A “Watchful Eye” on ROP

Paul Weber, JD, ARM VP Risk Management/Legal

Digest, Winter 2010

To view the graphs and tables referenced in this article, go to http://www-test5.omic.com/new/digest/Digest%20Win%2010%20FINAL.pdf

There is no greater liability exposure in ophthalmology than the examination and treatment of premature babies at risk for retinopathy of prematurity (ROP). unlike most care provided by ophthalmologists, ROP is hospital-centered, multidisciplinary care with a very narrow window in which to provide timely examination, treatment, and follow-up. The challenges include providing ophthalmic care to infants who are often very sick, guaranteeing smooth patient discharge or transfer of care, and ensuring that caregivers understand the importance of compliance with follow-up appointments. This patient safety/liability risk is unlike any other that OMIC has grappled with in its 23-year history. The main obstacle has been developing a multidisciplinary, systematic approach to dealing with this unique liability risk. OMIC believes it has found such a system in the St. Luke’s Hospital and Health Network’s Watchful Eye Program for Retinopathy of Prematurity (©2008 St. Luke’s Hospital of Bethlehem, Pennsylvania).

The Concept

The Watchful Eye program is a fairly simple model of hospital- centered care (see conceptual map on page 4). Its premise is the overall management of ROP care by a Retinopathy of Prematurity Coordinator (ROPC). The ROPC participates in and monitors the ROP care of the infant, both as an inpatient and outpatient, until the infant reaches full retinal vascularization and is no longer at risk. OMIC’s own ROP claims analysis and safety net (see “ROP: Creating a Safety Net” at www-test5.omic.com) has pointed out the importance of an ROPC. Identifying the concept of an ROP tracking system and coordinator is clear-cut; however, the Watchful Eye program demonstrates that the commitment and attention to detail required to develop, implement, and monitor results is a complex process that cannot be underestimated.

An Interdisciplinary Approach

The Watchful Eye program was developed by an interdisciplinary team at St. Luke’s Hospital and Health Network in Bethlehem, Pennsylvania. The team included nursing administration, nursing staff, legal counsel, ophthalmology, neonatology, and social services. This type of collaboration is the essential first step in the creation and implementation of an ROP patient safety program. The St. Luke’s team also underscores the fact that high level leadership within the hospital administration is indispensable to ensuring the success of such a program.Besides preventing blindness in premature infants, an important goal of the Watchful Eye program is to reduce St. Luke’s exposure to large losses arising from ROP claims. The leadership of St. Luke’s learned in 2006 of the $20 million dollar judgment against a Pennsylvania hospital and neonatologist who were found to be jointly responsible for discharging an at-risk infant and failing to provide adequate follow-up care—just one of several multimillion dollar ROP verdicts passed down in recent years. For St. Luke’s, the decision was straightforward: allocate the requisite time and money to proactively prevent this type of claim or pay untold millions in damages sometime in the future.

The Role of the ROPC Nurse

There are many more facets to the Watchful Eye program than this article can address. (See “Keeping a Watchful Eye on Retinopathy of Prematurity” in Neonatal Network, Sept/Oct 2008; v. 27, n. 5.) However, the heart of the program is the ROPC, a registered nurse with neonatal nursing experience who is responsible for identifying and tracking infants, assisting the ophthalmologist during the screening exam, and caregiver education. At St. Luke’s, the ROPC is a 16-hour-per-week position. The thorough development of this key position is a feature that underscores the innovative aspect of the Watchful Eye program. The patient safety challenge has always been how to ensure that there is someone who will take responsibility for monitoring the infant until the risk has passed. The ROPC nurse takes full responsibility and is dedicated to the inpatient and outpatient tracking of ROP care of premature babies in the program. until now, inpatient and outpatient tracking and monitoring has been fragmented, leading to tragic injury to the infants and finger-pointing among the healthcare providers and caregivers. In fact, several surveys of ophthalmologists indicate that the liability risk arising from improperly tracking and monitoring ROP care convinces many to simply stop providing ROP services. This exodus of well-qualified, well-trained ophthalmologists creates a public health risk.

