Sexually Transmitted Diseases:
Neisseria gonorrhoeae Outbreak: Unintended Consequences of Electronic Medical Records and Using an Out-of-State Laboratory—California, July 2009–February 2010
Murray, Erin L. PhD, MSPH*†; Samuel, Michael C. DrPH†; Brodsky, Jennifer MPH†; Akiba, Christopher F. MPH†; King, Courtney BA†; Li, Michael MPH†; Wollesen, Miriam MA†; Gonzales, Patricia E. BS†; Watt, James P. MD, MPH‡; Bolan, Gail MD†
From the *Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, GA; and †Sexually Transmitted Diseases Control Branch and ‡Division of Communicable Disease Control, California Department of Public Health, Richmond, CA
The authors thank Joe Sanchez, Romni Neiman, and Carol Kong at the California Department of Public Health for their field and epidemiologic support; Susan Philips and Mark Pandori at the San Francisco Department of Public Health for their laboratory support; and Diana Bensyl at the Centers for Disease Control and Prevention for her comments on the manuscript. The outbreak investigation and preparation of this manuscript were conducted in full collaboration with the county department of health staff. These staff would have been coauthors on this manuscript if county anonymity was not desired. The county jail and juvenile hall and Healthcare Organization A were all fully cooperative throughout the investigation and provided critical support.
Supported by the California Department of Public Health.
Conflicts of interest: The authors have no conflicts of interest to declare.
Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Current affiliation of Erin L. Murray: Immunization Branch, California Department of Public Health, Richmond, CA. Current affiliation of Jennifer Brodsky: Family Health Care Nursing, School of Nursing, University of California San Francisco, 2 Koret Way, Room N-411, San Francisco, CA. Current affiliation of Christopher Akiba: Department of Psychiatry and Behavioral Sciences, The Washington Institute for Mental Health Research and Training, 9601 Steilacoom Blvd, Tacoma, WA. Current affiliation of Michael Li: Chiang Mai University School of Medicine, Suthep, Mueang Chiang Mai, Chiang Mai, Thailand. Current affiliation of Miriam Wollesen: The Wright Institute, 2728 Durant Ave, Berkeley, CA. Current affiliation of Gail Bolan: Division of Sexually Transmitted Disease Prevention, Centers for Disease Control and Prevention, Atlanta, GA.
Correspondence: Erin L. Murray, PhD, MSPH, Immunization Branch, California Department of Public Health, 850 Marina Bay Parkway, Richmond, CA 94804. E-mail: Erin.Murray@cdph.ca.gov.
Received for publication June 15, 2012, and accepted March 11, 2013.
Abstract: Twenty of 37 gonorrhea cases identified during an outbreak were diagnosed at one health care organization that used an out-of-state laboratory. The results were transmitted into electronic medical records without provider notification. Delays in treatment and reporting were identified. Systems should be implemented to ensure provider notification of electronic laboratory results.
Neisseria gonorrhoeae, a common sexually transmitted infection, is a major cause of pelvic inflammatory disease, ectopic pregnancy, and infertility and can facilitate HIV transmission.1 The gonorrhea (GC) incubation period is typically 1 to 14 days, and infections are often asymptomatic among women.2 California law requires that providers report N. gonorrhoeae positive test results to the local health jurisdiction (LHJ) of the patient’s residence within 7 calendar days and that laboratories report N. gonorrhoeae positive test results to the LHJ in which the submitting health care provider is located within 1 business day.3,4 In addition, California laboratories referring testing to an out-of-state laboratory are responsible for reporting diseases identified by the out-of-state laboratory.4 Local health jurisdictions must report cases to the California Department of Public Health (CDPH) at least weekly.5
An outbreak of GC occurred on July 1, 2009, to February 28, 2010 among residents of a rural California county. A total of 37 GC cases were identified during the outbreak period, including one case infected twice, which was more than double the number of cases seen in previous years. One hospital with an affiliated clinic, Healthcare Organization A (HOA), was determined to have reported most cases. Because of this, interviews with HOA administrators, clinicians, and laboratory staff were conducted to determine N. gonorrhoeae testing and reporting procedures and data flow in 2008 to 2009 as part of our outbreak investigation. A line list of patients who tested positive for N. gonorrhoeae in 2008 to 2009 was requested. In addition, an out-of-state laboratory that performed N. gonorrhoeae testing for HOA also provided a line list of county residents positive for N. gonorrhoeae. Line lists from all data sources were compared to identify unreported cases and discrepancies. Patients diagnosed during the outbreak period were also contacted for an interview to ensure treatment, provide education, identify risk behaviors, and elicit sex partner information; however, this report focuses on describing the findings from the investigation at HOA and the role of the out-of-state laboratory.
