ROP Risk Management
Information is abstracted below from the updates Ophthalmic Mutual Insurance Company’s (OMIC) “OMIC Safety Net material, Revised May 7, 2013 to reflect 2013 Policy Statement", (written by Anne M. Menke, R.N., Ph.D., OMIC Risk Manager, available at: http://www.omic.com/rop-creating-a-safety-net/) which discusses obstacles to ROP care, enlisting hospital support, claims experience, and risk management recommendations. This information is of interest to all who participate in delivery of care to infants at risk for ROP – whether OMIC insured or non-OMIC insured. Toolkits that detail every step in the care process are available at www.omic.com.
Retinopathy of Prematurity: Creating a Safety Net
Although claims for mismanagement of ROP are relatively infrequent, indemnity payments for these claims can be high due to the young age of the plaintiffs and the significant loss of vision that can result even with treatment. OMIC’s experience in helping ophthalmologists implement patient safety measures suggests that the liability for ROP care can only be decreased—and blindness prevented—if ophthalmologists work closely with neonatologists, nurses in Neonatal Intensive Care Units (NICUs), hospitals, and parents.
I. Why Is The ROP Process Of Care Problematic?
There are three aspects of ROP care that put premature infants and the entire healthcare team at risk:
- First, premature infants face a host of severe medical problems; some are life threatening, ROP is sight-threatening. The ophthalmologist is just one of a number of consultants who care for these patients. As a general rule, eye physicians come to the hospital at periodic intervals, usually one day each week, to evaluate those infants whom the neonatologist has identified as meeting the ROP screening criteria. Problems arise when babies are discharged or transferred before the follow-up date, or are unavailable at the time of the ophthalmologist’s visit (e.g., are undergoing surgical procedures, or are too ill).
- Second, parents/caregivers of premature infants tend to feel overwhelmed. These overwhelmed parents/caregivers cannot be relied up to schedule appointments, and may require significant follow-up efforts to ensure that screening and treatment occur at the appropriate intervals.
- Third, while all conditions need timely follow up, the treatment window for ROP is exceedingly short: once the need for intervention has been identified by the screening ophthalmologist, treatment must be provided within 48 to 72 hours. The entire team—ophthalmologists, neonatologists, pediatricians, nurses, and hospital—become targets of litigation when ROP care protocols break down. More importantly, a baby loses sight.
II. What Causes ROP Lawsuits?
ROP Claims Experience: Since its inception in 1987, ROP claims have been low frequency events (0.6% of total claims). While infrequent, ROP claims are the highest severity events in OMIC’s claims experience; that is, they require the most money to settle, since ROP often leads to bilateral blindness or severe visual loss. OMIC indemnity payments for ROP have ranged from $26,666 to $3,375,000. Non-OMIC ROP claims have had reported verdicts against an ophthalmologist of up to $38,000,000.
ROP Causation Analysis: It is important to remember that poor outcomes cannot always be prevented. In the case of ROP, some infants who are screened and treated per clinical guidelines still end up bilaterally blind. A review of OMIC’s claims experience, dividing causes into four categories (clinical, systems, physician and parent/patient), revealed that a breakdown in a process of care (most commonly follow-up) followed by a lack of physician knowledge or competency were the primary problem in most cases.
III. Risk Management Recommendations
The goal in continuing to revise and offer these sample protocols is first of all to help prevent blindness from ROP. In addition to promoting patient safety, we aim to minimize the liability exposures related to ROP care, and improve the defensibility of care if it is called into question. Risk management recommendations do not establish a standard of care. Rather, they serve as suggestions on how the healthcare team—the ophthalmologist, neonatologist/pediatrician, NICU nurses, hospital, and parents/caregivers—can create a safety net for these at-risk infants. These suggested risk management practices are designed to complement clinical recommendations (www.pediatrics.org/cgi/doi/10.1542/peds.2005-2749).
IV. Clarification Of Roles And Standardization Of Care Are The Key Components Of Safety Net
- The ROP toolkits at www.omic.com assign responsibility for each task in the ROP care process, both in the hospital (or other healthcare facility) and during outpatient care so that there is no confusion about who is responsible for decision making and follow-up.
- To create a safety net for these at-risk children, the entire team needs to be involved at critical junctures in the ROP care process. These points are tracking, the ongoing education of the parents/caregivers, and coordinating transfer of care to ophthalmologists at another hospital or in an outpatient setting.
- To evaluate weak spots in the “safety net,” conduct a risk analysis of your current process of care, and identify any steps in the toolkit protocols for which responsibility has not been assigned, or where care is not being provided according to current clinical guidelines (e.g., the “Policy Statement” or other published studies).