Double Check System and Filing

The Watchful Eye program employs a unique and very detailed “double check” strategy and filing system. The double check system ensures that at each step of the process there are two people checking the status of ROP care to be provided. The ROPC is always one of the people involved in the double check system, together with either the neonatologist or ophthalmologist (examining or treating), who follow the infant’s inpatient and outpatient care.

The actual documentation and recording of the double check is carried out through a detailed color coded filing system maintained by the ROPC as an adjunct to St. Luke’s electronic medical record (EMR) system. The ROP filing system is maintained even after the infant is discharged. Only when the infant reaches full retinal vascularization is the ROPC filing closed and scanned into St. Luke’s EMR system. The underpinnings of the double check strategy and filing system again hinges on the ROPC. Without an ROPC, the double check and filing system simply is not viable.

Caregiver Education

In most hospitals, the only healthcare provider who participates at each step of ROP care is the NICu nurse. The ROPC nurse interfaces not only with the neonatologist and ophthalmologist but, most critically, with the parents. The St. Luke’s Watchful Eye program now has an ROPC nurse responsible for the most precarious step in the care continuum: ensuring compliance with the follow-up appointment. The ROPC understands that caregivers are dealing with a needy infant requiring multiple post-discharge appointments and follow-up care. The ROP follow- up appointment is only one of many issues the caregiver must handle. Simply providing a document about the importance of the follow-up appointment is a precarious way to ensure compliance. The Watchful Eye program addresses the importance of follow-up care even before the infant’s first ROP examination in the NICu. As soon as it is determined that the infant needs to be followed for ROP, the ROPC approaches the parents and provides both oral and written information about ROP. The ROPC informs the family that the infant’s first eye exam will be at four weeks of age. The parents are invited to be present for the examination and are fully informed about the procedure. After the exam, the ROPC nurse assists in educating the family about the results.

Outpatient Coordination

When the infant is ready for discharge, the ROPC makes the follow-up appointment at the ophthalmologist’s office. In scheduling the appointment, the ROPC communicates the family’s needs to the ophthalmologist’s appointment scheduler. The ROPC nurse then records the appointment date on a discharge instruction form. Developed by the ROP team, the discharge form provides educational information about ROP and contains this disclosure: “If you fail to keep this (follow-up) appointment, the ophthalmologist and/or St. Luke’s Hospital and Health Network may contact the appropriate legal authorities, as required by law, in an effort to locate your baby and provide treatment.” After the parent signs the form, copies are made for the family, the ophthalmologist, and the hospital records. Again, it must be emphasized that this is only one step in the education and orientation process of the parent/caregiver. This step by itself would be too little too late.

Part of the Watchful Eye program is careful outpatient coordination with the ophthalmologist’s office. As noted above and in the conceptual map on page 4, the double-check strategy and filing system continues after the infant’s discharge from the hospital.

Unit-wide Orientation and Monitoring

 The Watchful Eye program is not an isolated component of care for the premature infant nor is it static. It is a dynamic process that has to be integrated into the infant’s overall care and updated when necessary. This multidisciplinary approach extends beyond the providers active in treating ROP to the NICu unit responsible for the overall care of the premature infant. The entire NICu unit needs to be oriented to the program, including social services, administrative staff, discharge planners, etc.

The process is dynamic in that the principles of continuous quality improvement are applied. An excellent example is a 2008 revision to the Watchful Eye program placing stronger emphasis on ROP education for parents prior to discharge to help them understand the potential risks and consequences of their infant’s condition. This increased emphasis on caregiver education has resulted in better outcomes while maintaining 100% follow-up compliance. The need for ROPC interventions dropped from 23% to 2% and the number of patients requiring surgery decreased from 6% to 2% in the year following this revision (see graph).

The “Watchful Eye” and OMIC

On behalf of the 325 OMIC insureds and other ophthalmologists who screen and treat for ROP, OMIC has been at the forefront of addressing the unique liability risks of ROP for more than two decades. During this time, it has become evident to us that many hospitals are reluctant to create and implement a comprehensive ROP tracking and monitoring program. This frustrates ophthalmologists who would provide ROP care if hospitals were more involved.

