BACKGROUND: We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories. METHODS: Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented. RESULTS: A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001). CONCLUSIONS: The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.
Clinical Laboratory Techniques/standards ; Diagnostic Errors/statistics & numerical data ; Humans ; Laboratories, Hospital/*standards ; Specimen Handling/standards

OBJECTIVE: To explore the general characteristics of medical negligence in surgery in order to provide the reference for forensic practices. METHODS: One hundred and twelve cases of medical negligence in surgical department were retrospectively analyzed in Fada Institute of Forensic Medicine and Science from 2008 to 2010. RESULTS: The common types of medical negligence cases in the surgery were improper operation procedure (28.57%), failure of consent (26.79%), and inadequate monitoring (22.32%). The results of complications included disability or functional impairment (61.61%), death (31.25%) and transient impairment with no obvious adverse reactions (7.14%). The most common roles played by the medical negligence cases were minor role (26.79%), equal role (19.64%), and slight role (14.29%). CONCLUSION Significant attention should be paid to the operation procedure, consent, and monitoring. It should be cautious to not make assessment on involvement degree of medical negligence.
Cause of Death ; China ; Diagnostic Errors/statistics & numerical data* ; Expert Testimony/legislation & jurisprudence* ; Female ; Forensic Medicine ; Humans ; Informed Consent ; Intraoperative Complications/mortality* ; Male ; Malpractice/statistics & numerical data* ; Medical Errors/statistics & numerical data* ; Retrospective Studies ; Surgical Procedures, Operative

ObjectiveTo study the clinical application value of the penile erectile strength measurement (PESM) band in the differentiation of psychogenic from organic erectile dysfunction (ED).

METHODSEighty ED patients unable to achieve or maintain adequate penile erection to complete sexual intercourse were included in the experimental group and another 40 healthy subjects with normal erectile function enrolled as controls. The ED cases were classified into mild, moderate and severe ED according to the IIEF-5 scores and divided into psychogenic and organic ED based on the results of the nocturnal penile tumescence (NPT) test. Then all the subjects underwent a three-night continuous monitoring with the PESM band and, according to the band fracture rate, the ED cases were also classified into psychogenic and organic ED. The rates of missed diagnosis, misdiagnosis and diagnostic coincidence of PESM were calculated with the results of NPT as the standard for differentiating psychogenic from organic ED.

RESULTSThe results of NPT tests revealed 51 cases of psychogenic and 29 cases of organic ED in the experimental group. The band fracture rate in PESM was 95.0% in the mild, 80.9% in the moderate and 52.8% in the severe ED patients. Of the 51 cases of psychogenic ED detected by NPT test, 43 were diagnosed as psychogenic and the other 8 as organic ED with the PESM band, with a coincidence rate of 84.3%. Of the 29 cases of organic ED revealed by NPT test, 5 were diagnosed as psychogenic and the other 24 as organic ED by PESM, with a coincidence rate of 82.8%. Normal erectile function with three-level fracture of the band was observed in the PESM of the normal controls, which showed a coincidence rate of 100% with the results of NPT tests. Based on the standard of the NPT test, the rates of missed diagnosis, misdiagnosis and diagnostic coincidence of the PESM band in differentiating psychogenic from organic ED were 15.7%, 17.2%, and 83.8%, respectively, with a Kappa value of 0.656 (P <0.05).

CONCLUSIONSThe penile erectile strength measurement band can be used as a screening tool for initial differentiation of psychogenic from organic ED.

Case-Control Studies ; Coitus ; Diagnostic Errors ; statistics & numerical data ; Erectile Dysfunction ; classification ; diagnosis ; physiopathology ; psychology ; Humans ; Male ; Penile Erection ; physiology

BACKGROUND/AIMS: Interval gastric cancer (IGC) is defined as cancer that is diagnosed between the time of screening and postscreening esophagogastroduodenoscopy (EGD). Unfortunately, little is known about the characteristics of IGC in Korea, a country with a high incidence of gastric cancer. The aim of this study was to evaluate the clinicopathologic characteristics of IGCs in Korea. METHODS: From January 2006 to July 2011, a total of 81,762 subjects underwent screening EGD at Yonsei University Health Promotion Center, Seoul, Korea. We defined missed cancer as cancer diagnosed within 1 year of screening EGD and latent cancer as cancer diagnosed more than 1 year after EGD. RESULTS: A total of 16 IGC patients (17 lesions; three missed cancers and 14 latent cancers) were identified, with a mean age of 60.68 years and a mean interval time of 19.64 months. IGCs tended to be undifferentiated (12/17, 70.6%), located in the lower body of the stomach (12/17, 70.6%) and exhibited flat/depressed endoscopic morphology (11/17, 64.7%). The patients with missed cancer were generally younger than the patients with latent cancer (51.3 years vs 62.8 years, p=0.037), and the patients with undifferentiated cancer were significantly younger than those with differentiated cancer (57.0 years vs 68.8 years, p=0.008). CONCLUSIONS: IGCs tended to be undifferentiated, located in the lower body of the stomach, and exhibited flat/depressed endoscopic morphology.
Age Factors ; Aged ; Carcinoma/pathology ; Delayed Diagnosis/statistics & numerical data ; Diagnostic Errors/statistics & numerical data ; Early Detection of Cancer ; Endoscopy, Digestive System/statistics & numerical data ; Female ; Humans ; Male ; Middle Aged ; Seoul ; Stomach/*pathology ; Stomach Neoplasms/*pathology

