© 2011 American Society for Healthcare Risk Management of the American Hospital Association

Published online in Wiley Online Library (wileyonlinelibrary.com) • DOI: 10.1002/jhrm.20086

JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 31, NUMBER 238

By Heather Annolino, RN, MBA, CPHRM

Claims & Litigation

Retinopathy of prematurity: Understanding and managing the risks of remote retinal imaging

Remote imaging improves access to care and decreases the necessity for on-site evaluation by an ophthalmologist. Currently, established criteria do not exist delineating when the use of reti-nal photography and telemedicine is appropriate, rather than a dilated indirect ophthalmoscopic examination. This article will dis-cuss the risk management strategies that practitioners and health-care organizations should employ to protect both themselves and patients before adopting this technology.

Retinopathy of prematurity (ROP) is a potentially blinding disease affecting preterm, low-birth-weight infants. It has become more common as both the number and survival rate of premature infants have increased.(1)

As prompt identification and treatment is necessary to cure ROP, current practice guidelines call for more frequent screening. However, the number of physicians who diagnose and treat the condition is decreasing, due to logisti-cal, reimbursement, and medical liability concerns. Remote retinal imaging has emerged as one possible solution to the growing need to evaluate and monitor at-risk infants.

Remote imaging improves access to care and decreases the necessity for on-site evaluation by an ophthalmologist. However, research has not conclusively proven the efficacy of remote imaging for ROP diagnosis. In addition, no established criteria exist delineating when the use of retinal photography and telemedicine is appropriate, rather than a dilated indirect ophthalmoscopic examination. Because remote image interpretation may vary from reader to reader, the procedure presents the risk of misdiagnosis and consequent liability.

Notwithstanding the potential exposures, a growing number of ophthalmolo-gists and neonatologists are either utilizing or considering the use of retinal imaging technology and telemedicine. In order to protect both patients and themselves, practitioners who adopt this technology should employ the follow-ing risk control strategies, at a minimum:

Utilize evidence-based standards to classify, diagram and record retinal findings• , such as the American Academy of Pediatrics’ “International Classification of Retinopathy of Prematurity Revisited,” which is available at http://aappolicy.aappublications.org/cgi/reprint/pediatrics;117/2/572.pdf.(2)

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DOI: 10.1002/jhrm AMERICAN SOCIETY FOR HEALTHCARE RISK MANAGEMENT • VOLUME 31, NUMBER 2 39

Foster a team approach • among those involved in remote imaging, including neonatal intensive care unit (NICU) staff, pediatricians, and ophthalmologists, in order to support consistent care, maintain open communication and foster appropriate follow-up and screening.

Collaborate with providers and staff to create written policies • governing key decisions, including transfer or discharge from the NICU.(3)

Implement a standard reading process• , including consulta-tion for indeterminate or controversial images.(4)

Set realistic time frames• for image reading and reporting and ensure consistent compliance with these guidelines.(5)

Automatically refer for standard ophthalmoscopy • all infants with unreadable images.

Carefully train staff members who operate the camera• and periodically assess and document their knowledge and competency.(6)

Institute a formalized ROP tracking system• for the hospital and ophthalmology practice.

Designate criteria for credentialing and privileging • ophthalmologists for telemedicine practice, addressing such areas as educational background, specialized training in remote imaging, and experience diagnosing and treating ROP.

Draft documentation guidelines• for the informed consent process, physician–patient discussions and other com-munications.

Formalize ROP education for all caregivers• and thoroughly document all training and education efforts.(7)

Promulgate record-keeping guidelines• , encompassing stor-age, archiving, and retrieval of images and data.

Establish telehealth equipment and maintenance standards • in compliance with accepted best practices.

Measure ROP and retinal imaging outcomes • and conduct ongoing quality monitoring for both the NICU and ophthalmologists.

Develop a policy and procedure for responding to and docu-• menting missed appointments and other forms of noncom-pliance.

In addition, organizations should address the following questions, although definitive answers to these questions have not yet emerged:

What digital imaging system should be used (eg, wide-• angle versus narrow-angled cameras, degree of imaging, and pixel resolution)?