OMIC believes the Watchful Eye program presents an opportunity for hospitals, nurses, neonatologists, and ophthalmologists to work together in a collaborative and innovative way to solve this problem. St. Luke’s Hospital and OMIC are in the process of bringing the Watchful Eye program to OMIC insureds and others interested in a comprehensive ROP tracking system. We anticipate a great deal of interest from the AAO, AAPOS, SOOp, and ASRS as we tackle one of ophthalmology’s greatest challenges: preventing blindness in premature infants.

Coverage for Medical Spa Liabilities

By Kimberly Wittchow

OMIC Legal Counsel

Digest, Spring 2009

There are liability risks when providing medical spa services, as well as in supervising or directing medical spa services and in owning and operating medical spas. The OMIC professional liability policy and broad regulatory protection policy cover some of these risks, but not all. Therefore, it is imperative to operate within OMIC’s coverage provisions or secure additional coverage elsewhere.

Medical Malpractice: Ophthalmologists

The OMIC policy (Coverage Agreement A) covers ophthalmologists for their direct patient treatment as long as it is within the ordinary and customary scope of practice of ophthalmologists and not specifically excluded within the policy language or by endorsement. Insureds who have limited their practice and are in a coverage classification other than full surgery (Surgery Class 3) must carefully check the wording of the endorsement pertaining to their class to ensure that the medical spa treatments they are performing are covered under their class. For example, to perform skin rejuvenation/tightening using radio frequency, one must be in Surgery Classes 2 or 3. However, Surgery Class 1 physicians may perform injections of Botox or collagen and other fillers. Your underwriter can provide a list of typical medical spa procedures and their minimum coverage classification requirements.

Medical Malpractice: OMIC-Insured Medical Spas, Directors, and Owners

OMIC offers coverage to medical spas under Coverage Agreement C, subject to underwriting review and approval. A specific medical spa application form is required and the facility must abide by OMIC’s underwriting requirements in order to be eligible for coverage. Coverage is available only for medical spas that are located within the owner’s ophthalmic practice or in the same building, and OMIC insureds (and immediate family) must hold at least 50% of the ownership. If the medical spa is an insured entity, then any persons affiliated with the medical spa as members, officers, directors, partners, or shareholders, including as medical directors, supervising physicians, or prescribing physicians (collectively “directors and owners”), will also be covered, but only in their capacity as directors and owners.

Coverage Agreement C covers claims against the spa and directors and owners for direct patient treatment attributed to the entity itself (occurring, for example, if the entity’s policies or procedures lead to the injury), as well as professional committee activity claims against its directors and owners (e.g., negligent credentialing of the utilizers of the medical spa). It also provides vicarious liability for the entity and its directors and owners, but only when the person for whom the spa, director, or owner is being held responsible was acting within the scope of his or her licensure, training, and professional liability insurance coverage, if applicable. It is imperative that medical directors and owners understand the licensure requirements for the various medical spa treatments offered at their facilities.

Medical Malpractice: Non-Insured Medical Spas, Directors, and Owners

OMIC’s policy specifically excludes coverage of an insured acting as a “medical director, supervising physician, or prescribing physician of a medical spa, not named in the Declarations.” This means that if the medical spa is not listed on the Declarations, the insured ophthalmologist is not covered for liability as a medical director of the spa, even though he or she is insured for direct patient treatment rendered at the medical spa.

Medical Malpractice: Ancillary Staff

Ancillary staff who provide services at medical spas, such as aestheticians, aesthetic nurses, and RNs, are covered by OMIC only if the employing physician or medical spa is named on the Declarations (Coverage Agreement B). Even if OMIC insures a physician owner of a non-OMIC-insured medical spa, there is no OMIC coverage for ancillary staff employed by the medical spa. Such ancillary staff employees should make sure the medical spa’s non-OMIC professional liability insurance covers them. under the OMIC policy, ancillary staff members have direct liability coverage only if they are acting within the scope of their training, licensure, and employment by and for the direct benefit of the employing insured named on the Declarations. Not only does the coverage agreement require appropriate licensure, there is also a specific exclusion that excludes coverage for direct patient treatment by any health care providers who don’t hold the required licenses, certifications, or accreditations to provide the services in question.