χ2 Tests and t tests were calculated for statistical comparisons by using SAS version 9.2 (SAS Institute Inc, Cary, NC). Days from specimen collection to treatment was calculated for all N. gonorrhoeae cases. Days from test result receipt to report to the LHJ was calculated for N. gonorrhoeae infections of cases diagnosed at HOA (date of test result receipt was not available from other health care providers).
Of the 37 GC cases identified during the outbreak, 30 (81%) were reported through routine public health surveillance, 3 (8%) were identified through field testing conducted during the outbreak investigation, and 3 (8%) were identified by reviewing HOA laboratory results. One person (3%) was a sex partner of a known case who accurately self-reported being positive. Thirty-six cases were identified through nucleic acid amplification test and 1 through Gram stain. The peak number of cases (12) occurred in November 2009 (Fig. 1).
Twenty-one (57%) of the 37 GC cases were diagnosed at HOA (20 at the out-of-state laboratory and 1 by Gram stain at the HOA laboratory). Fourteen (67%) of 21 infections among cases were presumptively treated for GC at the time of specimen collection at HOA, compared with 7 (44%) of 16 infections among cases diagnosed by other health care providers (P = 0.11). Among HOA cases not presumptively treated for GC, the mean number of days between specimen collection and treatment was 28 days (median, 22 days; range, 6–68 days), greater than 20 days longer than the same period reported for infections in cases of other health care providers (P = 0.05; Table 1).
Problems with reporting of N. gonorrhoeae test result data within HOA were identified. Electronic results from the out-of-state laboratory received by HOA were transmitted directly into the case’s electronic medical record (EMR) without sending a notification to a health care provider. In addition, discrepancies in disease reporting to the LHJ were identified. The out-of-state laboratory reported 45% of positive N. gonorrhoeae test results among county residents to CDPH but did not report any results to the LHJ. Furthermore, no records at the LHJ demonstrate that the HOA laboratory reported N. gonorrhoeae positive test results received from the out-of-state laboratory. Thus, providers were the only source of disease reports from HOA to the LHJ; disease reporting by HOA took a mean of 28 days (median, 16 days; range, 1–109 days) from positive result receipt.
Although social and behavioral characteristics likely contributed to the propagation of the outbreak (data not shown), this investigation is unique in that health care system attributes were also identified as contributing factors. First, the HOA EMR system, which supports care for most cases involved, was not designed to notify providers when a N. gonorrhoeae positive test result was received from the out-of-state laboratory. Time from specimen collection to treatment for nonpresumptively treated infections among HOA cases was substantially longer than treatment times among other providers. Lack of provider notification of N. gonorrhoeae positive test results within the HOA EMR system likely contributed to treatment delays and extended the duration of cases’ infectious periods, thus providing increased opportunities for ongoing N. gonorrhoeae transmission; however, no transmission events could conclusively be attributed to these delays.
Second, use of an out-of-state laboratory, without the local laboratory reporting as required, could have contributed to the propagation of this outbreak by delaying reporting to the LHJ, which resulted in delayed identification of substantial increases in GC cases in 2009. To increase reporting timeliness and completeness of notifiable conditions in California, redundancies have been built into disease-reporting regulations by requiring both providers and laboratories to report to LHJs.3,4 The LHJs are responsible for reporting to CDPH.5 During this outbreak, both the HOA providers and laboratory should have reported all cases identified at their facility.3,4 On average, it took HOA providers longer than 4 weeks to report N. gonorrhoeae cases to the LHJ, and the laboratory did not report any cases. In addition, 3 cases identified during retrospective record review at HOA were not previously reported to the LHJ. Because California law did not require the out-of-state laboratory to report to the LHJ, these positive test results were unnoticed. These cases should have been reported by the HOA laboratory as required by California regulations.4 This investigation revealed that using an out-of-state laboratory with direct transmission of results into an EMR caused delays in reporting and resulted in delays in follow-up, case treatment, and, in turn, partner investigation and treatment. This has implications beyond sexually transmitted disease reporting and might affect other critical public health reporting systems.
In addition to electronic laboratory reporting (ELR) systems between laboratories and health care providers, ELR between laboratories and public health departments could assist with improving laboratory reporting and allow for earlier detection of disease outbreaks; however, ELR systems between laboratories and public health departments were not in place in California during this outbreak. Health care providers should confirm that their EMR systems alert providers of all test results to permit timely treatment and follow-up. State and local health departments should ensure that providers and laboratories are aware of and adhering to state disease reporting regulations3,4 and that laboratories contracting with out-of-state laboratories, as well as the out-of-state laboratories, understand their reporting responsibilities and requirements.
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