria. Physicians and other insureds who end their CRICO coverage are still protected (insured) against malpractice claims associated with care that occurred during participation in the CRICO program. CRICO provides this extended reporting period (tail coverage) as part of the sponsoring institution’s policy, as long as the institution continues to participate in the CRICO program. No coverage is provided for any claim arising out of services rendered after an individual is no longer participating in the CRICO program. ________________________________________ * If you are employed by an affiliated practice group, separate coverage terms for tail may apply. Please contact Underwriting at 617.450.8219 for additional information.

Is my policy claims-made or occurrence?

CRICO Medical Professional Liability coverage is a claims-made policy with unlimited tail coverage. Claims-made policy : a policy that covers claims reported to the insurance carrier during the policy period. Occurrence policy : a policy that covers claims that occurred during the policy period. They can be reported to the insurance carrier either during the policy period or after the policy period. Claims-made policy with unlimited tail : a policy that covers claims reported to the insurance carrier during the policy period. However, once you leave the program you can continue to report claims that occurred while you had coverage.

What is tail coverage?

A claims-made policy provides liability coverage only if a claim is made during the policy period. However, in the event you leave the CRICO program, an unlimited tail provides you with an extended amount of time to report the claim when you are first made aware of it as long as the claim occurred during the time you were covered by CRICO.

Am I covered for expert witness testimony?

In regard to MPL, physicians are not covered for expert testimony unless one of the following is true: it is their own patient they are providing expert testimony for a government or quasi-government institution If you are testifying on behalf of CRICO, please contact your Claims Manager for details of coverage. For Association Liability (AL), coverage is only provided if your sponsor has AL coverage and is a signatory party to the contract.

Am I covered as a physician overseeing medical cases and/or participating in physician hiring or review processes?

Physicians who do not have a clinical appointment but are employed by their sponsor in a non-clinical role and are not practicing clinically in any capacity are covered under the sponsor’s MPL policy as an employee. Please contact your credentialing department for more information on program eligibility.

Is telehealth covered?

CRICO’s Medical Professional Liability policy responds to allegations of medical negligence regardless of where services are rendered, or where the allegation is filed. This includes telehealth services. Your sponsoring institution may have specific policies regarding telehealth practices. Please contact your Office of General Counsel for additional information. *The Health Resources Services Administration defines telehealth as the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration.

For domestic Medical Professional Liability (MPL) coverage $5,000,000 per claim and $10,000,000 per event For international MPL coverage $2,000,000 per event and $2,000,000 annual physician maximum* * Physicians employed by entities domiciled outside of Massachusetts may have different limits and coverages. Please contact your employer regarding your coverage.

Am I covered for moonlighting?

Staff physicians are covered for activities within their scope of professional responsibilities. For activities outside of your employment (such as moonlighting, consulting for a third party, acting physician for a summer camp, etc.), we recommend that you notify your Chief and your institution’s Office of General Counsel (OGC) and keep any documentation of your approved activities. We also recommend you review any employment contract you have with your institution to ensure you are meeting all reporting requirements. For any activities performed out-of-state, please note that you are subject to that state’s licensing requirements. Your sponsoring institution may have specific policies regarding out-of-state practice and/or telemedicine practice. Please contact your OGC for additional information.* As a fellow , a moonlighting waiver, which you can find in the Insurance Portal pages, must be completed. The waiver must also be signed by the Chief of Service and submitted to CRICO through the credentialing department. If you will be practicing out-of-state, you are subject to that state’s licensing requirements. If you will be moonlighting in an emergency room you are required to hold valid and current PALS or ACLS and ATLS certifications**. As a resident , a moonlighting waiver, which you can find in the Insurance Portal pages, must be completed. The waiver must also be signed by the Chief of Service and submitted to CRICO through the credentialing department. If you will be practicing out-of-state, you are subject to that state’s licensing requirements. If you will be moonlighting in an emergency room you are not covered unless enrolled in the Harvard-affiliated Emergency Medicine Residency Program. If you are enrolled in such a program you are required to hold valid and current PALS or ACLS and ATLS certifications. Please note that you will only be insured for the maximum number of hours per week that your hospital has approved residents to work. *Physicians employed by entities domiciled outside of Massachusetts may have different limits and coverages. Please contact your employer regarding your coverage. **Pediatric Advanced Life Support (PALS), Advanced Cardiac Life Support (ACLS), Advanced Trauma Life Safety (ATLS)

How often do I need to renew?

