Objectives The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability.
Accreditation

In 2013, multiple articles reporting the clinical trial of valsartan, an antihypertensive drug of more than US$ 1 billion annual sales from Novartis, were retracted due to data falsification.1,2 These included the Kyoto Heart Study presented by Dr. Hiroaki Matsubara at the European Society of Cardiology 2009 Congress and subsequently published in the European Heart Journal (EHJ).3,4 Aside from retraction of this article by EHJ, the American Heart Association (AHA) also retracted five papers published in three of its journals -- Circulation, Circulation Research, and Hypertension.4 Novartis employees were involved in the conduct and analysis of the Kyoto Heart Study and a second investigator-initiated trial, the Jikei Heart Study,5 although their participation was not acknowledged in publications and presentations of the data, while a Novartis employee who allegedly manipulated statistical data was listed as one of the academic authors, without disclosing the relation with the company.
Accreditation

PURPOSE: This study was conducted to develop a timeout protocol as the process of patients verification in the operating room, and to evaluate its effects. METHODS: The timeout protocol was developed based on the experience of practices and the universal protocol of JCAHO 2004. The subjects of this study were 192 surgical members working in the operating room at an university hospital in Daegu, Korea. RESULTS: The timeout protocol was developed in six steps; participants verification, encouragement of compliance, verification of right 3 PSP, agreement of surgical team members, verification of the parties to a patient, patient agreement. The data which have been resulted from the experimental group show significantly higher than those of control group as follows; cognition(t = -6.580, p = .000), contents of performance; progress of anesthesiologist as leader(chi-square = 29.029, p = .000), verification of right patient, right site and right procedure(chi-square = 40.663, p = .000), participation of surgical team(chi-square = 68.412, p = .000), and the number of cases of performance(chi-square = 242.900, p = .000). CONCLUSION: It suggests that medical accidents caused by failures in a preoperative verification process can be prevented if a timeout is conducted active involvement and effective communication among surgical team members for a final verification of the correct patient, procedure, and site.
Cognition ; Collodion ; Compliance ; Humans ; Joint Commission on Accreditation of Healthcare Organizations ; Korea ; Operating Rooms

PURPOSE: This study was conducted to develop a timeout protocol as the process of patients verification in the operating room, and to evaluate its effects. METHODS: The timeout protocol was developed based on the experience of practices and the universal protocol of JCAHO 2004. The subjects of this study were 192 surgical members working in the operating room at an university hospital in Daegu, Korea. RESULTS: The timeout protocol was developed in six steps; participants verification, encouragement of compliance, verification of right 3 PSP, agreement of surgical team members, verification of the parties to a patient, patient agreement. The data which have been resulted from the experimental group show significantly higher than those of control group as follows; cognition(t = -6.580, p = .000), contents of performance; progress of anesthesiologist as leader(chi-square = 29.029, p = .000), verification of right patient, right site and right procedure(chi-square = 40.663, p = .000), participation of surgical team(chi-square = 68.412, p = .000), and the number of cases of performance(chi-square = 242.900, p = .000). CONCLUSION: It suggests that medical accidents caused by failures in a preoperative verification process can be prevented if a timeout is conducted active involvement and effective communication among surgical team members for a final verification of the correct patient, procedure, and site.
Cognition ; Collodion ; Compliance ; Humans ; Joint Commission on Accreditation of Healthcare Organizations ; Korea ; Operating Rooms

While Joint Commission on Accreditation of Healthcare Organizations(JCAHO) and American College of Surgeon(ACS) have identified certain audit filters in trauma care, there are few studies to substantiate the value of these audit filters. Some researchers found that audit filters qualifiers were significantly associated with adverse outcomes, however, others were unable to reproduce such association. It is also necessary to test their validity and applicability in Korea. The purpose of this present study was to validate two trauma audit filters proposed by the JCAHO and the ACS, through the analysis of the relationship between timeliness of operation and risk-adjusted mortality. Among trauma audit filters, timeliness of operation in epidural or subdural hematoma(EDH/SDH) and intraabdominal injury were selected. By stratified random cluster sampling, 19 emergency medical centers (EMCs) were selected from 30 EMCs and all patients who received craniotomy or laparotomy in 1996 were evaluated in each hospital. Six medical records administrators reviewed medical records of 463 patients with EDH/SDH and of 508 patients with intraabdominal injury retrospectively. In other to adjust risk of mortality, timeliness of operation, age, Revised Trauma Score(RTS), ICD-9CM based ICISS, and experiences of transfer were included in logistic regression model. In the logistic regression models of all EDH/SDH or intraabdominal injury patients, timeliness of operation was not significant predictor of mortality. However, if patients who have been operated later than 12 hours were excluded from the statistical model, timeliness of operation showed significant or marginally significant relationship with mortality in the following situations; craniotomy > 4 hours in EDH(OR=30.46, p=0.032), craniotomy > 8 hours in SDH(OR=6.50, p=0.020), laparotomy > 2 hours in shock patients(OR=9.26, p=0.055). In addition to timeliness of operation, RTS and ICISS were significant variables in every logistic regression model, and experience of transfer and types of EMC were significant or marginally significant only in EDH. Timeliness of operation as audit filters for trauma care could not be applied to all cases. Early operations seem to improve clinical outcome only in the patients for whom emergent craniotomy or laparotomy were indicated. It could be interpreted as a phenomenon of 'confounding by indication'. Additional studies to establish more objective eligibility criteria for these audit filiters are needed.
Accreditation ; Administrative Personnel ; Craniotomy ; Delivery of Health Care ; Emergencies ; Humans ; Joint Commission on Accreditation of Healthcare Organizations ; Joints ; Korea ; Laparotomy ; Logistic Models ; Medical Records ; Models, Statistical ; Mortality ; Retrospective Studies ; Shock

No abstract available.
Accreditation ; Education, Medical ; Korea

No abstract available.
Accreditation ; Delivery of Health Care

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.
Accreditation ; Risk Management

No abstract available.
Accreditation ; Education, Medical ; Licensure

No abstract available.
Accreditation* ; Schools, Medical*