Risk Management Recommendations
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CLINICAL
PRACTICE MANAGEMENT
Advertisements for Medical/Surgical Services
Physician advertising is subject to rules and guidelines produced by the Federal Trade
Commission and the Food and Drug Administration, as well as state law. Professional societies,
such as the American Academy of Ophthalmology and the American Society of Cataract and Refractive
Surgeons, have also published information designed to promote professionalism and ethics.
Our "Advertising Medical Services"
explains the guidelines and the liability risks while the
"Advertising Review Form"
can help identify aspects of the advertisement that may be misleading or deceitful.
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Amblyopia Risk Reduction: Recommendations, Treatment Agreement, and Referral Report
Medical malpractice lawsuits for negligent treatment of amblyopia are infrequent, but the risk to the pediatric
patient’s vision is extreme. If not treated appropriately by age nine, the child can have permanent vision
loss. The main risk issue is noncompliance with patching and follow-up appointments. Click
here for recommendations, a
treatment agreement, and a referral report.
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Anesthesia Liability
Ocular anesthesia is challenging for both the ophthalmologist and the anesthesiologist. Special concerns include
patient anxiety about decreased vision, eye surgery, and pain or movement during eye surgery; multiple medical
co-morbidities, especially in elderly patients; pediatric patients, some premature with congenital syndromes;
limited access to the patient and need for immobility during surgery; problems with intraocular pressure and
anesthetic agents; and oculocardiac reflexes. Click here
for risk management recommendations to promote patient safety and reduce your professional liability exposure.
Ophthalmologists who would like more information about administering sub-Tenon's anesthesia can view this
demonstration video produced by Dr. James Salz and Dr. Samuel Masket.
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Avastin Use Recommendations and Consent Form
Avastin™ (bevacizumab) is administered off-label for the treatment of a number of ophthalmic conditions.
This document
answers many questions ophthalmologists have about the patient safety and professional liability risks of this
medication. Click here
for a patient consent form.
For AAO advisory, click here .
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Botox Cosmetic Issues and Injectable Safety Issues
Cosmetic Botox injections are frequently administered in ophthalmology practices. The risk management recommendations
in this document are designed to promote patient
safety and reduce the physician's liability exposure.
To learn more about injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical
procedures, please click here. To learn
more about the Kansas State Board of Healing Arts ruling on Lipodissolve, please download
this document.
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Cataract Surgery Interval Recommendations
Ophthalmologists are at times asked by patients who live far from the hospital or surgery center, or those with significant
medical co-morbidities, to perform cataract surgery on the same or consecutive days. This
risk management recommendation letter
will provide information for the physician to consider during the decision-making process.
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Cataract Surgery: recommendations, patient consent form, and patient information sheet
Cataract surgery is the most frequently performed ophthalmic procedure in the United States, and thus the source of the
majority of the medical malpractice claims reported to OMIC. When the outcome does not match these heightened expectations,
patients are more apt to complain not only to their ophthalmologist, but to acquaintances, insurance companies, regulatory
agencies, malpractice attorneys, and, in increasing numbers, even to the Ethics Committee of the American Academy of
Ophthalmology (AAO). Click here
for current OMIC risk recommendations regarding cataract surgery. Click
here
for a patient cataract surgery consent form. Click here
for a patient information sheet on cataract surgery.
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Coordinating Care with Optometrists
OMIC policyholders report on renewal applications that they are increasingly incorporating optometrists (ODs)
into their practices. The ophthalmologist, optometrist, and group need to understand ways to best coordinate
the care of the group's patients, and when and how they are liable for their own and each other's care.
Together they can develop written policies and protocols that clarify the respective roles of all members of
the health care team, reduce their liability exposure, and promote patient safety.
"Coordinating Care with Optometrists"
provides an overview of patient safety and liability risks, reasons for comanagement, legal issues,
credentialing, protocols, preoperative evaluation, and postoperative care. Click here
for a sample consent form.
