Presurgical Checklists Promote Good Documentation Practices
By Dean C. Brick, MD
[Digest, Fall, 1991]
A presurgical checklist helps ensure that all aspects of surgery, including informed consent, patient compliance and postoperative complications, are discussed with the patient. This cataract surgery checklist was developed by Byron H. Demorest, MD, and Richard A. Deutsche, MD, of the OMIC Risk Management Committee.
Prior to scheduling surgery
Alternative therapies have been explained.
No surgery
Surgery
Procedure electives have been discussed.
Spectacles
Contact lenses
IOL
Postoperative complications have been discussed with patient and, if appropriate, with patient’s family.
Patient has been told that results are not guaranteed and surgery could result in:
No improvement in vision
Worse vision (even total blindness)
Improvement in vision
Patient has been told that the implant might have to be removed, replaced, or become dislocated and have to be repositioned.
Patient has been told about other possible complications of surgery including:
Astigmatism
Image size difference
Need for prolonged medication
Infection
Retinal detachment
Corneal damage
Double vision
Hemorrhage
Lid droop
Pupil distortion
Pain
Glaucoma
Uveitis
Capsule clouding requiring laser treatment
Anesthesia options have been reviewed (general or local) and patient has been told about possible complications of anesthesia including:
Drug reactions
Brain damage
Death
At appointment preceding surgery
Informed consent form has been reviewed and signed.*
Medical evaluation has been performed.
Preoperative eye exam has been performed.
Visual acuity
Description of cataract
IOP
Macular function
Appearance of the optic nerve
Lab tests have been performed, if indicated, and reviewed.
CBC
Urinalysis
Chempanel
EKG
Chest x-ray
Patient’s medication and medical history have been reviewed.
Is patient currently taking any medications?
Is patient allergic to any medications?
IOL calculations reviewed.
Determine proper IOL power
IOL has been ordered.
Posterior chamber lens
Anterior chamber lens
No implant
Patient has been instructed on preoperative facial care.
Facial cleansing prior to surgery
No cosmetics on day of surgery
Patient has been instructed on any preoperative drops.
Patient has been instructed on diet on day of surgery.
Patient has been told what time to arrive for surgery and what time to expect to be able to go home.
Patient has arranged an escorted ride to and from surgery.
Postoperative follow-up appointment has been scheduled.
Eye has been examined for infection of globe and lids.
On the day of surgery
Confirm patient’s name.
Confirm which eye for surgery.
Prior to mydriatic drop, look for signs of discharge or infection of globe or lids.
Confirm that you have the correct IOL for that patient when you are in the operating room.
* Note in patient record that alternative therapies, risks and complications have been reviewed and signed by the patient and witness.
Reviewing Preoperative Tests and Studies
By Byron H. Demorest, MD
Argus, June, 1991
If you ask ophthalmic surgeons about the need for preoperative chest films or blood studies, you will get different opinions. With the emphasis now on outpatient surgery, however, most surgeons feel that few, if any, preoperative tests are warranted. From a risk management viewpoint, therefore, how important are such studies? Very! Particularly if such tests have been routinely ordered and then reveal a positive finding which is not followed up on.
Consider this scenario:
A patient enters the hospital for repair of a retinal detachment. The hospital requires a preoperative chest x-ray and certain blood studies. The chest file is done and the blood studies completed, but neither the surgeon nor the anesthesiologist giving the “stand-by” anesthesia reviews the patient’s chart preoperatively to see the report of the chest x-ray. The anesthetist does note a normal hemoglobin and blood potassium.
The surgery is only temporarily successful, and after a few months another chest file is done routinely prior to a second surgery on the eye. At this time, it is noted that the patient has lung cancer! A comparison with the first x-ray shows that the cancer has progressed significantly.
Why was the first x-ray not reviewed at the time of the first surgery? Although it was properly reported and read by the radiologist, a breakdown in protocol allowed the report to be returned to the patient’s file “unflagged.” Thus, it was overlooked by both the surgeon and the anesthesiologist.
The patient sues and is awarded a large settlement when an oncologist testifies that had the carcinoma been attended to at the time of the first x-ray report, the patient’s chances for survival would have been far better than they were by the time of the second x-ray.
The lesson here is that all reports of x-rays, laboratory work and pathology studies must be reviewed by the attending physician. Ophthalmologists may consider such tests to be redundant. Nevertheless, it is essential that the ophthalmologist personally review all tests, routine or otherwise. Failure to do so most certainly increases liability of the physician and causes complications for the patient.
Remember to set up a system in your office so that all reports are placed on your desk with the patient’s chart. Results of such tests should never be entered into the chart by your staff until you have had an opportunity to review each report, discuss positive findings with the patient, and place your initials on the report indicating that you have seen it.
