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1

Aggarwal, Kavita, Saurav Patra, Viyatprajna Acharya, Mahesh Agrawal, and Sri Krushna Mahapatra. "Application of six sigma metrics and method decision charts in improvising clinical Chemistry laboratory performance enhancement." International Journal of Advances in Medicine 6, no. 5 (September 23, 2019): 1524. http://dx.doi.org/10.18203/2349-3933.ijam20194155.

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Background: Six sigma is a powerful tool which can be used by laboratories for assessing the method quality, optimizing Quality Control (QC) procedure, change the number of rules applied, and frequency of controls run .The aim of this study was to quantify the defects or errors in the analytical phase of laboratory testing by sigma metrics and then represent the sigma value in Method Decision Chart.Methods: A retrospective study was conducted in a tertiary care hospital in Bhubaneswar, India. The clinical chemistry laboratory has been NABL accredited for the past 5 years and strictly quality checked. Internal and external quality control data was collected for a period of six months from January - June 2018 for 20 biochemical analytes. Sigma metrics for each parameter was calculated and plotted on method decision chart.Results: The sigma metrics for level 2 indicated that 6 out of the 20 analytes qualified Six Sigma quality performance. Of these seven analytes failed to meet minimum sigma quality performance with metrics less than three and another seven analytes performance with sigma metrics was between three and six. For level 3, the data collected indicated that seven out of 20 analytes qualified Six Sigma quality performance, six analytes had sigma metrics less than 3 and seven analytes had sigma metrics between 3 and 6.Conclusion: In our study Sigma value was highest for amylase and lowest for potassium. Use of alternative methods and/ or change of reagents can be done for potassium to bring the sigma value within an acceptable range.
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Thakur, Singh. "Total quality management, laboratory accreditation and external quality assessment schemes." Jugoslovenska medicinska biohemija 23, no. 3 (2004): 311–15. http://dx.doi.org/10.2298/jmh0403311t.

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Two contradictory pressures, ?high quality? and ?cost reduction? require the clinical laboratories to adopt effective management techniques such as Total Quality Management (TQM). It is not merely a management process for quality improvement in all spheres of industrial functioning but also a management philosophy for overall organization development. TQM has been adopted by many health care organizations including clinical laboratories in the developed world. In the developing countries, however, majority are still using the traditional frame work of quality management. Through the concept of Quality Assurance (QA) and Quality Control (QC) in health care laboratories in India is more than two decades old, it developed in a highly unequal plane and still faces multi factorial problems. External QA/ Proficiency Testing (PT) is used to compare performance of laboratories. This is recently made mandatory for accreditation process in India. Unfortunately only <10% of laboratories participate in EQA programs possibly due to high cost. Professional bodies/Institutions (ACBI, IAPM, ISHTM-AIIMS EHPT) and Government of India are working hard to make EQA Programs available at reasonable cost. National Board of Testing and Calibration Laboratories (NABL) has been setup by Department of Science and Technology, Government of India which has started accreditation of clinical laboratories since 1999. So for 33 laboratories (0.17%) has been accredited and almost the same number of applications are in process. The program is voluntary at the beginning, may be made mandatory later. We see a Herculean task ahead for NABL but they are doing a good job at low cost similar to international organization like ACP. The formation of laboratory policy with quality control as its integral part is very imperative in achieving, total quality management of clinical laboratories in India.
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Kaur, Harmanmeet, Labanya Mukhopadhyay, Nivedita Gupta, Neeraj Aggarwal, Lucky Sangal, Varsha Potdar, Francis Yesuraj Inbanathan, et al. "External quality assessment of COVID-19 real time reverse transcription PCR laboratories in India." PLOS ONE 17, no. 2 (February 8, 2022): e0263736. http://dx.doi.org/10.1371/journal.pone.0263736.

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Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.
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Kim, Jae Han, Eun Jin Choi, Gyuhyeon Hwang, Jae Ho Lee, and Mi-Soon Han. "Survey and Solutions for the Current Status of Quality Control in Small Hospital Laboratories." Journal of Laboratory Medicine and Quality Assurance 40, no. 2 (June 30, 2018): 101–8. http://dx.doi.org/10.15263/jlmqa.2018.40.2.101.

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LaBeau, Kathleen M., Marianne Simon, and Steven J. Steindel. "Quality Control of Test Systems Waived by the Clinical Laboratory Improvement Amendments of 1988." Archives of Pathology & Laboratory Medicine 124, no. 8 (August 1, 2000): 1122–27. http://dx.doi.org/10.5858/2000-124-1122-qcotsw.

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Abstract Context.—Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective.—To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. Design and Setting.—Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. Results.—Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. Conclusions.—Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.
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Bartlett, Raymond C. "Cost Containment in Infection Control: Effect of DRGs on Utilization of the Microbiology Laboratory." Infection Control 6, no. 8 (August 1985): 323–25. http://dx.doi.org/10.1017/s0195941700063190.

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Prospective reimbursement is changing hospital laboratories from profit centers to cost centers. As a result, hospital administrators will try to reduce expenses for operating laboratories. Clinical microbiology could suffer more seriously than other sections because these laboratories are least able to use automation to increase productivity. Both the volume of specimens submitted and the complexity of processing specimens continue to increase in most clinical microbiology laboratories and the only immediate solution, although unlikely, will be increases in personnel. Freezes on replacement hiring and elimination of vacated positions are already occurring in some laboratories. Increased work can be controlled by reducing the numbers of clinically unnecessary specimens that are submitted and the numbers of specimens that are of a type or of such quality that they would not be likely to produce clinically useful information. Secondly, the amount of work expended on certain types of specimens may be reduced both to eliminate unnecessary labor and produce reports that are actually more useful clinically. Eventually changes in the way in which hospitals and physicians are reimbursed may create a greater incentive for physicians to minimize laboratory use. In the meantime, the burden of living within available resources will fall on the clinical microbiologist.
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Yadav, Kapil, Rakesh Kumar, Chandrakant S. Pandav, and Madhukar G. Karmarkar. "Successful implementation of a laboratory iodization quality assurance system in small-scale salt production facilities in India." Public Health Nutrition 17, no. 12 (December 5, 2013): 2816–23. http://dx.doi.org/10.1017/s1368980013003145.

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AbstractObjectiveTo establish a laboratory iodization quality assurance system to support small-scale salt production facilities in India and to assess the level of agreement for the internal quality assurance (IQA) and external quality assurance (EQA) protocols.DesignOperational research. The IQA and EQA programme was established in the year 2008. Agreement between field laboratories and the reference laboratory for estimation of iodine content of salt from 2008 to 2011 was assessed. Agreement was assessed using the χ2 test, kappa statistics and the Bland–Altman plot.SettingSmall-scale salt producers in the states of Andhra Pradesh, Gujarat, Rajasthan, Tamil Nadu, Odisha and Karnataka; ‘field laboratories’ supporting the small-scale salt producers; and the ‘reference laboratory’ of the Regional Office (South Asia) of the International Council for the Control of Iodine Deficiency Disorders.SubjectsThree hundred small-scale salt producers in the states of Andhra Pradesh, Gujarat, Rajasthan, Tamil Nadu, Odisha and Karnataka and seventeen ‘field laboratories’.ResultsA total of 6573 salt samples for IQA and 347 salt samples for EQA were exchanged between field and reference laboratories during 2008–2012. Out of the total salt sample exchanges, 527 were from Andhra Pradesh and Odisha, 2343 from Gujarat, 2016 from Rajasthan and 1677 from Tamil Nadu and Karnataka. The overall between-laboratory agreement was for 61·6 % for IQA and 64·8 % for EQA. The mean difference between iodine content estimation of field laboratories and the reference laboratory was 0·3 ppm (sd 8·2 ppm) for IQA and –0·3 ppm (sd 3·5 ppm) for EQA.ConclusionsOur study successfully documents implementation of a laboratory iodization quality assurance protocol in laboratories supporting small-scale salt production facilities in India.
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Guillot, Sophie, and Nicole Guiso. "Follow-Up of External Quality Controls for PCR-Based Diagnosis of Whooping Cough in a Hospital Laboratory Network (Renacoq) and in Other Hospital and Private Laboratories in France." Journal of Clinical Microbiology 54, no. 8 (May 18, 2016): 2169–71. http://dx.doi.org/10.1128/jcm.00882-16.

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The French National Reference Centre (NRC) for Whooping Cough carried out an external quality control (QC) analysis in 2010 for the PCR diagnosis of whooping cough. The main objective of the study was to assess the impact of this QC in the participating laboratories through a repeat analysis in 2012.
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Tiffin, Shelley M., and Michael A. Noble. "External Quality Assessment of Transporting Infectious Substances in Canada." Canadian Journal of Infectious Diseases 10, no. 3 (1999): 246–51. http://dx.doi.org/10.1155/1999/658649.

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OBJECTIVE: To determine the degree of compliance with Transport Canada’s Transportation of Dangerous Goods Regulations for transporting infectious substances in Canada.DESIGN: A three-phase study including observation of packages arriving at the British Columbia Centre for Disease Control (BCCDC) provincial laboratory; observation of requested samples of either anEscherichia coliculture or serum, not human immunodeficiency virus (HIV) or HbsAg positive, from laboratories; and a questionnaire concerning training and certification of packers in laboratories.RESULTS: During phase 1, 500 packages arriving at the BCCDC provincial laboratory were assessed. All arrived intact, with 384 (76.8%) in a firm outer package. Only 178 (35.6%) contained absorbent material. Six samples were known to contain human immunodefiency virus or hepatitis B; all were appropriately packaged. Of the remainder, 11 (2.2%) were considered overpackaged, 192 (38.4%) acceptably packaged and 191 (38.2%) inadequately packaged. In phase 2, 138 requested packages were assessed. All arrived intact, 132 (95.7%) in a firm outer package. Ninety-six (69.6%) contained absorbent material. Only six (4.3%) were considered inadequately packaged. In phase 3, 171 laboratories responded to a questionnaire. Fifty-nine were from small laboratories, 53 from intermediate laboratories and 23 from large laboratories. Most laboratories (55.4%) relied on in-house resources to train packers. Only 26 (15.3%) facilities had no certified packers, and 60.8% noted they had a formal copy of the regulations available in the laboratory. Laboratory characteristics associated with the likelihood of overpackaging included number of technologists (χ2=5.72; P=0.058), number of samples processed by laboratories (χ2=8.46; P=0.015) and being a private laboratory as opposed to being a hospital laboratory (Fisher Exact two-tailed 0.040).CONCLUSIONS: Canadian laboratories tend to package safely and within the acceptable range of regulation, although not within the precision of regulation. Most laboratories have trained and certified packers. The most common error is the use of outer packaging that is not firm. Larger laboratories tend to overpackage resulting in increased costs.
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Chowdhury, Nasreen, Md Ibrahim, and Md Aminul Haque Khan. "Laboratory Errors: Types and Frequency in a Tertiary Hospital in Bangladesh." Journal of Bangladesh College of Physicians and Surgeons 33, no. 1 (June 5, 2016): 3–6. http://dx.doi.org/10.3329/jbcps.v33i1.27991.

