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Biomedical subjects

Ann M Gronowski

Publications and source records attributed to Ann M Gronowski.

At least 19 recordsLinked to original sources

Between a rock and a hard place: disclosing medical errors.

BACKGROUND: Healthcare-related errors cause patient morbidity and mortality. Despite fear of reprimand, laboratory personnel have a professional obligation to rapidly report major medical errors when they are identified. Well-defined protocols regarding how and when to disclose a suspected error by a colleague do not exist. PATIENT: We describe a woman with a well documented allergy to sulfamethoxazole who was treated with sulfadiazine that led to toxic epidermal necrolysis. After the patient's death, the laboratory medicine resident was asked by one of the patient's physicians to measure serum sulfadiazine, but only if the results were not reported in the patient's electronic medical record. The case was brought to the attention of a laboratory medicine faculty member and the hospital risk management team. ISSUES: Laboratorians are patient fiduciaries and are responsible for reporting errors. Most medical associations have codes of ethics that address disclosure of incompetence and errors, although the AACC's Guide to Ethics does not. New types of error, risk management, and root-cause analyses help to shift the focus to system errors and away from individuals' errors. This can lead to a healthcare environment that encourages truth and disclosure rather than fear and reprimand. Disposition: The individuals involved in the presented case fulfilled their fiduciary duty to the patient by reporting this incident. An extensive investigation showed that, in fact, no medical errors or misconducts had occurred in the care of the patient.

AIDS-Related Opportunistic Infections↗

A direct comparison between lamellar body counts and fluorescent polarization methods for predicting respiratory distress syndrome.

Our objective was to directly compare the diagnostic usefulness of lamellar body counting (LBC) and the TDx-FLM II assay (Abbott Laboratories, Abbott Park, IL) for predicting respiratory distress syndrome (RDS). This was a 5-year, retrospective, cohort study. A diagnosis of RDS was given to infants who received surfactant treatment and/or required ventilator support and/or continuous positive airway pressure for more than 24 hours. There were 172 infants without RDS and 12 with RDS included in the study. By using a TDx-FLM II cutoff of 55 mg/g or more for maturity, the sensitivity was 83%, specificity was 65%, predictive value of a mature result was 98%, and predictive value of an immature result was 14%. These results were similar to LBC using a cutoff of 50,000/microL or more with sensitivity of 92%, a specificity of 60%, a predictive value of a mature result of 99%, and a predictive value of an immature result of 14%. The LBC and TDx-FLM II methods have similar clinical usefulness.

Adult↗

Ischemia-modified albumin increases after skeletal muscle ischemia during arthroscopic knee surgery.

BACKGROUND: Ischemia can alter the ability of albumin to bind free metal atoms. Based on these biochemical changes, methods to quantify ischemia modified albumin (IMA) were developed to assist in the evaluation of patients with symptoms of cardiac ischemia. Since ischemia can occur in any vascular bed, the specificity of IMA for cardiac muscle ischemia is unclear and requires further investigation. METHODS: We evaluated the specificity of an IMA test in patients with skeletal muscle ischemia during arthroscopic knee surgery. A pressurized thigh cuff was continuously inflated to 300 mm Hg on the operative leg, in order to arrest blood flow during the procedure. Samples were collected before surgery, 15 min after surgery, and prior to discharge. RESULTS: Twenty-three patients were enrolled in the study. Median tourniquet time was 29 min (range 19-108). Median pre-operative IMA was 90.2 KU/l (range 77-101.6). Statistically significant (p<0.05) increases in IMA and myoglobin concentrations, and decreases in albumin concentrations were observed following tourniquet release and before discharge. CONCLUSIONS: Post-operative myoglobin elevations indicated that skeletal muscle ischemia was sufficient to produce detectable myocyte necrosis. Post-operative IMA increases are consistent with ischemic modification of albumin during exposure to ischemic conditions in skeletal muscle during and /or immediately after tourniquet application. However, the negative correlations between IMA and albumin results suggest that increases in IMA were in part due to lower post-operative albumin concentrations resulting in decreased cobalt binding.

Adult↗

Fetal lung maturity.

Respiratory distress syndrome of the newborn infant caused by immaturity of the fetal lung continues to be a clinical problem. Measurement of pulmonary surfactant production is the most effective way to evaluate pulmonary maturity. Since the first fetal lung maturity test was described more than two decades ago, advances in methodology have produced diagnostically sensitive tests that are both rapid and precise. Unfortunately, currently available tests continue to demonstrate low diagnostic specificity and remain poor predictors of fetal lung immaturity. We review the background, methodology, pre-analytical and analytical concerns, and clinical performance of various fetal lung maturity assays, and discuss the appropriate use and interpretation of these tests.