Proper Office Techniques Can Offer a Strong Defense in Malpractice Cases
By Michael F. Henrick, JD
Digest, Fall, 1991
(Recently OMIC settled a claim during trial for an injury resulting from a known complication of cataract extraction and lens implantation. Although the clinical issues did not raise significant questions concerning the standard of care provided per se, defense of the claim was hampered by some very fundamental risk management issues concerning documentation and communication of the known risks of surgery to the patient. In his article, Mr. Henrick, an OMIC defense attorney with more than 17 years experience in medical malpractice, reviews some of the legal problems he has encountered in defending ophthalmologists and other surgeons, and provides useful suggestions on how to avoid these common pitfalls.)
In surgery cases, medical malpractice litigation seldom arises from improper technique or a failed procedure. This is particularly true in ophthalmic cases which most often result from a known complication inherent in the type of surgery involved. When this happens the patient’s attorney will usually pursue two theories of liability: either the surgery was unwarranted or the patient was completely uninformed.
Unwarranted Surgery
When a patient claims through an attorney that a surgery was not warranted, the patient is maintaining that the complication or risk that occurred would not have occurred if the ophthalmologist had exercised the appropriate standard of care and refrained from surgery in the first place. This issue is obviously easy to deal with if without surgery the person would have died or suffered a great injury such as blindness. The legal problem arises for the ophthalmologist who recommends surgery to improve the patient’s quality of life. Procedures such as cataract extraction and IOL implantation fall into this category.
In most cases, without cataract surgery the patient would be able to continue with life, albeit with diminished visual acuity. The promise to not only correct a deteriorating process, but also to restore visual acuity to a level not experienced by the patient in many years can create unrealistic expectations in some patients. If a complication arises in these cases and the patient feels that his or her vision is worse than before surgery, this patient will be more likely to take an adversarial position against the surgeon.
Lapse in Documentation
With cataract extractions and IOL’s becoming commonplace, the ophthalmologist may be less likely to document his reasoning in recommending surgery. Traditional patient complaints of sensitivity to bright lights and difficulty reading are less often noted in the office chart and their absence is called into question when litigation arises. The patient who experiences a complication is quite likely to minimize the vision problems he had before surgery. Instead of recounting conversations with the physician where the risks and complications of surgery were discussed, the patient will primarily recall assurances from the physician and the emphasized need for surgery.
In trial, the plaintiff’s expert witness, because of a lack of notation in the records, will testify that the signs and symptoms prompting the ophthalmologist to recommend surgery either did not exist or were not as severe as the ophthalmologist actually found. Without documentation it comes down to the word of a layman against the word of a professional. In my experience, the jury may be more likely to suspect the professional who having lapsed in the simple task of charting may have lapsed elsewhere.
In a case my firm defended a number of years ago the jury was called upon to determine whether certain symptomatology existed warranting surgery. The plaintiff brought in family members and friends to testify that no such symptoms existed and the patient had never complained of any problems. The physician testified that the patient related continuous and increasing symptoms. Unfortunately, his records did not contain any documentation of what the patient told him. In talking to the jury after the verdict was returned in favor of the plaintiff, I learned that this lack of documentation not only made them believe that the symptoms did not exist, but also tended to destroy the doctor’s credibility with regard to the other issues of the case.
This whole scenario can essentially be avoided. Medical students, in learning to document a patient’s condition, are taught the acronym S.O.A.P. Subjective, Objective, Assessment and Plan. By taking the time to create the routine of documenting these elements of patient care, the physician establishes for all future purposes, including litigation, what the patient said, what the physician observed, the physician’s mental process and treatment strategy. Physicians go through this mental assessment of a patient’s condition anyway and by documenting a line or two under each heading they can often avoid hours later in depositions and trial. (Figure I.)
Clinical test results are also important in documenting the necessity of surgery. If you are relying upon an A-scan result or an intraocular pressure, write down the exact finding. If it is important enough to consider in assessing the need for surgery, it is important enough to document.
Informed Consent
When a known complication arises from surgery, the patient, or more likely the patient’s attorney, will claim that in consenting to surgery the patient had no idea that such a thing could happen. Many physicians confuse the presence of a signature on the consent form with a true informed consent.
Basically, an informed consent is an understanding between the physician and the patient where the patient is told of the possible major risks and complications inherent in the procedure and the alternative treatments available. The consent form is merely a memorialization or some evidence of this understanding. A signature on a consent form is only the final culmination of a much more significant process. That is the dialogue between the physician and the patient where the latter is given an opportunity to fully understand the important step they are both about to undertake.
This process, if properly followed, allows the physician and the patient to develop a relationship or partnership whose objective is the ultimate benefit to the patient of improving his vision. By developing such a relationship the patient is much more likely to understand the physician’s position when the infrequent complication arises.
