Noncompliance: A Frequent Prelude to Malpractice Lawsuits

Patients who do not show up for appointments or comply with treatment recommendations represent a significant professional liability risk for ophthalmologists.  This document will outline the issues and provide risk management recommendations to promote patient safety and protect physicians and their staff.

Examples of noncompliance that put the patient, staff, and physician at risk:

·      Glaucoma patient not taking medications as prescribed

·      Patient with symptoms suggestive of a CNS tumor refusing imaging studies or a neuro-ophthalmology consult

·      Parents of baby with ROP not bringing baby to ophthalmologist for follow-up examination

·      Patient with a retinal detachment refusing to go see a retinal specialist as recommended

·      Patient with proliferative diabetic retinopathy refusing laser treatment

·      Postoperative cataract patient not notifying ophthalmologist as instructed about eye pain and vision loss

·      Parent of child not enforcing patching regimen

 Why is noncompliance a problem?

·      Significant patient safety risk

o      Vision-, health-, or life-threatening condition progresses because:

§       Not diagnosed

§       Not effectively treated

·      Significant professional liability risk.  Even patients who did not follow the doctor’s orders sue physicians for:

o      Failure to diagnose

o      Failure to treat

o      Failure to monitor treatment

o      Failure to follow-up on missed appointments

o      Failure to explain risks of no treatment, also known as the failure to obtain informed refusal

·      Can interfere with the physician -patient relationship

o      Physician and staff

§       Frustrated by wasted time, money, resources

§       Feel unappreciated or taken advantage of

§       Distracted from diagnosing and treating

§       May not listen as well or take patient complaints as seriously

o      Patient

§       May be too embarrassed to explain reasons for noncompliance, such as financial problems or inability to read or understand instructions

§       May become defensive, demanding, hostile

§       May feel doctor or staff don’t care

§       Less likely to inform physician and staff of problems

Relationship between noncompliance and patient’s right to make healthcare decisions

·      Adult patients have the right to accept or refuse recommended care

·      Just as with informed consent, the patient must have sufficient information to make a meaningful decision

·      The patient is presumed “ignorant until educated” by healthcare providers

·      If the patient’s noncompliance contributed to the poor outcome, the jury assigns the patient a portion of the blame:  “contributory negligence”

Faced with patients’ noncompliance, what do ophthalmologists need to do to protect themselves and their patients?

·      To reduce professional liability, the ophthalmologist needs to confirm that the patient understands the health consequences of refusing care

·      The ophthalmologist may choose to terminate the relationship with a patient who continues to refuse to follow treatment recommendations

·      Anticipate problems with compliance when the patient has a new diagnosis, diagnostic procedure, consultation, treatment, or medication.  Involve staff in educational efforts.

o      Carefully explain the diagnosis and treatment plan

o      Give patients written treatment and medication instructions in patient-friendly language

o      Inform patients of common problems implementing treatment plans 

o      Consider giving patients with chronic or high risk conditions an information sheet:

§       Dr. Jones has determined that you have glaucoma and needs your help to take good care of your eyes.  Many of our patients with glaucoma have problems understanding this disease and following the doctor’s orders for treatment, so we want to spend some time talking to you about these issues to see if you have any questions and to find out if there is anything we can do to help you.  Let us know if you think these or other problems will make it hard for you to follow the doctor’s orders.  If problems develop after you start taking this medication, please call our office.

·      Problems paying for prescriptions

·      Transportation problems getting to tests and appointments

·      Confusion about why a test or medication is needed

·      Different ideas about what is wrong with your eye and what is needed to treat it

·      Difficulty administering the drops

·      Problems with side effects

·      Follow the ICEDD (Identify, Clarify, Educate, Decide, Document) approach below to identify and address noncompliance

·      Carefully schedule and track appointments

o      Follow the SIRAD (Schedule, Identify, Review, Act, Document) approach below for scheduling and handling cancellations and no-shows

Noncompliance with treatment recommendations:  ICEDD Approach (Identify, Clarify, Educate, Decide, Document)

