scholarly journals ISO 15189:2012 Accreditation and Certification: Are You Ready?

2015 ◽  
Vol 1 (2) ◽  
pp. 42-43
Author(s):  
Rajendra Dev Bhatt ◽  
Raj Kumar Shrestha ◽  
Dhruba Acharya
Keyword(s):  
Clinical Laboratory ◽  
Modern Medicine ◽  
Quality Service ◽  
Iso 15189 ◽  
Laboratory Results ◽  
Recent Advancement ◽  
The Status ◽  
Treatment Prognosis ◽  
Huge Investment

“The quality of shoes reflects the status of man and standard of toilets reflect the status of family”: we mean to say- quality matters in day-to-day living. Despite less recognition and prioritization of clinical laboratory in former years, the recent advancement in modern medicine has compelled the health professionals to intensify its importance in diagnosis, treatment, prognosis and management of diseases. It is estimated that 70-80% of clinical decisions are based upon information derived from laboratory results. The simultaneous concern on quality of clinical diagnosis has been noted in developing country like Nepal. A huge investment in automation for the sake of quality services has also justified the fact that quality definitely matters. However, the enigma of quality service in clinical laboratory still exists in our health environment. Hence, we attempted to poke a part of the process of developing quality services in diagnostic fraternity. 

Document Control Practices in 120 Clinical Laboratories

2009 ◽  
Vol 133 (6) ◽  
pp. 942-949
Author(s):  
Paul N. Valenstein ◽  
Ana K. Stankovic ◽  
Rhona J. Souers ◽  
Frank Schneider ◽  
Elizabeth A. Wagar
Keyword(s):  
Patient Outcomes ◽  
Clinical Laboratory ◽  
Standard Setting ◽  
Clinical Laboratory Improvement Amendment ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Laboratory Results ◽  
Control Failures

Abstract Context.—A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.—To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.—Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.—Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.—Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

scholarly journals Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Liboria López Yeste ◽  
Silvia Izquierdo Álvarez ◽  
Antonia R. Pons Mas ◽  
Luisa Álvarez Domínguez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Test Results ◽  
Correct Interpretation ◽  
Laboratory Management ◽  
Iso 15189 ◽  
Effective Implementation ◽  
Clinical Laboratories ◽  
Global Trend ◽  
Laboratory Results ◽  
Critical Results

Abstract The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

2022 ◽  
pp. 215-229
Author(s):  
Antonia Mourtzikou ◽  
Marilena Stamouli ◽  
Georgia Kalliora ◽  
Ioanna Petraki ◽  
Christina Seitopoulou ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Quality Indicators ◽  
Six Sigma ◽  
Laboratory Testing ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Iso 15189 ◽  
Pareto Method ◽  
Analytical Phase

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

scholarly journals Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Libòria López Yeste ◽  
Antonia R. Pons Mas ◽  
Leonor Guiñón Muñoz ◽  
Silvia Izquierdo Álvarez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Information Management ◽  
Clinical Laboratory ◽  
Clinical Sample ◽  
Internal Quality ◽  
Clinical Samples ◽  
Clear Understanding ◽  
Iso 15189 ◽  
Technical Performance ◽  
Laboratory Information Management

Abstract ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.

Strategic Role of Zakat in Multidimensional Quality of Life in Sijunjung, Indonesia

2018 ◽  
Vol 15 (1) ◽  
pp. 55-72
Author(s):  
Herlin Hamimi ◽  
Abdul Ghafar Ismail ◽  
Muhammad Hasbi Zaenal
Keyword(s):  
Quality Of Life ◽  
Positive Impact ◽  
Wealth Distribution ◽  
Absolute Poverty ◽  
Before And After ◽  
The Status ◽  
Being There ◽  
The Impact

Zakat is one of the five pillars of Islam which has a function of faith, social and economic functions. Muslims who can pay zakat are required to give at least 2.5 per cent of their wealth. The problem of poverty prevalent in disadvantaged regions because of the difficulty of access to information and communication led to a gap that is so high in wealth and resources. The instrument of zakat provides a paradigm in the achievement of equitable wealth distribution and healthy circulation. Zakat potentially offers a better life and improves the quality of human being. There is a human quality improvement not only in economic terms but also in spiritual terms such as improving religiousity. This study aims to examine the role of zakat to alleviate humanitarian issues in disadvantaged regions such as Sijunjung, one of zakat beneficiaries and impoverished areas in Indonesia. The researcher attempted a Cibest method to capture the impact of zakat beneficiaries before and after becoming a member of Zakat Community Development (ZCD) Program in material and spiritual value. The overall analysis shows that zakat has a positive impact on disadvantaged regions development and enhance the quality of life of the community. There is an improvement in the average of mustahik household incomes after becoming a member of ZCD Program. Cibest model demonstrates that material, spiritual, and absolute poverty index decreased by 10, 5, and 6 per cent. Meanwhile, the welfare index is increased by 21 per cent. These findings have significant implications for developing the quality of life in disadvantaged regions in Sijunjung. Therefore, zakat is one of the instruments to change the status of disadvantaged areas to be equivalent to other areas.