Such a relationship can only form by an interpersonal dialogue between these partners. The introduction of other office personnel as third and fourth parties to this process has the effect of distancing the original participants and creating the impersonal attitude that is necessary for litigation to develop. Signature on a consent form does not automatically result in dismissal of a lawsuit based on informed consent. Its significance will be severely compromised if the patient testifies that “The physician was in a hurry” or “I could not read the form and was told to sign it” or “It was a form that I was told I needed to sign if I wanted surgery.”
Establish a Routine
Ophthalmologists who do four or five cataract extractions and IOL implants in a day may be unable to recall the specifics of each case, and thus the routine for obtaining an informed consent becomes more important. Although the physician may not so much remember the specific conversation with patient Jones about the risks or complications involved, he should be able to establish that “this is the routine I always follow and these things tell me that I followed the routine in this case.”
What Do I Mean By Routine?
Time, place and person. The ophthalmologist should have a built-in routine for personally reviewing the entire consent form with the patient and should encourage the patient to ask questions.
Timing is important in dealing with the informed consent. The form should not be presented for signature until the physician meets with the patient and discusses the contemplated surgery. To ensure that the patient is familiar with the entire document in cases such as the multi-page form recommended by the Food and Drug Administration, the patient should not only sign the signature blank on the last page, but also initial all preceding pages.
Presentation of the form should not be made when the patient might have more difficulty reading such as after dilation of the pupils. Plaintiffs’ attorneys when confronted with an executed consent form oftentimes attempt to establish that the signature was obtained at a time when the patient was either under the influence of a pre-anesthetic agent or some analgesic. Many hospitals require that the consent form be executed prior to the day of surgery in cases of inpatient hospitalization or upon arrival at the hospital for same-day surgery. By establishing such a routine it can be later determined by comparison with the medication records and the testimony of the witnesses that the patient was competent when executing the form.
Presurgical Checklists
For ophthalmologists who find their practice does not lend itself to routine, another possibility in encouraging good documentation practices could be the use of a presurgical checklist. In defending hospitals as well as physicians, I have found that these lists insure that all the appropriate steps, including discussing surgery and obtaining informed consent, are completed before surgery. The list used can be tailored to a particular type or practice.
Unfortunately, litigation is retrospective in its evaluation of a physician’s performance and one cannot anticipate all things that will occur in the care of a patient. Following my suggestions is no guarantee that you will avoid litigation, but following a routine similar to that suggested here will make the job of the plaintiff’s attorney all the more difficult and increase the likelihood of a successful defense.
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Safe Medical Devices Act: Reporting Requirements and Risk Management Concerns
By Pamela S. Schremp, RN, MSN, CRNO
Argus, September, 1992
A new law mandating the reporting of injuries resulting from defective medical devices is generating concern among ophthalmologists, risk managers and others that the reports could be interpreted as an admission of liability by the user.
The Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to report all incidents in which a medical device or user error may have caused or contributed to the death, serious injury or serious illness of a patient. Physicians’ offices are exempt from reporting such incidents, but surgicenters such as those run by many ophthalmologists are not. Additionally, the new law’s interim guidelines require that user error by, for example, an ophthalmologist working in a hospital must be reported.
All reports filed under the SMDA are available for public disclosure under the Food and Drug Administration’s (FDA) Freedom of Information Act, although information that constitutes an invasion of personal privacy is presumably deleted from the report prior to its release. However, the FDA recognizes that submission of a report is not necessarily an admission that the submitter, the device, the facility or its employees caused or contributed to the event being reported. The law does state that reports are not admissible into evidence unless the report contains false information and the facility, individual or physician filing the report knew this information was false.
Reports, however, can be obtained by a plaintiff’s attorney and possibly used as background information to build a case. To protect against this, reports should include a disclaimer indicating that it is submitted “in accordance with the Safe Medical Devices Act (21 CFR 803.32 (c)) and does not constitute an admission that the device, the reporting facility or its employees caused or contributed to the event which is the subject of the report.”
User facilities have always had the option to voluntarily report such events to the manufacturer. However, prior to November 1991, when the SMDA took effect, few reports were ever filed. Consequently, the federal government enacted mandatory reporting by user facilities to assist in the detection of defective medical devices and assure their rapid removal from the market.
Final regulations for the SMDA have not yet been promulgated. Tentative final rules were issued in November 1991, with broad definitions that left room for interpretation. For example, a “device” refers to any instrument, apparatus, implement, machine, in vitro reagent or other related article intended for use in the diagnosis or treatment of a patient (21 USC 331 (h)). Under this definition, most equipment used by ophthalmologists, including lasers, microscopes, tonometers and intraocular lenses, is subject to SMDA requirements.