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Introduction: In our country, very few of clinical laboratories are running proper quality control program and to the best of our knowledge the preanalytical, analytical, and postanalytical rates of laboratory errors have not been studied extensively. In this study we evaluated the preanalytical, analytical, and postanalytical components of laboratory errors in 3,200 consecutive specimens of a clinical chemistry laboratory in a tertiary hospital for measurement of different analyte concentrations in plasma or serum. Materials and methods: This study was conducted during the period from June 2009 to July 2010 on 3,200 specimens. Analytical errors were detected by repeat analysis of primary sample and by checking quality control. Results: The numbers of preanalytical, analytical and postanalytical errors were 23, 14 and 76 respectively among 32000 tests that we have done on 3,200 specimens (average 10 tests per specimen). Moreover, the causes of errors were analyzed and it was found that preanalytical errors were mostly due to specimen drawn distal to IV infusion, specimen for potassium first drawn into GREY tube (containing sodium fluoride and K EDTA) and then transferred into GREEN tube, long tourniquet time and underfilling of blood collection tube. The analytical errors were due to random and systemic errors and postanalytical errors were due to transcription errors. Conclusion: Results of our study suggest that errors mostly occur in the postanalytical part of testing and they are due to transcription errors. To reduce the laboratory errors we suggest introduction of Laboratory Information System (LIS) of the clinical laboratories connected with Hospital Management System along with stringent quality control program in preanalytical, analytical and postanalytical stages.J Bangladesh Coll Phys Surg 2015; 33(1): 3-6
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Duncan, A., and P. G. Hill. "A UK Survey of Laboratory-Based Gastrointestinal Investigations." Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 35, no. 4 (July 1998): 492–503. http://dx.doi.org/10.1177/000456329803500403.

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A survey of hospital laboratory services has demonstrated marked deficiencies in the performance of gastrointestinal function tests. The repertoire of gastrointestinal investigations available varies widely between laboratories and, in general, analyses are performed infrequently. Most laboratories do not perform internal quality control, and inter-laboratory reproducibility of some analytes is very poor. A wide variety of protocols and reference ranges are in use, many of which are unevaluated. Some analytical methods and protocols in current use are outdated, with published improvements not being applied.
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Petersen, Per, Una Sølvik, Sverre Sandberg, and Anne Stavelin. "Internal quality control of prothrombin time in primary care: comparing the use of patient split samples with lyophilised control materials." Thrombosis and Haemostasis 102, no. 09 (2009): 593–600. http://dx.doi.org/10.1160/th09-02-0082.

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SummaryMany primary care laboratories use point-of-care (POC) instruments to monitor patients on anticoagulant treatment. The internal analytical quality control of these instruments is often assessed by analysing lyophilised control materials and/or by sending patient samples to a local hospital laboratory for comparison (split sample).The aim of this study was to evaluate the utility of these two models of prothrombin time quality control. The models were evaluated by power functions created by computer simulations based on empirical data from 18 primary care laboratories using the POC instruments Thrombotrack, CoaguChek S, or Hemochron Jr. Signature. The control rules 12S, 13S, exponential weighted moving average, and the deviation limits of ± 10% and ± 20% were evaluated by their probability of error detection and false rejections. The total within-lab coefficient of variation was 3.8% and 6.9% for Thrombotrack, 8.9% and 10.5% for CoaguChek S, and 9.4% and 14.8% for Hemochron Jr. Signature for the control sample measurements and the split sample measurements, respectively. The probability of error detection was higher using a lyophilised control material than a patient split sample for all three instruments, whereas the probability of false rejection was similar. A higher probability of error detection occurred when lyophilised control material was used compared with the patient split samples; therefore, lyophilised control material should be used for internal analytical quality control of prothrombin time in primary health care.
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Hwang, Sung Ho, Dong Uk Park, Kwon Chul Ha, Hyun Woo Cho, and Chung Sik Yoon. "Airborne bacteria concentrations and related factors at university laboratories, hospital diagnostic laboratories and a biowaste site." Journal of Clinical Pathology 64, no. 3 (January 5, 2011): 261–64. http://dx.doi.org/10.1136/jcp.2010.084764.

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AimsTo evaluate concentrations of airborne bacteria in university laboratories, hospital diagnostic laboratories, and a biowaste site in Seoul, Korea. To measure total airborne bacteria (TAB), the authors assessed sampling site, type of ventilation system, weather and detection of Gram-negative bacteria (GNB), indoors and outdoors.MethodAn Andersen one-stage sampler (Quick Take 30; SKC Inc) was used to sample air at a flow rate of 28.3 l/min for 5 min on nutrient medium in Petri dishes located on the impactor. A total of 236 samples (TAB, 109 indoor and nine outdoor; GNB, 109 indoor and nine outdoor) were collected three times in each spot from the 11 facilities to compare airborne bacteria concentrations.ResultsTAB concentrations ranged from undetectable to 3451 CFU/m3 (mean 384 CFU/m3), and GNB concentrations from undetectable to 394 CFU/m3 (mean 17 CFU/m3). TAB concentrations were high in window-ventilated facilities and facilities in which GNB were detected; concentrations were also high when it was rainy (all p values <0.05). TAB concentrations correlated significantly with GNB (r=0.548, p<0.01), number of bacteria species (r=0.351, p<0.01) and temperature (r=0.297, p<0.01). The presence of heating, ventilating, and air conditioning (HVAC), the number of TAB species and the detection of GNB affect TAB concentrations in laboratories.ConclusionsIt is recommended that special attention be given to regular control of indoor environments to improve the air quality of university and hospital laboratories.
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Zuijderhoudt, Floris M. J., Cas W. Weykamp, and Hans L. Willems. "Measurement of urinary porphyrins and porphyrin precursors in Dutch hospital laboratories: a review of quality control over 5 years." Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 40, no. 4 (July 1, 2003): 417–18. http://dx.doi.org/10.1258/000456303766477084.

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Background: We evaluated a quality control scheme for the measurement of urinary uroporphyrin, coproporphyrin, total urinary porphyrins and precursors of urinary porphyrins, δ-aminolevulinic acid and porphobilinogen that was performed in The Netherlands during a period of 5 years. Methods: Six quality control samples were distributed each year to the participating laboratories. Mean concentrations and the corresponding coefficients of variation were calculated. Results: Coefficients of variation varied widely and were very high in the concentration ranges that can be found in patients with low-grade porphyria. Conclusion: Commutable calibrators are needed to improve the laboratory diagnosis of porphyria.
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Bhatt, Rajendra Dev, Dipesh Tamrakar, Bishal Maharjan, Rajendra Dual, Raj Kumar Shrestha, Surndra Koju, and Prabodh Risal. "Boost Up Quality Assurance through Regular Evaluation of Proficiency Testing Performance." Annals of Clinical Chemistry and Laboratory Medicine 3, no. 1 (January 23, 2018): 3–7. http://dx.doi.org/10.3126/acclm.v3i1.17296.

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Background: Participation in External Quality Assessment (EQA) program with practice of Internal Quality Control (IQC) is the excellent indicator of good laboratory practice (GLP) to assure quality services. EQA is an essential component of Quality Assurance to assess the analytical performance compared within same methods of other laboratories. It is also important to detect equipments failure, identifying reagent problems, reviewing staff training as well as to initiate and evaluate corrective action timely.Methods: This is descriptive analysis of the feedback received from EQAS body for twenty routine biochemical parameters which are most commonly performed in the Clinical Biochemistry Laboratory of Dhulikhel Hospital. Variation Index Score (VIS), Overall Mean VIS (OMVIS) and Standard Deviation Index (SDI) of all parameters for the year 2014 and 2015 were analyzed statistically.Results: On the analysis of twenty routine biochemical parameters regularly participated in EQAS, over all mean variation index score (OMVIS) of individual tests found 55%, 30% and 15% under good, very good and satisfactory category respectively.Conclusion: Participation and periodic evaluation of EQAS indicators along with practice of internal quality control has been galvanizing good laboratory practice and scientifically it boost up quality service in clinical laboratories.
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Arora, Pankaj. "Quality Assurance Program in Radiodiagnosis in a Tertiary Care Hospital in India." International Journal of Research Foundation of Hospital and Healthcare Administration 1, no. 1 (2013): 8–12. http://dx.doi.org/10.5005/jp-journals-10035-1002.

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ABSTRACT Context The specialty of radiodiagnosis has been revolutionized by the advent of technology. This has put additional onus on the practitioners to maintain strict quality control to improve efficiency, lower exposure as well as cost. Aims The aim of the study is to determine quality assurance program in radiodiagnosis in order to identify the gaps and possible avenues of improvement. Settings and design The cross-sectional study was conducted in a tertiary care hospital in India in the second half of calendar year 2008. Materials and methods The department did not have a defined and documented quality assurance program. Hence, the factors which are part of such a QAP were identified and the practices in the department against those factors were compared. The scoring was done based on the degree of compliance; complete, partial or no compliance. Results A total of 23 parameters/subparameters were evaluated to find out the extent of quality assurance program being implemented in the study setting. Out of maximum 230, a score of 135 was achieved by the department. Conclusion The department of radiodiagnosis in the tertiary care institute need to institute a QAP for improving the quality and efficiency for better utilization of resources. Key messages Quality Assurance Program must be instituted in different departments, Radio diagnosis in the instant case, for efficient utilization, quality output and effective cost control. All these will contribute to patient safety practices. How to cite this article Arora P. Quality Assurance Program in Radiodiagnosis in a Tertiary Care Hospital in India. Int J Res Foundation Hosp Healthc Adm 2013;1(1):8-12.
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Dorji, Kuenzang, Rixin Jamtsho, Puja D. Samal, Partab Rai, and Dorji Wangchuk. "Department of pathology and laboratory medicine at Jigme Dorji Wangchuck National Referral Hospital striving for quality: external quality assessment scheme in hematology." Bhutan Health Journal 2, no. 1 (May 13, 2016): 5–10. http://dx.doi.org/10.47811/bhj.15.