·      IDENTIFY the non-compliance

o      Know what treatment was ordered.  To do so, review prior medical record entries before each visit

o      To verify that patient obtained recommended tests, procedures, consultations, consider implementing a follow-up system

§       Step 1:  Physician discloses to patient and documents in the record order for  test/referral

§       Step 2:  Information entered into tracking system

·      Follow-up tracking form

·      Logbook or card file

·      Computer tracking

§       Step 3:  Test/procedure/consultant report reviewed, dated, and initialed by physician

·      If report not received in usual time, call for results

·      If patient did not show up for test/consultation, follow-up with patient

§       Step 4:  Communicate results to patient, document discussion in record, file report, complete tracking form

§       Step 5:  Communicate and document treatment plan

·      Patient advised: No further follow-up needed

·      Patient advised:  follow-up appointment scheduled for ____

·      Patient advised:  referred to Dr. ____ for ______

·      Patient advised:  additional test/procedure ________ needed

o      Question patient about how/whether treatment plan implemented by asking open-ended questions in a non-judgmental manner

§       Medication

·      “I see Dr. Jones prescribed a new medication for your glaucoma at your last visit.  Could you tell me how you are using it?”

§       Diagnostic procedure/test/consult ordered by the ophthalmologist

·      “We called to get the results of your MRI and were told that you had cancelled it.  Was there some kind of problem? Could you tell me why you didn’t have this done?”

·      CLARIFY the reason why the patient is not complying with treatment recommendations

o      Never scheduled test or procedure/never filled prescription/lost medication but didn’t refill

§       Financial difficulties

§       HMO authorization problems

§       Transportation difficulties

§       Child care problems

§       Confusion about disease or need for treatment

§       Fear of the significance of the results of the test, procedure, consultation

o      Not using medication as ordered

§       Not following schedule

§       Not instilling drops correctly

§       Confusion about how to implement treatment recommendations

§       Misunderstanding of why treatment is needed or consequences of not having treatment

§       Problems with side effects

·      EDUCATE the patient about the disease process, treatment recommendations, and consequences of non-compliance

o      Target the education to the reasons for non-compliance

o      When possible, identify social service resources that may help

§       Some pharmaceutical companies provide free or reduced-cost medications

§       Know enrollment criteria and process for state and federal assistance

§       Be aware of transportation services for patients

o      If treatment not authorized by HMO, act as patient advocate and appeal decision

o      Verify that the patient understands the points being made

§       Ask for return demonstration of how to use medication

§       Ask patient to explain in his or her own words

o      Give written material whenever possible

o      Use visual teaching aids:  videos, charts, diagrams, models of eye

·      DECIDE:  come to an understanding of the patient’s decision about care AND the ophthalmologist’s decision about continuing care if patient still refuses to follow recommendations

o      Document the plan and discussion if the patient agrees to follow ophthalmologist’s original recommendations or the physician and patient have agreed on a new treatment plan

o      If the patient continues to refuse the treatment plan, the ophthalmologist must decide how to proceed

§       “Open door policy”: physician-patient relationship still effective and physician wants to give patient opportunity to continue treatment dialogue

·      patient may need more time to make decision

·      patient may later opt to follow recommendations

·      risk management recommendations

o      perform a careful history and examination at each visit and carefully note any disease progression

o      follow ICEDD process as above, being careful to educate the patient again about the disease and consequences of no treatment

o      document the findings, discussion, and the patient’s decision

§       Physician-patient relationship no longer effective

·      ophthalmologist feels will not be able to persuade patient to accept treatment

·      ophthalmologist not comfortable with the patient safety and liability risks of refused treatment

·      disruptive, hostile, violent patient

·      See OMIC “Termination of the physician-patient relationship” guidelines and sample forms (available at www.omic.com)

o      Evaluate abandonment issues

o      Give written notice sufficiently in advance to procure other care

o      Obtain written authorization for transfer of records

·      DOCUMENT:  the findings, discussion, and decision

o      Depending upon the degree of risk to the patient’s vision and health, consider asking the patient to sign an informed refusal document

§       Sample form available at www.omic.com

Missed Appointments:  The SIRAD Approach (Schedule, Identify, Review, Act, Document)

Missed appointments can lead to delays in diagnosis and treatment.  They may also be the first sign of patient dissatisfaction with a physician’s care.  A careful system of scheduling appointments and reviewing missed ones provides the ophthalmologist with the opportunity to intervene before the patient’s health or the physician-patient relationship further deteriorates.  Ophthalmologists often ask how much follow-up of missed appointments is necessary, and when they should stop.  There are no clear cut answers to these questions.  The safest approach is to follow-up on all missed appointments.

