Performance review of the National Blood Safety Improvement Project in Korea (2004-2009)

BACKGROUND: In 2004, the Korean government and blood transfusion community deliberated on the issue of a national blood system reform and agreed to implement a 5-year project (2004-2009) to further improve safety measures. Our study delineates the basis of the current national blood program and analyzes the performance of this 5-year project initiated by the Korean government. METHODS: A performance review of the 5-year project was conducted from May 2009 to February 2010 using various approaches. Numerous data and documentation were collected from the Korean Red Cross and the Korean Centers for Disease Control and Prevention and reviewed by experts. Approximately 20 interviews with representatives of stakeholder groups were conducted to gather information, opinions, and perceptions. We conducted a nationwide field survey on a total of 144 blood donor centers. RESULTS: Among the 5 major categories of the 5-year project, blood donor recruitment, laboratory testing, and product manufacturing were improved in terms of quality performance. Specifically, government's financial support ensured that the infrastructure of blood donor centers and blood laboratory centers improved. The pivotal role of the government contributed to improvements in the national blood program and enhanced national surveillance for blood safety. CONCLUSION: Korea has made a tremendous effort with positive outcomes to provide safety measures for blood products for transfusion in its citizens. In all areas of blood management, from blood donations to transfusions, continuous developments in monitoring safety standards and practices are paramount.

The Status of Use of Leukoreduced Blood Products in Korean Hospitals

BACKGROUND: Leukoreduced blood components are recommended for prevention of non-hemolytic febrile transfusion reactions, HLA alloimmunization, platelet transfusion refractoriness, and transfusion-transmissible diseases. In addition, prestorage leukoreduction may be advantageous to poststorage leukoreduction. The authors investigated the current status of usage of leukoreduced blood components in Korea. METHODS: We surveyed 2,373 medical facilities, where blood components were supplied from Korean Red Cross blood centers and/or Hanmaeum blood center during one year period between January and December 2009. The survey was conducted about the current situation of usage of leukoreduction by web-based program (http://bms.cdc.go.kr), and 743 facilities answered and were analyzed. RESULTS: The leukoreduced RBC components comprised 10.3% (prestorage leukoreduction, 91,066 units, 5.7%; poststorage leukoreduction 73,192 units, 4.6%) of the total 1,593,098 units of RBC components used in 743 medical facilities. The leukoreduced platelet concentrates comprised 33.1% (458,552 units) of the total 1,386,184 units of platelet concentrates used in 397 medical facilities. If 1 single donor platelet is counted as 6 platelet concentrates, 48.9% of the total platelet components used were leukoreduced. CONCLUSIONS: The proportion of leukoreduced blood components to the total blood components used in Korea was much lower than that in Unites States of America, especially lower in the use of prestorage leukoreduction of RBC components. Further studies are required for cost-effectiveness and demand-supply amounts of leukoreduced blood components, and appropriate prestorage leukoreduction has to be performed in Korea based on these studies.

The Hemoglobin Distribution of Korean Blood Donors / 대한수혈학회지

BACKGROUND: The current donor selection criteria need to be revised to ensure a reliable blood supply and for donor protection. This study was conducted to analyze the distribution of hemoglobin (Hb) levels of blood donors and to estimate the change of eligible donors when using the revised Hb criterion. METHODS: The Hb levels of all the blood donors who visited the Korean Red Cross Blood Center (KRCBC) between November 9th, 2010 and November 15th, 2010 were measured with a portable hemoglobinometer (HemoCue). The Hb levels of all the eligible donors and some of the deferred donors who visited the Hanmaeum Blood Center (HBC) from April 26th, 2010 to April 30th, 2010 and from November 9th, 2010 to November 15th, 2010 were measured with a portable hemoglobinometer (Hemo_Control). RESULTS: A total of 7,521 donors (6,500 eligible donors and 1,021 deferred donors) were enrolled. The donation eligibility rate at the KRCBC, which is where all the donors were examined, was 84.2% (3,409/4,049) and the deferral rate was 15.8% (640/4,049). The percent of blood donors whose Hb level was less than 12.5 g/dL was 2.1% of the men (44/2,145) and 34.9% of the women (664/1,904), respectively. The percent of female deferred donors with a Hb level of 12.0~12.4 g/dL was 19.3% (109/564) and the percent of male eligible donors with a Hb level of 12.5~12.9 g/dL was 2.6% (54/2,069). At the HBC, and with some deferred donors being excluded, the deferral rate of males and females was 2.0% (36/1,799) and 20.6% (345/1,673), respectively. CONCLUSION: About 20% of the female deferred donors could be expected to participate when a less strict Hb criterion (> or =12.0 g/dL) is applied. This study is thought to be helpful in order to determine the number of donors according to the Hb criteria and to create improved criteria.