Coverage renews automatically. However, if at any time you have a change in employment status, specialty, sponsor/employer, or responsibilities, you will need to contact your credentialing department and complete any required CRICO paperwork to maintain your insurance coverage.

I think it’s important to chart the truth about patients who don’t take care of themselves or aren’t cooperative in their care. How do I do that without alienating them?

As long as your documentation is accurate, and not intentionally judgmental or disrespectful, you should continue to include whatever information is needed to assist future care and to enable the patient to understand their health status and health issues.

As of April 5, 2021, what do I have to do?

As of April 5, 2021 , you, your facility, or your practice will need to share electronic health records with the patients at their request. Clinical notes must be shared by health systems by April 5, 2021 and shared with a patient’s third-party smart phone app or other device by October 6, 2022.

I understand that I might be at risk for what I didn’t document, but can I be sued for what I did write in a patient’s chart?

What was or was not documented is rarely the primary reason a patient files a claim or suit alleging malpractice, but the medical record is, essentially, the “key witness” in such proceedings. Any issues with that record (gaps, ambiguity, insensitivity) serves to undermine the defense of standard and appropriate medical care, and has the potential to create an impression of negligence.

I write my notes for myself and other clinicians who understand the terminology, abbreviations, and shorthand; will I need to change to non-clinical language?

While there are medical record documentation practices that may be hard-wired for all clinicians, chart etiquette deserves extra attention now that non-clinicians will also see what you write. This doesn’t mean you have to dramatically alter how and what you chart, but you will want to be sensitive to terminology and descriptive language that may be unnecessarily hurtful or confounding to a lay reader. When unsure, it is a good rule of thumb to mirror the way that you would speak with a patient in your notes. Specific language that is required for billing and coding should not be altered.

How is the OpenNotes research initiative related to the Cures Act?

While the “information blocking” regulations that are included in the Cures Act are informally referred to as the “open notes rule,” the Act does not formally endorse the (non-profit) OpenNotes program. Because OpenNotes has been promoting the benefits of patient access and helping health care providers implement such access across the U.S. for more than 10 years, that program’s website and staff are well-positioned to offer collegial support as the Cures Act takes effect.

Who is liable for an information blocking violation if a health information portal that my patients use (over which I have no control) malfunctions?

There are several exceptions within the rule for uncontrollable events, such as the inability to fulfill the request for access, exchange, or use of electronic health information due to a natural or human-made disaster, public health emergency, public safety incident, war, terrorist attack, civil insurrection, strike or other labor unrest, telecommunication or internet service interruption, or act of military, civil or regulatory authority. In such cases, you must provide a written response to the requestor within 10 business days of receipt of the request with the reason(s) why the request is infeasible.

What do I do if a patient points out a typo or mistake? Can I change the record after the fact without getting into trouble?

The institution(s) where you practice should have policies and processes for patients to request amendments to their notes (e.g., Medical Records/Health Information Department).

I don’t have enough time for my patients as is; will I be expected to spend time explaining my notes, too?

It is best to assume that your patients will access their notes, thus best to explain any specific things for them to look for (new test results, reminders, milestones, etc.). Tell them what you are looking for or may expect to find when you order a test, and that they may see the results before you do. The OpenNotes team reports that, in the 10 years of studying the effects of patients reading their notes, clinicians have not reported a significant increase in visit time or emails from patients.

I sometimes talk to patients by phone or text. Do those have to be made available?