BACKGROUND/AIMS: Interval gastric cancer (IGC) is defined as cancer that is diagnosed between the time of screening and postscreening esophagogastroduodenoscopy (EGD). Unfortunately, little is known about the characteristics of IGC in Korea, a country with a high incidence of gastric cancer. The aim of this study was to evaluate the clinicopathologic characteristics of IGCs in Korea. METHODS: From January 2006 to July 2011, a total of 81,762 subjects underwent screening EGD at Yonsei University Health Promotion Center, Seoul, Korea. We defined missed cancer as cancer diagnosed within 1 year of screening EGD and latent cancer as cancer diagnosed more than 1 year after EGD. RESULTS: A total of 16 IGC patients (17 lesions; three missed cancers and 14 latent cancers) were identified, with a mean age of 60.68 years and a mean interval time of 19.64 months. IGCs tended to be undifferentiated (12/17, 70.6%), located in the lower body of the stomach (12/17, 70.6%) and exhibited flat/depressed endoscopic morphology (11/17, 64.7%). The patients with missed cancer were generally younger than the patients with latent cancer (51.3 years vs 62.8 years, p=0.037), and the patients with undifferentiated cancer were significantly younger than those with differentiated cancer (57.0 years vs 68.8 years, p=0.008). CONCLUSIONS: IGCs tended to be undifferentiated, located in the lower body of the stomach, and exhibited flat/depressed endoscopic morphology.
Age Factors ; Aged ; Carcinoma/pathology ; Delayed Diagnosis/statistics & numerical data ; Diagnostic Errors/statistics & numerical data ; Early Detection of Cancer ; Endoscopy, Digestive System/statistics & numerical data ; Female ; Humans ; Male ; Middle Aged ; Seoul ; Stomach/*pathology ; Stomach Neoplasms/*pathology

BACKGROUND: In unrelated hematopoietic stem cell transplantation, the accuracy of HLA registry typing (RT) of donors is important for timely search and coordination of HLA-matched donors. We analyzed discrepancies between HLA RT and confirmatory typing (CT) results of stem cell donors in Korean and foreign registries. METHODS: We analyzed the HLA typing results of 834 donors for whom CT was performed at Seoul National University Hospital between April 1997 and March 2010. For CT, DNA typing was used in majority of the cases and HLA-A and HLA-B serological typing was used in some early cases. The discrepancies between the typing results were analyzed at the serological/generic level. RESULTS: The overall discrepancy rate (RT error rate) was 3.2%, and the rate was similar in the Korean and foreign registries. The discrepancy rates in the Korean and foreign registries were more than 10% in the 1997-2001 searches, but decreased to less than 3% in the 2002-2010 searches. Analysis of 19 cases of RT errors in the Korean registry revealed 3 cases of sample switchover errors and 16 cases of typing errors in one of the HLA-A, HLA-B, or HLA-DR loci. The RT error rate in Japan Marrow Donor Program was lower than those in other foreign registries. CONCLUSIONS: The error rate of HLA RT results of unrelated stem cell donors in the Korean registry was similar to those in the foreign registries, and has decreased in the recent searches following the change in the typing method from serological to DNA typing.
Diagnostic Errors/statistics & numerical data ; HLA Antigens/*genetics ; *Hematopoietic Stem Cell Transplantation ; Hematopoietic Stem Cells/metabolism ; Histocompatibility Testing/*methods ; Humans ; *Registries ; Tissue Donors

OBJECTIVETo summarize the major pathological findings, causes of deaths and reasons for misdiagnosis of 141 autopsy cases and thereby to improve the diagnosis level and reduce misdiagnosis.

METHODA retrospective analysis of pathological reports and clinical materials of 141 pediatric autopsy cases from June, 1986 to June, 2006 of our department was performed. Classification was based on (1) international classification of diseases of the World Health Organization; (2) age: cases 28 d-3 years old were defined as infants and young children group, -7 yeas olds were defined as preschool age group, -14 years olds were school age group; (3) when statistics was conducted, the first 3 items of the clinical diagnoses were counted. If one of them was consistent with the pathological diagnosis, it was regarded as basically in accordance with the pathology, if none of the first 3 was consistent with pathological diagnosis, the case was regarded as misdiagnosed.