Development of an Inspector Training Program for Korean Blood Establishments / 대한수혈학회지

BACKGROUND: Standardized management and surveillance at a national level is essential to maintain blood product safety. Officials of the Korean Division of Human Blood Safety Surveillance, Korea Centers for Disease Control and Prevention, and Korean laboratory transfusion medicine specialists, currently participate as inspectors in the Korean National Blood Inspection Program for Blood Establishments. However, lack of definitive guidelines and absence of standardized inspector training programs compromise the goal of objective and consistent safety management results. In this study, we propose establishment of written inspection guidelines and a clearly documented accreditation training program. METHODS: Inspector training programs in the US and EU were reviewed online and the results of the Korean National Blood Inspection in our country performed during last 4 years were analyzed. RESULTS: We suggested inspection guidelines for every question of inspection checklists. Also, for the questions similar to those of Laboratory Accreditation Program of the Korean Society for Laboratory Medicine (KSLM), guidelines were proposed as 'Results of Laboratory Accreditation Program of the KSLM could be concerned if inspected laboratory obtained 2 year accreditation lately'. We suggest an 18hr-basic training program composed of lectures, e-learning and a visit to a blood center, as well as 12hr-continuing courses, should be established. CONCLUSION: To establish the Blood Inspection Program in a more systematic manner, thorough management and training of inspectors are essential. We expect the guidelines and training program for inspectors, suggested in our study, will be the cornerstone for creating a more professional quality management system and further ensure the safety of the national blood management system.

International Comparison of the Eligibility Criteria for Apheresis Donors / 대한수혈학회지

BACKGROUND: There has not been a comprehensive review to compare the international eligibility criteria for apheresis donation. This study assessed the international variations of the eligibility criteria for apheresis donors to help improve our national criteria for safer and more efficient screening of donors. METHODS: We reviewed the websites of the American Red Cross, Canadian Blood Service, Australian Red Cross Blood Service, New Zealand Blood Service, Japanese Red Cross Society, Hong Kong Red Cross (HKRC), Health Sciences Authority of Singapore and the National Blood Service of the UK (NBS) and the European Union (EU). Only those criteria that were different from ours were analyzed. RESULTS: A considerable number of differences were identified between the international criteria and our criteria. The lower age limit was 17~18 years and the upper limit were 50~69 years for plasma donation and 50~59 years for platelet donation. The regulations for donation frequency ranged from none to 12~57 times/year for plasma and none to 12~24 times/year for platelets. The donation interval for plasma and platelets was 1~4 weeks. A minimum hemoglobin level of 12.5 g/dL was used in most countries, excluding the HKRC (11.5 g/dL for women). The NBS and EU had criteria regarding the volume of donation. CONCLUSION: Different international eligibility criteria for apheresis donors are used according to the characteristics of each country. Thus, the compiled data from various countries will provide the basis to improve our national eligibility criteria for apheresis donors.

Survey Analysis of Medical Staff at Blood Centers on the Perspectives of the Current Donor Selection Criteria / 대한수혈학회지

