BACKGROUND: Majority of clinical laboratories disseminate laboratory test information through guidebooks or handouts. However, these methods cannot instantly confer information, for example, when a novel laboratory test is introduced, or a change is made to a test request procedure or type of specimen involved. To overcome these limitations, we developed a mobile web application that is a laboratory test information repository, initially for use in Korea. METHODS: We established a laboratory master database of searchable laboratory test information using a web-based framework. Information pertaining to clinical test indications, interpretation of test results, and related laboratory tests was revised; test request guidelines were also updated. Information concerning tests that are occasionally subject to change and newly introduced tests was updated promptly. RESULTS: Our mobile web-based application uses the domain name www.schlab.org and can also be accessed via a desktop browser. The information for each test includes basic details such as specimen type, container, turnaround time, and so on and an introduction in addition to a more detailed explanation of associated tests and usage recommendations. The number of monthly visitors to the site was 529 (649 page views), with visitors using the mobile web for 31 seconds per visit. CONCLUSIONS: We developed a mobile web application that provides information on laboratory tests. We improved on the existing method of transmitting such information (i.e., a laboratory request guidebook) by offering a system that provides updated test information and increased accessibility. Our method is expected to reduce instances of inaccurate or unnecessary test orders, improper specimen collection, delayed specimen arrival, and inappropriate treatment.
Clinical Laboratory Services ; Information Services ; Korea ; Mobile Applications ; Specimen Handling ; Smartphone

As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

BACKGROUND: This study aimed to investigate the current statuses of eight hormone tests (testosterone, estradiol, prolactin, progesterone, luteinizing hormone, follicle-stimulating hormone, parathyroid hormone, and thyroglobulin) used by clinical laboratories in Korea. METHODS: From November 1 to December 31, 2016, we surveyed 300 laboratories that participated in the regular proficiency survey program administered by the Korean Association of Quality Assurance for Clinical Laboratory. The survey comprised a questionnaire designed to address factors related to these hormone tests, including the measurement methods, instruments, test numbers per month, turnaround times, reporting units and ranges, reference ranges, and internal or external quality control methods. RESULTS: Fifty-four (18.0%) of 300 laboratories replied to the survey questionnaire. Each laboratory performed hormone analyses that used variable instruments, commercial kits, and calibrators. The test numbers per month, turnaround times, and reporting units (particularly for testosterone) varied among laboratories. Most laboratories used reference intervals that had been transferred from other references and were verified using in-house samples. Many laboratories that assessed luteinizing hormone, follicle-stimulating hormone, and parathyroid hormone levels did not participate in the proficiency survey program conducted by The Korean Association of Quality Assurance for Clinical Laboratory. CONCLUSIONS: We hope that the results of this study, which investigated the status of hormone testing at Korean diagnostic laboratories, will facilitate improvements in the quality of hormone testing and promote the development of guidelines for testing.
Clinical Laboratory Services ; Estradiol ; Follicle Stimulating Hormone ; Hope ; Korea* ; Laboratory Proficiency Testing ; Luteinizing Hormone ; Parathyroid Hormone ; Progesterone ; Prolactin ; Quality Control ; Reference Values ; Surveys and Questionnaires

BACKGROUND: It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. METHODS: We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. RESULTS: A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). CONCLUSIONS: Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.
Clinical Laboratory Services/*standards ; Clinical Laboratory Techniques/instrumentation/methods ; Coronavirus Infections/*diagnosis/epidemiology/virology ; Disease Outbreaks ; Humans ; Middle East Respiratory Syndrome Coronavirus/genetics/isolation & purification ; RNA, Viral/analysis ; Real-Time Polymerase Chain Reaction ; Republic of Korea/epidemiology ; Sputum/virology ; Surveys and Questionnaires

OBJECTIVETo study the use of hypertension related physical examinations, laboratory tests and anti-hypertension drugs among district and community based hospitals in Beijing and to analyze the possible hardware (examination, test, drug) problems under the application of the "China Hypertension Guide" in those hospitals.

METHODSThe survey was carried out in 40 hospitals in Chaoyang and Haidian districts, including 9 district level hospitals, and the rest at community level. Questionnaire survey and in-depth interview were used to collect information from the leaders of related departments in those hospitals.

RESULTS(1) The hardware condition of district hospital satisfied the implicit requirements of hypertension evaluation and treatment in "China hypertension Guide". (2) 64.5% of the community level hospitals had the basic equipments and routine laboratory tests for diagnosis and treatment on hypertension, but 35.5% of them lack of tests on blood chemistry (potassium, sodium, creatinine) and urine protein. (3) 71.0% of community level hospitals could not judge the patient's "target organ damage" independently. (4) Both district and community level hospitals had all major types of anti-hypertension drugs in there pharmacy except ARB.

CONCLUSIONWhen necessary laboratory tests for both district and community level hospitals were provided, they could accomplish the tasks of hypertension treatment and management. However, the community level hospitals should cooperate with hospitals at higher level to have a comprehensive clinical understanding of patients with high blood pressure.

China ; Clinical Laboratory Techniques ; statistics & numerical data ; Cross-Sectional Studies ; Diagnostic Services ; statistics & numerical data ; Hospitals, Community ; statistics & numerical data ; Humans ; Hypertension ; diagnosis ; drug therapy ; Pharmaceutical Services ; statistics & numerical data ; Surveys and Questionnaires

Pharmacogenetics is a rapidly evolving field and the number of pharmacogenetic tests for clinical use is steadily increasing. However, incorrect or inadequate implementation of pharmacogenetic tests in clinical practice may result in a rise in medical costs and adverse outcomes in patients. This document suggests guidelines for the clinical application, interpretation, and reporting of pharmacogenetic test results based on a literature review and the collection of evidence-based expert opinions. The clinical laboratory practice guidelines encompass the clinical pharmacogenetic tests covered by public medical insurance in Korea. Technical, ethical, and regulatory issues related to clinical pharmacogenetic tests have also been addressed. In particular, this document comprises the following pharmacogenetic tests: CYP2C9 and VKORC1 for warfarin, CYP2C19 for clopidogrel, CYP2D6 for tricyclic antidepressants, codeine, tamoxifen, and atomoxetine, NAT2 for isoniazid, UGT1A1 for irinotecan, TPMT for thiopurines, EGFR for tyrosine kinase inhibitors, ERBB2 (HER2) for erb-b2 receptor tyrosine kinase 2-targeted therapy, and KRAS for anti-epidermal growth factor receptor drugs. These guidelines would help improve the usefulness of pharmacogenetic tests in routine clinical settings.
Antidepressive Agents, Tricyclic ; Atomoxetine Hydrochloride ; Clinical Laboratory Services ; Codeine ; Cytochrome P-450 CYP2C19 ; Cytochrome P-450 CYP2C9 ; Cytochrome P-450 CYP2D6 ; Expert Testimony ; Genetic Testing ; Humans ; Insurance ; Isoniazid ; Korea ; Pharmacogenetics ; Protein-Tyrosine Kinases ; Tamoxifen ; Warfarin