Non-laboratory Personnel Research Articles

Operating room blood delivery turnaround time: a College of American Pathologists Q-Probe Study of 12647 units of blood components in 466 institutions.

Objectives To determine the normative distribution of time elapsed for blood bank personnel to fill nonscheduled operating room (OR) blood component orders in hospital communities throughout the United States, and to examine hospital blood bank practices associated with faster blood component delivery times. Design Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the times elapsed for blood bank personnel to fill nonscheduled emergent orders from hospital ORs for red blood cell (RBC) products, fresh frozen plasma (FFP), and platelets (PLTs). Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices. Setting and participants Four hundred sixty-six public and private institutions located in 48 states in the United States (n = 444), Canada (n = 9), Australia (n = 8), the United Kingdom (n = 4), and Spain (n = 1). Main outcome measures The median time elapsed between requests for blood components by OR personnel and the retrieval of those components by blood component transport personnel, and the median time elapsed between requests for blood components by OR personnel and the arrival of those components in ORs. Results Participants submitted data on 12 647 units of RBCs, FFP, and PLTs. The median aggregate request-to-retrieval turnaround times (TATs) for RBCs, FFP, and PLTs ranged from 30 to 35 minutes, and the median aggregate request-to-arrival TATs for RBCs, FFP, and PLTs ranged from 33 to 39 minutes. Most of the TAT was consumed by events occurring prior to, rather than after release of components from blood banks. Shorter prerelease TATs were associated with having surgical schedules that listed patients' names and procedures available to blood bank personnel prior to surgeries, and having adequate clotted specimens in the blood bank and completed type-and-screen procedures performed before requests for blood components were submitted to blood banks. Among the fastest-performing 10% of participants (90th percentile and above), request-to-retrieval TATs ranged from 12 to 24 minutes for the 3 blood components, whereas among the slowest-performing 10% of participants (10th percentile and below), request-to-retrieval TATs ranged from 63 to 115 minutes for the 3 components. Median TATs ranged from 33 to 37 minutes for the 3 components. Institutions with TATs in the fastest-performing 25th percentile more frequently stored cross-matched RBCs in the OR daily, stocked PLTs for unexpected surgical use, stored PLTs in or near the OR, and had laboratory rather than nonlaboratory personnel deliver components to the OR than did those institutions with TATs in the slowest-performing 25th percentile. Conclusions Hospital blood bank personnel can deliver blood components to the OR in slightly longer than 30 minutes, measured from the time that those units are requested by OR personnel. Practices aimed at saving time before components are released from blood banks will be more efficient in reducing overall TAT than those practices aimed at saving time after components are released from blood banks. Specific practices associated with shorter blood delivery TATs included providing blood bank personnel with access to the names of surgical patients potentially requiring blood components, having pretransfusion testing completed on those patients prior to surgery, having ample blood products on hand, and having laboratory personnel control blood product delivery.

Stratus CS Stat Fluorometric Analyzer

Stratus CS Stat Fluorometric Analyzer

Cancer incidence and work place exposure among Swedish biomedical research personnel.

This cohort study aimed to elucidate cancer occurrence in relation to occupational exposure to specific chemical, biological and physical agents among biomedical research laboratory personnel in Sweden. Standardized incidence ratios (SIRs) for the period 1970-1994 were calculated for specific exposures in the laboratory group (n = 3,277) and for personnel working in non-laboratory departments (n = 2,011), as an internal reference group. Expected numbers were based on national cancer rates. The total number of cancer cases was lower than expected in both laboratory and non-laboratory personnel. Elevated SIRs were noted for malignant melanoma among female laboratory employees for whom use was reported of solvents (SIR 2.73; CI 1.10-5.63) and of selected carcinogenic (International Agency for Research on Cancer (IARC) group 2B) agents (SIR 3.15; CI 1.16-6.85). A light increase of the risk estimate for breast cancer was also observed. In general, there were few cases of cancer in this comparatively young cohort, but the findings give some indication of increased risks for malignant melanoma in female laboratory personnel after exposure to organic solvents or substances classified by IARC as being possibly carcinogenic.

