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PubMed2003

Development and operation of a quality assurance system for deviations from standard operating procedures in a clinical cell therapy laboratory.

BACKGROUND: Errors and accidents, or deviations from standard operating procedures, other policy, or regulations must be documented and reviewed, with corrective actions taken to assure quality performance in a cellular therapy laboratory. Though expectations and guidance for deviation management exist, a description of the framework for the development of such a program is lacking in the literature. Here we describe our deviation management program, which uses a Microsoft Access database and Microsoft Excel to analyze deviations and notable events, facilitating quality assurance (QA) functions and ongoing process improvement. METHODS: Data is stored in a Microsoft Access database with an assignment to one of six deviation type categories. Deviation events are evaluated for potential impact on patient and product, and impact scores for each are determined using a 0- 4 grading scale. An immediate investigation occurs, and corrective actions are taken to prevent future similar events from taking place. Additionally, deviation data is collectively analyzed on a quarterly basis using Microsoft Excel, to identify recurring events or developing trends. RESULTS: Between January 1, 2001 and December 31, 2001 over 2500 products were processed at our laboratory. During this time period, 335 deviations and notable events occurred, affecting 385 products and/or patients. Deviations within the 'technical error' category were most common (37%). Thirteen percent of deviations had a patient and/or a product impact score > or = 2, a score indicating, at a minimum, potentially affected patient outcome or moderate effect upon product quality. DISCUSSION: Real-time analysis and quarterly review of deviations using our deviation management program allows for identification and correction of deviations. Monitoring of deviation trends allows for process improvement and overall successful functioning of the QA program in the cell therapy laboratory. Our deviation management program could serve as a model for other laboratories in need of such a program.

Cell- and Tissue-Based Therapy↗
PubMed1992

Delayed detection of an increase in resistant Acinetobacter at a Detroit hospital.

OBJECTIVE: To study an increase of antimicrobial-resistant Acinetobacter baumannii and to assess reasons for the delayed detection of this increase. DESIGN: Review of medical, laboratory, and infection control records. Plasmid profile analysis of available A baumannii isolates. SETTING: A 340-bed trauma and intensive care hospital in Detroit, Michigan. RESULTS: The number of hospitalized patients with resistant A baumannii increased during late 1989 and early 1990: 4 in September, 10 in October, 12 in November, 18 in December, and 23 in January (chi square for trend = 14.6, p = .0001). Forty-four (66%) of the 67 patients culture-positive for resistant A baumannii had respiratory tract colonization or infection. Of 11 resistant isolates, 6 had a similar plasmid profile and 5 had no plasmids. Under the hospital's targeted surveillance system, only positive cultures from blood or wounds were investigated; this largely respiratory increase of resistant A baumannii went unrecognized until January 1990. CONCLUSIONS: Antimicrobial resistance in A baumannii is an important concern. Such resistance is not necessarily plasmid mediated. Targeted surveillance for this and other agents of nosocomial infection should be used with caution, particularly in hospitals with many debilitated patients.

Acinetobacter↗
PubMed1997

High frequency of pseudobacteremia at a university hospital.

A prospective survey of all positive blood cultures was performed during a 6-month period at a 390-bed, tertiary-care teaching hospital in St Louis, Missouri. Data were collected from the clinical microbiology laboratory, medical records, and physicians caring for patients with positive blood cultures. Of 5,732 blood cultures, 261 (4.6%) were positive, and approximately half of these (51.3%) were categorized as false positive. Positive cultures were significantly more likely to be true positives if obtained from patients with malignancies or if they became positive within the first 48 hours of incubation.

Bacteremia↗
PubMed1975

Control of cost and medical relevance in clinical microbiology.

Government and third-party payers are applying increasing effort to control rising medical laboratory costs by restricting laboratory budgets. This threatens quality in clinical microbiology, where lack of automation has hampered increased productivity. A solution was sought by curtailing work on duplicates and specimens of poor quality using empirically derived objective criteria. One to 43% of specimens of various types were of insufficient quality to warrant planting, and 6-95% of isolates obtained in mixed culture were not subject to complete bacteriologic work-up because of evidence of superficial contamination. Combined with other controls this reduced bacteriology laboratory costs by 12%. Simultaneously, preliminary reports of examination of direct smears were provided for most specimens, and telephone reports were rendered when processing was incomplete to allow prompt resubmission of specimens. The impression that the information contributed to more rapid accurate diagnosis and treatment of infectious disease was gained.

Cervix Uteri↗
PubMed1976

A worksheet summary system for clinical laboratory management.