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Confidentiality/Privacy Issues and Malpractice Claims
Physicians often have questions about sharing protected health information (PHI) with their
professional liability carrier or an attorney during the investigation and litigation of
a medical malpractice incident, claim, or lawsuit.
"Confidentiality/Privacy Issues and Malpractice Claims"
provides general information in dealing with six common scenarios.
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Dilating Drops: Patient Safety and Liability Risks
Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures.
They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to
perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis
or failure to diagnose, as well as surgical complications due to poor visibility. This
document will address the patient
safety risks and malpractice allegations, and provide risk management recommendations.
See also: Discuss Potential Side Effects of Eye Drops,
Information Regarding Dilating Drops (for the patient),
Making Your Office Safe, and
Closed Claims Studies - Patient Slip and Fall Following Dilation.
Driving Issues: Vision Requirements for Driving
Several resources are available to assist ophthalmologists in determining whether patients are able to
drive, and what to do when they are not. Click here
for a link to "Vision Requirements for Driving," which discusses the components of an examination of a patient's driving
ability. Click here
to access the American Medical Association's "Physician's Guide to Assessing and Counseling Older Drivers."
For a discussion of the duty to warn patients and confidentiality issues, click
here
to see OMIC Vice President Paul Weber, JD's article, "When Patients Shouldn't Drive".
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Discontinuing Treatment for Financial Reasons
Costly diagnostic equipment and rapidly evolving treatment options that rely heavily upon technology contribute to making
ophthalmology an expensive medical specialty. While some businesses can pass such costs onto the consumer, ophthalmology
practices are limited by what health plans and the government are willing to pay. Decreases in reimbursement from these
payers may prompt some physicians to reevaluate their bottom line and consider discontinuing treatment. Before taking such
a step, ophthalmologists would be well-advised to consider the patient safety and professional liability risks. Click
here
for more information.
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Employees: Providing Medical Care, Services, or Products
Physicians may treat their employees. There are patient safety and professional liability risks, however,
if the physician does not provide medical care and services to employee patients in the same manner as any
other patient. This
risk management recommendation letter will examine those risks and provide recommendations on how
to minimize them.
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EMTALA (Emergency Medical Treatment and Active Labor Act)
This federal law governs how patients are treated in emergency rooms, and imposes duties on
ophthalmologists who serve on-call to hospitals.
EMTALA: An Overview for Ophthalmologists provides information on the basic obligations hospitals and
physicians have under EMTALA. The
Ophthalmologist's Role in Emergency Care focuses on on-call and follow-up duties.
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Endophthalmitis/TASS Recommendations and AAO/ASCRS Reports
While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the
incidence of endophthalmitis and TASS. In its review of OMIC's claims experience and the lessons
learned from it, this article offers risk management guidance on more effective prevention,
recognition, and response to these sight-threatening conditions. The AAO and ASCRS have asked
ophthalmologists to track and report TASS cases. This document
contains the reporting forms. An effective response depends upon careful coordination and
cooperation among the facility, surgeon, and patient. The facility needs to sequester all involved
materials, interview staff, and evaluate equipment, devices, solutions, medications, and the
sterilization process. All aspects of the investigation should be carefully documented. The
investigation will help locate the responsible organism or toxic agent, ascertain liability,
and determine what steps to take to remedy any identified problems. Dr. Mamalis's group
developed an Excel-based protocol that can be used for individual or clustered cases of infectious
or sterile endophthalmitis, which is available here.
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eRisk Guidelines
The eRisk Guidelines
have been developed by the eRisk Working Group for Healthcare, a consortium of professional liability carriers,
medical societies and state licensure board representatives. OMIC is part of this group, and helped develop
and revise these guidelines for email and other internet-based physician services.
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Fluorescein Angiography: Preventing and Responding to Complications
Fluorescein angiography is an invasive procedure with associated risks and notably, but rarely, of a
life-threatening allergic reaction. These
risk management recommendations have been compiled to assist you and your staff so that you may both
prevent and better respond to the risks of the procedure. Issues addressed here include delegation of
tasks, informed consent, emergency response equipment, and management of complications. Click
here for the
Fluorescein Angiography Consent Form.
