W. Claiborne Dunagan

Mandatory Influenza Vaccination of Health Care Workers: Translating Policy to Practice

BACKGROUND Influenza vaccination of health care workers has been recommended since 1984. Multiple strategies to enhance vaccination rates have been suggested, but national rates have remained low. METHODS BJC HealthCare is a large Midwestern health care organization with approximately 26,000 employees. Because organizational vaccination rates remained below target levels, influenza vaccination was made a condition of employment for all employees in 2008. Medical or religious exemptions could be requested. Predetermined medical contraindications include hypersensitivity to eggs, prior hypersensitivity reaction to influenza vaccine, and history of Guillan-Barré syndrome. Medical exemption requests were reviewed by occupational health nurses and their medical directors. Employees who were neither vaccinated nor exempted by 15 December 2008 were not scheduled for work. Employees still not vaccinated or exempt by 15 January 2009 were terminated. RESULTS Overall, 25,561 (98.4%) of 25,980 active employees were vaccinated. Ninety employees (0.3%) received religious exemptions, and 321 (1.2%) received medical exemptions. Eight employees (0.03%) were not vaccinated or exempted. Reasons for medical exemption included allergy to eggs (107 [33%]), prior allergic reaction or allergy to other vaccine component (83 [26%]), history of Guillan-Barré syndrome (15 [5%]), and other (116 [36%]), including 14 because of pregnancy. Many requests reflected misinformation about the vaccine. CONCLUSIONS A mandatory influenza vaccination campaign successfully increased vaccination rates. Fewer employees sought medical or religious exemptions than had signed declination statements during the previous year. A standardized medical exemption request form would simplify the request and review process for employees, their physicians, and occupational health and will be used next year.

Reporting of medical errors: an intensive care unit experience.

ObjectiveTo determine the occurrence and type of medical errors in an intensive care setting using a voluntary reporting method. DesignProspective, single-center, observational study. SettingThe medical intensive care unit (19 beds) at an urban teaching hospital. PatientsAdult patients requiring at least 48 hrs of intensive care. InterventionsProspective reporting of medical errors. Measurements and Main ResultsDuring a 6-month period, 232 medical events were reported involving 147 patients. A total of 2598 patient days were surveyed yielding 89.3 medical events reported per 1000 intensive care unit days. The source of the reports included nurses, who reported most of the medical events (59.1%), followed by physicians-in-training (27.2%) and intensive care unit attending physicians (2.6%). One hundred thirty (56.2%) medical events occurred within the intensive care unit and were judged to involve patient careproviders who were working directly in the intensive care unit area. One hundred and two (43.8%) medical events were commissions or omissions that occurred outside of the intensive care unit during patient transports or in the emergency department and hospital floors. Twenty-three (9.9%) medical events leading to a medical error resulted in the need for additional life-sustaining treatment, and seven (3.0%) medical errors may have contributed to patient deaths. ConclusionMedical errors appear to be common among patients requiring intensive care. Medical events resulting in an error can result in the need for additional life-sustaining treatments and, in some circumstances, can contribute to patient death. Patient healthcare providers appear to be in a unique position to identify medical errors. Institutions should develop formalized methods for the reporting and analysis of medical errors to improve patient care.

The Attitudes and Experiences of Trainees Regarding Disclosing Medical Errors to Patients

Purpose To measure trainees’ attitudes and experiences regarding medical error and error disclosure. Method In 2003, the authors carried out a cross-sectional survey of 629 medical students (320 in their second year, 309 in their fourth year), 226 interns (159 in medicine, 67 in surgery), and 283 residents (211 in medicine, 72 in surgery), a total 1,138 trainees at two U.S. academic health centers. Results The response rate was 78% (889/1,138). Most trainees (74%; 652/881) agreed that medical error is among the most serious health care problems. Nearly all (99%; 875/884) agreed serious errors should be disclosed to patients, but 87% (774/889) acknowledged at least one possible barrier, including thinking that the patient would not understand the disclosure (59%; 525/889), the patient would not want to know about the error (42%; 376/889), and the patient might sue (33%; 297/889). Personal involvement with medical errors was common among the fourth-year students (78%; 164/209) and the residents (98%; 182/185). Among residents, 45% (83/185) reported involvement in a serious error, 34% (62/183) reported experience disclosing a serious error, and 63% (115/183) had disclosed a minor error. Whereas only 33% (289/880) of trainees had received training in error disclosure, 92% (808/881) expressed interest in such training, particularly at the time of disclosure. Conclusions Although many trainees had disclosed errors to patients, only a minority had been formally prepared to do so. Formal disclosure curricula, coupled with supervised practice, are necessary to prepare trainees to independently disclose errors to patients by the end of their training.

