Quality Assessment/Assurance/Control

Control the release of coagulation test results

STA Coag Connect is a software accessory for the STA family of hemostasis analyzers to control the release of patient coagulation test results. A single STA Coag Connect can be used to manage up to four coagulation instruments. With remote QC, the quality manager can access quality control results and charts of connected instruments within a hospital, integrated health network and/or remote clinics. The autoverification capability provides a review-by-exception process that optimizes both operator time and test result TAT. An easy to use rule-based system offers flexibility and efficiency, so test results within the rules are approved and released automatically. The system offers enhanced security and traceability, and all results can be automatically archived per user-defined protocols.

Diagnostica Stago

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Parathyroid hormone quality control

PTH Control is a human-serum-based liquid quality-control (QC) product designed to monitor parathyroid hormone (PTH) tests available on many automated PTH methods including those available from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, Siemens Healthcare, and Tosoh Bioscience. PTH testing is increasingly used in the clinical laboratory as a method to assess calcium regulation by the body. PTH has a direct impact on calcium absorption (and release) within the human body, and has been linked to osteoporosis and other clinical conditions. PTH Control is offered as a trilevel multipack to provide effective coverage of the PTH assay range on automated methods. Assigned PTH values are supplied for laboratory staff to expedite the process for setup of a new QC product. Access to the LabLink xL peer-comparison program is available for PTH Control data submission and direct comparison to a worldwide user base.

Thermo Fisher Scientific

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Hematology and reticulocyte controls

Liquichek Hematology Control and Liquichek Reticulocyte Control (A-I) are designed to monitor the precision of hematology parameters on Abbott CELL-DYN Sapphire and CELL-DYN 4000 systems. Liquichek Hematology Control (A-I) is available in three levels, with a 75-day shelf life and 8-day open-vial stability. Liquichek Reticulocyte Control (A-I) is available in two levels, with a 75-day shelf life and 14-day open-vial stability. The Unity Interlaboratory Program with peer-group comparison is available for use with these controls, which can help improve the quality of lab test results, and help meet regulatory and accreditation requirements. Data entry to the Unity software can be conveniently automated with UnityConnect or WebConnect connectivity solutions.

Bio-Rad Laboratories

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BK virus low and high positive controls

OptiQual BKV Low and High Positive Controls are standardized, full-process controls for molecular BK virus testing, these products can help labs accurately assess performance of BK virus tests and ensure quality results. Designed and manufactured according to ISO 17511, the BKV controls are assigned traceable values with uncertainty measurements and possess superior reproducibility and consistency in results from lot to lot. These controls also effectively mimic authentic patient samples, consisting of whole, unaltered virus in an EDTA plasma matrix. This ready-to-use, high-quality design allows labs to monitor the full molecular-testing process with confidence and ease, from extraction through amplification and detection. The OptiQual BKV Low and High Positive Controls are for in vitro diagnostic use.

AcroMetrix

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Liquid quality control sera

The Acusera quality control sera are ready-to-use liquid controls that eliminate the need for reconstitution to minimize the risk of human error, and save labs time and money. The liquid controls are available for clinical chemistry, immunoassay, cardiac, blood gas, and urinalysis. The Acusera range of quality controls covers more than 170 parameters. These are third-party controls not designed or optimized for use with a specific manufacturer’s instrument, calibrator, or reagent. The company also offers a 24/7 Internet-driven peer-group reporting system and RIQAS, an external quality-assurance scheme supplies customers with 15 EQA programs. The company can also provide customized quality-control materials tailor made to fit the customer’s specifications.

Randox

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Strep test kit includes quality control

The OSOM Strep A test with QC Inside is intended for the qualitative detection of Group A Streptococcal antigen from throat swabs or confirmation of presumptive Group A Streptococcal colonies recovered from culture, providing results within five minutes. The OSOM Ultra Strep A Test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcal antigen directly from throat-swab specimens, providing results within seven minutes. Both test kits feature QC Inside, which supplies two additional test sticks with each kit, so all tests are for direct patient use. This feature is also included with the OSOM Influenza A&B test kit. Each kit includes test sticks, swabs, reagent bottles, extraction tubes as well as positive and negative control material (sodium nitrite and acetic acid) for external quality-control testing. Online training is available for both kits.

Genzyme Diagnostics

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HbA1c control with intact RBCs

A1c-Cellular HbA1c control with intact red-blood cells (RBCs) is appropriate for immunoassay and ionic exchange HPLC methodologies and is assayed for the Bio-Rad D-10 and Variant/II; Ortho-Clinical Diagnostics VITROS 5,1 FS; Arkray Menarini ADAMS A1c HA-8160; Beckman Coulter Synchron CX/LX and Unicel DxC 600/800 Synchron; Siemens Healthcare Diagnostics, Dimension; Roche Diagnostics Cobas INTEGRA; and the Tosoh G7/G8 and A1c 2.2 Plus. The product is a ready-to-use liquid control with intact RBCs which enables validation of the crucial lysing step in the testing protocol as required when running patient samples. A1c-Cellular is available in 1.5-mL glass vials and 2.0-mL cap-pierceable plastic vials for HbA1c analyzers with autosampling capabilities. This product offers an open-vial stability of 30 days and a closed-vial stability of six months.