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Introduction: Quality Assurance comprising External Quality Assessment Scheme (EQAS) and Internal Quality Control (IQC) is an indispensible part of the laboratory analytical process to ensure reliable results from the laboratories. However, due to various challenges in many developing countries such as limitations in resources and manpower, EQAS samples are often given less importance at laboratories. The objective of this study is to assess performance on hematology EQAS samples received from Pacific Paramedical Training Center- External Quality Assesment Scheme (PPTC-EQAS) and International External Quality Assesment Scheme-United Kingdom (IEQAS-UK)since 2007 and 2008 respectively. The findings from this study will be helpful to establish an effective system to ensure timely follow up and corrective actions to improve the quality of laboratory services. Methods:The feedback of the EQAS results submitted thrice a year to the PPTC-EQAS and six times a year to the IEQAS-UK since 2007 and 2008 respectively were reviewed to assess the laboratory’s performance and to determine the effectiveness of EQAS participation for improving the performance of laboratory hematology in Bhutan. Results:For PPTC-EQAS, the average yearly scores were 69.00%, 75.00%, 87.66%, 87.50%, 70.00%, 80.33%, 80.50%, 85.00% for the years 2007-2014. For IEQAS-UK, the average yearly scores were 76.66%, 75.95%, 77.91%, 85.83%, 92.50%, 63.88% and 98.14% for the years 2008-2014. Our results show inconsistent performances on both EQAS samples despite gradual improvement over the last seven years. Conclusions:We conclude that, strengthening the system for regular follow up and implementing corrective actions for the outlying results in addition to replacement of the equipment could improve the trend and ensure consistency of the performance.
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Gaydos, C. A., P. A. Rizzo-Price, P. Balakrishnan, P. Mateta, S. R. Leon, S. Verevochkin, Y. P. Yin, T. C. Quinn, L. C. Strader, and W. Pequegnat. "Impact of international laboratory partnerships on the performance of HIV/sexually transmitted infection testing in five resource-constrained countries." International Journal of STD & AIDS 22, no. 11 (November 2011): 645–52. http://dx.doi.org/10.1258/ijsa.2011.010527.

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To review a quality control and quality assurance (QC/QA) model established to ensure the validity and reliability of collection, storage and analysis of biological outcome data, and to promote good laboratory practices (GLPs) and sustained operational improvements in international clinical laboratories, we conducted a two-arm randomized community-level HIV behavioural intervention trial in five countries: China, India, Peru, Russia and Zimbabwe. The trial was based on diffusion theory utilizing a Community Popular Opinion Leaders (CPOLs) intervention model with behavioural and biological outcomes. The QC/QA model was established by the Biological Outcome Workgroup, which collaborated with the Data Coordinating Center and John Hopkins University Reference Laboratory. Five international laboratories conducted chlamydia/gonorrhoea polymerase chain reaction (PRC)-based assays, herpes simplex virus type 2 enzyme immunoassay (EIA), syphilis serology (rapid plasma regain and Treponema pallidum particle agglutination assay, HIV serology (EIA/Western blot) and Trichomonas vaginalis culture. Data were collected at baseline, 12 and 24 months. Laboratory performance and infrastructure improved throughout the trial. Recommendations for improvement were consistently followed. Quality laboratories in resource-poor settings can be established, operating standards can be improved and certification can be obtained with consistent training, monitoring and technical support. Building collaborative partnership relations can establish a sustainable network for clinical trials, and can lead to accreditation and international laboratory development.
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Varghese, Bindi. "Management Practices in Hospital Administration: a study of the Challenges Faced by the Healthcare Organisation in South India." Atna Journal of Tourism Studies 6, no. 1 (August 14, 2021): 1–15. http://dx.doi.org/10.12727/ajts.6.1.

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This paper accentuates the need for quality assurance and standardization norms for hospital administration which is the need of the hour. Lack of effective administration practices in the hospital and hospitality sector necessitate the need for a total quality management approach in the Healthcare Sector. Application of quality control systems is a vital aspect that hospitals in South India cannot disregard. It would lead the South in a new direction by ensuring quality and enhancing customer satisfaction. Hence, this paper makes an attempt to understand the hospital management practices in South India effectively. The research addresses Medical Tourism as a ‘cost effective’ private medical care initiative in collaboration with the tourism industry for patients needing surgical and other forms of specialised treatment. This process is being facilitated by the corporate sector involved in medical care as well as the tourism industry – both private and public. There is also a constant effort taken by corporate hospitals to support medical tourism to its fullest potential. India today has copious opportunities to compete with other developed nations and building a quality health care system of its own.
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M. S., Ameen Abdulla, and Kavilal E. G. "Analytical Investigation of Higher Education Quality Improvement by Using Six Sigma Approach." HighTech and Innovation Journal 3, no. 2 (February 24, 2022): 196–206. http://dx.doi.org/10.28991/hij-2022-03-02-07.

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For over two decades in India, the technical industry's unique selling proposition (USP), with its wide infrastructure of technical institutes, has been capable of supplying best-in-class engineers. But recently, this claim does not hold water. According to the All India Council for Technical Education (AICTE), about 2.6 lakh mechanical engineers graduate every year in India. But the real count of industry ready mechanical engineers is approximately 7%. Hence, there is a need to assess the quality of engineering education in India to reduce the flaws in higher education. The purpose of the paper is to identify the various defects associated with technical education and eliminate those defects using various quality tools. This research is based on the six sigma technique, which is used to assess the quality criteria proposed by the National Board of Accreditation India (NBA). The proposed model is then applied to a typical tier II Indian engineering college located in south India. Six Sigma has two main methodologies: DMAIC and DFSS. The DMAIC (Define, Measure, Analyze, Improve, and Control) methodology is implemented for existing systems, whereas DFSS (Design for Six Sigma) is for assuring quality in new products. In this project, the conclusion is driven by the DMAIC methodology. Various statistical and non-statistical tools are employed in this research. The tools used are CTS-CTQ, SIPOC, Pareto chart, normal process capability analysis, one-way ANOVA, Ishikawa diagram, FMEA, RCBD, and SPC chart. All the statistical processes are done using Minitab analytical software. From the results, it is identified that the factors that have a risk priority number (RPN) greater than 300 need improvement, such as versatility in program curriculum, laboratories and workshops, and credibility among universities. Six Sigma can be achieved by developing proper strategies for mitigating these defects. Doi: 10.28991/HIJ-2022-03-02-07 Full Text: PDF
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Pankawase, Jitesh M., and Vitthal Shinde. "Effect of Pre-Analytical Errors on Turnaround Time of Central Clinical Laboratory: A Study Protocol." ECS Transactions 107, no. 1 (April 24, 2022): 17457–64. http://dx.doi.org/10.1149/10701.17457ecst.

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Clinical laboratories are crucial for medical care and recovery because they have evidence from body fluid analysis. Laboratory observations are used to make the majority of medical decisions. As a result, clinical lab results must be precise and timely. Laboratory quality management systems must include the influence of pre-analytical procedures in regions, including non conformance detection and control, continuous upgrade, internal audit, and quality indicators in order to be accredited as per ISO 15189:2012. Quality assurance (QA) has risen to the top of the priority list as a major source of worry. In terms of QA, "errors" in lab services are the most significant category that laboratories constantly monitor and assess. It is the responsibility of the clinical laboratory to provide precise and punctual results. The pre-analytical phase, on the other hand, is directly connected to the specimen collecting method and is mostly out of the laboratory's direct control; additionally, the majority of pre analytical mistakes are caused by human errors. As a result, the most essential and required methods to prevent these mistakes are phlebotomy team education and training programs. In this article, we have observed the effect of pre-analytical errors on turnaround time of central clinical laboratory of the hospital and also discovered the way to decrease the pre-analytical errors of inpatient samples.
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Lestari, Anak Agung Wiradewi. "PERAN DOKTER SPESIALIS PATOLOGI KLINIK DALAM AKREDITASI RUMAH SAKIT (The Role For Clinical Pathologist in Hospital Accreditation)." INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY 21, no. 1 (April 15, 2018): 102. http://dx.doi.org/10.24293/ijcpml.v21i1.1267.

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The hospital accreditation of 2012 version assessment, performed through the evaluation of the implementation of hospitalaccreditation standards. It’s consisting of four (4) standards groups. The laboratory service is one component of the Assessment ofPatients (AOP) chapters. The role of Clinical Pathologist in this accreditation can be internal as well as external. In the laboratoryservices standard, there are 13 sections each with element of judgment. Some of the challenges are still encountered in the meeting forthe accreditation standards include the need for an agreement between the Clinical Pathologist and the Physician, perhaps even the roleof the Indonesian Association of Clinical Pathologist and Laboratory Medicine (IACPLM) to determine the values of which one has thecritical value, that should be reported by the laboratory to physician. In addition, most laboratories currently in Indonesia do not havea reference value corresponding to the population and geography. This would be the task of the specialist (us) together/IACPLM to beable to formulate the reference value or discuss it with the Hospital Accreditation Committee in order to obtain the same perception ofthe reference value. But considering the determination of the reference value is not a simple matter and this will require cost as well.Another challenge is controlling the laboratory equipment used in wards, such as Point of Care Testing (POCT) devices. Most POCTis used in wards is not provided by the laboratory. The hospitals should regularly receive reports and review the quality control of thereference laboratory. But so far, most of the reference laboratories do not report the results of quality control to the hospital laboratory.In one assessment standard, stated that the hospitals should have access to contact an expert of diagnostics specialist such concernedto parasitological, virological, or toxicological. The question is whether the Clinical Pathologist can not be regarded as an expert inparasitological and virological diagnostics?
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Bhattacharya, Sanjay, Ramkrishna Bhalchandra, Mammen Chandy, VenkataRaman Ramanan, Aseem Mahajan, JeevaRatnam Soundaranayagam, and Subrata Garai. "Role of water quality assessments in hospital infection control: Experience from a new oncology center in eastern India." Indian Journal of Pathology and Microbiology 57, no. 3 (2014): 435. http://dx.doi.org/10.4103/0377-4929.138745.