Process improvement for bedside capillary glucose testing in a large academic medical center: the impact of new technology on point-of-care testing

Point-of-care testing (POCT) for the management of patients with diabetes has become a standard of care. Originally, diabetic monitoring was accomplished by manual urine dipsticks. The development of hand-held, battery-operated capillary glucose monitors radically improved the ability of physicians and nurses to monitor diabetic patients during their hospital stay. Capillary glucose meters have been shown to provide accurate results under controlled conditions, but a number of early meters had issues with the quality of testing when used by non-laboratory personnel. Bedside capillary glucose testing was first initiated in our hospital in 1990, using a first-generation glucose meter that could measure a glucose value within 2 min. Operator errors were common because the glucose strips required wiping and the testing required timing. Furthermore, these early meters had no data storage or data management capabilities. In 1995, we transitioned to a second-generation meter with a rudimentary data management and storage capability that could be downloaded to a portable laptop. A log of quality control (QC) data could be derived from the download. A major problem with this device was the need to bring the instruments and laptop together, which was labor intensive and difficult to sustain over long periods of time in a large institution. We recently implemented a third-generation instrument (the Abbott Precision PCx) with a data management system (Precision NET). This device significantly expands the data management and networking capabilities of the bedside glucose meter, as shown in Table 5. Glucose values can now be performed in a fraction of the time of the first-generation meters, the need to wipe the glucose strips has been eliminated, and only certified operators can use the instrument. Networking technology allows for centralized quality control management, and the ability to network with other point-of-care technologies using intranet and in the near future internet applications. Collectively, these developments have radically improved the efficiency and quality of bedside capillary glucose testing, and have significantly enhanced the ability to manage this important technology.

Comparison of a Portable Capillary Whole Blood Coagulation Monitor and Standard Laboratory Methods for Determining International Normalized Ratio

The international normalized ratio (INR) is the current standard for monitoring anticoagulation therapy. Although simple to determine, it normally requires venipuncture and extensive laboratory resources for specimen handling and analysis. The portable capillary whole blood coagulation monitor is an alternative to laboratory venipuncture. Its promoted advantages are: it obtains a blood sample by finger-stick versus venipuncture; rapid turnaround time for results; resultant dosage adjustments (as appropriate) performed in minutes versus hours or days after testing; relative ease of use by nonlaboratory personnel; and potential for home monitoring. This project compared the results of INRs obtained through the venipuncture/laboratory process to INRs obtained by the portable monitoring process at the National Naval Medical Center. A correlation coefficient of 0.97 was determined. The difference in the mean INR results of the two testing methods was not clinically significant (p = 0.269). The portable monitor was determined to be a viable alternative to laboratory testing.

An inexpensive and reliable new haemoglobin colour scale for assessing anaemia.

AIM: To describe a new inexpensive method (the WHO Colour Scale) for estimating haemoglobin concentration from a drop of blood by means of a colour scale, and to compare its...

On-site laboratory monitoring on the intensive care unit. Blood gas, electrolyte, glucose, hemoglobin and lactate determination with the CIBA Corning 865 Analysis System