“Serious injury or illness” means those injuries that are life threatening, result in permanent body function impairment or permanent damage to a body structure, or necessitate immediate medical or surgical intervention to prevent permanent body function impairment or permanent damage to a body structure (21 CFR 803.3) (r). The last phrase of the definition has created confusion and left room for interpretation.
Examples of ophthalmic related incidents that presumably must be reported under the SMDA include removal or exchange of an intraocular lens due to pseudophakic bullous keratopathy, severe corneal ulcer in an extended wear contact lens patient requiring hospitalization, and laser beam reflection causing a burn to a resident wearing the wrong goggles in a hospital-sponsored eye clinic. Even though the observer wore the wrong goggles, the last example is reportable as user error under the SMDA’s tentative final rules. The rules included user error to assist the manufacturer in obtaining information that might make the device safer or easier to use.
Reports must be submitted to the manufacturer within 10 working days after the facility becomes aware of information that reasonably suggests a possibility that a device may have caused or contributed to the death, serious injury or serious illness of a patient of the facility. If the manufacturer is unknown, the event must be reported to the FDA. Events in which a device may have caused or contributed to a patient’s death must be reported to the FDA as well as to the manufacturer. The user facility must also submit a semiannual summary of previously reported events to the FDA by Jan. 31 and July 31 of each year.
Even though final regulations for the SMDA have not yet been released, tentative rules are in effect, and all ophthalmologists are advised to become acquainted with them. To obtain a copy, contact OMIC, 655 Beach Street, San Francisco, CA 94109.
Ophthalmologists who own or manage ambulatory surgery centers should establish policies and procedures for determining if an event is reportable and for sequestering equipment (including disposables such as tubing) that may have been involved in a reportable event until its safe use can be assured. These policies should address:
To what extent will the center investigate the event?
How and under what circumstances will the device be released to the manufacturer?
Who will be responsible for putting the SMDA into operation, including recordkeeping and report submission? Be sure to include a disclaimer statement in every SMDA report submitted to the manufacturer and to the FDA.
Making Your Office Safe
By Monica L. Monica, MD, PhD
Argus, December, 1992
An ophthalmologist’s liability regarding patient care extends to general liability as well as to medical liability. Most general liability claims made against physicians involve “slips and falls” experienced by patients while in the office or on office property. The fact that the physician may not own or control the property does not preclude being named as a co-defendant in lawsuits involving general liability accidents.
As with most medical malpractice insurance carriers, less than 20% of OMIC’s claims are of the “slip and fall” variety. Still, settlements and judgments of such claims may range from a few thousand to tens of thousands of dollars, particularly if the ophthalmologist or office staff was negligent in supervising an elderly or visually impaired patient. Visual impairment following dilation can also raise questions of liability and be the basis of many “slip and fall” suits against ophthalmologists.
What can we do as ophthalmologists to limit our exposure to general liability claims? How can we insure the safety of our patients while they are in our office or on our office property?
Providing a safe environment for patients should be a routine followed by all office staff. Responsibility for the patient does not begin and end in the exam chair, but when the patient walks in and out of the office. Conducting an audit of your premises and safety policies using these common sense safety tips may minimize the likelihood of a general liability claim:
- Make sure that office floor coverings are easily traversed by patients on foot, on walkers or in wheelchairs. Discourage the use of area rugs, especially in patient pathways. Too often the corners of these rugs dislodge and catch the patient’s footing.
- Watch and assist patients when seating them on stools. Make sure the rollers of the stool do not easily slide, carrying the stool out from under the patient. Stools with locking devices are preferable, especially when performing office laser procedures.
- Patients with mobility problems should be supervised and assisted at all times when being moved in and out of exam rooms or on and off chairs. This is especially important for individuals who are blind or have low vision.
- Do not leave elderly patients unattended in exam or treatment rooms.
- Make sure hallways are well lighted and easily traversed by patients on foot, on walkers or in wheelchairs.
- Pathways leading to the office and parking lot areas should be well lighted and free of obstacles. If lighting is a problem in your building, discuss it with your landlord.
- Ramps are extremely helpful in entrance and exit areas.
- Patients whose pupils have been dilated should not be allowed to leave the office until they are comfortable with their vision. Provide mydriatic spectacles or drops to reverse dilation. Suggest that patients take a taxi home or arrange for a family member or friend to drive them.
- If toy chests or play areas are provided for children, make sure there are no tiny toy parts that could easily be swallowed. Examine toys for sharp edges that could cut a child.
- Routinely check equipment and office furnishings for loose fittings and unstable tables or chairs.
When conducting an audit of your office, keep in mind that the Americans with Disabilities Act (ADA) requires that public accommodations, which include physicians’ offices, must be constructed and altered to comply with the law’s accessibility standards. Some of the recommended alterations to your office not only will reduce your risk of liability, but also may be required by law.