Medical error disclosure among pediatricians: choosing carefully what we might say to parents.

OBJECTIVE To determine whether and how pediatricians would disclose serious medical errors to parents. DESIGN Cross-sectional survey. SETTING St Louis, Missouri, and Seattle, Washington. PARTICIPANTS University-affiliated hospital and community pediatricians and pediatric residents. Main Exposure Anonymous 11-item survey administered between July 1, 2003, and March 31, 2004, containing 1 of 2 scenarios (less or more apparent to the childs parent) in which the respondent had caused a serious medical error. MAIN OUTCOME MEASURES Physicians intention to disclose the error to a parent and what information the physician would disclose to the parent about the error. RESULTS The response rate was 56% (205/369). Overall, 53% of all respondents (109) reported that they would definitely disclose the error, and 58% (108) would offer full details about how the error occurred. Twenty-six percent of all respondents (53) would offer an explicit apology, and 50% (103) would discuss detailed plans for preventing future recurrences of the error. Twice as many pediatricians who received the apparent error scenario would disclose the error to a parent (73% [75] vs 33% [34]; P < .001), and significantly more would offer an explicit apology (33% [34] vs 20% [20]; P = .04) compared with the less apparent error scenario. CONCLUSIONS This study found marked variation in how pediatricians would disclose a serious medical error and revealed that they may be more willing to do so when the error is more apparent to the family. Further research on the impact of professional guidelines and innovative educational interventions is warranted to help improve the quality of error disclosure communication in pediatric settings.

Patient safety event reporting in critical care: a study of three intensive care units.

Objective:To increase patient safety event reporting in three intensive care units (ICUs) using a new voluntary card-based event reporting system and to compare and evaluate observed differences in reporting among healthcare workers across ICUs. Design:Prospective, single-center, interventional study. Setting:A medical ICU (19 beds), surgical ICU (24 beds), and cardiothoracic ICU (17 beds) at a 1,371-bed urban teaching hospital. Patients:Adult patients admitted to these three study ICUs. Interventions:Use of a new, internally designed, card-based reporting program to solicit voluntary anonymous reporting of medical errors and patient safety concerns. Measurements and Main Results:During a 14-month period, 714 patient safety events were reported using a new card-based reporting system, reflecting a significant increase in reporting compared with pre-intervention Web-based reporting (20.4 reported events/1,000 patient days pre-intervention to 41.7 reported events/1,000 patient days postintervention; rate ratio, 2.05; 95% confidence interval, 1.79–2.34). Nurses submitted the majority of reports (nurses, 67.1%; physicians, 23.1%; other reporters, 9.5%); however, physicians experienced the greatest increase in reporting among their group (physicians, 43-fold; nurses, 1.7-fold; other reporters, 4.3-fold) relative to pre-intervention rates. There were significant differences in the reporting of harm by job description: 31.1% of reports from nurses, 36.2% from other staff, and 17.0% from physicians described events that did not reach/affect the patient (p = .001); and 33.9% of reports from physicians, 27.2% from nurses, and 13.0% from other staff described events that caused harm (p = .005). Overall reported patient safety events per 1,000 patient days differed by ICU (medical ICU = 55.5, cardiothoracic ICU = 25.3, surgical ICU = 40.2; p < .001). Conclusions:This card-based reporting system increased reporting significantly compared with pre-intervention Web-based reporting and revealed significant differences in reporting by healthcare worker and ICU. These differences may reveal important preferences and priorities for reporting medical errors and patient safety events.

How trainees would disclose medical errors: educational implications for training programmes.

Medical Education 2011: 45: 372–380

Risk managers, physicians, and disclosure of harmful medical errors.