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Giant Cell Temporal Arteritis
Allegations of failure to diagnose are common in medical malpractice lawsuits against ophthalmologists.
This document
focuses on giant cell (temporal) arteritis. The risk management recommendations can help promote
patient safety and reduce liability exposure.
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Handling the Disruptive or Dangerous Patient
Providing care that improves a patient's quality of life leads to many very rewarding patient physician
relationships. However, the unfortunate reality is that ophthalmologists and their staff sometimes need
to deal with very angry and sometimes violent patients. See the sample
Policy and Procedure for Disruptive or Dangerous Patient to educate and protect staff and others
from patients who behave in a disruptive or threatening manner.
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Hemorrhage Associated With Ophthalmic Procedures
Ophthalmologists routinely warn patients that ophthalmic surgery could result in infection, vision loss,
and hemorrhage. OMIC claims data indicates that ophthalmologists who do not properly screen patients for
bleeding risks and manage hemorrhage when it occurs often face malpractice lawsuits. An OMIC closed case
study of hemorrhage following blepharoplasty that resulted in a large settlement is presented to highlight
errors in management that led to blindness and a subsequent lawsuit. Many other aspects of the prevention
and management of hemorrhage deserve attention. The few discussed
here
have figured most prominently in malpractice cases.
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HIPAA Authorization
OMIC has revised the authorization
to make it easier for patients to understand.
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History and Physical Examinations
Many patients contemplating eye surgery also have medical conditions that could increase the risk of
the operative or diagnostic procedure and anesthesia/sedation. In 2002, CMS began mandating a
reassessment within 7 days prior to surgery, and JCAHO recently instructed facilities that the
patient's condition must be updated within 24 hours of the procedure. As a result, ophthalmologists
are being asked to either conduct the reassessment themselves or cosign one done by a Certified
Registered Nurse Anesthetist (CRNA), Physician's Assistant (PA), or Nurse Practitioner (NP). Click
here
for OMIC's risk management recommendations.
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Informed Consent: Obtaining and Verifying
To honor the patient's right to make decisions about health care, ensure patient understanding, and prevent
allegations of lack of informed consent, follow these risk management guidelines. Click
here
for recommendations on obtaining and verifying informed consent. Click
here
for a sample checklist of questions and steps in the informed consent process, "Consent to Treatment Certification Document".
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INTACS: Off-Label Therapeutic Use for Post-LASIK Ectasia
Intacs® are intrastromal corneal ring segments available through Addition Technology, Inc., and
FDA-approved for the treatment of myopia. Although initially approved for elective refractive surgery, some
ophthalmologists use them as a therapeutic treatment for ophthalmic conditions such as keratoconus or
post-refractive surgery ectasia. Click
here
for the risk management recommendation. Click
here
for the consent form.
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Interpreters for Deaf and Limited English Proficiency (LEP) Patients
Physicians are well aware of the central role clear communication plays in the physician-patient
relationship. Patients with limited English proficiency or who are deaf present special challenges
to effective interactions. Ophthalmologists often have questions about how to obtain and reimburse
interpreters, and whether family members can fulfill this role. These documents will provide some
basic information on the federal rules concerning these topics and present risk management
recommendations on how to best meet the needs of these patients and the practice. Click
here
for guidance with deaf patients; click
here
for suggestions with LEP patients.
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Intraoperative Floppy Iris Syndrome
A syndrome named intraoperative floppy iris syndrome or IFIS has been linkedto a medication called Flomax,
which is prescribed for men with prostatic hypertrophyand women with urinary retention. Click
here
to link to an AAO article by Dr.David F. Chang that gives recommendations on how to prepare for and manage it.