·      SCHEDULE based upon medical need

o      Always indicate the follow-up interval in the medical record, and ask staff to schedule the follow-up appointment before the patient leaves the office so the patient is in the system

§       This prevents patients from “falling through the cracks” and affords the physician the opportunity to notice noncompliance with other treatment recommendations, such as diagnostic tests and consultations.

o      Screen telephone calls carefully so correct type of appointment is given (see OMIC’s “Telephone Screening of Ophthalmic Problems,” available at www.omic.com)

·      IDENTIFY missed appointments.  Ask staff to notify you each day of:

o      Cancellations

o      Rescheduled appointments

o      No-shows

·      REVIEW missed appointments

o      Type and interval of follow-up needed is a medical decision

o      Patients who choose their own follow-up interval for a rescheduled appointment risk not getting the treatment they need in a timely fashion

§       Example:  Parents of a baby with ROP kept rescheduling their appointment, so the staff did not notify the physician.  Unfortunately, by the time the baby was seen, it was too late to treat the ROP and prevent blindness.

·      ACT on missed appointments

o      YOUR PATIENTS

o      Instruct staff to call patient to find out reason for missed appointment and to reschedule, being sure to give the interval: 

§       “Call patient to reschedule; needs to be seen within 1 week.”

o      Send letter if no answer, only reached answering machine, or patient refuses to be seen during recommended interval

§        “Missed appointment” letter  (see sample letter at end of document)

·      Send this letter to patients who you are willing to still treat

·      “You missed/cancelled your appointment of _____ and we were unable to speak to you by telephone.”

·      Include “informed refusal” information that addresses the risks of not getting recommended care (see sample letter)

§        “Noncompliant letter” ((see sample letter at end of document)

·      Physicians may wonder whether to continue treating patients who repeatedly miss appointments or refuse to follow treatment recommendations.  The “noncompliant” letter gives such patients one last chance to schedule an appointment before assuming that the patient has terminated the relationship

·      Physicians may want to use it routinely as a final step when the patient does not respond to the “missed appointment” letter within a determined period of time

·      Include “missed appointment” information above

·      PLUS “If we have not heard from you within three weeks, we will assume that you have transferred your care to another physician and have terminated your relationship with this office. We will transfer a copy of your medical records to your new physician upon receipt of a signed authorization to do so.  An authorization form is enclosed for your convenience.”

·      See OMIC “Termination of the Physician-Patient Relationship” for limits on when and how to terminate care, and sample termination letter, available at www.omic.com)

§       Termination” letter

·      Physicians may choose to terminate the relationship with patients who do not comply with treatment recommendations or keep follow-up appointments.

·      “After careful consideration, I feel it would be in your best medical interest to seek the services of another ophthalmologist. I have decided to discontinue as your ophthalmologist effective 30 days from the date you receive this letter for the following reason(s)…”

·      See OMIC “Termination of the Physician-Patient Relationship” for limits on when and how to terminate care, and sample noncompliant and termination forms, available at www.omic.com)

o      PATIENTS REFERRED FROM OTHER PHYSICIAN BUT NOT YET SEEN

o      Notify the referring physician that the patient did not show up for, or cancelled, the appointment.

o      Clarify with the referring physicians that he or she will follow-up with the patient

o      Send a fax to the referring physician confirming that you notified him or her of the no-show, and that the physician agreed to follow-up with the patient

o      If you cannot reach the referring physician, or the referring physician does not agree to follow-up with the patient

§       Send the patient a “missed appointment” or “noncompliant” letter

·      DOCUMENT

o      Document all calls with patients and other providers

o      Keep copies of letters sent to patients and other providers in the medical record

o      “Certified” letters, return receipt requested

§       May be helpful as evidence but not required

§       Consider when the patient could experience significant vision loss or other harm

§       Can be helpful in convincing the patient of the seriousness of your concerns

§       Send the letter also by regular mail in case the patient refuses to sign for it or is not home when delivery is attempted

How much follow-up is enough?