BACKGROUND: The donor selection criteria should ensure the safety of both the donors and the recipients of blood products. However, modifications may help promote more blood donors in keeping with the rapidly aging Korean population. Our goal was to gather opinions of the medical staff at blood centers on the current donor selection criteria. METHODS: A survey was sent out via email to 55 medical staff at hospital blood banks, the Korean Red Cross and Hanmaeum blood centers. The survey included 14~16 questions regarding age, weight, donation volume, donation interval and frequency, hemoglobin, blood pressure, pulse rate, and the level of alanine aminotransferase (ALT). RESULTS: Survey responses from 38 out of 55 (69.1%) medical staff were analyzed. The donor selection criteria that showed significantly higher acceptable rates included the upper age limit (71%, P=0.009) and whole blood donation frequency and intervals (68%, P=0.023). The ALT level showed the highest unacceptable rate (84%, P<0.0001) and other criteria with significantly higher unacceptable rates included donor weight (68%, P=0.023) and donation volume (76%, P=0.001). Responses from medical staff at supply blood banks and hospital blood banks showed a significant difference regarding the use of parent/guardian consent forms in blood donors that were 16 years or younger (75% versus 41%, respectively; P=0.0368). CONCLUSION: This study outlines the perspectives of medical staff at blood centers regarding the current donor selection criteria. According to the survey, the ALT level, donor weight, and donation volume should be considered for revision. These results can be referenced in the future when proposing modifications to the donor selection criteria.

The Current Status of Informed Consent for Transfusion in Korea and Development of a Standard Informed Consent for Transfusion / 대한수혈학회지

BACKGROUND: This study was conducted to standardize the written informed consent form for transfusion to establish the recipient's self-determination and safe blood transfusion procedures of hospitals. This survey focused on doctors' acknowledgment on informed consent before conducting a transfusion and its current situation. METHODS: Data collection was conducted in 11 tertiary hospitals from February 2010 to March 2010 with random sampling among the 30 hospitals that have a blood transfusion committee. The survey was carried out in the division of medical services that supports blood transfusion or in the blood transfusion committee of each hospital. The questionnaires focused on the necessity of written consent and its contents before transfusion. Also, informed consent forms were collected when a hospital already had an informed content form. RESULTS: The majority of hospitals (94.9%) agreed about the necessity of informed consent. However, only 6.7% of hospitals were obtaining informed consent before transfusion. The contents of the written form were the necessity of blood transfusion (94.9%), the adverse effects of transfusion (84.1%) and beneficiary of the transfusion (64.6%). Twenty-eight point two percent of the medical institutions were obtaining informed written consent forms and keeping them in the medical records. The problems for obtaining informed consent before a transfusion was insufficient standardized forms (40.4%) and a lack of time (33.9%). CONCLUSION: Though doctors agreed to the provision of information through consent forms, there were no standardized procedures and forms. Therefore, this study introduced the written form to medical institutions and academies. Also, it was applied to hospitals as an evaluation index in 2010. The written informed consent form can contribute to the safety of blood transfusions in the medical area.

A Study on the Improvement of Blood Donor Health Questionnaire / 대한수혈학회지

BACKGROUND: For the safety of blood resources, the Blood Donor Health Questionnaire (DHQ) should be modified and improved allowing donors to answer questions with further accuracy. To accomplish this, it is essential to identify any part of this questionnaire that is donors find inconvenient. METHODS: The problems of the current DHQ were examined through a poll of donors at the Korean Red Cross and other hospital blood service centers from November 2008. We also compared the structure and contents of the Korean DHQ to similar document in eight other countries. RESULTS: Donors thought that the current DHQ was too complicated, took too much time (27.3%) and probed too much into a donors private life (51.2%), making it difficult to answer honestly. The Korean DHQ focuses on a deferral period and uses special medical terminology in order for an interviewer to make easy decisions regarding donor eligibility. In contrast, other questionnaires tend to focus on a donor's recall of memory, use simple vocabulary, and emphasize donor's duties, and therefore, these documents are easy for donors to understand and complete CONCLUSION: Donor-oriented DHQs using simply terminology, help donors with memory recall and emphasize a donor's duty. Also, such a document allows donors to answer frankly. Therefore donor-oriented DHQs provide a great degree of blood resource safety than interviewer-oriented DHQs.