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Leaving a Practice or Retiring
Physicians leave practices for many reasons, including illness, retirement, changes in employment
status, and personal or family needs. Both the individual ophthalmologist and the practice
need to take steps in order to promote continuity of care, prevent allegations of abandonment,
and ensure that all involved physicians have access to the medical records in the event the
care is ever called into question. Taking these steps will also ensure compliance with
provisions of contracts and with requirements of state medical boards. Taking
these steps
will also ensure compliance with provisions of contracts and with requirements of state
medical boards.
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Medical Records Retention
OMIC is pleased to provide guidelines for medical records retention for ophthalmic practices.
The guidelines can be accessed by clicking here.
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Noncompliance Guidelines with Sample Missed Appointment Letter
Patients who do not show up for appointments or comply with treatment recommendations represent a significant
professional liability risk for ophthalmologists.
This document outlines the
issues and provide risk management recommendations to promote patient safety and protect physicians and
their staff, as well as sample missed appointment
and noncompliant
letters. These sample
missed appointment
and
noncompliant
letters are also available in Spanish.
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Observers Present During Medical Procedures
Ophthalmologists or ophthalmic surgery or laser centers at times require or desire the presence of observers
during an ophthalmic procedure. Such observers include sales representatives from medical device or medical
equipment manufacturing companies, visiting colleagues, or family members. Patients sometimes want their
family members to be with them during a procedure. In order to honor the patient's right to privacy and the
physician's and facility's duty to protect the confidentiality of medical information, and to ensure the
safety of patients, staff, and visitors, certain policies and procedures need to be in place.
This document
will provide an overview of the issues associated with observers, and provide a sample consent form.
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Off-label Drugs and Devices
Sample Language For Off-label Consent. Physicians are well-advised to obtain informed consent for off-label
devices or drugs. Click
here for
sample consent language to incorporate into consent forms as needed.
Click
here for a list of
articles and forms about the use of off-label and unapproved drugs and devices.
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Office Based Surgery for Adults
Some ophthalmic surgical procedures can be safely performed in an office surgical suite.
Others with higher risk profiles raise a number of concerns. If a patient experiences a serious
complication or poor outcome and decides to sue the ophthalmologist, all aspects of the care will
be questioned, including the decision to perform the procedure in the office.
This document
will provide an overview of the issues associated with office based surgery for adults.
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Research or the Practice of Medicine?
The growing number of medications under use and investigation to treat retinal and other conditions
of the eye often lead to questions about how to distinguish between research and medicine.
This determination is important, as physicians who conduct research are subject to state and
federal law. This
document
addresses research, "off-label" use, and when an investigational drug exemption
is required.
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NEW:
2nd Edition of "ROP: Creating a Safety Net" and "ROP: Materials for Creating a Hospital Safety Net," "Materials for Creating an Office Safety Net"
OMIC introduced our "ROP Safety Net" materials in 2006. They have been revised and expanded. Click
here
for the updated 2nd edition of "ROP: Creating a Safety Net," which discusses obstacles to ROP care,
enlisting hospital support, claims experience, and risk management recommendations. OMIC has
developed detailed protocols addressing every step in the sequence of ROP care for both the
hospital and ophthalmologist's office. The ROP Toolkit includes the protocol, clinical guidelines,
a letter to educate parents about ROP, an informed consent document for laser surgery, and a sample
job description for the ROP Coordinator. Click
here
for the ROP Caregivers Letters in English and in Spanish. Click
here
for the hospital version. Click
here
for the office version.
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Telephone Screening of Ophthalmic Problems
Making medical decisions on the basis of the limited information obtained over the telephone is
a risky--albeit necessary--aspect of ophthalmic practice. To promote patient safety and reduce
your liability exposure, develop and implement a telephone screening protocol. Click
here
for a risk analysis and OMIC's sample contact forms and screening guideline. Click
here
for a printable after-hours telephone call form.
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Terminating the Physician-Patient Relationship
Following our termination guidelines can help minimize the risk of patient harm, and reduce the
likelihood of allegations of patient abandonment. See
Terminating the Physician-Patient Relationship.
