Quality assurance review of death certificates: a pilot study

BACKGROUND: Although quality assurance programs for medical examiners are required by the National Association of Medical Examiners' Inspection and Accreditation Checklist, quality assurance programs specifically targeting death certificate completion have not been addressed. The Fulton County Medical Examiner, Atlanta, GA, has implemented a pilot quality assurance program for death certificate information, and this report contains information about 1 year's experience with the program. METHODS: All death certificates are reviewed by the case medical examiner(s) and chief medical examiner prior to their release to funeral homes. Death certificates with errors are retained for quality assurance and review purposes, and needed corrections are made before death certificates are released. During a 1-year period, death certificates with errors were collected and then reviewed and tabulated by type of error. RESULTS: Between May 26, 2003, and May 25, 2004, the Fulton County Medical Examiner certified 1267 deaths. Of these, 47 (4%) were found to contain errors that were corrected and an additional 52 (4%) had been amended for various reasons. The most common errors were misspellings in causes of death or poor or incomplete wording in injury-related information. Forty-seven percent of errors involved omitted, incomplete, or incorrect information that was potentially significant. The most common reason for amended certificates was unexpected detection of acute intoxications among people with significant cardiovascular disease. CONCLUSIONS: Quality assurance review of death certificates can assist in preventing the release of death certificates with incomplete, erroneous, or omitted information and may also be useful as an educational forum regarding completion of the death certificate.     

Variability in cancer death certificate accuracy by characteristics of death certifiers

Death certificates are the source for mortality statistics and are used to set public health goals. Accurate death certificates are vital in tracking outcomes of cancer. Deaths may be certified by physicians or other medical professionals, coroners, or medical examiners. Idaho is one of 3 states that participated in a Centers for Disease Control and Prevention-funded study to assess the concordance between cancer-specific causes of death and primary cancer site among linked cancer registry/death certificate data. We investigated variability in the accuracy of cancer death certificates by characteristics of death certifiers, including certifier type (physician vs coroner), physician specialty, years of experience as death certifier, and number of deaths certified. This study showed significant differences by certifier type/physician specialty in the accuracy of cancer mortality measured by death certificates. Nonphysician coroners had lower accuracy rates compared with physicians. Although nonphysician coroners certified less than 5% of cancer deaths in Idaho, they were significantly less likely to match the primary site from the cancer registry. Results from this study may be useful in the future training of death certifiers to improve the accuracy of death certificates and cancer mortality statistics.     

Mind your manners: quality of manner of death certification among medical examiners and coroners in Taiwan

To assess the quality of manner of death (MOD) certification among medical examiners/coroners (ME/Cs) in Taiwan, death certificates issued in 2002 for which the final MOD was suicide or undetermined were extracted for analysis. Indicators of the quality of MOD certification included (1) MOD not given by the ME/Cs; (2) MOD assigned by the ME/Cs was changed by the coder; (3) ratio between undetermined and suicide deaths (U/S ratio). There were 450 death certificates for which the ME/Cs did not assign the MOD in the original certificate. Three fifths (285/450) of them were issued by 4 ME/Cs. The same 4 ME/Cs also had extremely high U/S ratios (1.25-1.84) compared with the average (0.31). The overall quality of MOD certification among ME/Cs in Taiwan was fair; only a small number of ME/Cs had poor quality in MOD certification. The high U/S ratio among the 4 ME/Cs would certainly affect the suicide mortality rates of the counties the 4 ME/Cs were in charge of. Actions should be taken to improve the certification quality of these 4 ME/Cs.     

Principles of records and coding causes of death as a result of craniocerebral injury

Discusses modern requirements to coding of death causes in cases of craniocerebral injury in accordance with the 10th revision of International Statistical Classification of Diseases and Health-Related Problems (ICD-10). Offers the ways to fill in medical certificates of death with consideration for the items of ICD-10 and classification of craniocerebral injuries.     