What is the standard image set for each eye?•

How many total images should be captured? •

What specific images should be evaluated?•

Finally, areas of risk associated with telemedicine—including, among others, informed consent, confidential-ity, technology failure, physician–patient relationship, standard of care, licensure, venue, and jurisdiction—also should be examined. By implementing a sound risk con-trol strategy and reviewing current literature on ROP and retinal imaging, providers can enhance patient safety while minimizing their liability exposure.

REFERENCES

1. According to the Centers for Disease Control and Prevention’s National Center for Health Statistics (NCHS), the rate of preterm births grew by more than 20% between 1990 and 2006, and since then has declined slightly, to 12.3% of all births in 2008. Martin J, Osterman M, Sutton P. Are preterm births on the decline in the United States? Recent data from the National Vital Statistics System. NCHS Data Brief. May 2010; 39. Available at: www.cdc.gov/nchs/data/databriefs/db39.pdf. Accessed March 9, 2011.

2. Screening examination of premature infants for retinopathy of prematurity. Policy Statement of the Section on Ophthalmology, American Academy of Pediatrics; American Academy of Ophthalmology; and the American Association for Pediatric Ophthalmology and Strabismus. Pediatrics. February 2006;117(2):572–576. Available at: http://aappolicy.aappublications.org/cgi/reprint/pediatrics;117/2/572.pdf. Accessed March 9, 2011.

3. Ibid.

4. Chiang M, Starren J, Du Y, et al. Remote image based retinopathy of prematurity diagnosis: A receiver operating characteristic analysis of accuracy. Br J Ophthalmol. October 2006;90(10):1292–1296. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC1857452/pdf/1292.pdf. Accessed March 9, 2011.

5. Screening examination of premature infants for retin-opathy of prematurity.

6. Chiang M, Keenan J, Starren J, et al. Accuracy and reliability of remote retinopathy of prematurity diag-nosis. Arch Ophthalmol. March 2006; 24(3):322–327. Available at: http://archopht.ama-assn.org/cgi/reprint/124/3/322.pdf. Accessed March 9, 2011.

7. Screening examination of premature infants for retin-opathy of prematurity.

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JOURNAL OF HEALTHCARE RISK MANAGEMENT • VOLUME 31, NUMBER 2 DOI: 10.1002/jhrm40

ADDITIONAL RESOURCES

Chiang M, Wang L, Busuioc M, et al. Telemedical retin-opathy of prematurity diagnosis: Accuracy, reliability, and image quality. Arch Ophthalmol. November 2007;125 (11):1531–1538. Available at: http://archopht.ama-assn.org/cgi/content/full/125/11/1531?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=accuracy+and+reliability+of+remote+retinopathy+of+prematurity+diganosis&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT. Accessed March 9, 2011.

Kemper A, Wallace D, Quinn G. Systematic review of digital imaging screening strategies for retinopathy of prematurity. Pediatrics. October 2008;122(4):825–830. Available at: http://pediatrics.aappublications.org/cgi/reprint/122/4/825. Accessed March 9, 2011.

Lajoie A, Koreen S, Wang L, et al. Retinopathy of prema-turity management using single-image vs. multiple-image telemedicine examinations. Am J Ophthalmol. August 2008;146(2):298–309. Public access author manuscript available from the National Institutes of Health at: www.ncbi.nlm.nih.gov/pmc/articles/PMC2580058/pdf/nihms60723.pdf. Accessed March 9, 2011.

ABOUT THE AUTHOR

Heather Annolino, RN, MBA, CPHRM provides health-care consulting services for physicians, nurses, medical group practices, hospitals, long-term care facilities, and other healthcare providers. Heather has over 18 years’ experience in the healthcare industry and almost 10 years in risk man-agement. Her clinical experience was primarily focused on pediatrics and emergency nursing and she has many years of management experience in both the emergency department and risk management. Heather received a Bachelor of Science in Nursing from the University of Wisconsin and a Master

of Business Administration from DePaul University. She is a Certified Professional in Healthcare Risk Management (CPHRM) and is a current member of the American Society for Healthcare Risk Management (ASHRM) and the Chicagoland Healthcare Risk Management Society (CHRMS).

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