This article describes a simple method for summarizing total activity from the worksheets used at each workstation in a clinical laboratory. Monthly reports display day-to-day trends in total workload, as well as changes in the ratio between charged and total tests. Cumulative summaries of the monthly reports display month-to-month trends of total workload, as well as the ratio between charged and total tests. These reports also provide: (1) a simple method to calculate "lost revenue" (difference between total "chargeable" work and credited revenue); (2) more rapid and more uniform calculation of CAP workload units. In the author's laboratory, time required to maintain this data base and calculate CAP workload units has been less than the time previously required for calculation of CAP workload units alone.

Cost-Benefit Analysis↗
PubMed2004

Determination of dermal exposures during mixing, spraying and wiping activities.

Dermal exposure measurements were collected as part of RISKOFDERM, a European dermal exposure study which aims to improve the understanding of the nature and range of dermal exposures to hazardous substances throughout the European Union. Exposure measurements were collected to enable a predictive model to be developed for regulatory risk assessment purposes. In this paper dermal exposure data are presented for three generic job tasks: spray painting, wiping surfaces and mixing/dilution of formulations. The particular workplace settings included a dockyard and three medical laboratories. In the dockyard the tasks involved spray application and mixing of anti-foulant paint. For laboratory workers the observed tasks were preparation of biocide solution and wiping of surfaces with the disinfectant. Each dermal exposure measurement was derived from the mass of trace analyte on cotton gloves and 11 fabric patches, which were cut from whole-body dosimeters, representing the main anatomical areas of the body. The percentage mass of trace analyte in the formulation was determined by analysis to enable the total mass of the product on the anatomical areas to be calculated. The sampling periods were recorded to enable calculation of the dermal exposure rate, which is expressed as micro g total formulation/cm(2)/h. The geometric mean dermal exposure rate for the hands during spray painting was 2760 micro g/cm(2)/h (n = 24). The exposure rate for the rest of the body was 175 micro g/cm(2)/h (n = 35). Mixing of the paint involved higher exposure rates for both the hands and body, with a geometric mean of 31 200 micro g/cm(2)/h (n = 9) for the hands and 327 micro g/cm(2)/h (n = 14) for the rest of the body. For small-scale routine disinfection of surfaces using small quantities of biocide the principal anatomical area affected was the hands, with a geometric mean dermal exposure rate of 1840 micro g/cm(2)/h (n = 6). During systematic disinfection of laboratory surfaces with larger quantities of the biocide solution, the geometric mean dermal exposure rate for the hands was increased to 139 000 micro g/cm(2)/h (n = 24). In this case there was increased exposure of the body: principally the arms, legs, chest and head. The measured dermal exposure rate during preparation of the biocides (mixing) was very low, with a geometric mean value for the hands of 13 micro g/cm(2)/h (n = 16). There was a high level of variability observed in the results within each task. It is suggested that dermal exposures are partly dependent on human behaviour and on the occurrence of accidental contact with contaminated surfaces. This makes interpretation of the results difficult for predictive risk assessment purposes.

Disinfectants↗
PubMed2006

Cost-effectiveness of postremission intensive therapy in patients with acute leukemia.

BACKGROUND: We assessed the cost-effectiveness of high-dose arabinoside (HiDAC)-based and allogeneic stem-cell transplantation (alloSCT)-based therapy in patients with acute leukemia. PATIENTS AND METHODS: We analyzed the outcome, cost and cost-effectiveness of 106 patients treated from January 1994 to January 2002 [94 acute myelogenous leukemia (AML)/12 acute lymphoblastic leukemia (ALL)]. Forty-two young patients at either intermediate or unknown cytogenetic risk received postremission intensive therapy (24 HiDAC-based/18 alloSCT-based therapy). RESULTS: After a median follow-up of 50 months, the estimated 7-year overall survival for the HiDAC-based group showed a tendency to be higher than the alloSCT-based group (48% versus 28%, P = 0.1452). The HiDAC-based group spent a significantly lower total cost ($US51,857 versus 75,474, P = 0.004) than the alloSCT-based group. Cost-effectiveness analysis showed that the mean cost per year of life saved for the HiDAC-based group is considerably less expensive than the alloSCT-based group ($US11,224 versus 21,564). The reduced total cost for the HiDAC-based group originated from lower cost in room fees, medication, laboratory and procedure, but not in blood transfusion and professional manpower fees. CONCLUSION: For the postremission therapy in young AML patients at either intermediate or unknown cytogenetic risk, cost-effectiveness of HiDAC-based therapy compares favorably with that of alloSCT-based therapy, which deserves further clinical trials.

Adult↗
PubMed2006

Presentation, survival prospects, and predictors of death in Eisenmenger syndrome: a combined retrospective and case-control study.