Licensure Actions

OMIC’s policy also provides defense-only coverage (paying up to $25,000 in legal fees) for any investigation, disciplinary proceeding, or action for review by a regulatory agency, such as the medical board, arising from a patient complaint of an injury resulting from the insured’s direct patient treatment at a medical spa or elsewhere. This coverage does not include any fines or penalties and doesn’t cover investigations based on other people’s actions. This coverage is only for ophthalmologists and would not protect nurses or other licensed staff being investigated for scope of practice violations. If an injury to a patient is not alleged, but a licensing proceeding is instituted against the ophthalmologist by a state licensing authority, the OMIC Broad Regulatory Protection Policy will cover legal expenses for the investigation up to $25,000 (with a $1,000 deductible).

Cosmetic Treatment by Technician Results in Fine and Suspended License for Medical Director

By Ryan Bucsi, OMIC Senior Litigation Analyst

Digest, Spring 2009

ALLEGATION: Negligent supervision of unlicensed staff performing laser skin resurfacing.

DISPOSITION: Lawsuits were settled on behalf of the OMIC insured for a collective $48,750. Insured was fined $35,000 and his license suspended for aiding and abetting the unlicensed practice of medicine.

Case Summary

In two separate cases occurring one week apart, patients received Intense Pulse Light (IPL) treatment from a technician in a medical spa. Following treatment, each patient complained of being burned. The spa returned the money in both cases and even compensated one patient for her missed time from work. Nonetheless, they sued the OMIC-insured ophthalmologist in his role as medical director of the spa even though he had not been present at either procedure.

Analysis

The ophthalmology expert who reviewed this case testified that one of the patients had experienced normal skin darkening that was likely to improve. The other patient was a smoker with prior skin damage from the sun and no new injury. While the expert concluded that the patients were not harmed, he shared the plaintiffs’ concerns about the delegation process. First, he noted that neither the insured nor another physician documented a pre-treatment exam or the reasons for recommending IPL. Next, the expert could not find an order for the technician to perform the treatment, a protocol defining treatment parameters, or an indication from any physician of subsequent examinations. As the medical records contained only documentation by the technician, the expert concluded that the technician made treatment decisions and performed the IPL sessions without supervision. Delegation of such authority for medical decision-making, he opined, was below the standard of care. The insured initially disagreed with the review and reported that regardless of the laws and regulations, it was quite common for physicians he knew to designate a “range of therapy” for IPL treatments. Based upon the technician’s training and skills, she had been granted the discretion to adjust the IPL power up or down within that range in order to achieve the desired result. The insured also did not feel that his presence was required for these treatments as they were routinely performed by technicians in his area. He acknowledged, however, that his medical board had already determined that such delegation was illegal. Moreover, the expert reported that he was always physically present on site in his own practice when IPL procedures were being performed by his technicians. The insured was certain that written consent for at least one of the procedures had been obtained; however, the consent document could not be located and there were no documented risk/benefit discussions.

Risk Management Principles

Experts base their review of malpractice claims upon the standard of care—reasonable prudence—not the “standard of the community.” Attorneys remind physicians, moreover, that ignorance or violation of laws and regulations may make a case indefensible, even if the care was properly rendered and there were no injuries. The physician remains liable for damages sustained by patients cared for by his staff and under his supervision, even if he has properly delegated, trained, and supervised the staff. If the cause of the injury cannot be attributed to the staff or equipment, the indemnity payment is made on behalf of the physician, not the practice, as happened here. In compliance with federal and state law, the payments made on behalf of the OMIC insured were reported to the National Practitioner Data Bank and the state board and were available to health care facilities performing credentialing reviews. The state board levied a $35,000 fine and suspended the insured’s medical license. This fine was not covered by the OMIC insurance policy since the insured’s role was limited to being the medical director of a non-OMIC insured spa.

