Fourth-Generation Fan Assessment Numeration System (FANS) Design and Performance Specifications

Abstract Objectives Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument. Methods The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated. Results The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of −0.1 mmol/mol (−0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of −1.0 and 0.9 mmol/mol (−2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias −0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP). Conclusions Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.

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Towards a Multi-Formalism Multi-Solution Framework for Model-Driven Performance Engineering

Advances in Systems Analysis, Software Engineering, and High Performance Computing - Theory and Application of Multi-Formalism Modeling ◽

10.4018/978-1-4666-4659-9.ch003 ◽

2013 ◽

pp. 34-55

Author(s):

Catalina M. Lladó ◽

Pere Bonet ◽

Connie U. Smith

Keyword(s):

Queueing Network ◽

Network Models ◽

Performance Model ◽

Analysis Model ◽

Model Driven ◽

Performance Engineering ◽

Performance Specifications ◽

Interchange Format ◽

And Performance ◽

Model Interchange

Model-Driven Performance Engineering (MDPE) uses performance model interchange formats among multiple formalisms and tools to automate performance analysis. Model-to-Model (M2M) transformations convert system specifications into performance specifications and performance specifications to multiple performance model formalisms. Since a single tool is not good for everything, tools for different formalisms provide multiple solutions for evaluation and comparison. This chapter demonstrates transformations from the Performance Model Interchange Format (PMIF) into multiple formalisms: Queueing Network models solved with Java Modeling Tools (JMT), QNAP, and SPE·ED, and Petri Nets solved with PIPE2.

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Process capability and stability of analytical systems assessed from proficiency testing data

Clinical Chemistry ◽

10.1093/clinchem/40.5.723 ◽

1994 ◽

Vol 40 (5) ◽

pp. 723-728 ◽

Cited By ~ 2

Author(s):

R W Jenny

Keyword(s):

Proficiency Testing ◽

Control Charts ◽

Total Quality ◽

Statistical Process ◽

Laboratory Performance ◽

Continuous Quality ◽

Valuable Adjunct ◽

Capability Analysis ◽

Performance Specifications ◽

And Performance

Abstract Participation in a proficiency testing (PT) program is a valuable adjunct to laboratory activities dedicated to the maintenance of reliable analytical methods. The PT program may facilitate continuous quality improvement if laboratory performance is presented in the context of expectations espoused by healthcare professionals for optimal patient care. Statistical process control (SPC) and capability analysis are tools used by industry in a Total Quality Management environment to characterize and monitor the performance of its processes relative to performance specifications. I conceptualized the use of an analytical system by many laboratories as a process that periodically produces results from the analysis of PT specimens. I treated a set of five PT results (theophylline) reported by a laboratory as a process sample and subjected the samples collected from many laboratories to SPC and capability analysis. The control charts--mean-(X-bar) and s-charts--produced by the analysis readily identify significant analytical errors in the context of peer performance and performance specifications provided by the regulatory program and analytical goal setting. The capability index (desirable Cp > 1.0) determined from clinical specification limits for the three analytical systems evaluated suggests an opportunity for improvement of laboratory performance.

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Selecting an Automated Parenteral Nutrition Compounder Device at a Tertiary Care Institute in Saudi Arabia

Hospital Pharmacy ◽

10.1177/0018578720965408 ◽

2020 ◽

pp. 001857872096540

Author(s):

Imraan Joosub ◽

Zohair Emara ◽

Mohamed Eltantawi ◽

Talal Alzeiby ◽

Osama Khateery ◽

...

Keyword(s):

Saudi Arabia ◽

Parenteral Nutrition ◽

Selection Process ◽

Tertiary Care ◽

Limiting Factor ◽

Technical Standards ◽

Comparative Review ◽

Performance Specifications ◽

And Performance ◽

American Society

Background: With advances in hospital automation, selecting an automated compounding device (ACD) for compounding parenteral nutrition (PN) may be challenging. A well-designed comparative review that considers safety and technical standards could assist in the selection process. United States Pharmacopeia chapter <797> and The American Society of Hospital Pharmacists (ASHP) has provided guidance on the safety and accuracy of ACDs. Objective: Utilizing a checklist of technical and performance specifications investigators sought to assess the adequacy of compounders available in the Kingdom of Saudi Arabia. Method: Investigators compared the NutriMiX KS-240 and the Exactamix EM 2400. A literature review of practice standards, safety, technical, and performance specifications was conducted. These were developed into a checklist of 46 technical and performance specifications. Investigators evaluated each ACD using the checklist. Results: It was found that 43 (93.48%) of the technical and performance specifications, required by the hospital, were met by the NutriMix KS-240, while 39 (84.78%) were met by Exactamix EM 2400. Conclusion: This review found that although ACDs comply with the majority of standards and specifications, software integration with the hospital information system may be a limiting factor in selecting an ACD. The investigators concluded that the NutriMiX KS- 240 matches the technical and performance specifications for automated compounders required by our institution.

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