Possibilities and prospects of conservative therapy for endometriosis, as a chronical progressing disease (review of literature)

GYNECOLOGY ◽  
2020 ◽  
Vol 22 (1) ◽  
pp. 14-18 ◽  
Author(s):  
Tatyana Yu. Pestrikova ◽  
Elena A. Yurasova ◽  
Igor V. Yurasov
Keyword(s):  
Quality Of Life ◽  
Abnormal Uterine Bleeding ◽  
Modern Medicine ◽  
Reproductive Age ◽  
Aim Analysis ◽  
Scientific Publications ◽  
Terra Incognita ◽  
Positive Effect

Relevance. Endometriosis is a common gynecological disease that affects up to 10% of women of reproductive age worldwide and is the main cause of pain and infertility. Endometriosis is a disease, although it has been known for a long time, nevertheless, in many ways it represents terra incognita for modern medicine. Aim. Analysis of literature on the feasibility of long-term and the use of the drug dienogest 2 mg (Vizanne), which has a positive effect on the quality of life of patients with endometriosis. Materials and methods. To write this review, a search was made for domestic and foreign publications in Russian and international search engines (PubMed, eLibrary, etc.) over the past 13 years. The review included articles from peer-reviewed literature. Results. The review presents data on the difficulties of verifying the diagnosis of endometriosis due to a combination of this pathology with pain, infertility, abnormal uterine bleeding. The pathogenesis of the origin of endometriosis-associated pain is presented. The efficacy of the use of the drug dienogest (Vizanne), which has a powerful antiproliferative effect that reduces the main symptoms of endometriosis (pain, bleeding), is substantiated. The expediency of long-term and safe use of the drug dienogest (Vizanne), which has a positive effect on the quality of life of patients with endometriosis, has been proved. Conclusions. Numerous scientific publications confirm the feasibility of prolonged use of the drug dienogest (Vizanne), to achieve remission during endometriosis.

KUALITAS PELAYANAN IZIN MENDIRIKAN BANGUNAN (IMB) RUMAH TINGGAL DI KECAMATAN KRAMAT JATI JAKARTA TIMUR

2015 ◽  
Vol 1 (2) ◽  
pp. 101
Author(s):  
Della Arumnitas Sudrajat ◽  
R. Akhmad Munjin ◽  
Irma Purnamasari
Keyword(s):  
Descriptive Analysis ◽  
Direct Interaction ◽  
Sampling Technique ◽  
Service Process ◽  
Improve Quality ◽  
Quality Service ◽  
Building Permit ◽  
Service Building ◽  
Theory Framework

This study aims to determine how service quality of Building Permit in District Kramat JatiResidential, East Jakarta. The population in this research is 48 people in the district who filed a Keramat Jati Residential petition. The method used in this research is descriptive analysis. The sampling technique used in this study is Incidental Sampling, which sampling technique by coincidence, that anyone who by chance met with the researchers can be used as a sample, which is deemed suitable by research. Then the amount used as many as 48 people. Theory framework used in this study is Ratminto and Winarsih 2006. Service is an activity or a description of the activities that take place in the direct interaction between a person with another person or machine physically and provide customer satisfaction. The result is that the services provided by the Kramat Jati’s subdistrict officer for the community applicant Building Permit Residential, located in the Good criteria with interpretation number is 3.52. The conclusion of this study is still a lack of discipline of officers in the service process that makes the event of delay that hinder the implementation of the applicant service Building Permit Residential, the researchers recommend the discipline of officers need to be improved so that every service process can run well and can improve quality of care provided to the public.Keywords : Quality Service, Building Permit, the Applicant Building Permit

Treatment Peculiarity of the Chronic Trophic Ulcers with Different Pathogenic Mechanism

2020 ◽  
Vol 62 (1) ◽  
pp. 12-16
Author(s):  
Oksana K. Melekhovets ◽  
Tetyana O. Kharchenko ◽  
Victor F. Orlovskiy ◽  
Iuirii V. Melekhovets ◽  
Alevtina S. Radko ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Healing Process ◽  
Modern Medicine ◽  
Lower Limbs ◽  
Chronic Venous Disease ◽  
Venous Disease ◽  
Second Stage ◽  
Group 2