Fetal Organ Maturity↗

Diagnostic considerations in the measurement of human chorionic gonadotropin in aging women.

BACKGROUND: Human chorionic gondadotropin (hCG) screening tests are performed on nearly all female patients of childbearing age before any medical intervention. Although older women usually have negative hCG test results, positive results do occur and may cause clinical confusion. We examined changes with age in serum hCG concentrations in nonpregnant women and investigated the use of serum follicle-stimulating hormone (FSH) measurements as an aid to interpreting higher than expected ("positive") hCG results. METHODS: We used 240 serum specimens for each of 4 female cohorts: pregnant, > or =18 years; nonpregnant, 18-40 years (premenopausal); nonpregnant, 41-55 years (perimenopausal); and nonpregnant, >55 years (postmenopausal). Patients were excluded if they had an ectopic pregnancy, a history of trophoblastic disease or a germ-cell tumor, or if no chart was available for review. Quantitative hCG and FSH tests were performed on each specimen. RESULTS: Serum hCG concentrations in nonpregnant women increased with the age of the women. hCG results were higher and significantly different (P < 0.0001) for nonpregnant women >55 years (<2.0 to 13.1 IU/L) compared with nonpregnant women 18-40 years (<2.0 to 4.6 IU/L) and 41-55 years (<2.0 to 7.7 IU/L). Nineteen nonpregnant women >40 years of age had hCG concentrations > or = 5.0 IU/L, all with an FSH concentration >32.4 IU/L. The highest FSH concentration in pregnancy was 7.3 IU/L. CONCLUSIONS: Serum hCG increases with age in nonpregnant women. A cutoff of 14.0 IU/L should be used when interpreting hCG results in women >55 years of age. Pregnancy is unlikely in perimenopausal women 41-55 years of age with an hCG between 5.0 and 14.0 IU/L if serum FSH is >20.0 IU/L.

Adolescent↗

Predicting respiratory distress syndrome using gestational age and fetal lung maturity by fluorescent polarization.

OBJECTIVE: This study was undertaken to design a predictive model for assessing the risk of developing respiratory distress syndrome (RDS) by using gestational age (GA) and results from a quantitative fluorescence polarization-based fetal lung maturity assay (TDx FLM II). STUDY DESIGN: The study populations from the 3 largest published studies analyzing the association between TDx-FLM II and the development of RDS were combined for this analysis. A total of 509 patients were included in this study; 57 gave birth to infants who had RDS develop, and 452 gave birth to infants who were unaffected. Logistic regression analysis was used to model the odds of RDS as a function of GA, TDx FLM II ratio, and study site. RESULTS: The absolute and relative risks of an infant having RDS develop as a function of GA and TDx FLM II were calculated. The odds of RDS decrease 31% for each increasing week of GA and decrease 67% for each 10 mg/g increase in the TDx FLM II ratio. GA-specific TDx FLM II cutoffs are provided for sensitivities between 84% and 100%. The bias-adjusted area under the receiver-operating characteristic curve for the classification of RDS, based on GA and TDx FLM II ratio, was 0.957 with the use of the logistic model. CONCLUSION: The incorporation of GA into the evaluation of fetal lung monitoring allows for individualized, GA-specific risk assessment and provides GA-specific cutoffs with increased specificity.

Cohort Studies↗

The mean weekly increment of amniotic fluid TDx-FLM II ratio is constant during the latter part of pregnancy.

OBJECTIVE: The purpose of this study was to determine the mean weekly increment in amniotic fluid TDx-FLM II ratio during the latter part of pregnancy. STUDY DESIGN: All women who underwent > 1 amniocentesis for the determination of fetal lung maturity between 1998 and 2004 were identified retrospectively. Clinical information and TDx-FLM II ratios were collected from the participant's chart and analyzed. RESULTS: The gestational age of all participants at the first TDx-FLM II test was 31.2 to 37.5 weeks (mean, 34.7 +/- 1.4 weeks of gestation). The median interval between the 2 tests was 7 days (range, 5-36 days). We found that the mean weekly increment of TDx-FLM II was 14.4 +/- 9.9 mg/g (surfactant to albumin) and remained constant across the gestational ages. CONCLUSION: The mean weekly increment of TDx-FLM II is 14.4 +/- 9.9 mg/g and is constant during the latter part of pregnancy. This information, combined with the gestational age, should be useful in treating women with an initial immature test.