英国法上"死亡"定义之考察

本文从英国判例法和医学行业标准两个方面考察了英国法上“死亡”这一概念的发展过程,阐释了传统的心跳和呼吸停止标准与脑死亡标准的关系以及英国社会目前对死亡定义所存在的疑虑和争议,并且指出了英国法对我国的借鉴意义。本文通过对英国法上死亡定义的考察,以期对我国目前正在进行的脑死亡法的起草工作有所助益。     

The use of mental status in death certification of suicide

A 5-year study (1982-1986) illustrates the use of mental status in death certification of suicide in 182 consecutive cases from Marion County, Oregon, U.S.A. The presence of specific mental illness was documented in Part II of the filed death certificate whenever sufficient data supported such a diagnosis. This study represents, so far as we are aware, the first use of mental illness in the routine death certification of suicide. The study subjects were described in terms of sex; age group; the presence or absence of a suicide note; the anatomical cause of death (Part I of the death certificate); and the presence of mental illness, severe physical illness, or alcohol abuse (Part II of the death certificate) as contributive to the death. About half (97 of 182 = 53.30%) of the study group was diagnosed as suffering from a major affective disorder. Another portion (18 of 182 = 9.89%) was classified as schizophrenic. A subgroup of 18 men, all of whom were residents of state mental or correctional institutions at the time of death, was also briefly described.     

Cause-of-death query in validation of death certification by expert panel; effects on mortality statistics in Finland, 1995

The correctness of selection, coding and registration of underlying cause-of-death is important for the quality of mortality statistics. One measure to improve quality is the query to the certifier for verification of the underlying cause-of-death. In Finland, 3478 death certificates, 7.1% of total 49074 certifications in 1995, were considered questionable by statisticians. The expert panel at Statistics Finland was able to resolve 2813 (80.9%) of them. However, 665 (19.1%) certificates needed to be further queried from the certifier. Of these, 318 (47.8%) were re-assigned to another ICD-9 category or to the applicable three-digit category within the main category of heart and vascular diseases, resulting in changes from a 17.00-fold increase in rheumatic heart diseases (ICD-9 codes 390-398) to a decrease of about one-half (0.45-fold change) in unspecified neoplasms (codes 235-239). However, a statistically significant impact on national mortality statistics was not observed in any of applied ICD categories. Among all questionable death certificates, most prone to query of the certifier, and with a statistical significance of P<0.05, were those with no cause-of-death specified, those stating underlying cause-of-death as non-specified neoplasms (with a observed/expected ratio, O/E, of 1.69), and heart and vascular diseases (1.45), with its subcategories of ischaemic heart diseases (1.33) and other heart diseases (2.92). Death certificate validation, by expert panel consultations and query to the certifiers, and the importance of estimation of the validity of cause-of-death information on death certificates are strongly pointed out in a continuous strive for correct and reliable mortality statistics.     

Evaluation of certifier practices regarding alcohol-related deaths: Fulton County Medical Examiner's Center, Atlanta, Georgia, 2004

CONTEXT: Alcohol can contribute to various manners of death by acute intoxication that places a person at risk for fatal injury, acute fatal alcohol poisoning, or the various fatal complications of chronic abuse with or without superimposed acute intoxication. The reporting of alcohol use on the death certificate may vary with office policy or procedure, certifier judgment, and the timing of information received during investigation. OBJECTIVE: To determine the number of deaths including mention of alcohol use in the investigative case file, the number of death certificates on which alcohol use is reported, the number of discrepancies between the 2, and the possible reasons for observed discrepancies. DESIGN, SETTING, AND PARTICIPANTS: Retrospective case review of all deaths where alcohol use was mentioned in the investigative case file and/or on the death certificate for deaths investigated by the Fulton County Medical Examiner in Atlanta, Georgia, during a 1-year period between January 1, 2004, and December 31, 2004. MAIN OUTCOME MEASURES: Percentage of deaths with alcohol use reported on the death certificate, tabulation of where and how alcohol use is reported on the death certificate, and tabulation of the differences between the investigative case file and death certificate regarding alcohol's possible role in causing death. RESULTS: Among the 1324 deaths certified by the office, 105 (8%) had alcohol use reported on the death certificate. The majority (67%) of these cases were natural deaths. Sixty-nine (5%) deaths had mention of alcohol use in the investigative case notes but did not include it on the death certificate. Twenty-five (2%) deaths had mention of alcohol on the death certificate but did not have mention of it in the investigative case file based on our search criteria. However, subsequent review of additional case follow-up information disclosed a history of alcohol use or acute intoxication in each case. CONCLUSIONS: The data show that more natural deaths are considered to be directly caused by alcohol than other manners of death. For the unnatural manners of death (excluding acute alcohol poisoning), alcohol use is often viewed by medical examiners as an incidental, associated finding or risk factor surrounding the circumstances of death rather than being an actual cause of death. In such cases, alcohol use is often omitted from the death certificate. For deaths directly caused by alcohol, the proportion of cases involving possible underreporting or overreporting of alcohol involvement was relatively small and usually involved the omission of chronic alcohol use from the death certificate. Researchers need to be aware of potential limitations of death certificate data for studying alcohol-related deaths.     