RESULTS(1) The top three major pathological diagnosis and causes of death were: 1) Classified according to system: 41 cases had tumor (29.1%), 25 cases had respiratory diseases (17.7%), 18 cases had infectious diseases (12.7%); 2) Classified according to disease: 18 cases had malignant histiocytosis, 12 cases had sepsis, 11 cases had lobular pneumonia. (2) The causes of deaths changed gradually. The top cause of death was respiratory diseases during the former 10 years and was tumor during the latter 10 years; the materials showed that 95 cases were 28 d-3 years old (67.4%), and some rare diseases, such as mediastinal and lung chorionic epithelioma (choriocarcinoma), and pulmonary alveolar proteinosis were found. (3) In 90 cases the clinical diagnosis was basically in accordance with the pathological diagnosis (63.8%) and misdiagnosis was found in 51 cases (36.2%).

CONCLUSIONFor clinical diagnosis of critically ill patients, both common and rare diseases should be considered. Analysis of autopsy materials could confirm and/or correct clinical diagnosis and is helpful to summarize clinical diagnosis experience.

Adolescent ; Autopsy ; statistics & numerical data ; Cause of Death ; Child ; Child, Preschool ; Diagnostic Errors ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Pathology, Clinical ; Retrospective Studies

Adolescent ; Adult ; Child ; Child, Preschool ; Diagnostic Errors ; statistics & numerical data ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Ulnar Nerve ; injuries ; Ulnar Neuropathies ; diagnosis

Cone-beam CT (CBCT) of Elekta can be used to analyze the setup errors in intensity modulated radiotherapy. A total of 240 patients with head and neck cancer were chosen in the period from October, 2009 to October, 2010. Their CBCT images were obtained after initial setup, and registered to the planning CT images, and then the setup errors on translational directions (X, Y, Z) and on rotational directions (U, V, W) were obtained and analyzed. The results showed that the setup errors on translational directions in Y-axis and Z-axis were larger than in X-axis, and the setup errors on rotational directions in Y-axis was much more obvious than those on the other two directions, which should be taken care during the patient daily setup. It may be concluded that the CBCT system can improve the precision for radiotherapy.
Cone-Beam Computed Tomography ; methods ; Head and Neck Neoplasms ; diagnostic imaging ; radiotherapy ; Humans ; Radiotherapy Setup Errors ; prevention & control ; statistics & numerical data ; Radiotherapy, Intensity-Modulated

OBJECTIVETo evaluate the present status of pulmonary embolism (PE) misdiagnosis in China.

METHODSDocuments on PE misdiagnosis published in Chinese-language journals between 2001 and 2004 were identified by searching the China Hospital Knowledge Database in China National Knowledge Infrastructure Web (CNKI-CHKD). Retrospective review items include: patient symptoms, medical examination tools, treatments and prognosis, causes of death, hospitals involved. The recent situation on PE misdiagnosis was also compared to that in year between 1980 to 2000. The number of published literatures on PE and PE misdiagnosis from 1994 to 2004 was also searched.

RESULTS(1) A total of 110 documents with 1540 misdiagnosed PE patients were found. The misdiagnosis time varies from 0.5 hour to 16 years and was 1.86 years on average. (2) Once the misdiagnosis be corrected, the prognosis could be improved by antithrombotic and thrombolytic therapies compared with those without antithrombotic and thrombolytic therapies (OR 11.67, 95% CI 5.861-23.249). The major causes of death were sudden death, resistant shock in patients without antithrombotic and thrombolytic therapies while the causes were sudden death, cerebral hemorrhage and resistant shock in PE patients received antithrombotic and thrombolytic therapies. (3) Literatures on PE misdiagnosis were most from provincial hospitals [37 papers with 547 cases (33.6%, 35.5%)] and municipal hospitals [43 papers with 671 cases (39.1%, 43.6%)]. (4) The number of papers published on PE and PE misdiagnosis from 1994 to 2004 increased steadily by an average of 26.6% and 9.1%, respectively. (5) PE was misdiagnosed to more than 70 kinds of diseases and the top 4 were coronary heart disease in 449 cases (26.8%), pneumonia in 217 cases (12.9%), congestive heart failure in 142 cases (8.5%) and pleurisy in 114 cases (6.8%).

CONCLUSIONS(1) PE misdiagnosis is still a critical issue now in China and early diagnosis and effective treatment is essential for a better prognosis. (2) The differential diagnosis among PE and coronary heart disease and pneumonia need to be emphasized to avoid the PE misdiagnosis. (3) Efforts should be made through continuing education on clinical professionals to improve their knowledge on PE in China.

Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; China ; Diagnosis, Differential ; Diagnostic Errors ; statistics & numerical data ; Female ; Humans ; Male ; Middle Aged ; Pulmonary Embolism ; diagnosis ; Young Adult