scholarly journals Internal quality control of blood products: An experience from a tertiary care hospital blood bank from Southern Pakistan

2018 ◽  
Vol 10 (01) ◽  
pp. 064-067 ◽  
Author(s):  
Sadia Sultan ◽  
Hasan Abbas Zaheer ◽  
Usman Waheed ◽  
Mohammad Amjad Baig ◽  
Asma Rehan ◽  
...  
Keyword(s):  
Quality Control ◽  
Factor Viii ◽  
Blood Bank ◽  
International Standards ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Minimal Risk ◽  
Care Hospital ◽  
Blood Products ◽  
The Mean

Abstract INTRODUCTION: Internal quality control (IQC) is the backbone of quality assurance program. In blood banking, the quality control of blood products ensures the timely availability of a blood component of high quality with maximum efficacy and minimal risk to potential recipients. The main objective of this study is to analyze the IQC of blood products as an indicator of our blood bank performance. METHODS: An observational cross-sectional study was conducted at the blood bank of Liaquat National Hospital and Medical College, from January 2014 to December 2015. A total of 100 units of each blood components were arbitrarily chosen during the study. Packed red cell units were evaluated for hematocrit (HCT); random platelet concentrates were evaluated for pH, yield, and culture; fresh frozen plasma (FFP) and cryoprecipitate (CP) were evaluated for unit volume, factor VIII, and fibrinogen concentrations. RESULTS: A total of 400 units were tested for IQC. The mean HCT of packed red cells was 69.5 ± 7.24, and in 98% units, it met the standard (<80% of HCT). The mean platelet yield was 8.8 ± 3.40 × 109/L and pH was ≥6.2 in 98% bags; cultures were negative in 97% of units tested. Mean factor VIII and fibrinogen levels were found to be 84.24 ± 15.01 and 247.17 ± 49.69 for FFP, respectively. For CP, mean factor VIII and fibrinogen level were found to be 178.75 ± 86.30 and 420.7 ± 75.32, respectively. CONCLUSION: The IQC of blood products at our blood bank is in overall compliance and met recommended international standards. Implementation of standard operating procedures, accomplishment of standard guidelines, proper documentation with regular audit, and staff competencies can improve the quality performance of the transfusion services.

scholarly journals Internal quality control in blood and component bank in a tertiary healthcare center in Northern India

2021 ◽  
Vol 6 (2) ◽  
pp. 115-118
Author(s):  
Kafil Akhtar ◽  
Radhika Arora ◽  
Umrah Malik ◽  
Ankita Parashar ◽  
Murad Ahmad ◽  
...  
Keyword(s):  
Quality Control ◽  
Factor Viii ◽  
Red Cells ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Blood Component ◽  
Minimal Risk ◽  
Blood Components ◽  
The Mean ◽  
Rbc Count

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.

Determining the adequate number of internal quality control levels: the example of coagulation factor VIII assay

2008 ◽  
Vol 19 (5) ◽  
pp. 433-437 ◽  
Author(s):  
Frédéric Sobas ◽  
Laurent Mazliak ◽  
Audrey Bellisario ◽  
Mathieu Lefranc ◽  
Anne Lienhart ◽  
...  
Keyword(s):  
Quality Control ◽  
Factor Viii ◽  
Coagulation Factor ◽  
Internal Quality Control ◽  
Coagulation Factor Viii ◽  
Internal Quality ◽  
Adequate Number

scholarly journals The Internal Standard “The Policy and Procedure of the System for Internal Quality Control of Audit Services”

2019 ◽  
Vol 86 (3) ◽  
pp. 107-115
Author(s):  
O. E. Lubenchenko
Keyword(s):  
Quality Control ◽  
Control System ◽  
Internal Standard ◽  
Financial Statements ◽  
International Standards ◽  
Quality Control System ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Audit Firm ◽  
Policy And Procedure

New Laws of Ukraine “On Accounting and Financial Reporting in Ukraine” and “On Audit of Financial Statements and Auditing” require the enhanced responsibility of auditors for auditing results. Creation of the body of public oversight over the auditing requires the continuing improvement of the internal control system through implementing internal company standards. The article proposes the elaborated procedure and key components of the internal standard “The Policy and Procedure of the System for Internal Quality Control of Audit Services”. The structure of the internal audit includes the following sections: glossary of terminology; leadership responsibilities for quality within the audit firm; ethical requirements; acceptance and continuance of client relationships; human resources; engagement performance (work documents on performance of previous engagement procedures, on planning of auditing engagements, on final procedures, other work documents); monitoring of quality control system and individual engagements; appendices. For understanding of International Standards of Auditing, the preamble of the internal standard should contain key notions and definitions. An important aspect is recording of issues creating the appropriate environment for control: style and essential principles of the audit firm management; organizational structure and specialization of the audit firm; sharing of responsibility and authorities of management and other personnel; personnel management policy (requirements for recruitment and dismissal, professional development, assessment of work quality, system of rewards). The audit firm sets and records the procedures to be applied to assure the compliance with ethical principles (honesty, objectivity, professional competency, confidentiality, professional behavior), and for identification and prevention of threats to its independence. The general procedures for acceptance are as follows: assessment of the firm’s resources for engagement performance, assessment of the client’s integrity, reaching agreement on the engagement terms and continuance of client relationship. The section “Human resources” of the internal standard contains the procedures for personnel recruitment, continuance of cooperation with personnel, assessment of their competence and capacities to perform auditing engagements, use of disciplinary actions (if necessary). The section “Engagement performance” of the internal standard includes the description of policies and procedures for collecting sufficient and acceptable audit evidence in order to form the auditor’ opinion about financial statements. For companies with public significance, in conformity with the law, the review of auditor’s report is envisaged, and the structure of the reviewer’s report is proposed. Once the reviewer’s report is received by the audit firm and differences in opinions are settled, the auditor’s report on financial statements, the supplementary report to the auditing committee, and the report to supervisory bodies (if necessary) will be made. The section “Monitoring of the internal standard” includes recording of procedures for monitoring of quality control system (the existence of quality control system and its compliance with current legal requirements, International Standards of Auditing and internal standards). Use of the internal standard “The Policy and Procedure of the System for Internal Quality Control of Audit Services” can essentially increase the quality of auditing and other engagements on ensuring confidence and related services.  