BACKGROUND Physicians are encouraged to disclose medical errors to patients, which often requires close collaboration between physicians and risk managers. METHODS An anonymous national survey of 2,988 healthcare facility-based risk managers was conducted between November 2004 and March 2005, and results were compared with those of a previous survey (conducted between July 2003 and March 2004) of 1,311 medical physicians in Washington and Missouri. Both surveys included an error-disclosure scenario for an obvious and a less obvious error with scripted response options. RESULTS More risk managers than physicians were aware that an error-reporting system was present at their hospital (81% versus 39%, p < .001) and believed that mechanisms to inform physicians about errors in their hospital were adequate (51% versus 17%, p < .001). More risk managers than physicians strongly agreed that serious errors should be disclosed to patients (70% versus 49%, p < .001). Across both error scenario, risk managers were more likely than physicians to definitely recommend that the error be disclosed (76% versus 50%, p < .001) and to provide full details about how the error would be prevented in the future (62% versus 51%, p < .001). However, physicians were more likely than risk managers to provide a full apology recognizing the harm caused by the error (39% versus 21%, p < .001). CONCLUSIONS Risk managers have more favorable attitudes about disclosing errors to patients compared with physicians but are less supportive of providing a full apology. These differences may create conflicts between risk managers and physicians regarding disclosure. Health care institutions should promote greater collaboration between these two key participants in disclosure conversations.

Failure of high-dose oral acyclovir with or without immune globulin to prevent primary cytomegalovirus disease in recipients of solid organ transplants☆☆☆

Abstract purpose: To assess the efficacy of acyclovir and intravenous immune globulin (IVIG) for cytomegalovirus (CMV) prophylaxis in high-risk recipients of solid organ transplants. patients and methods: We randomized 21 CMV-seronegative organ transplant recipients with seropositive donors (D+R−) to receive oral acyclovir, 800 mg four times daily, or, in addition to acyclovir, IVIG, 300 mg/kg, every 2 weeks for six doses. Patients were followed closely for the development of CMV infection and disease. results: All but one prophylactically treated patient (95%) developed CMV infection. Fifteen of 21 patients (71%) who received prophylaxis fulfilled criteria for CMV disease. Disease onset was delayed in those who received IVIG, but this did not reach statistical significance. Ganciclovir was used for treatment in 15 of the 21 patients (71%). conclusions: Acyclovir, with or without IVIG, did not prevent primary CMV infection or disease in D+R− solid organ transplant recipients at our institution. Moreover, most patients were treated with ganciclovir despite the use of prophylaxis. Given the ready availability of ganciclovir to treat CMV disease, we recommend a reappraisal of the role of CMV prophylaxis by these means in the solid organ transplant population.

Symptomatic Cytomegalovirus Infection in Renal Transplant Recipients Given Either Minnesota Antilymphoblast Globulin (MALG) or OKT3 for Rejection Prophylaxis

To compare the impact of using Minnesota antilymphoblast globulin (MALG) versus the monoclonal antibody, OKT3, on the development of symptomatic cytomegalovirus (CMV) infection, we reviewed a cohort of 130 cadaveric renal transplant recipients enrolled in a prospective comparison of MALG versus OKT3 for rejection prophylaxis. Among the 112 patients at risk for CMV, prophylactic MALG was associated with an increased risk of symptomatic infection (relative hazard [rh] = 3.31; 95% confidence interval CI], 1.50 to 7.30; P = 0.003). Transplantation of kidneys from CMV-seropositive donors into CMV-seronegative recipients (rh = 5.22; 95% CI, 2.34 to 11.63; P = 0.00004), first transplantation (rh = 4.76; 95% CI, 1.06 to 21.3; P = 0.039), and acute rejection therapy (rh = 2.03; 95% CI, 0.98 to 4.21; P = 0.055) were also associated with an increased risk. Prophylactic MALG followed by treatment with any agent for acute rejection was strongly correlated with symptomatic CMV infection (rh = 4.46; 95% CI, 3.71 to 5.21; P = 0.00006). Symptomatic CMV infection was not only more frequent, but more severe in recipients of prophylactic MALG, and more MALG recipients were treated with ganciclovir. There was no difference in rejection rate for the two rejection prophylaxis regimens (P = 0.625). Prophylactic OKT3 results in less risk of symptomatic CMV infection than prophylactic MALG in cadaveric renal transplant recipients who are seropositive for CMV or whose donors are seropositive for CMV.(ABSTRACT TRUNCATED AT 250 WORDS)