An Analysis of Blood Usage and Blood Wastage in Korea Hospitals in 2008 / 대한수혈학회지

BACKGROUND: Investigating the blood usage and blood wastage in Korea hospitals national wide, and including all types of medical institutes, has not been sufficient with the only study having been carried out by the KCDC thorough an Academic Research Contract in 2007. Yet that study was limited due to lack of participation from hospitals. Our study tried to establish a fundamental database for blood transfusion management by investigating the current status of blood products usage, under the KCDC's supervision, to improve participation from medical institutes. METHODS: From January to December in 2008, the Blood Bank, Red Cross of the Republic of Korea looked into the blood product supply of all the medical institutes and we conducted a national survey using questionnaires distributed via the local public health centers on the blood use, blood waste, the reasons for waste and the inventory of the remaining blood. The supply, as compared to the actual use of blood products in the same period, was analyzed by the Korean Red Cross. RESULTS: The total amount of blood products distributed by the Korean Red Cross to medical institutes in 2008 increased by 13.8% for platelets, 11.5% for RBC products, 8.4% for apheresis products and 2% for FFPs, as compared with that of 2006. A total of 2,500 institutions participated in the questionnaire and 60.7% (1,517 out of 2,500 institutes) of the institutes sent feed-back. The total amount of blood use was 3,483,636 units and 52% of the consumption was focused in metropolitan areas like Seoul, Geong-Ki and Busan. The total wastage rate for blood was 1.2% and it was 4.8% for institutes with admitting capacities of 100 beds or less, with expiration of the storage date being the main reason for wastage, while the wastage rate was 1.1% for general hospitals with admitting capacities of 500 beds or more, with an improving patient status or death being the main reason. CONCLUSION: The results of this study were similar to those of 2007, but the participation rate from medical institutes was much increased. Establishment of an investigational system for the use of blood products in medical institutes on a national level is needed to secure data for dealing with the increased projected demand of blood/blood products in the future.

Efficiency Evaluation of Nozawa-Style Black Light Trap for Control of Anopheline Mosquitoes

House-residual spraying and insecticide-treated bed nets have achieved some success in controlling anthropophilic and endophagic vectors. However, these methods have relatively low efficacy in Korea because Anopheles sinensis, the primary malaria vector, is highly zoophilic and exophilic. So, we focused our vector control efforts within livestock enclosures using ultraviolet black light traps as a mechanical control measure. We found that black light traps captured significantly more mosquitoes at 2 and 2.5 m above the ground (P 0.05). Based on these findings, we concluded that each black light trap in the livestock enclosures killed 7,586 female mosquitoes per trap per night during the peak mosquito season (July-August). In May-August 2003, additional concurrent field trials were conducted in Ganghwa county. We got 74.9% reduction (P 0.05) in the livestock enclosures. The black light trap operation in the livestock enclosures proved to b9e an effective control method and should be incorporated into existing control strategies in developed countries.

A Case of Transfusion Transmitted Hepatitis A Virus Infection Identified Through a Lookback Study / 대한수혈학회지

Hepatitis A virus (HAV) is mostly transmitted by the oral-fecal route. However, rare cases of transmission via blood transfusion still exist. A retrospective study was designed to trace a case of transfusion transmitted HAV (TTHAV) infection through the Post Donation Infection (PDI) system in Korea in 2006. We report here on a case of TTHAV that was identified through a lookback study. A 35-year old woman received 6 units of packed red cell transfusion when undergoing Caesarian section in a hospital. Ten days later, she developed a high fever and sore throat. Anorexia and abdominal pain developed in 45 days after transfusion. She was diagnosed with acute tonsillitis at the hospital, and she was not aware of her HAV infection at that time. Then, a donor informed the blood center of his HAV infection 10 days after donation to request his blood be discarded. The recipients of the blood were traced and epidemiological studies lead to the patient, which prompted her serum to be collected and tested. Finally, TTHAV was identified for this patient with positive anti-HAV IgG/IgM results. This is the first case of TTHAV to be identified through the HAV lookback study in Korea.

Epidemiological Survey of Hantaan Virus Infection of Wild Rodents Trapped in Jeollanam-do, 2003~2004

Hantaan virus (HTNV) is widely distributed in Korea and has been known to cause haemorrhagic fever with renal syndrome (HFRS). Hantaviruses are carried by numerous rodent species throughout the world. Especially, the stripedfield mice, Apodemus agrarius, is the natural host for Hantaan virus in Korea, In this study, a total 117 wild rodents of 2 species (A. agrarius, Crocidura laciura) were trapped from six county (Damyang- gun, Hwasun-gun, Gokseong-gun, Jangheung-gun, Hampyeong-gun and Boseong-gun) in Jeonnam province from Sep. 2003 to Nov. 2004 for epidemiological survey. As determined by the indirect immunofluorescent antibody (IFA) test, IgG antibodies against HTNV were detected in 13.4% (14/103) of A. agrarius captured on above the areas. Serologic evidence for HTNV infection was not found in 14 C. laciura. 5 of A. agrarius were positive of hantaan viral RNA amplication from lung tissue of 14 seropositive A. agrarius by RT-PCR. For isolation of the hantaan virus, the lung tissue homogenate of 14 seropositive A. agrarius inoculated Vero E6 cells, but virus was not isolated.