AIMS: To characterize contemporary Eisenmenger patients at a large centre for adult congenital heart disease, assess survival prospects, and identify predictors of death in this population. METHODS AND RESULTS: All Eisenmenger patients under follow-up at our centre since 2000 (n=171, mean age 37+/-12 years) were included. To identify predictors of mortality, a case-control study was performed. Data including symptoms, functional class, medication, laboratory, and electrocardiographic and echocardiographic parameters are presented. Iron deficiency was common and strongly related to phlebotomy (relative risk 4.1, P<0.0001). Haemoglobin concentration was inversely related to arterial oxygen saturations in iron-replete patients (P<0.001) but not in iron-deficient patients. During a median follow-up of 67 months, 20 patients died. Survival at 40, 50, and 60 years of age was 94, 74, and 52%, respectively. When compared with healthy individuals, median survival was reduced by approximately 20 years in Eisenmenger patients and was worst in those with complex lesions. Predictors of mortality included functional class, signs of heart failure, history of clinical arrhythmia, QRS duration and QTc interval, and low serum albumin and potassium levels. CONCLUSION: Despite good short-term prognosis, life expectancy is markedly reduced in Eisenmenger patients. Markers of heart failure and parameters associated with arrhythmia are of prognostic value in terms of mortality and may guide clinicians caring for Eisenmenger patients.

Adolescent↗
PubMed1977

The reporting of communicable diseases.

Surveillance of communicable diseases in the United States depends on the reporting of cases by primary physicians. It is widely recognized, however, that significant numbers of such cases are not reported. Reporting rates for many communicable diseases have never been determined. In this study, discharge records of 11 hospitals in Washington, DC were searched for cases of selected communicable diseases, and the percentage of these cases reported was determined. Five hundred and seventy of 93,563 (0.61%) patients hospitalized over the study period had one of these communicable diseases. Reporting rates for each were as follows: viral hepatitis, 11%; H. influenzae meningitis, 32%; salmonellosis, 42%; meningococcal meningitis, 50%; shigellosis, 62%; tuberculosis, 63%; total cases, 35%. There is indirect evidence that low reporting rates are not restricted to the area studied. Supplemental reporting by medical laboratories, hospital infection control, and record room personnel were suggested as additional soruces of case reports.

Communicable Diseases↗
PubMed1980

The establishment and practice of forensic medicine in Iraq.

The development of a legal curriculum in Iraq included the subject of forensic medicine. In 1972 the College of Medicine in Baghdad included teaching in forensic medicine, and this has continued as the six current medical schools were established in the country. A central Medical Laboratory was established in 1918 and in 1919 a medicolegal department was included. An autopsy service was added to this department in 1920. After several changes the current activities are under the direction of the Ministry of the Interior. Professor A. I. Kayssi was the first active practitioner of forensic medicine in Iraq and he has been succeeded by Dr. W. M. Ali, who was a student and colleague. Each Province of Iraq has Medicolegal Centers whose Directors confer with the Central Institute of Baghdad. This Institute has responsibility for investigation of deaths and the examination of the living involved in sexual attacks or identification problems. The autopsy rate is 2784 per year in this institute. Iraq has 10.5 million people in an area smaller than the state of Texas. Baghdad, the largest city has less than 2 million.

Academies and Institutes↗
PubMed2000

Description of compensated and uncompensated disseminated intravascular coagulation (DIC) responses (non-overt and overt DIC) in baboon models of intravenous and intraperitoneal Escherichia coli sepsis and in the human model of endotoxemia: toward a better definition of DIC.