Introduction: Trophic ulcers of the lower extremities are an unresolved problem of modern medicine. The treatment of this pathology requires new methods that optimize care regimens and improve patients’ quality of life. Aim: The study to improve efficacy of treatment of the patients with trophic ulcers of the lower limbs with consideration to pathogenesis. M aterials and Methods: The study included 32 patients with chronic venous disease C6 (1st group) and 31 with diabetes mellitus type 2, moderate severity, compensation stage with diabetic foot syndrome II stage according to Wagner’s classification (2nd group). In addition to basic therapy in both groups photodynamic therapy was added at the first stage of the study, and at the second stage plasma rich in growth factors was prescribed. Results: At baseline evaluating of the chronic venous disease demonstrates that a total score in patient of the 1st group was 20,9 points on a modified VCSS scale; after two weeks – 15,71 points (improvement by 24.83%), and 6 weeks after–9,72 points (improvement by 53.49%). In patients with DM (2nd group) at the baseline a total score average was 13,91 points according to S(AD)SAD-1 scale; after 2 weeks – 12,29 (improvement by 11,65%), after 6 weeks – 6,39 points (improvement by 54,06%). Conclusions: The inclusion of photodynamic therapy and plasmatherapy in complex therapy in both groups led to a significant improvement of the healing process and helps to reduce the depth and area of the wound surface. However, the wound healing in patients in group 2 was slower.

Dietary Modifications in Fissure-in-ano: A Qualitative Study Based on Persian Medicine

2020 ◽  
Vol 16 (6) ◽  
pp. 860-865
Author(s):  
Sedigheh Tavakoli-Dastjerdi ◽  
Mandana Tavakkoli-Kakhki ◽  
Ali R. Derakhshan ◽  
Azam Teimouri ◽  
Malihe Motavasselian
Keyword(s):  
Modern Medicine ◽  
Integrative Approach ◽  
Future Research ◽  
Common Disease ◽  
Fissure In Ano ◽  
High Fiber ◽  
Baked Goods ◽  
Persian Medicine

Background: Anal fissure (AF) is a common disease associated with severe pain and reduced quality of life. Factors related to lifestyle, including diet and bowel habits, play a pivotal role in its pathogenesis. Most of the chronic fissures are not responsive to drugs and more likely to recur. Given the significance of diet in Persian medicine (PM), investigation on physiopathology and appropriate foods can be useful for decreases in AF symptoms and consequences. Objective: This study was intended to evaluate the role of diet in the formation and progression of AF from the perspective of PM. Methods: In this study, the most important resources of PM dating back to thousands of years were reviewed. All these textbooks contained a section on AF, its causes, and treatment. Further analysis was performed on these resources in comparison with databank and resources of modern medicine to develop a food-based strategy for AF management. Results: From the view of PM, the warmth and dryness of anus temperament accounted for AF. Both Persian and modern medicine identified constipation as another cause for AF. Therefore, avoidance from some foods and commercial baked goods was recommended. Both Persian and modern medicine forbad the following foods: potato, cabbage, cauliflower, pasta, beef, fish, and so forth. High fiber and oligo-antigen diets with some limitations have garnered more attention. Conclusion: An integrative approach is recommended employing both Persian and modern medicine for AF. There have been some evidence in this regard, however standardized clinical trials are required for future research.

PERBANDINGAN KUALITAS PELAYANAN ANTARA PERPUSTAKAAN PROVINSI KEPRI DENGAN KOTA TANJUNG PINANG

2017 ◽  
Vol 2 (3) ◽  
pp. 288
Author(s):  
Dimas Satriadi
Keyword(s):  
Service Quality ◽  
Public Service ◽  
Quantitative Methods ◽  
Quality Service ◽  
Data Collecting ◽  
Service Institution ◽  
Better Than

<p><em>The quality of public service is an important and it must have bye the each public service institution. Includes the library as a public service institution giving service for the all visitors. This research aims to know the comparisation of Kepri Province Libraries quality service  and Tanjungpinang City Libraries quality service. The method used in this research is quantitative methods with questionnaire to 40 responden as samples. This questionnaire as an data collecting instruments. These results indicate the quality of two libraries is good. But, if they compared the service quality of  Province Kepri  Libraries is better than  Tanjungpinang City Libraries. This look from average scored  results is 152,61 points  for Kepri Province Libraries, and 150,66 points for Tanjungpinang City Libraries, in the good categories</em></p><p>Kualitas pelayanan publik merupakan hal yang penting dan harus dimiliki oleh masing-masing lembaga pelayanan publik. Termasuk perpustakaan sebagai lembaga pelayanan publik yang memberikan pelayanan kepada semua pengunjung. Penelitian ini bertujuan untuk mengetahui perbandingan kualitas layanan Perpustakaan Provinsi Kepri dan kualitas pelayanan Perpustakaan Kota Tanjungpinang. Metode yang digunakan dalam penelitian ini adalah metode kuantitatif dengan 40 responden sebagai sampel. Kuesioner ini sebagai alat pengumpul data. Hasil penelitian ini menunjukkan kualitas kedua perpustakaan suda bagus. Tapi jika dibandingkan kualitas pelayanan Perpustakaan Provinsi Kepri lebih baik dari pada Perpustakaan Kota Tanjungpinang. Hasil dari hasil rata-rata ini adalah 152,61 poin untuk Perpustakaan Kepri Province, dan 150,66 poin untuk Perpustakaan Kota Tanjungpinang, dalam kategori baik.</p><p><em><br /></em></p>

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