Seroepidemiological Characteristics of Haemorrhagic Fever with Renal Syndrome from 1996 to 2005 in Korea

Haemorrhagic fever with renal syndrome (HFRS) caused by Hantaan viruses has been one of the principal acute febrile disease in Korea. To analysis the sero-epidemiological patterns of HFRS, 4,177 patient sera of acute febrile illness submitted for serological assay to National Institute of Health from Community Health Centers, Institutes of Health and Environment and hospitals from 1996 to 2005 were examined for antibodies against Hantaan virus by indirect immunofluorescent assay (IFA). Serum samples with greater than 1:32 antibody titer were considered positive. The results were analyzed seroepidemiologically by annual, sexual, seasonal, age and regional distribution of HFRS patients. Out of 4,177 serum samples tested, 1,415 samples (33.9%) were positive to Hantaan virus. The ratio of males (48.2%, 682/1,415) to females (38.2%, 541/1,415) was 1.3:1. Seasonal incidence showed that 69.5% (985/1,415) of cases occurred from October to December, resulting with higher prevalence in November (41.3%, 584/1,415). Regionally, seropositive rates of samples collected in Gyenggi, Gangwon and Chungbuk were 39.9% (564/1,415), 19.3% (274/1,415) and 8.5% (120/1,1415), respectively. Age distributions of seropositive of HFRS were detected from 20 to 79 years (78%).

A Case of Fatal Plasmodium Vivax Malaria with Multi-organ Failure / 감염과화학요법

Vivax malaria is a re-emerging infectious disease in Korea with cumulating 19,416 cases as of December 2003 since 1993. Vivax malaria is generally a benign disease with few severe complications. Even in the worldwide literature, there are only small number of case reports on severe complications. We experienced a fatal vivax malaria in a previously healthy young adult with severe multi-organ failure and fatal massive pulmonary hemorrhage. The patient presented with abdominal pain and shock. There were splenic hemorrhage, disseminated intravascular coagulation, oliguric acute renal failure requiring dialysis, and pulmonary hemorrhage leading the patient finally to death. The initial parasitemia was 2,046/?L. Thin smear and PCR revealed only Plasmodium Vivax. There was no explainable cause of death except for the only serological suggestion of Mycoplasma pneumoniae infection without correlating clinical evidence. This is a first case of fatal vivax malaria in Korea since its re-emergence in 1993. Further case monitoring is needed to define whether this is a index case or an isolated one.

A Case of Fatal Plasmodium Vivax Malaria with Multi-organ Failure / 감염과화학요법

Vivax malaria is a re-emerging infectious disease in Korea with cumulating 19,416 cases as of December 2003 since 1993. Vivax malaria is generally a benign disease with few severe complications. Even in the worldwide literature, there are only small number of case reports on severe complications. We experienced a fatal vivax malaria in a previously healthy young adult with severe multi-organ failure and fatal massive pulmonary hemorrhage. The patient presented with abdominal pain and shock. There were splenic hemorrhage, disseminated intravascular coagulation, oliguric acute renal failure requiring dialysis, and pulmonary hemorrhage leading the patient finally to death. The initial parasitemia was 2,046/?L. Thin smear and PCR revealed only Plasmodium Vivax. There was no explainable cause of death except for the only serological suggestion of Mycoplasma pneumoniae infection without correlating clinical evidence. This is a first case of fatal vivax malaria in Korea since its re-emergence in 1993. Further case monitoring is needed to define whether this is a index case or an isolated one.