Streck

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Assayed chemistry control

MicroFD Assayed Chemistry Control is a serum-based control intended to simulate human patient samples for the purpose of monitoring the precision of laboratory-testing procedures. The control has been assayed specifically for 30 different analytes on the following chemistry analyzers: Abbott ARCHITECT c8000; Roche COBAS 6000; Alfa Wassermann ACE; Roche COBAS Integra; Alfa Wassermann ACE Alera; Roche COBAS 400+; Beckman CX5; Roche COBAS Mira S; Beckman CX7; Roche COBAS Mira+; Beckman CX9; Roche Hitachi 911; Beckman DXC600; Roche Hitachi 912; Medica EasyRA; Roche Modular; Olympus AU400; Siemens Advia 1200; Olympus AU2700; Siemens Advia 1650; Ortho Vitros 250; Siemens/Dade Dimension RxL; Ortho Vitros 5,1 FS; and Siemens/Dade Dimension Xpand. Packaged separately as 10 5-mL vials of Level 1 and Level 2, this lyophilized or freeze-dried product is stable for 14 days after reconstitution.

Audit MicroControls

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New whole-blood quality control verifies accuracy

The CD4 Count is a whole-blood quality control for verifying the accuracy of the BD FACSCount flow cytometer. The easy-to-read CD4 assay includes absolute counts and percent positive ratios on the cellular populations of CD3, CD4, and CD8 T-lymphocytes. These parameters are used in the diagnosis and treatment of HIV/AIDS patients. In addition, CD4 Count’s clinically relevant levels of CD4 cells help clinicians evaluate the instrument’s ability to read both normal and depressed levels. This product offers a 30-day open-vial stability, which allows labs to run the control every day, saving money. The 90-day closed-vial stability means fewer orders and reduced shipping costs.

Streck

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Improved qPCR results quality

The PCS Pipette Calibration System is for use in qPCR applications, and is an ideal solution due to its ability to rapidly measure small liquid volumes at high accuracy and to give NIST (National Institute of Standards and Technology)-traceable results. qPCR assays are becoming increasingly common in labs, are highly volume-dependent, and require several liquid volume steps. Easy to use, the PCS can verify the performance of a pipette’s accuracy and precision in minutes, allowing labs to conduct interim verification checks between regularly scheduled calibrations and before critical assays for stronger confidence in results.

Artel

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Improve testing quality

The hematology program from Randox International Quality Assessment Scheme (RIQAS) offers quick and easy quality analysis for eight analytes. With over 8,100 participants in 70 countries worldwide, RIQAS helps labs assess their analytical performance and compare it to other labs using the same methods and instruments. Liquid-stable whole-blood samples, supplied every three months, are analyzed on a biweekly basis with eight required hematology analytes included in each sample: Hct, Hb, MCH, MCHC, MCV, PLT, RBC, and WBC. As a result of feedback from participants, samples are now supplied in 2-mL primary tubes and can be placed directly in hematology analyzer.

Randox Laboratories

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Product focus

Standardizing pipette calibration in a large laboratory organization results in economic and quality gains

By Paula Pou

Large laboratory organizations with many departments find it difficult to allocate responsibility effectively for quality control. While a centralized, top-down approach can simplify regulatory compliance, distributing responsibility for calibration to individual departments has distinct advantages.

ARUP Laboratories in Salt Lake City, UT, a national clinical and anatomic-pathology reference laboratory, recently decentralized pipette quality control (QC) across its departments with great success. Working closely with a provider of liquid-handling quality-assurance technology, the lab implemented a standardized process for over 1,500 pipettes used in 71 departments. A pipette calibration system (PCS) and its associated pipette-tracking software were used to facilitate this process. ARUP also formed a pipette users group, drawing representatives from participating departments to ensure that standardized protocols were continually implemented with input from the entire organization.

Different tolerances, data requirements, naming conventions, and standard operating procedures (SOPs)
often would be associated with the same pipette model.

By putting into practice rigorous quality standards through this initiative, ARUP realized significant economic benefits. This outcome was achieved by reducing the number of tests that had to be rerun due to known or perceived pipetting error, thus minimizing wasted time and materials.

ARUP’s need for quality

Based in the University of Utah Research Park in Salt Lake City, ARUP offers more than 2,000 clinical tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays. As with any medical laboratory, pipetting is a critical component of the organization’s operations. Regular pipette calibration has always been an important part of ARUP’s QC system. Because many of the tests are extremely sensitive and results often determine patient diagnoses and treatment regimens, accurate and precise pipetting, especially when working with low volumes, is crucial for the success of the laboratory.

The drive to decentralize calibration

Based in the University of Utah Research Park in Salt Lake City, ARUP offers more than 2,000 clinical tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays. As with any medical laboratory, pipetting is a critical component of the organization’s operations. Regular pipette calibration has always been an important part of ARUP’s QC system. Because many of the tests are extremely sensitive and results often determine patient diagnoses and treatment regimens, accurate and precise pipetting, especially when working with low volumes, is crucial for the success of the laboratory.