A sample termination letter
is also available in Spanish.
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Terminating the Physician-Patient Relationship for Financial Reasons
It is well established that physicians may discharge a patient for a number of reasons,
including non-payment. Click
here
for a discussion of this issue. Click
here
for a sample letter.
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St. Luke's "Watchful Eye": A Hospital Based ROP Safety Program
OMIC is pleased to provide you with the St. Luke's Hospital & Health Network Watchful
Eye Implementation Manual. The Watchful Eye is a hospital-based program for timely
screening and follow-up of retinopathy of prematurity.
Click here to go to the
Watchful Eye manual and related documents.
The "Watchful Eye" was recently translated into Spanish. The manual is called
"Ojo Vigilante". Click
here
to go to Ojo Vigilante and related documents.
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Traumatic Eye Injuries
Allegations of failure to diagnose are common in medical malpractice lawsuits against
ophthalmologists. This document will focus on traumatic eye injuries, and follow a
patient who was referred to an ophthalmologist with a history of being struck in the
eye with metal when a screwdriver shattered a screw. There was a delay in diagnosing
a metallic foreign body. The resulting endophthalmitis could not be successfully
treated, and the patient required an enucleation and prosthesis. The risk management
recommendations offered
here
can help promote patient safety and reduce liability exposure.
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Triamcinolone Acetonide (Kenalog&trade Triesence&trade Trivaris&trade) Recommendations and Consent form
On June 18, 2008, the American Academy of Ophthalmology (AAO) announced in the Academy
Express that the FDA had approved an injectable triamcinolone acetonide suspension (TA)
for ophthalmic use. Trivaris,™ manufactured by Allergan Inc. (Irvine, CA), is the
second approved drug; it joins Triesence™ (Alcon, Ft. Worth, TX). These drugs were
approved for a limited number of indications: sympathetic ophthalmia, temporal arteritis,
uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
All other use is, therefore, "off-label." While not approved for ocular use, Kenalog™
(Bristol-Myers Squibb, New York, NY) remains available and will no doubt continue to be widely
used. OMIC has revised its
consent form
for triamcinolone acetonide so that it can be used for these three medications. If you
are using Trivaris™ or Triesence™ off-label, or using Kenalog,™ inform the
patient of the off-label use and include an explanation of this in your consent form.
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Unanticipated Outcomes: Steps for Responding
Dealing with unanticipated outcomes is one of the most difficult aspects of medical practice,
especially if an error contributed to the result. While many physicians want to talk to their
patients about adverse events, they may hesitate to do so for a variety of reasons. OMIC has
always encouraged its policyholders to communicate honestly and compassionately with their
patients about unanticipated outcomes. In order to provide more guidance for ophthalmologists
on how to handle these difficult situations, OMIC offers these risk management recommendations.
Please click
here
to access these guidelines.
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Unapproved Devices
Ophthalmologists are privy to various treatment alternatives, many of which are tested and employed
by their peers around the world long before they are approved for use here in the U.S. Before
deciding whether or not to use the newest device available, physicians would be well advised to
evaluate the patient safety and professional liability risks. Our checklist, "Risk Analysis of
Unapproved Devices," is a useful tool and can be accessed
here.
For an overview of the risks of using unapproved devices, refer to
When FDA Leaves Doctors To Their Own Devices.
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Verisyse™ Phakic Implant Informed Consent
Click here
for recommendations and consent form.
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Visian ICL™ Phakic Implant Surgery
Click
here
for recommendations and
here
for consent form.
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Wrong Site Surgery and of Wrong IOL Placement
OMIC would like to call your attention to the important work being done by various organizations
to prevent wrong site surgery and wrong IOL placement. Refer to the links below:
-
The American Academy of Ophthalmology, which is available here.
here .
-
The ASORN( American Society of Ophthalmic Registered Nurses) website,which is available here.
-
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has proposed a Universal Protocol for Eliminating Wrong Site, Wrong Procedure, and Wrong Patient Surgery, which is available here.