Yes. Clinically relevant information exchanged during any form of patient encounter needs to be contemporaneously documented in the patient’s medical record, and thus immediately available to the patient.

What happens if a patient finds an inconsequential mistake, or is offended by what they read in their record?

As with any shift in the delivery of health care, broader and deeper access to clinical documentation may become a factor in both a patient (or family) deciding to file a malpractice claim or suit, and in the defense of cases brought for any type of allegation. More likely, however, is that a careful reading of clinical notes will aid patients (and their attorneys, if applicable) in better understanding their care encounters, and dispelling the notion of negligent practice. And, although patients may be aggrieved by innocent errors, or terms and descriptions they see in their records—and may express those feelings to their providers—it is unlikely that any fruitful pursuit of legal action would ensue (unless the documentation was egregiously unprofessional). If there are specific concerns related to a documentation error or issue raised by a patient, contact your patient safety and/or risk management office for assistance in how best to respond.

Are my interests really protected by CRICO?

The medical institutions that are shareholders in the CRICO insurance program have an inherent interest in the well-being of the insured physicians (and other health care providers) who care for patients in their facilities. By law, ethics, and mandate of the CRICO shareholders, the medical provider—not the insurance company—is the client of the attorney asked to represent a CRICO-insured defendant in a medical malpractice claim. Within tripartite systems such as CRICO’s, the insured defendant, the attorney, and CRICO work together to provide the best defense against a malpractice claim. The assigned attorney is—to the fullest degree—the defendant’s advocate.

How can I find out if I have a report in the National Practitioner Data Bank?

The National Practitioner Data Bank collects and discloses the following data only to authorized users: negative information on health care practitioners, including malpractice awards, loss of license or exclusion from participation in Medicare or Medicaid. Wikipedia Overview NPDB Home Page

What criteria are used to select medical experts?

Careful research is necessary when obtaining expert medical witnesses whose role is to educate the jury about all pertinent issues relating to the case and to provide the basis for the standard of care established by the defense. CRICO considers the following factors when selecting expert medical witnesses: Is the individual a hands-on expert (i.e., clinician), or an academician who can testify on a purely scientific level? Can the expert communicate technical information clearly and simply to a lay jury? Is the expert willing and available to testify in court? Has the expert testified on this subject before? CRICO strives for an objective opinion by a knowledgeable and articulate witness who has ongoing clinical or research experience which has bearing on the case at hand. Has he or she written specifically on the medical issues pertinent to the case? The expert will need to be prepared to explain anything he or she has authored which can be construed to contradict the basis of his or her testimony in this case. Was the expert board-certified in the same specialty as the defendant at the time of the incident? Does the expert belong to the appropriate professional organizations and societies? Does the expert live and practice in the same state as the defendant physician? Local experts are more likely to be recognized by jurors. They also incur fewer travel and scheduling conflicts.

Why do some cases settle before trial?

Most settlements involve cases in which the clinical care fell below the applicable standard of care. This is typically determined by the inability to obtain credible expert testimony that the standard of care was met. CRICO’s philosophy is to defend all cases supported by expert reviewers. However, some circumstances make cases difficult to defend even when the clinical care was appropriate.

What will I need to do during the course of a medical malpractice lawsuit against me?

In Massachusetts, the majority of cases take between three and five years to complete. Suits can be dropped or dismissed after the original filing or take years to go through the entire trial and appeal process. Occasional spurts of activity take place during the otherwise slow and deliberate process. While this may be frustrating, it is typical of civil litigation. Legislative and judicial attempts to speed the process in Massachusetts have yet to meet the goal of a three-year time frame. For CRICO-insured defendants, your involvement will include: Meeting with a CRICO claim representative to review events surrounding the claim Meeting with the defense attorney assigned to defend you Assisting the defense team in preparation for the tribunal Preparing answers to the plaintiff's interrogatories Preparing and testifying at the deposition (where the plaintiff's attorney will ask you specific questions about your background and the events involved in the allegation of negligent care). Depositions last anywhere from a few hours to more than a day If the case continues to trial, you will need to spend as much time as necessary with your defense attorney and CRICO claim representative preparing your testimony. Trials can run from a few days, to weeks in length. Defendants are asked to be present at as much of the trial as possible.