The Risks of Not Adjusting Performance Measures for Sociodemographic Factors

The National Quality Forum (NQF) recently convened an expert panel to make recommendations on a much-debated topic: whether to risk-adjust health care outcomes for sociodemographic factors present at the initiation of medical care and treatment. The panel completed its work in early July 2014, making the following recommendation: When there is a conceptual relationship (i.e., logical rationale or theory) between sociodemographic factors and outcomes or processes of care and empirical evidence (e.g., statistical analysis) that sociodemographic factors affect an outcome or process of care reflected in a performance measure: those sociodemographic factors should be included in risk adjustment of the performance score (using accepted guidelines for selecting risk factors) unless there are conceptual reasons or empirical evidence indicating that adjustment is unnecessary or inappropriate; and the performance measure specifications must also include specifications for stratification of a clinically-adjusted version of the measure based on the sociodemographic factors used in risk adjustment. (1) The Centers for Medicare & Medicaid Services (CMS) has an opposing view, as reflected in the following comments from their director of quality measurement and health assessment posted on the NQF Web site after the expert panels release of draft recommendations in March 2014: Currently, CMS does not adjust quality outcomes measures for patient socio-economic status (SES) because of the concerns that doing so would establish a different standard of care for providers based on the SES of the patients they care for and mask disparities in the quality of care provided CMS is concerned that this recommendation could be a setback to the goal of equity within the health care system. We are concerned that the recommendation that is being made to risk adjust for sociodemographic factors is premature, given the lack of evidence that has been generated to warrant such a recommendation. (1) The expert panel received 667 public comments from 158 organizations on this draft report: 143 supported the recommendations, 8 (including the CMS) opposed them, and 7 were mixed. Health care providers almost uniformly, along with some consumer advocates, supported the recommendations. They are concerned that, absent sociodemographic factor risk-adjustment methods that recognize a higher degree of difficulty and greater resource utilization in producing optimal quality outcomes for low-income and otherwise disadvantaged patients, safety-net providers are unfairly tagged with poorer health outcomes. The opposed and mixed points of view came from purchasers, other consumer advocates, and measure developers. Purchasers and opposing consumer advocates are concerned about masking disparities in health outcomes, different standards of care, and the lack of transparency. Measure developers are concerned that risk adjustment for sociodemographic factors will burden their methods with added complexity and that data available in the public domain may be insufficient to do the necessary calculus and still produce reliable and valid results. Why is adjustment for sociodemographic factors so hotly contested? All parties seem to embrace new reward and recognition programs that encourage optimal quality outcomes. Of note, however, the quality measures themselves are typically measures of variation in outcomes, comparing actual observed outcomes with predicted or expected outcomes and then making comparisons among providers by using various statistical models and methods. Under current NQF policy, the predicted or expected values are risk-adjusted for clinical factors that are present at the initiation of medical care and treatment, but not for sociodemographic factors. The CMS and other payers have publicly signaled an intention to move billions of dollars away from physicians and hospitals receiving traditional fee-for-service payments to pay-for-performance based on health care quality outcome measures (such as hospital readmission rates), shared savings models (such as accountable care organizations), and full-risk capitation plans (such as Medicare Advantage). Under each new payment model, outcome measures are used to ensure high quality, keeping in mind that favorable variations from a predicted or expected outcome will be rewarded and unfavorable variations will be penalized. If risk adjustment of health care outcomes based on a combination of clinical and sociodemographic factors explains away too much of the variations in outcomes (quality and cost), the remaining variations may be insufficient to pass a test of statistical significance. The Table shows data from BJC HealthCare in St. Louis, Missouri, that inform our position on risk adjustment for sociodemographic factors. It presents a discharge-weighted poverty rate for each BJC HealthCare adult hospital. This geographic measure of sociodemographic factors reflects the average poverty rate of the census tracts where each hospitals patients live (not where the hospitals are located). The 4 hospitals with the highest discharge-weighted poverty rates also have the highest all-cause, all-condition readmission rates1 is a teaching hospital (Barnes-Jewish Hospital), 2 are nonteaching safety-net hospitals (Christian Hospital and Alton Memorial Hospital), and 1 is a rural hospital (Parkland Health Center). Table. Discharge-Weighted Poverty Rates by Census Tract, All-Cause Readmission Rates, and Readmission Rate Penalties of BJC HealthCare Hospitals For individual hospitals, such as Christian Hospital or Parkland Health Center, the absence of risk adjustment for sociodemographic factors has consequences. Both hospitals disproportionately serve Medicaid recipients and uninsured patients. Christian Hospital and Parkland Health Center operate with negative margins of