There is no easy answer to this question, and decisions should be made on a case-by-case basis.  In general, the amount of follow-up should be tailored to the risk involved.  These recommendations should, however, cover most situations with adults who have the ability to participate in making medical decisions.  Physicians who treat pediatric patients, or those with diminished capacity, who are at risk for serious vision loss may need to take additional steps.  Ophthalmologists would be well-advised to seek assistance in these situations by calling the Risk Manager of their professional liability carrier.   Physicians who have included patients in the decision-making process, educated them about their disease and recommended treatment, as well as noticed and addressed noncompliance should feel confident that they have met their ethical and professional obligations. 

OMIC policyholders who have additional questions or concerns about noncompliant patients may call Anne M. Menke, R.N., Ph.D., OMIC Risk Manger, for assistance at (800)562-6642, extension 651.  

Revised 1/2005

DISCLAIMER:  This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted. This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.

NOTE:  This sample letter is provided as a guideline only and should be modified according to the situation. Be sure to place a copy of the letter in the patient’s chart.  If the patient’s condition warrants a certified letter, send it both certified and through the regular mail.  Place the letter and the signed return receipt in the patient’s chart.

Sample Letter to Patient Who Missed/Cancelled Appointment

[CERTIFIED MAIL-RETURN RECEIPT REQUESTED:  only if patient risks serious vision loss, otherwise use regular mail]

(Date)

Dear (Patient):

You have canceled your follow-up appointment on (date) without rescheduling. We were unable to reach you by telephone.

Continued care is essential to the health of your eyes. You have an eye condition which will worsen without proper care (If the patient has a condition that requires specific care, state the care AND the consequences of  no care in clear, patient-friendly language.  If the patient has a condition that needs regular follow-up, state the frequency and urgency of the follow-up, AND state the consequences of not getting the follow-up at the recommended time in clear, patient-friendly language.)  Permanent damage may occur, resulting in visual loss or blindness. Kindly realize this letter is not meant to alarm you. We only wish to inform you of the seriousness of your condition, as it was also explained during office visits, and encourage you to seek proper care.

Please contact our office as soon as possible to reschedule.

With best regards,

(Physician’s Signature & Name)

This sample letter is provided as a guideline only and should be modified according to the situation. Be sure to place a copy of the letter and the signed return receipt in the patient’s chart, but realize that a letter of termination does not automatically offer a defense against a charge of abandonment.  Place the letter and the signed return receipt in the patient’s chart.

Sample Letter to Noncompliant Patient

CERTIFIED MAIL-RETURN RECEIPT REQUESTED [send also through regular mail]

(Date)

Dear (Patient):

You have canceled your follow-up appointment on (date) without rescheduling. We have tried multiple times to reschedule your missed appointment. To date, you have not responded to our efforts. It is our understanding that you may have terminated your care with our office.

Continued care is essential to the health of your eyes. You have an eye condition which will worsen without proper care (If the patient has a condition that requires specific care, state the care AND the consequences of  no care in clear, patient-friendly language.  If the patient has a condition that needs regular follow-up, state the frequency and urgency of the follow-up, AND state the consequences of not getting the follow-up at the recommended time in clear, patient-friendly language.)  Permanent damage may occur, resulting in visual loss or blindness. Kindly realize this letter is not meant to alarm you. We only wish to inform you of the seriousness of your condition, as it was also explained during office visits, and encourage you to seek proper care.

If we have not heard from you within three weeks, we will assume that you have transferred your care to another physician and have terminated your relationship with this office. We will transfer a copy of your medical records to your new physician upon receipt of a signed authorization to do so.  An authorization form is enclosed for your convenience.

With best regards,

(Physician’s Signature & Name)

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