Adolescent↗

Rules-based detection of discrepancies between TSH and free T4 results.

BACKGROUND: Analytical errors in clinical laboratory testing are unavoidable. Recent reports have suggested the idea of "physiological profiling" which uses several results from a given patient to identify clinically unlikely results. The objective of this study was to establish rules-based criteria for identifying physiologically unlikely TSH and free T(4) (fT(4)) results. METHODS: For a 30-month period, all samples with fT(4) concentrations >2 ng/dl and TSH concentrations >0.1 micro IU/ml were investigated. RESULTS: Among 7918 plasma samples for which both TSH and fT(4) concentrations were measured, 18 (0.23%) had fT(4) and TSH exceeding the investigated limits. Of these, two were due to heterophile antibody interference (with the TSH assay), one was proven to be due to random error, four could be explained by the patients' conditions, three were from infants <1 week of age, and the remaining eight were unresolved, primarily due to insufficient sample, discarded samples, and inability to obtain patient histories. CONCLUSIONS: This study defined a rules-based alert system for clinically unlikely combinations of TSH and fT(4) results. This pilot study demonstrates that this system is capable of detecting at least two different types of laboratory errors that would have otherwise gone undetected.

Adult↗

Establishment of reference intervals for markers of fetal thyroid status in amniotic fluid.

Fetal goiter can arise as a result of fetal hyper or hypothyroidism. Although this condition is rare, it can be life threatening. Detection of fetal goiter in utero is possible with the aid of ultrasound, but proper prenatal treatment depends on knowledge of hormonal status. Amniotic fluid (AF) sampling is less technically demanding and poses fewer risks to the fetus than cordocentesis for fetal serum sampling, but well-established reference ranges for AF thyroid studies are not available in the literature. We have established reference intervals for AF (TSH), total T(4) (tT(4)), and free T(4) using stored AF samples. The reference intervals were: TSH (n = 127), less than 0.1-0.5 mU/liter, with a median of 0.1 mU/liter; tT(4) (n = 129), 2.3-3.9 microg/dl (30-50 nmol/liter), with a median of 3.3 microg/dl (4 nmol/liter); and free T(4) (n = 119) less than 0.4-0.7 ng/dl (5-9 pmol/liter), with a median of 0.4 ng/dl (5 pmol/liter). These intervals represent the largest study done to date on third trimester AF using automated immunoassays. A literature search of fetal goiter revealed a number of cases of hypothyroidism. Seven cases reported AF TSH concentrations (range, 1.1-28.9 mU/liter) and four reported AF tT(4) concentrations [range, 0.98-1.25 micro g/ml (13-16 nmol/liter)], all of which fell outside our reference intervals. These data support the use of AF to diagnose fetal hypothyroidism, reducing the need to resort to a riskier procedure such as cordocentesis.

Adult↗

Preanalytical factors that influence the Abbott TDx Fetal Lung Maturity II assay.

BACKGROUND: The TDx Fetal Lung Maturity II (FLM II) assay uses amniotic fluid to assess lung maturity of the unborn infant. We investigated common preanalytical factors that influence FLM results, including centrifugation, sample storage, and contamination by whole blood. METHODS: We tested 18 specimens after centrifugation and after resuspension by vortex-mixing. We also analyzed 23 specimens stored at -20 degrees C for up to 448 days and then thawed (duplicate measurements), 20 specimens stored at 4 degrees C, and 24 specimens stored at room temperature. In addition, we evaluated the effects of whole blood diluted into 19 different specimens. RESULTS: Centrifugation significantly decreased FLM II results from baseline (P <0.0001), and resuspension returned results to baseline values (P = 0.286). Storage at -20 degrees C produced highly variable results that demonstrated a nonsignificant negative trend associated with storage time. Specimens were stable for 24 h when stored at 4 degrees C and 16 h at room temperature. Blood contamination produced significantly positive differences in results only in specimens with baseline values < or =39 mg/g with a 5.8 mg/g increase in FLM II for every 0.1 x 10(12)/L increase in the erythrocyte count (slope = 58.4). CONCLUSIONS: Resuspension of centrifuged specimens produces clinically valid FLM II results. Results from specimens stored at -20 degrees C can be highly variable and decrease over time. Results from specimens stored at 4 degrees C and at room temperature are stable for 24 and 16 h, respectively. Blood contamination up to 0.03 x 10(12) erythrocytes/L is acceptable for FLM II analysis.

Albumins↗