For decision-making in the ICU, rapid and accurate analysis of vital laboratory parameters is essential. The industry provides devices which analyse these parameters on a decentralised setting and which are designed for use by non-laboratory personnel. We investigated whether accuracy and handling of a new analyser (Ciba-Corning 865, Chiron Diagnostics, Medfield, USA) are good enough for basing clinical decisions on the measured parameters. The Ciba-Corning 865 allows measurement of blood gases, electrolytes, haemoglobin, glucose and lactate by use of photometric, ion-selective, enzymatic and electrochemical sensors in less than 18 microliters of whole blood. In a cardiac surgical intensive-care unit the accuracy of the device was tested by comparison to 61 measurements of quality control reagents, 48 tonometered blood samples and 536 parallel measurements in the clinical laboratory. Besides a 10-minute instruction, the participating personnel had no formal training with the device. The differences between measurements in quality control reagents and tonometered blood and the expected value were lower than 5%. The comparison with clinical laboratory measurements showed correlation coefficients from 0.94 (sodium) to 0.99 (glucose, lactate). The biases in Bland-Altman analyses were below 5%, the limits of agreement were found to be in a clinically acceptable range for all parameters. During the test period no technical problems occurred with the analyser and good acceptance by the personnel was found. The measured parameters were accurate enough to be used for therapeutic decisions in acute care medicine. Although it should not be a complete alternative to the clinical laboratory, because of rapid analyses, small sample volumes and easy handling the use of the Ciba-Corning 865 is advantageous for patients and users.

Evaluation of i-STAT portable clinical analyzer in a neonatal and pediatric intensive care unit

Objective: To evaluate the Point-of-Care (POC) i-STAT system for measuring blood gases (pH, pC0 2, p0 2) and whole blood electrolytes (sodium, Na +; potassium, K + and ionized calcium, iCa 2+) in the neonatal and pediatric intensive care units. Design and Methods: The i-STAT system was evaluated for imprecision, necessity of running quality control and accuracy. Comparison of patients' samples analyzed by the i-STAT system and the Ciba Corning 288 blood gas analyzer were performed. The reliability of the i-STAT system when performed by non-laboratory personnel was assessed. Results: The system was evaluated for imprecision and linearity using three concentrations of aqueous standards. Except for p0 2, the %CVs were <3.0 for all the analytes (pH, pC0 2, Na +; K + and iCa 2+) at all the three concentrations. Using whole blood studies the precision data gave %CVs that were <3.5 for all the analytes. Linearity studies showed good linearity over the five different concentrations tested. Comparison of the i-STAT and the Ciba Corning 288 blood gas analyzer was assessed by split sample measurement. Patients' results from the i-STAT correlated well with the Ciba Corning 288 blood gas analyzer ( r = 0.99 for pH, pC0 2, and p0 2 and 0.95 to 0.99 for Na +; and K +) with the exception of iCa 2+) ( r = 0.73). There was no significant difference in the results when operated by PICU/NICU nurses or laboratory personnel. A further study was made to assess whether routine quality control (QC) samples are necessary when using the i-STAT system. The regression analysis (slope and correlation coefficient) of the results from instruments run with and without QC samples gave results close to 1, indicating that there is no need to run additional quality control (QC). Conclusion: The POC testing analyzer i-STAT is a reliable alternative to the traditional blood gas analyzers and provides marginal improvement in turnaround time when compared with the service received from the PICU/NICU laboratory. Costs need to be carefully controlled.

Evaluation of i-STAT portable clinical analyzer in a hemodialysis unit

Objective: To evaluate a hand held portable i-STAT analyzer used for point-of-care testing in a hemodialysis unit. Design and Methods: Imprecision and comparison studies. Assays by nonlaboratory personnel. Results: Study of both quality control solutions and hemodialysis patients' duplicate blood specimens with 6+, E3+, EC6+, and EC8+ cartridges both gave CVs for sodium, potassium, chloride, pH, and ionized calcium of 0 to 2.2%. CVs for hematocrit, glucose and pCO 2 for whole blood duplicates were 4.6, 3.5, and 4.0%. The mean differences between i-STAT and central laboratory values for the above compounds and urea, when expressed as a % of mean central laboratory values were 0.2 and 3.1 % except for an ionized calcium value of 4.3% (for which there is an explanation) and for glucose (11 %) that were both higher for i-STAT. Preliminary data suggest that sodium, potassium, ionized calcium, and pH can be assayed in the aqueous dialysate fluid used for hemodialysis. Conclusions: We confirm previous reports that i-STAT cartridges give simple, rapid, and reliable values for sodium, potassium, chloride, urea, glucose, and hematocrit that are clinically acceptable when performed by nonlaboratorians, but also suggest the same conclusions apply to ionized calcium, pH, and p co 2 The hemodialysis unit may prove to be one of several hospital units where the analyzer has considerable value.