OBJECTIVE: Work toward a better definition of disseminated intravascular coagulation (DIC) by characterizing the difference between compensated and uncompensated responses of the hemostatic system to inflammatory stress in baboons and human subjects using global coagulation and molecular marker assays of hemostatic, inflammatory, and endothelial perturbation. DESIGN: We conducted prospective evaluation of the response of baboons to increasing concentrations of intravenous Escherichia coli, human subjects to intravenous endotoxin, and baboons to intraperitoneal E. coli. SETTING: Animal laboratory and medical intensive care facilities, University of Oklahoma Medical School laboratories. SUBJECTS: Cynocephalus baboons; normal healthy male human subjects (age, 24-37 yrs). MEASUREMENTS AND MAIN RESULTS: Global coagulation assays, white blood cell counts, and molecular marker assays (ELISA) of components of the inflammatory and hemostatic systems, neutrophil release products, and endothelial injury. A fall in both fibrinogen concentration and platelet counts indicated a decompensated hemostatic response to inflammatory stress (ie, overt DIC). These responses were observed 2-6 hrs after intravenous infusion of 10(9) and 10(10) colony-forming units (CFU)/g of E. coli and after implantation of 10(11) CFU/g of E. coli into the peritoneal cavity. However, 6 hrs after E. coli challenge, these tests were much less reliable as markers of overt DIC because the fibrinogen underwent an acute phase response and the platelet count fell and remained depressed for 48 hrs in the face of a coagulopathic response that was already beginning to resolve, as reflected by a rising fibrinogen concentration. This lack of reliability was particularly evident in the E. coli peritonitis studies, in which one third of the animals recovered, one third remained sick for up to 14 days, and one third died. In contrast, fibrin degradation products and the molecular markers thrombin/antithrombin, soluble fibrin monomer, protein C, and activated protein C/inhibitor complexes responded consistently in a dose-dependent manner regardless of the length of time after challenge. These variables exhibited this dose response to 106 and 108 CFU/g of E. coli in absence of a fall in fibrinogen concentration. This was defined as a compensated hemostatic response to inflammatory stress (ie, non-overt DIC). The values of these variables correlated closely with rising concentrations of markers of neutrophil activation (elastase/alpha 1 antitrypsin) and endothelial injury (soluble thrombomodulin). This was particularly evident in the human response to endotoxin, in which there was abundant evidence of hemostatic marker response in absence of a fall in platelet or fibrinogen concentration, both immediately after endotoxin infusion (first stage, 0-8 hrs after endotoxin) and later (second stage, 12-48 hrs after endotoxin). CONCLUSION: Global coagulation tests are most useful in detecting overt consumptive coagulopathy (overt DIC) near the time of challenge or injury (1 to 6 hrs). Molecular markers can detect and grade the degree of hemostatic stress of a non-overt consumptive coagulopathy (nonovert DIC). These markers correlate with degree of endothelial cell injury and reveal a reperfusion injury stage (second stage) in the human endotoxin model of compensated hemostatic stress after all clinical symptoms have subsided and the subjects have returned to work.

Animals↗
PubMed1998

The economic value of caring.

A heuristic method for monetizing effects of caring is presented. Practitioners' caring behaviors have economic value to health care organizations through effects on patient satisfaction, physiology, self-disclosure, and self-esteem, and subsequent use of medications, laboratory tests, and procedures. These effects are monetized as revenues generated, costs avoided, costs reduced, and externalities.

Caregivers↗
PubMed1983

Dose-response relationships for radium-induced bone sarcomas.

The incidence of bone sarcomas among 3055 female radium-dial workers who entered the dial industry before 1950 was used to determine dose-response relationships for the induction of bone sarcomas by radium. Two subpopulations were analyzed: all measured cases who survived at least 5 yr after the start of employment and all cases who survived at least 2 yr after first measurement. The first constituted a group based on year of entry; it contained 1468 women who experienced 42 bone sarcomas; the expected number was 0.4. The second comprised a group based on first measurement; it contained 1257 women who experienced 13 bone sarcomas; the expected number was 0.2. The dose-response function, I = (C + alpha D + beta D2)e-gammaD, and simplifications of this general form, were fit to each data set. Incidence (I) was in units of bone sarcomas per person-yr; (D) was the quantity (muCi) of radium that entered the blood. Two functions, I = (C + alpha D + beta D2)e-gammaD and I = (C + beta D2)e-gammaD, fit the data for year of entry (p greater than or equal to 0.05); both these functions and I = (C + alpha D) fit the data for first measurement. The function I = (C + beta D2)e-gammaD was used to predict the number of bone sarcomas in all other pre-1950 radium cases (medical, laboratory and other exposures); fewer were actually observed than the fit of this function to the female dial workers predicted.

Adult↗
PubMed1999

Radioisotope laboratory audits.

Elsewhere in this issue, Robin Elliott outlined a successful program for performing annual radiation safety management program audits. The results of such audits provide a useful means of evaluating and correcting deficiencies or weaknesses in a radiation safety program. At our institution we also perform an annual audit of each radioisotope lab oratory for the same reasons.

Humans↗
PubMed2002

Piloting a new radiation protection program strategy: rewarding compliance rather than sanctioning non-compliance.

In an attempt to improve compliance with historically problematic radiation protection program requirements, a novel incentive program was created in cooperation with a major vendor of biomedical research products. Researchers using radioisotopes that placed orders from a partnering vendor were afforded an added price discount if verified by the institutional radiation safety program to be in compliance with laboratory contamination survey requirements. The program, piloted for a period of 1 y, resulted in a total institutional savings of approximately $2,200 and a 27% improvement in compliance with targeted objectives when compared with previous years. Feedback from pilot participants was extremely positive, as the program served to shift the perception of the radiation protection program from one that sanctions non-compliance to one that rewards compliance. The relative success of the pilot program suggests that the approach may be broadly applicable both within radiation safety programs and other safety-related settings as well.

Cooperative Behavior↗