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Pandit, AP, Neha Bhagatkar, and Mallika Ramachandran. "Personal Protective Equipment used for Infection Control in Dental Practices." International Journal of Research Foundation of Hospital and Healthcare Administration 3, no. 1 (2015): 10–12. http://dx.doi.org/10.5005/jp-journals-10035-1030.

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ABSTRACT The potential size of India's dental market is vast and is expected to become one of the largest single country markets for overseas dental products and materials. The total market for the dental equipment and materials is estimated to be around US$ 90 million annually. There are more than 1, 80,000 dental professionals in India, 297 dental institutes and over 5,000 dental laboratories. Thus, there is a huge potential for the market of personal protective equipment (PPE) used for infection control in dentistry. India's market for dental products is extremely dynamic, with a current estimated growth rate of between 25 and 30%. Overall, the dental market is expected to grow by 20%.1 The personal protective equipment used in the practice of dentistry in India. Since dentistry is predominantly a surgical discipline, it leads to exposure to the pathogenic microorganisms harbored in blood, body fluids and other potentially infectious material. Thus, the use of adequate and good quality PPE is imperative for infection control in dental practice. With the growing potential of India's dental market, the growth of the market for PPE is inevitable. But, it is equally important to raise the awareness among dental community about good quality products adhering to required standards to prevent the usage of low-cost, uncertified and sub-standard products that decrease the safety levels of personnel. The present study is conducted with a view to observe the personal protective equipment used for infection control in dental practices. How to cite this article Pandit AP, Bhagatkar N, Ramachandran M. Personal Protective Equipment used for Infection Control in Dental Practices. Int J Res Foundation Hosp Healthc Adm 2015;3(1):10-12.
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Zarbo, Richard J., Bruce A. Jones, Richard C. Friedberg, Paul N. Valenstein, Stephen W. Renner, Ron B. Schifman, Molly K. Walsh, and Peter J. Howanitz. "Q-Tracks." Archives of Pathology & Laboratory Medicine 126, no. 9 (September 1, 2002): 1036–44. http://dx.doi.org/10.5858/2002-126-1036-qt.

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Abstract Context.—Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome. Objective.—To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine. Design.—Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control. Setting.—Hospital-based laboratories in the United States (98%), Canada, and Australia. Participants.—Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs. Main Outcome Measures.—Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use. Results.—Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation. Conclusions.—Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.
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Sianipar, Osman. "ROLE OF DELTA CHECK IN CLINICAL LABORATORY SERVICES." INDONESIAN JOURNAL OF CLINICAL PATHOLOGY AND MEDICAL LABORATORY 25, no. 1 (April 10, 2019): 111. http://dx.doi.org/10.24293/ijcpml.v25i1.1517.

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Delta check is a process during post-analytical phases to detect discrepancies of test results before reporting by comparing current patient values to the previous test result. It is one of the efforts in assuring the quality of laboratory test results. It has to be done although control of sampling, control of method, control of the instrument, control of reagents as well as control of data distribution has been done well. The difference between those two test results is compared to a delta check limit that is specific for the test parameter within a predefined time interval. A time interval is flexible, and usually, most hospital laboratories choose 24 or 48 hours. Delta check limits should be defined so that both acceptable and unacceptable changes could be detected. Delta check limits should be based upon the total expected variation on both biological, and analytical variation. Delta check limits can be expressed as the absolute or percent difference between two consecutive results. The delta check system is addressed to evaluate changes in patient condition as well as quality sample issues and patient misidentification.
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Laxmi, Rajamanickam Venkata, A. Ramya, S. Vanaja, and Payala Vijayalakshmi. "Microbiological Surveillance of Hospital Environment in Chevella, India." Journal of Pure and Applied Microbiology 15, no. 3 (August 4, 2021): 1449–54. http://dx.doi.org/10.22207/jpam.15.3.38.

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Microbiological air contamination in operation theatres (OTs) and labor rooms (LRs) is a major risk factor for surgical site infection. Routine monitoring in vulnerable areas such as OTs and LRs should always be performed as part of infection control to evaluate the contamination by microorganisms and monitor for the presence of nosocomial agents. The present study is aimed to isolate and identify various pathogens in a hospital environment. The research was performed in the Bacteriology lab, Microbiology Department, Dr.Patnam Mahender Reddy Institute of Medical Sciences, Chevella, Ranga Reddy district, Hyderabad, India between November 2017 and November 2020 for a period of 3 years. Surface swabbing and settle plate techniques were two sampling techniques used in the analysis. A total of 3492 samples were collected from various hospital surface sites and 5 OTs and LR sites and equipment via the swab technique, while a Petri plate gravitational settling (passive) sampling method was selected for the collection of air samples and all these samples were properly transferred to the microbiology laboratory and processed by standard microbiological protocols. A total of 3492 surface swabs were taken from 5 OTs, LR sites and equipment from the hospital. Out of these 294 (8.42%) were culture positive and 3198 (91.58%) were culture negative. Among 294 microbial isolates, the highest number was reported from Bacillus spp. 212 (72.11%) and least number was from Pseudomonas spp. 6 (2.04%). Through air sampling methods, bacterial isolates were isolated from OTs and LR of various clinical departments and it was found that the highest bacterial count was reported from general surgery (677 CFU/m3) followed by orthopaedics (585 CFU/m3). Most of the microbial isolates isolated from OTs and LR of clinical departments found be species belonging to Bacillus spp. and Coagulase-negative Staphylococci (CoNS). In developing countries, routine indoor air quality management in healthcare facilities needs to be constantly monitored and appropriate measures are taken to detect and prevent acquired infections in hospitals. Settle plate methods for air and surface swabbing, also in resource-limited settings, are very useful, simple and cost-effective techniques for OT and LR monitoring.
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Njeru, Carol. "Evaluation of Quality Control in Clinical Chemistry and Hematology Using Sigma Metrics." American Journal of Clinical Pathology 152, Supplement_1 (September 11, 2019): S80. http://dx.doi.org/10.1093/ajcp/aqz116.001.

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Abstract Objectives The aim of this study was to evaluate clinical chemistry and hematology laboratory performance using six sigma metrics. Methods Clinical chemistry data and hematology data were analyzed from Bungoma Referral Hospital. Five parameters from renal and liver function tests were studied over a period of 6 months (December 2016 to May 2017). Data from IQC and EQA participation were used. The analytes were plasma creatinine, aspartate transaminase (AST), alanine transaminase (ALT), total serum protein, and total and direct bilirubin. Hematology parameters, namely white blood cell count (WBC), red blood cell count (RBC), and hemoglobin (Hb) levels, were studied. Data from IQC and EQA participation were used. Sigma metrics was calculated using total allowable error as per CLIA recommendations. Bias was calculated from HUQAS EQA participation while coefficient of variation was calculated from IQC data collected during the abovementioned months. Results Clinical chemistry had sigma metrics below 3; the highest sigma value was 2.01 while the lowest sigma value was 0.85. Hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4. Conclusion Clinical chemistry analytes had sigma levels less than 3; method performance improvement with stringent internal quality control and correct setting of control limits need to be applied. Application of sigma metrics in addition to daily internal quality control can identify analytical deficits and improvement in clinical laboratories. Most hematological parameters had sigma levels above 3. The highest sigma value was 7.21 while the lowest sigma value was 3.87. Only one level of sigma was below 4.
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Morozov, Sergey Yu, Natalya N. Kamynina, Andrey V. Andrey V. Vorykhanov, Marina V. Smirnova, Alexey A. Lobachev, Tatiana Yu Morozova, and Marina A. Morozova. "Evaluation of the effectiveness of internal quality control of medical care during control and supervision activities in medical organizations." City Healthcare 2, no. 3 (October 21, 2021): 6–16. http://dx.doi.org/10.47619/2713-2617.zm.2021.v2i3;6-16.

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Introduction. Currently, medical organizations of Moscow Healthcare Department have a three-level system of internal control for assessing the quality and safety of medical activities. At the same time, insurance companies have adopted a logically consistent, alternating multi-level system of inspections (medical and economic control) and evaluations (medical and economic evaluation, quality of medical care evaluation). Methods, techniques, criteria and guidelines for external and internal control of the quality and safety of medical activities are different. In this regard, assessment of the effectiveness of internal quality control of medical care in medical organizations during control and supervision activities is an important task that requires an evidence-based decision. Objectives. To provide evidence for the effectiveness of assessment criteria when conducting internal quality control of medical care and to determine their impact on effective performance of medical organizations. Materials and methods. The authors studied the results of 10 inspections and 36 evaluations of regulatory and supervisory authorities (insurance companies, Federal Service for Surveillance in Healthcare (Roszdravnadzor), etc.) and systematized the reasons for applying deductions and penalties. We performed a comparative analysis with evaluation criteria used by the heads of structural divisions (departments, laboratories) of City Clinical Hospital named after brothers Bakhrushin of Moscow Healthcare Department, as well as other private medical organizations. Authors studied technical capabilities of various automated information systems (Megaclinic, Asklepius, Doctor’s Automated Workstation, EMIAS for polyclinics and hospitals, etc.). Results. Authors performed comparative analysis of criteria used in inspections and evaluations of external and internal control of the quality and safety of medical activities. Analysis showed that the currently used assessment criteria do not fully ensure fulfillment of requirements and guidelines, violation of which entails financial sanctions (deductions, fines). Conclusion. It is necessary to develop and implement methods for organizing and conducting internal control of quality and safety of medical activities to create «effective criteria» that will minimize financial sanctions (deductions, fines) applied during various inspections (evaluations) of control and supervisory authorities.
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Boerma, G. J., A. P. Jansen, R. T. Jansen, B. Leijnse, and R. van Strik. "Minimizing interlaboratory variation in routine assays of serum cholesterol through the use of serum calibrators." Clinical Chemistry 32, no. 6 (June 1, 1986): 943–47. http://dx.doi.org/10.1093/clinchem/32.6.943.