Adverse Event FAQ

Do you know what to do when things go wrong?

Related To: Claims, Communication

While information in the medical record should never be deleted, obliterated, or altered after the fact, the judicious use of an addendum in a medical record is reasonable, as long as the addendum is designated as such and dated. Accepted rationale for including an addendum would be for the correction of facts (i.e., persons involved, time of event, sequence of events) and for the addition of facts or clarifying information. Individuals who participated in the care, but were unable to access the record until a later date, may also provide added information. Addenda should not be used to state opinions, perceptions, or defenses.

Arguments Supporting Addenda

Accuracy: The witness to the event may not be the person who documents it. Inaccuracies, even those that appear minor, should be corrected by someone who did witness the event.

Recall: Recording everything that is happening during an emergency situation is often impossible. Witnesses to an event may recall details at a later time, in which case, an addendum is appropriate.

Clarification: Information previously thought irrelevant may be deemed pertinent upon review of the case by an objective clinician. In this case, clarifying comments should be added to the record if they are pertinent to future care.

Arguments Against Addenda

Perception: The major argument against writing addenda is the potential that they may be perceived as attempts to falsify or change the record of fact. Inappropriately phrased, an addendum may appear to be "self-serving" rather than providing information important in the course of a patient's recovery. For example, following an adverse event, individuals may attempt to explain their own particular role (or lack of one) in addenda. This appears defensive, does not contribute to the care of the patient, and should be avoided.

Vulnerability: An addendum will be interpreted by plaintiff counsel as an attempt to alter the medical record and, if at all possible, used to support his or her client's claim. Seemingly insignificant record details are often magnified and used effectively to emphasize a plaintiff's point.
When a serious adverse event occurs, sincere sympathy and compassion expressed to the patient and/or family is often the most important response to help diffuse a potentially volatile situation. Rather than taking a defensive stance against accusations of substandard care, the health care team should refrain from castigation or infighting and immediately begin the following positive measures:

Assess the situation and communicate with the patient and family
- Determine who from the health care team will discuss the event, with whom (the patient and/or responsible family member), and when.
- Achieve consensus among team members as to the factual details and sequence of what occurred and what needs to be done in response.
- Discuss how the details of the event, the outcome, and the treatment plan will be explained.
- Maintain contact with each other and the patient/family for questions. Repeated requests for an explanation of the event is a common reaction of angry or anxious patients and family members.
- Organize a family meeting if several relatives are involved in the patient’s care or if treatment decisions are complicated.
- Contact the institutional risk manager and complete any institutional reporting requirements (potential claim, medical device failure, etc.) if indicated.
- Empathize with the patient and family; offer emotional support. If appropriate, apologize for the patient's distress,without admitting liability.
- Attempt to reconcile opposing perceptions of what has occurred.
- Accept responsibility for follow up of serious complaints, but do not accept or assign blame, or criticize the care or response of other providers.
The Medical Record
- Assign the most involved and knowledgeable staff member(s) to record factual statements of the event in the patient’s record and any follow-up needed or done as a result of the incident
- Avoid writing in the record any information unrelated to the care of the patient (e.g., incident report filed, legal office notified).
Additional Resources

Guidelines for Disclosure After an Adverse Event
No.

In Massachusetts, any statements, writings, or benevolent gestures relating to the suffering of patients involved in an unexpected outcome are inadmissible as evidence of liability. Even so, some types of apologies are better than others. An apology that includes such words as I am so sorry that my treatment caused you harm is inappropriate.

A sincere expression of regret following a poor outcome or upsetting experience, such as I am sorry this happened coupled with a discussion about future treatment options can demonstrate an empathetic and caring attitude. Apologies can help to mitigate any anger the patient may feel, and communicate that you will work with the patient to improve the outcome.
Yes, in some cases.