ARUP was an early adopter of the PCS for calibrations in its reagent-production lab. As the organization grew, the reagent lab assumed responsibility for calibrating many of the pipettes used organization-wide. The reagent lab, however, often confronted a backlog of pipettes and experienced challenges in handling uneven workflow.

''Since most departments specified quarterly calibration intervals, calibration requests would peak and overload the lab at the end of each quarter,"  says Jeff Howard, ARUP quality specialist.

Another difficulty with this centralized approach was that — although the actual calibration was performed by the reagent lab — each individual department was responsible for the cleaning, maintenance, and calibration frequency of its pipettes as well as setting tolerance limits associated with different pipette types.

As ARUP expanded and its pipette population grew, more challenges arose. There were discrepancies in the calibration procedures among different labs. Different tolerances, data requirements, naming conventions, and standard operating procedures (SOPs) often would be associated with the same pipette model. Users of a pipette could set their own preferences, potentially leading to the same pipette being entered into the data-tracking system two or three times. This duplication led to inefficiencies and hampered ARUP’s ability to garner useful data from the pipette tracking system. To remedy these issues, ARUP decided to decentralize the pipette calibration function and install multiple PCS instruments throughout its facility, which allowed each functional department to assume responsibility for the calibration and maintenance of their own pipettes.

"Pipetting technology was critical in facilitating this changeover,"  adds Howard. “It has enabled us to standardize pipette quality procedures across our entire organization.''

Users group standardizes pipette-calibration protocols to facilitate and oversee its decentralized approach, ARUP created a pipetting users group, bringing together QC staff from across the organization. The group spans all levels of the organization: lab technologists, quality specialists, and group managers.

The users group began by standardizing calibration methodology, frequency, and tolerance limits. For example, a particular pipette with a range of 20 µL to 200 µL could have different calibration procedures associated with it based on the department in which it was used. Now, following users-group standards, the policy is set: The pipette is calibrated quarterly at three volumes (20 µL, 100 µL, 200 µL) with defined tolerance limits for accuracy and precision.

The group also helped standardize how the data-tracking system was used. Pipette-tracking software is designed to manage QC of an entire population of pipettes. It schedules calibrations, automates data collection during calibrations, and produces all documentation for regulatory compliance. The software also enforces the calibration methodology and tracks who is responsible for calibrating specific pipettes.

By standardizing calibration methodologies and procedures for each pipette, the group eliminated duplications and redundancies, reducing the data in the system by two-thirds. The group also standardized how the system was used so that each pipette now has a defined nomenclature, specific serial number, and specified SOPs.

The users group streamlined the entire quality process, making management of calibration data more efficient. Howard notes, “By implementing standardized policies across the board, we were really able to speed up the entire system, making it more effective and productive over the long term."

Next step: standardize pipetting-technique training

One advantage of assigning calibration responsibility to the departments that actually use the pipettes was that it made ARUP more aware of the need to train users in proper pipetting technique. Since the PCS provides immediate feedback on pipetting performance, ARUP could observe errors in accuracy and precision based on variability in technique. The organization decided to create a training program to ensure that all pipette users were proficient in pipetting.

To streamline this training process, the users group is designing an online tutorial in pipetting technique that will be mandatory for all technical staff. The tutorial combines information from the organization’s pipette vendor’s quality-management certification seminar, in which ARUP recently participated, and ARUP’s own internal SOPs.

The online tutorial is merely the first step in ARUP’s training initiative. The organization also plans to implement a wet-lab training class that will merge elements of the vendor’s training program and the best practices currently in use at ARUP. All incoming technical staff will be required to learn about and practice proper technique and receive hands-on experience using the PCS. The PCS is uniquely suited for training staff because a trainee can perform a 10-data-point calibration, complete with documentation, in less than three minutes. This quick feedback allows trainees to see the positive impact of minimal changes in technique.

“Even for technical staff who do not use pipettes daily, merely having them go through this training significantly raises awareness about the relationship between pipetting technique and quality," says Zachary Wilkey, quality specialist at ARUP.“ That fits with the overall goal of the users group: to standardize our quality procedures throughout the organization and make quality a priority."

The benefits of quality

Rigorous quality procedures is the economic benefit associated with a high degree of accuracy and precision in liquid- delivery operations. “The users group’s emphasis on standardizing quality not only ensures data integrity, it also saves us money over the long term," says Howard.

If pipettes are properly calibrated and operators are well trained in proper technique, there are fewer run failures over time. This minimizes material waste — such as expensive solvents and reagents — and also saves time and labor allocated to re-running tests.

“Quality is a goal in its own right," says Howard, “but there is also a strong business case for maintaining high standards. The pipette users group is executing that mission at ARUP."

PaPaula Pou is a life sciences writer based in New York. She can be reached at ppou@abipr.com. The products used by ARUP in its standardization initiative were ARTEL’s PCS Pipette Calibration System and associated Pipette Tracker software.

Published: May, 2010