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Abstract A cholesterol standardization program was developed in The Netherlands for clinical laboratories that use their analytical results as indicators of cardiovascular risk. Participants with sufficient precision but inaccurate results are encouraged to use serum-based calibrators as a means to decrease bias. A regional pilot survey and thereafter a national one were carried out in 31 and 138 laboratories, respectively, to investigate whether use of the serum-calibration procedure could improve routinely performed cholesterol measurements. To participants in our national quality-control surveys were mailed three calibrators (pooled human serum) and five human-serum controls, for analysis of cholesterol on four different days. Reference method values had been assigned to the calibrators by the Netherlands Reference Laboratory, applying the U.S. Centers for Disease Control modification of the Abell-Kendall procedure. Using the calibration curves based on results for the serum calibrators decreased the between-laboratory variation (SD) by at least 50%, with improved accuracy for non-enzymatic methods. The initial within-laboratory precision was generally good, and improvements in it were small. To our knowledge, standardization results involving so many routine hospital laboratory procedures have not been previously reported.
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Akhtar, Kafil, Radhika Arora, Umrah Malik, Ankita Parashar, Murad Ahmad, and Smriti Prasad. "Internal quality control in blood and component bank in a tertiary healthcare center in Northern India." IP Journal of Diagnostic Pathology and Oncology 6, no. 2 (June 15, 2021): 115–18. http://dx.doi.org/10.18231/j.jdpo.2021.025.

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Quality control describes steps taken by blood and component bank to ensure that tests are performed correctly. Primary goal of quality control is transfusion of safe quality of blood. It is to ensure availability of efficient supply of blood and blood components. Internal quality control is the backbone of quality assurance program. To analyze the internal quality control of blood components in modern blood banking as an indicator of our blood bank performance. An observational cross sectional study conducted at the Blood and Component Bank, JN Medical College and Hospital from 2018 to 2020. Each blood component was arbitrarily chosen during the study on monthly basis. Selection criteria was 1.0% of total collection or minimum 4 bags per month. Packed red cells were evaluated for hemoglobin, hematocrit, RBC count; platelet concentrates for pH, yield and culture; fresh frozen plasma and cryoprecipitate were evaluated for unit volume, factor VIII and fibrinogen concentration. The mean HCT of packed red cells was 65.75+7.42%, volume was 238+26.25ml, Hb was 20.5+0.15g/dL and RBC count of 5.89x10+0.30x10. The mean platelet yield was 5.7x10, pH was ≥6.8+0.175 and volume was 82.5+13.75ml; cultures were negative and swirling was present in all the platelet units tested. Mean factor VIII and fibrinogen levels were found to be 95.25 +7.37and 307.5+41.37gm/l for FFP respectively. Mean volume, PT and APTT were 215+32.5ml, 14.15+0.325 sec and 29.50+1.5 sec respectively. The quality control of blood components ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients.
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Rajkumar, Prabu, Sukumar Bharathy, C. P. Girish Kumar, Balaji Veeraraghavan, Valsan Verghese, Nivedita Gupta, Boopathi Kangusamy, Muthusamy Ravi, and Yuvaraj Jayaraman. "Hospital-based sentinel surveillance forStreptococcus pneumoniaeand other invasive bacterial diseases in India (HBSSPIBD): design and methodology." BMJ Open 10, no. 4 (April 2020): e034663. http://dx.doi.org/10.1136/bmjopen-2019-034663.

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IntroductionStreptococcus pneumoniaeis one of the frequently isolated organisms and an important aetiological agent of invasive bacterial diseases (IBD) like pneumonia, meningitis and sepsis. As a measure to control the burden of IBD, the Government of India introduced Pneumoccocal Conjugate Vaccine-13 (PCV-13) in the Universal Immunization Program in high burden districts of five states in a phased manner from 2017 onwards. It is essential to understand the trend of circulating pneumococcal serotypes associated with IBD in the prevaccination and postvaccination scenarios to decide on the expansion of vaccination programmes and PCV reformulation. This manuscript describes the protocol for hospital-based sentinel surveillance forS. pneumoniaeand other organisms causing IBD across various geographical regions in India.Methods and analysisHospital-based surveillance is established in selected hospitals to recruit children aged 1–59 months with symptoms of pneumonia and other IBD. Diagnostic criteria were adapted from standard WHO case definitions. Case Report Forms (CRFs) are used to collect data from the enrolled children. Blood, cerebrospinal fluid (CSF) and other normally sterile body fluids are collected and subjected to microscopy, cytology, latex agglutination, biochemistry, bacteriological culture and real-time PCR as applicable. Pneumococcal isolates are serotyped and tested for assessing antimicrobial resistance patterns. Data will be analysed by simple descriptive statistics to estimate the proportion of pneumonia and other IBD due toS. pneumoniae,Hemophilus influenzaetype b andNeisseria meningitidis. Prevalence of bacterial infection, circulating pneumococcal serotypes, antibiotic resistance patterns, serotype variability across seasons and regions will be described in terms of percentage with 95% confidence interval.Ethics and disseminationThe institutional review boards of the coordinating centre, all sentinel sites, regional and national reference laboratories approved the project. The results will be published in peer-reviewed journals and shared with stakeholders for deciding on revising vaccination strategy appropriately.
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Liu, Yuhong, Yu Pang, Jian Du, Wei Shu, Yan Ma, Jingtao Gao, Lijie Zhang, Shaofa Xu, and Liang Li. "An Overview of Tuberculosis-Designated Hospitals in China, 2009-2015: A Longitudinal Analysis of National Survey Data." BioMed Research International 2019 (August 20, 2019): 1–8. http://dx.doi.org/10.1155/2019/9310917.

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Design. A national tuberculosis- (TB-) designated hospital survey was conducted in 2015 to identify significant changes since 2009 in implementation of TB-testing services within hospitals of various types and administrative levels in various regions in China. Methods. In 2015, all TB-designated hospitals were required to complete questionnaires designed by the National Clinical Center for TB. Community hospitals also completed simplified questionnaires as part of the study. Results. Overall, in 2015 there were 1685 TB-designated hospitals in China, consisting of 1335 (79.2%) county-level hospitals and 350 (20.8%) hospitals at the prefecture level and above. The percentage of counties with TB-designated hospitals in the western region (57.4%) was significantly lower than corresponding percentages for eastern and middle regions (70.3% and 96.5, respectively). Based on data recorded on hospital surveys in both 2009 and 2015, significant differences were noted between years in proportions of general hospitals with TB wards and of specialized infectious disease hospitals (P < 0.01). Of 1256 county-level laboratories conducting smear microscopy, only 979 (79%) performed external quality control evaluations of test results in 2015. For prefecture-level hospitals, 70% (234/334), 76% (155/203), and 67% (66/98) of hospitals obtained external quality control validations of smear microscopy, phenotypic DST, and molecular test results, respectively. Conclusions. Although China’s health reform efforts have resulted in improved TB patient access to quality health care, more attention should be paid to balancing the distribution of medical facilities across different regions. In addition, laboratory capabilities and quality control systems should be strengthened to ensure delivery of high-quality laboratory services by TB-designated hospitals throughout China.
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Saraswat, Pallavi, Rajnarayan R. Tiwari, Muralidhar Varma, Sameer Phadnis, and Monica Sindhu. "Hospital-acquired infection awareness and control practices among healthcare staff: an evaluation." British Journal of Healthcare Management 27, no. 11 (November 2, 2021): 296–302. http://dx.doi.org/10.12968/bjhc.2020.0037.

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Background/Aims Hospital-acquired infections pose a risk to the wellbeing of both patients and staff. They are largely preventable, particularly if hospital staff have adequate knowledge of and adherence to infection control policies. This study aimed to assess the knowledge, awareness and practice of hospital-acquired infection control measures among hospital staff. Methods A cross-sectional study was conducted among 71 staff members in a tertiary healthcare facility in Karnataka, India. The researchers distributed a questionnaire containing 33 questions regarding knowledge of hospital-acquired infections, awareness of infection control policies and adherence to control practices. The results were analysed using the Statistical Package for the Social Sciences, version 16.0 and a Kruskal–Wallis test. Results Respondents' mean percentage score on the knowledge of hospital-acquired infections section was 72%. Their mean percentage scores on the awareness and practice of infection prevention measures sections were 82% and 77% respectively. Doctors and those with more years of experience typically scored higher. Conclusion The respondents had an acceptable level of knowledge, awareness and adherence to infection control practices. However, continued training is essential in the prevention of hospital-acquired infections. The majority of the respondents stated that they were willing to undertake training in this area, and this opportunity should be provided in order to improve infection control quality.
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Jacob, Edward, It-Koon Tan, Kim-Seng Chua, and See-Heng Lim. "Integrated laboratory information system in a large hospital laboratory in Singapore." Journal of Automatic Chemistry 14, no. 6 (1992): 223–29. http://dx.doi.org/10.1155/s1463924692000403.

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This paper describes an integrated approach to the computerization of all major disciplines of laboratory medicine and pathology. Installed in the Department of Pathology, Singapore General Hospital (SGH), the computer system discussed comprises a RISC-based Data General Aviion 6200 computer and Meditech MAGIC software. The system has been interfaced with the hospital host IBM computer and supports patient information transfer, result reporting, phlebotomy management, and compilation of laboratory and financial management reports. The main functions of the system include: on-line and off-line acquisition of patient information and test data; preparation of single/combined/cumulative reports; transmission of reports within and between laboratories; instantaneous provision of data in response to telephone enquiries; calculations of quality control/workload/productivity statistics and indices; and generation of billing lists. The computer enables reports to be provided on patient tests results in individual wards, at various specialist out-patient clinics, and in the Accident and Emergency Department of the SGH through the IBM mainframe, as well as to remote printers installed at several other major hospitals.The use of the MAGIC integrated laboratory information system has resulted in a significant increase in laboratory efficiency and productivity.
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Novis, David A., Jane C. Dale, Ron B. Schifman, Stephen G. Ruby, and Molly K. Walsh. "Solitary Blood Cultures." Archives of Pathology & Laboratory Medicine 125, no. 10 (October 1, 2001): 1290–94. http://dx.doi.org/10.5858/2001-125-1290-sbc.