Technological, economic, and political feasibility in OSHA's Air Contaminants Standard

In 1989, after almost two decades of substance-by-substance standard setting, the Occupational Safety and Health Administration (OSHA) promulgated its Air Contaminants Standard, imposing new exposure limits for 376 toxic substances encountered in U.S. industry. In marked contrast to earlier regulations, the Air Contaminants Standard has generated relatively little industry opposition. This paper analyzes the standard in the context of the twenty-year debate over the appropriate role for technological feasibility and economic compliance costs in occupational health policy. The political feasibility of the new standard is traced to OSHA's abandonment of "technology forcing" in favor of reliance on "off-the-shelf" technologies already in use in major firms. While important as an embodiment of OSHA's new "generic" approach to regulation, the Air Contaminants Standard cannot serve as a model for future occupational health policy, due to its reliance on informal, closed-door mechanisms for establishing regulatory priorities and permissible exposure limits.     

Discrepancies in Death Certificates,Public Health Registries,and Judicial Determinations in Italy

The death certificate is mandated by civil law and serves as a medical‐scientific document useful for biostatistics and epidemiological research. For a variety of reasons, death certificates can be misclassified. We reviewed data from self‐inflicted deaths collected over an 8‐year period by the Forensic Institute of the University Sacro Cuore of Rome (Italy). Four hundred and thirty‐five of 2904 were classified as self‐inflicted deaths (15%). The comparison with death certificates processed by the local public health authority (ASL) and by the Italian National Census Bureau (Istat) and with the judicial investigation results available in the Italian Penal Court archive shows some discrepancies. One‐hundred and twenty‐four of 435 deaths were not considered to be self‐inflicted but due to a crime (29% overrecording suicide) with a higher reduction for women, suggesting that it is easier to confuse a murder for suicide in female cases. Any discrepancies between the mortality and crime data are discussed in details.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.     

Certifying Death in the United States

Accurately identifying death and its causes is integral to the compilation of mortality data and ultimately to the operation of the criminal justice and public health systems. A clear understanding of who is in charge of such processes is paramount to establishing the quality, or lack thereof, of the information provided in death certificates. Our study provides a comprehensive overview of all state statutes identifying death investigators charged with classifying and certifying death in the United States. We found that state statutes designate a broad range of individuals as responsible for the classification and certification of death. Those vary by state and set of circumstances and can include medical examiners, coroners, pathologists, other physicians, registered nurses, and more. Our findings highlight the important need for a unified standard of qualifications in the medico‐legal system, as well as, regulatory reform at the state level regarding who can complete and sign death certificates.     

Approval tests and standards for closed-circuit escape respirators. Final rule

This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs.     

Cancer treatment clinical trials--DoD. Notice of demonstration project

This notice is to advise interested parties of a demonstration project in which the DoD will expand a current demonstration for breast cancer treatment clinical trials to include all cancer treatment clinical trials under approved National Institutes of Health, National Cancer Institute (NCI) clinical trials. Participation in these clinical trials will improve accessing to promising cancer therapies for CHAMPUS eligible beneficiaries when their conditions meet protocol eligibility criteria. DoD financing of these procedures will assist in meeting clinical trial goals and arrival at conclusions regarding the safety and efficacy of emerging therapies in the treatment of cancer. This demonstration project is under the authority of 10 U.S.C. 1092.     