As this case indicates, a cosmetic procedure with seemingly minor clinical risks may end up causing severe consequences for the physician. Protect yourself if you are delegating medical procedures. Know your state laws. Ensure that you are competent to perform a procedure yourself prior to training non-physician personnel to perform it. Keep files with evidence of adequate training, competency evaluations, and protocol development and review. For each patient, evaluate the necessity of a procedure, and write an order for staff to perform the procedure, including treatment parameters. Document the informed consent discussion and ask the patient to sign a procedure-specific consent form. See the Hotline article in this Digest for information on what can be delegated.

CO2 Laser Skin Resurfacing: Watch Out for Marketing Liability

By Joe F. Arterberry, MD, and Paul Weber, JD

Argus, February 1997

Skin resurfacing with the CO₂ laser is a relatively complex surgical innovation that has captured the attention of the medical community and the public. Much of the public’s fascination can be traced to aggressive marketing of the procedure, which has led many patients to expect superb results without side effects. Unfortunately, such results are not always achievable despite optimal surgical technique and attentive post-treatment care.

The combination of aggressive marketing and high patient expectations sets the stage for costly litigation when patients suffer real or perceived complications following CO₂ laser resurfacing. The most likely allegations relate to inadequate training resulting in suboptimal performance of the procedure, lack of informed consent, and inadequate laser precautions.

In their haste to sell ophthalmologists very expensive laser systems, manufacturers and sales representatives may not emphasize the substantial amount of education and training necessary to perform this procedure properly. At a minimum, education and training should include:

• A solid foundation in the basic science of lasers and laser interaction with tissues.
• An understanding of skin anatomy and wound healing.
• Didactic courses on specific types of CO₂ laser delivery systems.
• Initial CO₂ resurfacing surgical experience under a preceptor or proctor.
• A laser safety course.

The laser operative team also should have proper training and adhere to stringent laser safety precautions, including:

• Following fire precautions (e.g., avoiding alcohol-based prep solutions and topical, flammable anesthetic agents, etc.).
• Wearing glasses with sideshields or goggles.
• Using dulled metallic corneal shields and dulled low- or nonreflective metallic surgical instruments to prevent specular reflections and to protect tissues from accidental photoablation.
• Using an approved smoke evacuator to remove a potentially infectious laser plume.

All documentation of CO₂ laser education, training and safety courses attended by the ophthalmologist and staff should be kept on file. Continuing education is equally important in this area since the technology and the procedures related to it are relatively new and constantly evolving.

Prior to coming to the ophthalmologist’s office, the patient may already have been misinformed about this procedure by glitzy newspaper and magazine ads or television infomercials touting only the benefits of CO₂ laser skin resurfacing. It is the ophthalmologist’s responsibility to determine the patient’s prior knowledge and understanding of this procedure and to give patients accurate and current information regarding its risks, benefits and alternatives. Some of this information can be provided by non-ophthalmologists; however, the responsibility for securing informed consent from the patient cannot be delegated. Commercial videotapes and educational materials are available to begin the informed consent process, and OMIC has developed an informed consent document for CO₂ laser skin resurfacing that can be requested by fax from OMIC’s Risk Management Department at 415-771-7087. It must be emphasized that these videos, brochures and informed consent documents are no substitute for an ophthalmologist’s detailed discussion with the patient. The fact that this discussion took place should be documented by the physician either on the informed consent document or in the patient’s chart.

Patients need to understand that while the initial results of CO₂ laser skin resurfacing have been very promising, long-term results or effects are currently indeterminate. For instance, with every pass of the CO₂ laser spot, a quantifiable thickness of skin is ablated, ranging from 50-150 microns depending upon the laser parameters used, and a varying thickness of dermis is thermally damaged. Therefore, pending completion of clinical studies, it may be prudent to inform heliotropes or “sun-worshippers” about the increased risk of or susceptibility to developing cutaneous malignancies subsequent to their “resurfacing.”