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Abstract Objective.—To determine the frequency with which solitary blood culture samples were submitted to laboratories serving small hospitals and to ascertain whether certain hospital practices relating to the performance of blood cultures were associated with lower solitary blood culture rates (SBCRs). Design.—Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the numbers of solitary blood culture sets from adult patients submitted to their laboratories and answered questions about their institutions' practice characteristics relating to the collection of blood culture specimens. Setting and Participants.—Three hundred thirty-three public and private institutions with a median occupied bed size of 57. Participants were located in the United States (n = 329), Canada (n = 3), and Australia (n = 1). Main Outcome Measure.—The solitary blood culture rate was defined as the number of instances in which only 1 blood culture venipuncture was performed on an individual patient during a 24-hour period divided by the total number of blood culture venipunctures that were performed during the study period. Results.—Participants submitted data on 132 778 adult patient blood culture sets. The SBCRs were 3.4% or less in the top-performing 10% of participating institutions (90th percentile and above), 12.7% in the midrange of participating institutions (50th percentile), and 42.5% or more in the bottom-performing 10% of participating institutions (10th percentile and below). In half the participating institutions, the SBCRs for inpatients were 8.3% or less and for outpatients, 22% or less. Solitary blood culture rates were lower for institutions in which phlebotomists rather than nonphlebotomists routinely collected blood culture specimens, in which internal policies required drawing at least 2 blood culture sets, in which hospital personnel contacted clinicians when their laboratories received requests for solitary blood culture sets, and in which quality control programs monitored SBCRs routinely. Conclusions.—Hospitals can achieve SBCRs under 5%. Those hospitals with particularly high SBCRs may lower their rates by altering certain institutional practices.
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Bolgiano, Barbara, Eilís Moran, Nicola J. Beresford, Fang Gao, Rory Care, Trusha Desai, Ida Karin Nordgren, et al. "Evaluation of Critical Quality Attributes of a Pentavalent (A, C, Y, W, X) Meningococcal Conjugate Vaccine for Global Use." Pathogens 10, no. 8 (July 23, 2021): 928. http://dx.doi.org/10.3390/pathogens10080928.

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Towards achieving the goal of eliminating epidemic outbreaks of meningococcal disease in the African meningitis belt, a pentavalent glycoconjugate vaccine (NmCV-5) has been developed to protect against Neisseria meningitidis serogroups A, C, Y, W and X. MenA and X polysaccharides are conjugated to tetanus toxoid (TT) while MenC, Y and W polysaccharides are conjugated to recombinant cross reactive material 197 (rCRM197), a non-toxic genetic variant of diphtheria toxin. This study describes quality control testing performed by the manufacturer, Serum Institute of India Private Limited (SIIPL), and the independent control laboratory of the U.K. (NIBSC) on seven clinical lots of the vaccine to ensure its potency, purity, safety and consistency of its manufacturing. In addition to monitoring upstream-manufactured components, samples of drug substance, final drug product and stability samples were evaluated. This paper focuses on the comparison of the vaccine’s critical quality attributes and reviews key indicators of its stability and immunogenicity. Comparable results were obtained by the two laboratories demonstrating sufficient levels of polysaccharide O-acetylation, consistency in size of the bulk conjugate molecules, integrity of the conjugated saccharides in the drug substance and drug product, and acceptable endotoxin content in the final drug product. The freeze-dried vaccine in 5-dose vials was stable based on molecular sizing and free saccharide assays. Lot-to-lot manufacturing consistency was also demonstrated in preclinical studies for polysaccharide-specific IgG and complement-dependent serum bactericidal activity for each serogroup. This study demonstrates the high quality and stability of NmCV-5, which is now undergoing Phase 3 clinical trials in Africa and India.
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Ogboi, J. S., I. Ume, Z. Mohammed, A. Usman, A. Bashaar, C. Okoro, and L. Lawal. "Audit report: Baseline health facility assessment of quality assurance for malaria diagnosis in existing government hospital laboratories in Sokoto State, Nigeria." African Journal of Clinical and Experimental Microbiology 23, no. 2 (May 13, 2022): 159–67. http://dx.doi.org/10.4314/ajcem.v23i2.6.

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Background: Quality laboratory services are needed to direct reasonable malaria case management through malaria microscopy and rapid diagnostic test. This study assessed the existing diagnostic capacities including laboratory structures and systems, human resource, skills and competences, using the standardized WHO/NMEP EQA assessment tool. Methodology: Data were collected by an assessment team using a standardized assessment instrument/checklist drawn from WHO/NMEP assessment tool and analyzed with Open Data Kit (ODK) and Open-source suite of tools on Android mobile devices from September 3-11, 2020. The use of ODK allowed data to be collated offline where internet services were poor or unavailable and uploaded thereafter. Results: Of the 24 laboratory facilities assessed, diagnostic services on malaria are routinely done with combined malaria rapid diagnostic test (mRDT) and microscopy at 17 (65.0%) laboratories, microscopy only at 7 (27.0%)laboratories, while only mRDT was performed in 1 (3.8%) laboratory due to lack of functional microscopes, supplies, or trained personnel in microscopy. In the 24 facilities providing laboratory services, 16 (63.0 %) had one of the staff received basic malaria microscopy and mRDT training in the year prior to the assessment, and 23 (96.0%) of the laboratories had at least one functional electric binocular microscope. None of the laboratory had a good structured quality assurance/quality control procedure or standard operating procedures for either microscopy or mRDT. Conclusion: There were gaps in laboratory services due to lack of well-established quality control framework and ineffective communication system, which could have substantial impacts on the quality and accessibility of malaria diagnosis. These issues can be addressed by improving laboratory services. French title: Évaluation de base par les établissements de santé de l'assurance qualité pour le diagnostic du paludisme dans les laboratoires hospitaliers gouvernementaux existants dans l'État de Sokoto, au Nigéria Contexte: Des services de laboratoire de qualité sont nécessaires pour diriger une prise en charge raisonnable des cas de paludisme grâce à la microscopie du paludisme et au test de diagnostic rapide. Cette étude a évalué les capacités de diagnostic existantes, y compris les structures et les systèmes de laboratoire, les ressources humaines, les aptitudes et les compétences, à l'aide de l'outil d'évaluation EQA standardisé de l'OMS/NMEP. Méthodologie: Les données ont été collectées par une équipe d'évaluation à l'aide d'un instrument d'évaluation/liste de contrôle standardisée tirée de l'outil d'évaluation de l'OMS/NMEP et analysées avec Open Data Kit (ODK) et une suite d'outils open source sur les appareils mobiles Android du 3 au 11 septembre 2020 L'utilisation d'ODK a permis de rassembler les données hors ligne lorsque les services Internet étaient médiocres ou indisponibles et de les télécharger par la suite. Résultats: Sur les 24 établissements de laboratoire évalués, les services de diagnostic du paludisme sont systématiquement effectués avec un test de diagnostic rapide du paludisme combiné (mRDT) et une microscopie dans 17 laboratoires (65,0%), la microscopie uniquement dans 7 laboratoires (27,0%), tandis que seul le mRDT a été effectué. dans 1 (3,8%) laboratoire en raison du manque de microscopes fonctionnels, de fournitures ou de personnel qualifié en microscopie. Dans les 24 établissements fournissant des services de laboratoire, 16 (63,0 %) avaient un membre du personnel ayant reçu une formation de base en microscopie du paludisme et mRDT au cours de l'année précédant l'évaluation, et 23 (96,0%) des laboratoires avaient au moins un microscope binoculaire électrique fonctionnel. Aucun des laboratoires ne disposait d'une bonne procédure structurée d'assurance qualité/contrôle qualité ou de modes opératoires normalisés pour la microscopie ou le mRDT. Conclusion: Il y avait des lacunes dans les services de laboratoire en raison de l'absence d'un cadre de contrôle de la qualité bien établi et d'un système de communication inefficace, ce qui pourrait avoir des impacts substantiels sur la qualité et l'accessibilité du diagnostic du paludisme. Ces problèmes peuvent être résolus en améliorant les services de laboratoire.
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Verma, Nirmal, Nitin Kamble, Dhiraj Bhawnani, Kiran Makade, Monika Dengani, and Tarun Kaushik. "Evaluation of level of satisfaction among indoor patients attending in a tertiary care hospital of Rajnandgaon (C.G.), India." International Journal Of Community Medicine And Public Health 5, no. 4 (March 23, 2018): 1428. http://dx.doi.org/10.18203/2394-6040.ijcmph20181212.

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Background: Patient expression is an important source of information in screening for problems and developing an effective plan of action for quality improvement in health care organizations. Assessing satisfaction has been mandatory for quality control of any hospital, which has resulted in an increasing number of projects devoted to the concept of satisfaction and determinant of patient satisfaction.Methods: The present Cross sectional Observational Hospital based study was conducted in Government Medical College Hospital, Rajnandgaon (C.G.) India during April 2016 to September 2016. A sample of 200 patients was taken who were admitted in different Indoor Patients Department of Clinical departments. Patients were selected according to inclusion and exclusion criteria. The information from the patients on various aspects of patient’s satisfaction like admission procedure, communication with staff, physical care, test and operation help availability, cleanliness, privacy related issues and overall satisfaction was obtained by interview with patients based on the semi structured questionnaire proforma.Results: In the present study, among IPD patient Male: Female ratio was 3:2 approx. Helpfulness of person at registration desk was ranked very good by 93% subject. Wheelchair was available for most of the patients (95%) but its availability when needed was ranked very good by 76% patients only. Majority of patient were satisfied with the behavior of the lab technician (89%), availability of lab results on given time (81%).Conclusions: This study shows that patients admitted in the various wards of hospital were satisfied with the quality of professional services by doctors, nursing and paramedical staff but problem lies with the availability of basic amenities. Overall present study shows that assessing satisfaction of patients is simple, easy and cost effective way for evaluating the hospital services.
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Prasetya, Hieronymus Rayi, Nurlaili Farida Muhajir, and Magdalena Putri Iriyanti Dumatubun. "PENGGUNAAN SIX SIGMA PADA PEMERIKSAAN JUMLAH LEUKOSIT DI RSUD PANEMBAHAN SENOPATI BANTUL." Journal of Indonesian Medical Laboratory and Science (JoIMedLabS) 2, no. 2 (October 1, 2021): 165–74. http://dx.doi.org/10.53699/joimedlabs.v2i2.72.