Comparison of concentrations of glycated hemoglobin (HbA 1c) in childrens' blood as determined by an immunonephelometric method and an ion-capture procedure - reference ranges

To assess the suitability of the i-STAT portable analyser for use by non-laboratory personnel, we measured blood gases and pH in venous blood samples from 100 dogs. Deming's regression and bias plots were used to compare i-STAT results with those obtained by laboratory professionals using two different autocalibrated benchtop analysers. Overall accuracy of the portable analyser proved excellent for pH, pO2, and pCO2 (r=0.978, 0.968 and 0.997, respectively), with Deming's regression slopes close to 1.00 (0.96, 0.97 and 1.08 for pH, pO2, and pCO2, respectively) and intercepts close to zero (0.28, 0.47 kPa and 0.46 kPa for pH, pO2, and pCO2, respectively). The accuracy of the i-STAT was also satisfactory for calculated parameters: bicarbonates, total CO2, base excess and oxygen saturation. Our findings show this portable analyser to be a valid substitute for expensive benchtop analysers in situations requiring mobility, or when small numbers of tests are to be performed by users not specialized in laboratory techniques.

Suitability of i-stat portable analyzer for blood gas testing by laboratory and non-laboratory personnel

Suitability of i-stat portable analyzer for blood gas testing by laboratory and non-laboratory personnel

Data Management Programs for Bedside Glucose Testing

Point-of-care testing programs are proliferating in hospitals because they can positively impact patient outcome. This point is best illustrated by nonlaboratory personnel performing glucose testing on nursing stations by using reflectance meters. To assist in the management of quality control and quality assurance data generated by such a program, four manufacturers offer data management options with six glucose meters. System features vary, but they all generally organize the data required by regulatory organizations. Future systems may include glucose testing among the battery of tests to be performed at the patient's bedside. Information gathered at the bedside could be transmitted to a laboratory information system via an infrared signal with software capable of managing this data. This is the first article of a two-part continuing education series on bedside testing. The second article will focus on hematology systems, and will be accompanied by the exam for CMLE credit in the January 1995 issue.

QUALITY ASSURANCE FOR BLOOD GLUCOSE MONITORING: The Balance of Feasibility and Standards

Capillary BGM is a test performed by persons with diabetes as well as health care professionals, i.e., nonlaboratory personnel. Although there are specific actions to be taken to enhance the quality of the test results, these recommendations are frequently not followed. Because therapeutic regimens for medication, diet, and exercise may be changed based on the BGM data and because there is a possibility of adverse outcome to a patient with erroneous results, assuring the quality of the data is reasonable. The challenge to nurses is to make what is reasonable also feasible and practical.

Transfer of Glucose Measurements Outside the Laboratory

Recent advances in technology have made it possible to meet the demand for rapid turnaround time of laboratory results by making the testing equipment accessible to nonlaboratory personnel. It is imperative that such testing, ie, nurses analyzing glucose at the patient’s bedside, be organized and monitored by the clinical pathology laboratory consistent with the requirements of various regulatory groups. An alternative program utilizing laboratory personnel involves use of a mobile cart for the analysis of glucose in patients with diabetic ketoacidosis. Both types of programs have been successfully implemented at a large suburban hospital.