Ophthalmologists who advertise CO₂ laser skin resurfacing need to be particularly careful about how they characterize this procedure. It is difficult to defend in court the ophthalmologist who advertises and markets the procedure as “safe,” “quick,” “effective,” or “gentle” if a patient has one of the known complications of the procedure. Should a lawsuit arise against an ophthalmologist who improperly advertises, a jury could determine that the misleading statements in the advertisements outweigh the force and effect of a thorough discussion of the risks by the ophthalmologist.

In conclusion, if the ophthalmologist approaches CO₂ laser resurfacing methodically and with a compulsive attention to detail and concern for the patient’s well-being, the surgical risk should be minimized.

Don’t Defer Emergency Cases When Covering Calls for a Colleague

By Richard A. Deutsche, MD

Argus, August, 1992

Weekend, night and vacation call scheduling presents potential risk management problems if the on-call ophthalmologist does not see emergency cases in a timely manner. A review of ophthalmic claims reveals instances in which the operating surgeon and the on-call ophthalmologist were sued for failing to treat postoperative complications in a timely manner.

One case involved an elderly man who had an uncomplicated extracapsular extraction with a posterior chamber intraocular lens performed on a Thursday. The eye was doing well when the operating surgeon saw the patient the following day. On Saturday, two days postop, the patient developed pain and decreased vision. After failing to reach the surgeon, who had signed out to another ophthalmologist for the weekend, the patient was eventually able to contact the covering ophthalmologist by phone. He relayed his symptoms and was told to take Tylenol.

The next day, still complaining of pain and decreased vision, the patient was referred to another on-call ophthalmologist. When the patient was seen that evening, a diagnosis of enophthalmitis was made. On Monday, the patient was seen by a retinal specialist who did a vitreous tap followed by the appropriate treatment for enophthalmitis. Despite these best efforts, the eye was lost. The patient sued the operating surgeon and both on-call ophthalmologists for abandonment and delay in diagnosis.

Another case involved a middle-aged woman who had an uncomplicated retinal detachment repair with intravitreal gas performed on Friday. That evening, she developed pain and blurred vision. She called the retinal specialist, who had gone out of town, and was referred to the on-call ophthalmologist who prescribed Empirin with codeine No. 4 for pain. The severe pain continued and her vision worsened.

When the on-call ophthalmologist saw the patient the next day, her intraocular pressure was 70. Although the ophthalmologist immediately began appropriate treatment for intravitreal gas and control of the glaucoma, permanent damage to the eye had occurred, presumably from the prolonged elevated intraocular pressure, and the eye was lost. The patient sued the retinal specialist and the on-call ophthalmologist for failure to respond to the emergency.

In both instances, the claims may have had stronger defenses or been avoided altogether if the ophthalmologist on call had seen the patient in a timely manner.

Ophthalmologists are strongly advised to adhere to these risk management principles when arranging or accepting weekend, night or vacation coverage:

• When signing out, be sure to inform the ophthalmologist who is taking your calls of any recent surgical cases or any problem patients.
• When on call, keep your home telephone line open as much as possible so the answering service can reach you.
• If you are taking calls for a colleague, be readily available and willing to see patients regardless of the time of day.
• Keep notes of telephone calls you take while on call, and place these notes in the proper charts when you return to the office.
• Inform your colleague of any patients who contacted you during his or her absence.
• Remember that certain general ophthalmic emergencies such as a chemical splash in the eye, perforating eye injury, recent bulging of the eye, rapid onset of vitreous floaters, curtains or veils across the vision, photopsia and foreign bodies in the eye must be evaluated immediately.
• Postoperative patients who complain of pain, acute complete or partial loss of vision, infectious discharge or increased redness of the eye must be seen by an ophthalmologist as soon as possible. Do not delegate this duty to a non-ophthalmologist.

By following these guidelines, you can provide your patients with optimal ophthalmic care and decrease your exposure to litigation.