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Internal quality assurance is a prevention and control activity that must be carried out by the laboratory continuously and covers all aspects of laboratory examination parameters. Hematology examination in the laboratory is carried out using a Hematology analyzer, but this tool has limitations, one of which is that it can make leukocyte count reading errors. In order for the results of the tool to be reliable, it is necessary to carry out quality control on the hematology analyzer. The use of Westgard multirule is commonly used in laboratories, but the application of six sigma is still very rarely used, especially in the field of hematology. This research aims to know the internal quality control of the analytical stage of the Hematology analyzer for the leukocyte count based on the analysis of Westgard and Six sigma. This type of research is descriptive research. The sample in this study is the control value data for the examination of the leukocyte count for 1 month at Panembahan Senopati Hospital. The data were analyzed using the Westgard rules and Six sigma. At low level, 13s deviation (random error) is obtained. At the normal level, there is a deviation of 12s (warning). At high level 12s deviation is obtained (warning). The sigma scale at all control levels shows a scale above 6. Analysis based on six sigma for leukocyte count showed an average of 7.16 sigma which indicates that leukocyte examination using a hematology analyzer has an accuracy of 99.9%.
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Pillay, Sureshnee, Jennifer Giandhari, Houriiyah Tegally, Eduan Wilkinson, Benjamin Chimukangara, Richard Lessells, Yunus Moosa, et al. "Whole Genome Sequencing of SARS-CoV-2: Adapting Illumina Protocols for Quick and Accurate Outbreak Investigation during a Pandemic." Genes 11, no. 8 (August 17, 2020): 949. http://dx.doi.org/10.3390/genes11080949.

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The COVID-19 pandemic has spread very fast around the world. A few days after the first detected case in South Africa, an infection started in a large hospital outbreak in Durban, KwaZulu-Natal (KZN). Phylogenetic analysis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genomes can be used to trace the path of transmission within a hospital. It can also identify the source of the outbreak and provide lessons to improve infection prevention and control strategies. This manuscript outlines the obstacles encountered in order to genotype SARS-CoV-2 in near-real time during an urgent outbreak investigation. This included problems with the length of the original genotyping protocol, unavailability of reagents, and sample degradation and storage. Despite this, three different library preparation methods for Illumina sequencing were set up, and the hands-on library preparation time was decreased from twelve to three hours, which enabled the outbreak investigation to be completed in just a few weeks. Furthermore, the new protocols increased the success rate of sequencing whole viral genomes. A simple bioinformatics workflow for the assembly of high-quality genomes in near-real time was also fine-tuned. In order to allow other laboratories to learn from our experience, all of the library preparation and bioinformatics protocols are publicly available at protocols.io and distributed to other laboratories of the Network for Genomics Surveillance in South Africa (NGS-SA) consortium.
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Jain, Shuchi, Pramod Kumar, Manish Jain, Megha Bathla, Shiv Joshi, Sushil Srivastava, Mahtab Singh, Ajit Sudke, Vikram Datta, and Poonam Shivkumar. "Increasing adherence to plotting e-partograph: a quality improvement project in a rural maternity hospital in India." BMJ Open Quality 10, Suppl 1 (July 2021): e001404. http://dx.doi.org/10.1136/bmjoq-2021-001404.

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Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. E-partograph is a modern tool for real-time computerised recording of labour data which improves maternal and neonatal outcome. The aim was to improve the rates of e-partograph plotting in all eligible women in the labour room from existing 30% to achieve 90% in 6 months through a quality improvement (QI) process.A team of nurses, obstetricians, postgraduates and a data entry operator did a root cause analysis to identify the possible reasons for the drop in e-partograph plotting to 30%. The team used process flow mapping and fish bone analysis. Various change ideas were tested through sequential Plan-Do-Study-Act (PDSA) cycles to address the issues identified.The interventions included training labour room staff, identification of eligible women and providing an additional computer and internet facility for plotting and assigning responsibility of plotting e-partographs. We implemented these interventions in five PDSA cycles and observed outcomes by using control charts. A set of process, output and outcome indicators were used to track if the changes made were leading to improvement.The rate of e-partograph plotting increased from 30% to 93% over the study period of 6 months from August 2018 to January 2019. The result has been sustained since the last PDSA cycle. The maternal outcome included a decrease in obstructed and prolonged labour with its associated complications from 6.2% to 2.4%. The neonatal outcomes included a decrease in admissions in the neonatal intensive care unit for birth asphyxia from 8% to 3.4%. It can thus be concluded that a QI approach can help in improving adherence to e-partography plotting resulting in improved maternal health services in a rural maternity hospital in India.
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Sharma, Lokesh Kumar, Rashmi Rasi Datta, and Neera Sharma. "Sigma Metric Evaluation of Drugs in a Clinical Laboratory: Importance of Choosing Appropriate Total Allowable Error and a Troubleshooting Roadmap." Journal of Laboratory Physicians 13, no. 01 (March 2021): 044–49. http://dx.doi.org/10.1055/s-0041-1726572.

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Abstract Objectives Stringent quality control is an essential requisite of diagnostic laboratories to deliver consistent results. Measures used to assess the performance of a clinical chemistry laboratory are internal quality control and external quality assurance scheme (EQAS). However, the number of errors cannot be measured by the above but can be quantified by sigma metrics. The sigma scale varies from 0 to 6 with “6” being the ideal goal, which is calculated by using total allowable error (TEa), bias, and precision. However, there is no proper consensus for setting a TEa goal, and influence of this limiting factor during routine laboratory practice and sigma calculation has not been adequately determined. The study evaluates the impact of the choice of TEa value on sigma score derivation and also describes a detailed structured approach (followed by the study laboratory) to determine the potential causes of errors causing poor sigma score. Materials and Methods The study was conducted at a clinical biochemistry laboratory of a central government tertiary care hospital. Internal and external quality control data were evaluated for a period of 5 months from October 2019 to February 2020. Three drugs (carbamazepine, phenytoin, and valproate) were evaluated on the sigma scale using two different TEa values to determine significant difference, if any. Statistical Analysis Bias was calculated using the following formula: Bias% = (laboratory EQAS result − peer group mean) × 100 / peer group mean Peer group mean sigma metric was calculated using the standard equation: Sigma value = TEa − bias / coefficient of variation (CV)%. Results Impressive sigma scores (> 3 sigma) for two out of three drugs were obtained with TEa value 25, while with TEa value 15, sigma score was distinctly dissimilar and warranted root cause analysis and corrective action plans to be implemented for both valproate and carbamazepine. Conclusions The current study evidently recognizes that distinctly different sigma values can be obtained, depending on the TEa values selected, and using the same bias and precision values in the sigma equation. The laboratories should thereby choose appropriate TEa goals and make judicious use of sigma metric as a quality improvement tool.
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Kumar Rastogi, Naveen, Kapil Goel, Tanu Jain, Samir V Sodha, Rajesh Yadav, Chandra Shekhar Aggarwal, and Akshay Dhariwal. "Evaluation of National Injury Surveillance Centre, India, 2015-16." Indian Journal of Community Health 32, no. 1 (March 31, 2020): 51–56. http://dx.doi.org/10.47203/ijch.2020.v32i01.011.

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Background: Globally, injuries accounts for 9% of all deaths, but India account for 11%. Due to limited data on injury characteristics, National Injury Surveillance Centre (NISC) was established in 2014 in New Delhi. Aim & Objectives: To evaluate attributes of NISC and make evidence-based recommendations. Methods and Material: We conducted cross-sectional study and used US Centers for Disease Control and Prevention guidelines to assess simplicity, flexibility, acceptability, stability, timeliness, representativeness, usefulness, and data quality. We reviewed 2015 records and interviewed 20 key-informants. We used Epi-Info7 for analysis. Results: NISC captured 4043 injuries in 2015 from one hospital. Among five data entry operators, four reported lengthy format, but all reported it easy. Among ten relevant key-informants, all reported data-management software easy. System demonstrated flexibility in three variables. All 20 staff reported willingness to participate, and 90% felt quarterly reporting acceptable. Regarding stability, data was collected for 361/365 days. Quarterly reports were available but only submitted annually. Regarding usefulness, all WHO-recommended variables included. Regarding data quality, 17% data-fields were missing. Conclusion: NISC is simple, flexible, stable, acceptable and potentially useful based on data captured. Timeliness based on annual reporting is high, can be improved to quarterly. We recommend training to improve data quality and integration of additional hospitals to improve representativeness.
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Oprea, Oana R., Elena Cristina Preda, Ion Bogdan Mănescu, and Minodora Dobreanu. "Setting up an own laboratory performance-based internal quality control plan - a model for complete blood count." Revista Romana de Medicina de Laborator 30, no. 4 (October 1, 2022): 477–82. http://dx.doi.org/10.2478/rrlm-2022-0036.