Simple high-performance liquid chromatographic methods for resolving complex mixtures

~1) had to be transferred. HPLC-GC transfer was automated, allowing the instrument to be situated in a production plant and run by non-laboratory personnel . Maris et a1.16 determined PCBs in sediment samples using HPLC for sample clean-up. Excellent agreement of the HPLC-GC results with GC results obtained with conventional sample pre-treatment was found. Volumes of 1804 were transferred into a 5-m uncoated pre-column using the retention-gap technique with efficient partially concurrent eluent evaporation (on-column interface). Results of another study17, viz. on the determination of organochlorine pesticides in surface water are shown in Fig. 3. Towards automated analysis Automation in the sense of applying autosamplers has become common practice. However, in view of the tremendous work involved in sample preparation, this represents automation of only a small portion thereof. More recently, robotics were introduced for automating simple manual routine work. However, robotics only allow automation of classical, inefficient techniques. We need higher separation power for removing by-products, to achieve more efficient sample preparation in fewer steps, and, ideally, these steps should be integrated on-line into the final analysis. Column switching techniques in HPLC are one approach towards this end. From this point of view, automated coupled HPLC-GC should become a must for all laboratories that must analyze large numbers of complex samples efficient1Y.

Enzyme Multiplied Immunoassay Test

The enzyme multiplied immunoassay (EMIT) is a widely used analytical drug screening method that has been marketed for use by nonlaboratory personnel. The technique relies on the measurement of an enzyme's ability to modify a substrate. In its most common form, lysozyme that has been labeled with the suspected drug is added to the urine specimen along with a bacterial suspension and antibody to the suspected drug. If no drug is present, the antibody to the drug will bind with the druglysozyme ysozyme complex, thereby inactivating the lysozyme and failing to affect the turbidity of the suspension. If drug is present, the antibody to the drug will bind with both the enzyme-labeled drug and the free drug, leaving some of the enzyme-labeled drug complex free to act on the bacteria in the suspension, thus modifying the turbidity of the solution.

Evaluation of EMIT and RIA high volume test procedures for THC metabolites in urine utilizing GC/MS confirmation.

Results of EMIT, Abuscreen RIA, and GC/MS tests for THC metabolites in a high volume random urinalysis program are compared. Samples were field tested by non-laboratory personnel with an EMIT system using a 100 ng/mL cutoff. Samples were then sent to the Army Forensic Toxicology Drug Testing Laboratory (WRAMC) at Fort Meade, Maryland, where they were tested by RIA (Abuscreen) using a statistical 100 ng/mL cutoff. Confirmations of all RIA positives were accomplished using a GC/MS procedure. EMIT and RIA results agreed for 91% of samples. Data indicated a 4% false positive rate and a 10% false negative rate for EMIT field testing. In a related study, results for samples which tested positive by RIA for THC metabolites using a statistical 100 ng/mL cutoff were compared with results by GC/MS utilizing a 20 ng/mL cutoff for the THCA metabolite. Presence of THCA metabolite was detected in 99.7% of RIA positive samples. No relationship between quantitations determined by the two tests was found.

Health, Safety and Environmental Criteria for Siting of Laboratory Facilities

The development of applicable criteria for assessing the suitability of a site for construction of full and partial containment laboratories for the analysis of unknown and highly toxic chemicals is described. The criteria, based on considerations of health, safety and environmental factors, are used to define critical considerations in site selection to minimize the risk to non-laboratory personnel and the surrounding environment. Criteria are synthesized from several sources using the assumption of a worst-case chemical release. Mechanical failures, human failures, critical events and social/legal limitations are investigated, as are the characteristics of a site which may limit construction of such a facility. A detailed description is made of the various types of laboratories and the types of samples analyzed in them. The final recommendations are summarized for five typical laboratory settings; they are based primarily on the potential impacts on people, property and natural resources. A single occupancy building in a rural setting is recommended as the most suitable site for a full containment laboratory. A single occupancy building in an industrial park setting is acceptable, while multiple occupancy buildings and sites which are more highly developed are unacceptable. Similar recommendations are made for partial containment and conventional laboratories.