The majority of patients who experience an adverse event or an unexpectedly bad outcome do not sue the institution or their physicians, or even lodge a complaint. In those cases where a patient or family member does express anger, dissatisfaction with care, or even their intent to seek legal advice, questions about the bill often arise.

One reasonable approach to resolving patient dissatisfaction on a case-by-case basis is to consider free servicing or writing off all or a portion of the patient’s bill. However, no one guarantees that this practice prevents or avoids future claims. Supporters of this approach say it promotes good will and improves customer satisfaction, and may thereby avert a claim. Others believe that patients who are inclined to sue will do so regardless of this assistance. In court, adjustments to a patient's bill are not considered an admission of liability. Free servicing is not recommended if doing so is unlikely to satisfy the patient.

The decision to not charge or to reimburse a patient when something goes wrong is based on a multitude of factors that change with every case.
- Is the adverse event or poor outcome due to an error?
- Is a provider at fault?
- Could the event have been prevented?
- What is the magnitude of the injury and amount of billings involved?
- Is this a one-time write off, or an open-ended clinical situation?
- In the opinion of the providers involved, the risk manager, and administrator, will the free care resolve the patient’s complaint, anger, and frustration with his or her care?
A corollary to free servicing is the practice of providing reimbursement for lost personal articles, such as dentures and glasses, stolen or lost valuables, and repair of dental injury occurring during intubation.

The ability to provide free service is an important tool in handling patient concerns at an administrative level. Involving caregivers in risk management decisions and communicating to them any action taken on behalf of a patient is also important.
What responsibilities does my office practice have for reporting medical device adverse events?

The Safe Medical Devices Act (SMDA) requires that any device user facility report certain types of medical device-related events to the Food and Drug Administration (FDA). Besides a hospital, a device user facility includes:
- an ambulatory surgical facility,
- a nursing home, or
- an outpatient diagnostic or treatment facility (such as a mammography unit or home health agency).
The requirements do not apply to a physician’s office, which is defined as one used for the primary purpose of examination, evaluation, and treatment/referral of patients.

All qualifying device user facilities have the same reporting responsibilities, regardless of size or complexity. Medical device-related deaths must be reported directly to the FDA and the manufacturer (if known), while events meeting the definition of device-related serious illness and serious injury are reported only to the manufacturer. (In the event a manufacturer is unknown, these reports go to the FDA.)

Device user facilities are also required to have written procedures for identifying and evaluating events that might be reportable. These facilities must also comply with documentation requirements, and provide employees with training and education about their obligations under the institution’s program. Programs in all settings are subject to FDA auditing for compliance with the mandatory reporting requirements.

Copies of the mandatory reporting form, instructions, and the coding manual can be obtained from the FDA by calling 1.800.638.2041. Or visit the FDA’s website.

Adverse Event FAQ

Arguments Supporting Addenda

Arguments Against Addenda

Assess the situation and communicate with the patient and family

The Medical Record

Additional Resources

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Nurse and APP Coverage FAQs

Miscellaneous FAQs

Cures Act FAQs

Employment Practices Liability

Patient Conflict FAQs

Office Practice FAQs

Adverse Event FAQ

Q: What are the pros and cons of using an addendum in a medical record after an adverse event?

Arguments Supporting Addenda

Arguments Against Addenda

Q: What should I do after a serious adverse event?

Assess the situation and communicate with the patient and family

The Medical Record

Additional Resources

Q: Is an apology after an adverse event treated as an admission of negligence?

Q: Is free servicing accounts to try to avoid claims a good idea?

Q: What responsibilities does my office practice have for reporting medical device adverse events?

More Frequently Asked Questions

Nurse and APP Coverage FAQs

Miscellaneous FAQs

Cures Act FAQs

Employment Practices Liability

Patient Conflict FAQs

Office Practice FAQs

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