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Abstract Quality Control (QC) in Romania is regulated by the Order of the Minister of Health no. 1608/2022 that modifies the previous Order 1301/2007. The new version of the Order introduces a more scientific approach by requesting the laboratories to assess test performance and then elaborate an appropriate internal QC plan. The aim of this study was to demonstrate how to design a QC plan for complete blood count (CBC) in an Emergency Laboratory with continuous activity, in order to comply with the new Order 1608/2022. QC data obtained over a three-month period (April-June 2022) from the Sysmex XN-1000 instrument of the Emergency Laboratory of the County Emergency Clinical Hospital of Târgu Mureș were included. In order to establish an appropriate QC plan, two models were applied and the following parameters were calculated: the number of daily QC runs (N), the probability of false rejection (Pfr), the QC frequency (run size), and the required QC rules. White blood cells achieved high performance, while Hematocrit performance was poor. Different levels of performance were achieved for Platelets. We emphasize that, when all parameters are measured on the same instrument, QC frequency and Pfr should be adjusted in order to develop a QC plan that “fits” all the parameters of the CBC as a whole. In our Emergency Laboratory, the calculated QC plan for CBC is N=2, Pfr=0.03, multi-rule 1:3s/2:2s/R:4s, and a run size of 95 samples which is approximately the same as the number of CBCs performed during one 12-hour shift.
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46

Beotra, Alka. "Drug Abuse in Sports: An Overview." Journal of Postgraduate Medicine, Education and Research 47, no. 2 (2013): 94–98. http://dx.doi.org/10.5005/jp-journals-10028-1063.

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ABSTRACT The use of drugs to enhance performance in sports is termed as doping and is prevalent since ancient times. In India, the trigger to setup facility for the testing of banned substances was the first positive of an Indian weight lifter in 1990 Auckland Commonwealth Games. The Indian laboratory got ISO/IEC 17025: 1999 accreditation in 2003 and WADA accreditation in 2008. It accomplished testing for the two major international games (1st Singapore Youth Olympics and 19th Commonwealth Games) in 2010 successfully. The evaluation of statistics of sample testing in India revealed the maximum number of positives in bodybuilding, athletics, kabbadi, weightlifting and powerlifting. The most prevalent group of drugs in the banned category was anabolic steroids followed by stimulants and diuretics. The implementation of highest standard of quality control is essential for the doping laboratories to ensure best laboratory practices along with the ongoing research to keep up with the advancements in detection of new substances. The sports persons also need to be more vigilant about the prevalent antidoping rules and regulations. How to cite this article Beotra A. Drug Abuse in Sports: An Overview. J Postgrad Med Edu Res 2013;47(2):94-98.
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Chauhan, Akashdeep Singh, Shankar Prinja, Sushmita Ghoshal, and Roshan Verma. "Cost-effectiveness of treating head and neck cancer using intensity-modulated radiation therapy: implications for cancer control program in India." International Journal of Technology Assessment in Health Care 36, no. 5 (September 23, 2020): 492–99. http://dx.doi.org/10.1017/s0266462320000677.

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BackgroundThe newer cancer treatment technologies hold the potential of providing improved health outcomes at an additional cost. So it becomes obligatory to assess the costs and benefits of a new technology, before defining its clinical value. We assessed the cost-effectiveness of intensity-modulated radiotherapy (IMRT) as compared to 2-dimensional radiotherapy (2-DRT) and 3-dimensional radiotherapy (3D-CRT) for treating head and neck cancers (HNC) in India. The cost-effectiveness of 3-DCRT as compared to 2-DRT was also estimated.MethodsA probabilistic Markov model was designed. Using a disaggregated societal perspective, lifetime study horizon and 3 percent discount rate, future costs and health outcomes were compared for a cohort of 1000 patients treated with any of the three radiation techniques. Data on health system cost, out of pocket expenditure, and quality of life was assessed through primary data collected from a large tertiary care public sector hospital in India. Data on xerostomia rates following each of the radiation techniques was extracted from the existing randomized controlled trials.ResultsIMRT incurs an incremental cost of $7,072 (2,932–13,258) and $5,164 (463–10,954) per quality-adjusted life year (QALY) gained compared to 2-DRT and 3D-CRT, respectively. Further, 3D-CRT as compared to 2-DRT requires an incremental cost of $8,946 (1,996–19,313) per QALY gained.ConclusionBoth IMRT and 3D-CRT are not cost-effective at 1 times GDP per capita for treating HNC in India. The costs and benefits of using IMRT for other potential indications (e.g. prostate, lung) require to be assessed before considering its introduction in India.
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Recasens, Valle, Araceli Rubio-Martinez, Pilar Giraldo, Jose F. Lucia, Manuela Dobon, Maria A. Montanes, Eduardo Bustamante, Juan R. Garcia-Mata, Juan R. Portillo, and Manuel Giralt. "Economical Analysis of Implementation of External Quality Controls in a General Hospital Hematology Laboratory." Blood 106, no. 11 (November 16, 2005): 5590. http://dx.doi.org/10.1182/blood.v106.11.5590.5590.

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Abstract Introduction: The Spanish rule UNE-EN ISO 15189 concerning to Clinical Laboratory establish the realization of external quality controls (EQC) in order to compare results between laboratories. In 2004, external quality controls programs were initiated in our laboratory provided by the AEHH and SEQC. Aim: To analyze the increase of cost in each determination when we apply these quality measures. Material and methods: Period of study January 2004– December 2004. Encoded information obtained from ModulabWin informatics system. Determinations provided by AEHH: general hematology (RBC, Hb, HTC, MCV, MHC, HMCC, WBC, reticulocytes, cellular morphology, platelets, protrombine time, partial tromboplastine time, fibrinogen) AT III, F VIII, Hb A2 and F, automated reticulocytes, activated protein C resistance, differential count of WBC: (neutrophiles, monocytes, lymphocytes, eosinophils, basophiles), erythrocyte sedimentation rate (ESR). Determinations provided by SEQC: total proteins, albumin, complement C3 and C4, IgA, IgG, IgM, transferrine, iron serum levels, haptoglobine, ferritine, reactive protein C, b 2-microglobuline. For each ECQ with only one specimen for a unique determination the increase of costs was calculated as follow: EQC cost / total number of determinations. For each EQC with more than one determination the increase of costs was calculated as follow: (EQC cost / total number of parameters)/ total number of determinations. Results: In ECQ with only one specimen for a unique determination, the increase of cost for each determination was ESR: 0.0033€, AT III: 0,1051€, FVIII: 1.79€, automated reticulocytes: 0,0334€, differential count of WBC 0,0033€. In EQC with more than one determination the increase of cost: were: Albumin and total proteins 0,0030€; C3 and C4: 0,0473€; activated protein C resistance: 0,0059€; IgA, IgG, IgM and b-2 microblobuline: 0,0030€; iron serum levels, Transferrine and Ferritine: 0,0025€; Haptoglobine: 0,0057€; RBC, Hb, HTC MCV, MHC, HMCC, WBC, platelets: 0,0003€ and for protrombine time, partial tromboplastine time and fibrinogen: 0,0007€. Conclusions: The EQC for F VIII has been the more expensive control related to the number of determinations, however it is justified because our laboratory is reference center for the area. The incorporation of EQC hardly has increase the global costs of different determinations in a General Hematology Laboratory, nevertheless the quality, reproducibility, validity and security of results obtained with this procedure justify the slight increase of costs. This work has been partially supported by a grant from Aragon Health Service.
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Kumar, Atul, Vikas H., Sidhartha Satpathy, and Abdul Hakim. "Epidemiological investigation into the source of water contamination at a tertiary care cancer hospital." International Journal of Research in Medical Sciences 6, no. 8 (July 25, 2018): 2796. http://dx.doi.org/10.18203/2320-6012.ijrms20183272.

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Background: Water quality impacts the performance of the hospitals and leads to drastic health service deterioration affecting infection control programs, along with safety of the patients and staff. Good quality water is an essential prerequisite to ensure optimal patient care, and the well-being of the staff and visitors in a hospital environment. Objectives was to study the current water supply and treatment system in the cancer hospital. Also, to carryout root cause analysis of the causes of episodes of diarrhoea amongst patients and staff and to identify the source of infection and suggest improvement in the existing system to prevent recurrence.Methods: There were 25 reported cases of diarrhoea and other gastrointestinal symptoms between May 12 and June 2 2017, allegedly due to water contamination occurring in admitted patients and staff of a tertiary care cancer hospital in north India. This was reported to Hospital Administration, which prompted an epidemiological investigation.Results: Formation of Biofilms on the plastic taps was found to be the main reason for contamination of water.Conclusions: It was very clear that deposition of biofilm within the plastic taps was the main reason of diarrhea among the patients.
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Das, Arghya, Rahul Garg, E. Sampath Kumar, Dharanidhar Singh, Bisweswar Ojha, H. Larikyrpang Kharchandy, Bhairav Kumar Pathak, et al. "Implementation of infection prevention and control practices in an upcoming COVID-19 hospital in India: An opportunity not missed." PLOS ONE 17, no. 5 (May 23, 2022): e0268071. http://dx.doi.org/10.1371/journal.pone.0268071.

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Infection prevention and control (IPC) program is obligatory for delivering quality services in any healthcare setup. Lack of administrative support and resource-constraints (under-staffing, inadequate funds) were primary barriers to successful implementation of IPC practices in majority of the hospitals in the developing countries. The Coronavirus Disease 2019 (COVID-19) brought a unique opportunity to improve the IPC program in these hospitals. A PDSA (Plan—Do—Study- Act) model was adopted for this study in a tertiary care hospital which was converted into a dedicated COVID-19 treatment facility in Varanasi, India. The initial focus was to identify the deficiencies in existing IPC practices and perceive the opportunities for improvement. Repeated IPC training (induction and reinforce) was conducted for the healthcare personnel (HCP) and practices were monitored by direct observation and closed-circuit television. Cleaning audits were performed by visual inspection, review of the checklists and qualitative assessment of the viewpoints of the HCP was carried out by the feedbacks received at the end of the training sessions. A total of 2552 HCP and 548 medical students were trained in IPC through multiple offline/onsite sessions over a period of 15 months during the ongoing pandemic. Although the overall compliance to surface disinfection and cleaning increased from 50% to >80% with repeated training, compliance decreased whenever newly recruited HCP were posted. Fear psychosis in the pandemic was the greatest facilitator for adopting the IPC practices. Continuous wearing of personal protective equipment for long duration, dissatisfaction with the duty rosters as well as continuous posting in high-risk areas were the major obstacles to the implementation of IPC norms. Recognising the role of an infection control team, repeated training, monitoring and improvisation of the existing resources are keys for successful implementation of IPC practices in hospitals during the COVID-19 pandemic.
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