The between-run component of variation in internal quality control.

1989 ◽  
Vol 35 (7) ◽  
pp. 1416-1422 ◽  
Author(s):  
K Linnet
Keyword(s):  
Quality Control ◽  
Control Charts ◽  
Systematic Errors ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Components Of Variance ◽  
Upper Limit ◽  
The Mean ◽  
Power Curves

Abstract Design of control charts for the mean, the within-run component of variance, and the ratio of between-run to within-run components of variance is outlined. The between-run component of variation is the main source of imprecision for analytes determined by an enzymo- or radioimmunoassay principle; accordingly, explicit control of this component is especially relevant for these types of analytes. Power curves for typical situations are presented. I also show that a between-run component of variation puts an upper limit on the achievable power towards systematic errors. Therefore, when the between-run component of variation exceeds the within-run component, use of no more than about four controls per run is reasonable at a given concentration.

scholarly journals The Evaluation of Analytical Performance of Immunoassay Tests by Using Six-Sigma Method

2017 ◽  
Vol 36 (4) ◽  
pp. 301-308 ◽  
Author(s):  
Rukiye Nar ◽  
Dilek Iren Emekli
Keyword(s):  
Quality Control ◽  
Six Sigma ◽  
Clinical Chemistry ◽  
Quality Measurement ◽  
Analytical Performance ◽  
Internal Quality Control ◽  
Internal Quality ◽  
Variation Database ◽  
The Mean ◽  
Six Sigma Methodology

SummaryBackground: The Six-Sigma Methodology is a quality measurement method in order to evaluate the performance of the laboratory. In the present study, it is aimed to evaluate the analytical performance of our laboratory by using the internal quality control data of immunoassay tests and by calculating process sigma values. Methods: Biological variation database (BVD) are used for Total Allowable Error (TEa). Sigma values were determined from coefficient of variation (CV) and bias resulting from Internal Quality Control (IQC) results for 3 subsequent months. If the sigma values are ≥6, between 3 and 6, and <3, they are classified as »world-class«, »good« or »un - acceptable«, respectively. Results: A sigma value >6 was found for TPSA and TSH for the both levels of IQC for 3 months. When the sigma values were analyzed by calculating the mean of 3 months, folate, LH, PRL, TPSA, TSH and vitamin B12 were found >6. The mean sigma values of CA125, CA15-3, CA19-9, CEA, cortisol, ferritin, FSH, FT3, PTH and testosteron were >3 for 3-months. However, AFP, CA125 and FT4 produced sigma values <3 for varied months. Conclusion: When the analytical performance was evaluated according to Six-Sigma levels, it was generally found as good. It is possible to determine the test with high error probability by evaluating the fine sigma levels and the tests that must be quarded by a stringent quality control regime. In clinical chemistry laboratories, an appropriate quality control scheduling should be done for each test by using Six-Sigma Methodology.

scholarly journals Auditor's responsibility during the audit of the application of management's principle of continuity in the preparation of financial statements

2020 ◽  
pp. 25-27
Author(s):  
Serhii SELISHCHEV
Keyword(s):  
Quality Control ◽  
Financial Statements ◽  
Legal Framework ◽  
International Standards ◽  
Professional Responsibility ◽  
Internal Quality Control ◽  
Business Continuity ◽  
Internal Quality ◽  
Audit Activity ◽  
Research Show

The article explores the information base on the regulation of auditor responsibility. The types of responsibilities and the main elements that need to be considered when evaluating the auditor's actions that may pose a risk to the entity's continued business are systematized. Recommendations have been made regarding the specific provisions of the internal company quality control audit policy in terms of ensuring that the auditor understands his or her professional responsibility. Therefore, attention should be paid to ensuring the internal quality control of the procedures performed by the auditor in collecting, organizing and analyzing information on threats to business continuity, notably by establishing a clear system of responsibilities and responsibilities between partners for the task. Thus, the rules of the internal quality control system for audit services have been developed in the aspect of ensuring pre-emptive measures of compliance with professional responsibility when planning and conducting audit procedures to verify the assumption of continuity of activity of an entity. The results of the conducted research show that the issue of control of the auditor's responsibility requires further elaboration, first of all, due to the updating of the legal framework for the regulation of audit activity. As a result of our research, we have developed a number of methodological recommendations aimed at combining the requirements of international standards, legislation and practice of auditing, in particular in the aspect of ensuring the responsibility of the auditor, in the process of assessing the risks of termination of the enterprise, by building a regulation that is a system of key elements of the auditor's responsibility, under a time to assess the risk of business continuity that can be adequately monitored by audit.

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