Epidemiology and Prevention Strategies of Rabies in Korea / 한국역학회지

Rabies is a uniformly fatal encephalitis and cannot be treated, therefore efforts must be focused on preventing the disease. The incidence of rabies in humans and animals has decreased with the introduction of rabies vaccination for animals since the early 1950s in Korea. There was no rabies occurrence either in human or animal for 8 years from 1985 to 1992. However, a case of animal rabies recurred in 1993. Since then, rabies endemic areas were expanded into 17 counties near the demilitarized zone, and 6 human cases were reported from the endemic areas of animal rabies. According to epidemic studies, wild raccoon dogs were suspected to be the transmission source of rabies in dogs, domestic animals, and other wild animals, which resulted in human rabies. Rabies prevention strategies were aimed at the animals capable of transmitting rabies or vaccination for the high risk group and postexposure prophylaxis for the bitten patients. Unfortunately, these activities were not conducted appropriately and substantially. All rabies victims were either not treated or did not receive timely and appropriate postexposure treatment. Prevention of rabies can only be achieved by securing political and financial support for an effective rabies program. Key activities for rabies prevention should include changing current public perception regarding rabies, strengthening surveillance for the exposed person to suspected rabid animals, and laboratory-based rabies surveillance.

Application of Hantavirus N Protein Expressed by E. coli System

Hantaan viruses cause haemorrhagic fever with renal syndrome (HFRS), resulting in severe morbidity and mortality in humans. The genome of Hantaan virus is composed of three segmented and single stranded negative sense RNA genome. In this study, we expressed nucleocapsid (N) proteins of Hantaan 76-118, Seoul 80-39 and Hantaan virus isolated in Korea (01-23) using E. coli system. These N proteins were fused with a thioredoxin protein for secretion of the expressed protein. The antigenicity of each expressed N proteins was examined in Western blot with sera from HFRS patients and normal controls. The expressed N proteins did not show any cross-reactivity with sera obtained from patients with leptospirosis and tsutsugamushi disease. These results suggest that our recombinant N proteins can be used for the development of diagnostic system to distinguish between HFRS and leptospirosis or tsutsugamushi.

An Outbreak of Vivax Malaria in Republic of Korea in 1999 / 감염

BACKGROUND: Annual occurrence of vivax malaria in Republic of Korea (ROK) has exceeded 1,000 cases since 1997. Military system is thought to be a important source of the current outbreak. We collected the information on malaria cases of ROK army, veterans and civilians which occurred in 1999, and analyzed the characteristics of the current outbreak. METHODS: Informations on malaria cases of ROK army, including name, age, sex, rank, force, day of onset, region, etc., were collected through the Office of Surgeon General at Headquarters of ROK army and then analyzed. Informations about malaria cases of veterans and civilians, including age, sex, day of onset, region, etc., were collected through the National Institute of Health and then analyzed. RESULTS:Among a total of 3,628 cases in 1999, 1,085 (29.91%) occurred in the military, 996 (27.45%) occurred in veterans, and 1,547 (42.64%) occurred in civilians. Monthly occurrence reached its peak level at July and had maintained to August. Yeoncheon, Cheolwon and Paju were the highest prevalence region. CONCLUSION: Case occurrence in ROK decreased in 1999 and it was contributed by chemoprophylaxis which has been done since 1997 in the military. It is thought that more attention must be given to protect the further spread of malaria infection.

Epidemiological Characteristics of Salmonella Strains Isolated recently in Korea

No abstract available.

Plasmid Profile and B - Lactamase Type of Multidrug - Resistant Salmonella typhi Isolated from Korea, 1997

Eight strains of multidrug-resistant (MDR) Salmonella typhi were isolated from Kyonggi area during January-February,1997. They were resistant to ampiciUin, amoxicillin, carbeniciillin, tetracycline, chloramphenicol, trimethoprim/sulfamethoxazole, trimethoprim. Eight strains had one plasmid respectively which size was approximately M.W 220 kb and showed same restriction pattern by endonuclease HindIII. The plasmid was similar to the plasmid in size that was related to multidrug resistant S. typhi isolated from southeast Asia. It were transferred by conjugation to recipient E, coli K-12 in frequency of 2.43 x10-4 - 1.73 x 10-2 and transconjugant showed same drug-resistant pattem with donor cells. All of 8 strains produced B-lactamase that was assummed to TEM-1 type by isoelectric focusing and PCR.