Availability of information to the public under the Freedom of Information Act; redelegation of authority--Office of the Secretary, HHS. Final regulation

The Department of Health and Human Services hereby amends its regulation implementing the Freedom of Information Act. This revision designates officials who shall have responsibilities for determining whether records must be withheld from disclosure, or released, under provisions of the Act (5 U.S.C. 552).     

RFLP band size standards: NIST standard reference material 2390

The procedural standard for DNA profiling developed by the U.S. advisory board on DNA quality assurance methods mandates annual confirmation of forensic DNA measurement systems against an appropriate reference material supplied by or traceable to the National Institute of Standards and Technology (NIST). NIST Standard Reference Material (SRM) 2390 is a suitable and appropriate standard for HaeIII restriction enzyme-based restriction fragment length polymorphism (RFLP) profiling systems. Originally issued in 1992, an among-laboratory SRM 2390 recertification study was initiated in 1997. Using data provided by the 20 state, local, or commercial forensic laboratory participants, quantitative band sizes values (expected mean values and associated bivariate tolerance intervals) are established for two different-source DNAs (female cell line K562 and healthy male "TAW") for genetic loci D1S7, D2S44, D4S139, D5S110, D1OS28, and D17S79. Methods for validating an RFLP measurement system, validating a control material or other secondary standard, and for tracing a particular set of RFLP measurements to NIST SRM 2390 are described in detail.     

Errors on death certificates requiring amendments: the Broward County experience

The medical examiner's office in Broward County is responsible for determining the cause and manner of death in cases falling under its jurisdiction and issuing death certificates on these decedents. Amendments are occasionally required to correct misinformation on death certificates or within the autopsy reports. The purpose of this study was to investigate the major causes for the amendments and to develop strategies to avoid future errors. We found 128 cases from 2006 to 2007 that required amendments; 103 contained sufficient data in the file for further analysis. Over this time period, 3790 death certificates were issued over that same period, resulting in a 3.37% amendment rate. In this study, the cohort included both males and females with a ratio of 2:1. Their ages ranged from newborn to 103 years, with a mean age of 49 years. Of the 103 amended cases, amendments were made to the cause (n = 30) and often the manner (n = 21) of death listed on the death certificate; the remaining changes were limited to the autopsy report. The most common reasons for amendments included reception of delayed laboratory findings (35%), acquisition of additional medical history (22.5%), and typographic errors (15.5%). Typographic errors mainly occurred because of inaccuracies in the names originally provided to our office, the use of aliases by decedents, incorrect personal/demographic history, or various misspellings by funeral homes or medical examiner staff. The most significant reclassifications involved changing certified natural deaths to accidental overdoses and vice versa, based on toxicological analysis. Because of delays in specimen turnaround, these amendments often were made months after the original death certificate was issued. STAT urine drug screening has been helpful in reducing the number of amendments made, but certain drugs of significance are missed by rapid screens. Given that our office performed complete toxicological analysis on all cases over this period, it seems likely that we detected several overdoses that would have been missed if natural deaths were not routinely screened for potential toxins.     

Privacy Act; exempt record system--Office of the Secretary, DHHS. Notice of proposed rulemaking

The Office for Civil Rights of the Department of Health and Human Services maintains a system of records entitled "Complaint Files and Log. HHS/OS/OCR." The Department intends to exempt this system from certain provisions of the Privacy Act, 5 U.S.C. 552a. The proposed exemption is authorized by subsection (k)(2) of the Privacy Act, which applies to investigative materials compiled for law enforcement purposes. The Office for Civil Rights (OCR) is authorized to gather information for civil and administrative law enforcement purposes pursuant to several statutes requiring nondiscrimination in programs or activities receiving Federal financial assistance. In order to maintain the integrity of the OCR investigative process and to access to complete and accurate information, the Department proposes to exempt this system, under subsection (k)(2), from the notification, access, correction and amendment provisions of the Privacy Act. The Department is requesting public comments on the proposed exemption.