Hospital-based Laboratories Research Articles

Glycodelin is present in pinopodes of receptive-phase human endometrium and is associated with down-regulation of progesterone receptor B

To test the hypothesis that glycodelin is localized on pinopodes and correlates with temporal immunostaining of leukemia inhibitory factor (LIF), LIF receptor (LIFR), and progesterone receptor B (PRB). Prospective clinical study. Hospital-based reproductive health unit and research laboratories. Twenty-five healthy fertile women with normal menstrual cycles. Endometrial biopsy specimens were obtained from healthy fertile women in the luteal phase of the menstrual cycle. Immunohistochemical staining of glycodelin, ultrastructural immunostaining of glycodelin, and double staining of glycodelin and PRB. Glycodelin is present in the glands when pinopodes appear. Glycodelin is localized on pinopodes but is also secreted from luminal epithelial cells regardless of pinopode formation. There was a negative correlation between glycodelin secretion from the glands and PRB staining. A weak correlation between the presence of LIFR (but not LIF) and glycodelin was found. Pinopode appearance, intense staining of LIFR in pinopodes and glycodelin staining in the glands are synchronized events. Down-regulation of PRB in the endometrium is concomitant with the presence of glycodelin in the endometrium, suggesting interaction.

Fear of needles and vasovagal reactions among phlebotomy patients

Anxiety associated with blood and injections is a common problem in medical settings and, in severe cases, affects sufferers’ ability to receive medically essential treatment. The present study was conducted to examine incidence of adverse reactions to venipunctures among phlebotomy patients, as well as to understand the demographic and psychological characteristics associated with such reactions. A large sample of participants undergoing venipuncture ( N = 3315) was recruited from hospital-based phlebotomy laboratories. Participants completed a brief questionnaire assessing psychological and physiological reactions to having their blood drawn. Results indicated that a small minority of patients experienced significant anxiety symptoms during venipuncture. Vasovagal reactions and vasovagal syncope were extremely infrequent. A tendency to experience pain, disgust, and fear of fainting during injections was associated with anxious responding to the venipuncture and a probable diagnosis of needle phobia. Theoretical and practical implications are discussed.

Interpretative strategies for lung function tests

SERIES “ATS/ERS TASK FORCE: STANDARDISATION OF LUNG FUNCTION TESTING” Edited by V. Brusasco, R. Crapo and G. Viegi Number 5 in this Series This section is written to provide guidance in interpreting pulmonary function tests (PFTs) to medical directors of hospital-based laboratories that perform PFTs, and physicians who are responsible for interpreting the results of PFTs most commonly ordered for clinical purposes. Specifically, this section addresses the interpretation of spirometry, bronchodilator response, carbon monoxide diffusing capacity ( D L,CO) and lung volumes. The sources of variation in lung function testing and technical aspects of spirometry, lung volume measurements and D L,CO measurement have been considered in other documents published in this series of Task Force reports 1–4 and in the American Thoracic Society (ATS) interpretative strategies document 5. An interpretation begins with a review and comment on test quality. Tests that are less than optimal may still contain useful information, but interpreters should identify the problems and the direction and magnitude of the potential errors. Omitting the quality review and relying only on numerical results for clinical decision making is a common mistake, which is more easily made by those who are dependent upon computer interpretations. Once quality has been assured, the next steps involve a series of comparisons 6 that include comparisons of test results with reference values based on healthy subjects 5, comparisons with known disease or abnormal physiological patterns ( i.e. obstruction and restriction), and comparisons with self, a rather formal term for evaluating change in an individual patient. A final step in the lung function report is to answer the clinical question that prompted the test. Poor choices made during these preparatory steps increase the risk of misclassification, i.e. a falsely negative or falsely positive interpretation for a lung function abnormality or a change …

The ATS/ERS consensus on clinical pulmonary function testing

Recently, the need for more uniform pulmonary function testing across the world has progressively increased. This prompted the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to appoint a joint Task Force to provide new combined standards. The Task Force consisted of 19 scientists with recognised expertise in pulmonary function testing, who met many times to produce their new standards, which, in July, started to appear as a series in five consecutive issues of the European Respiratory Journal [1–5]. The five manuscripts deal with the most relevant aspects of pulmonary function testing in hospital-based laboratories, including the following:

Translational Crossroads for Biomarkers

A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests for cancer care. Development and approval of several new markers and technologies have provided informative examples that include more specific markers for prostate cancer, more sensitive tests for ovarian cancer, more objective analysis of tissue architecture and an earlier indication of response to treatment in breast cancer. Although there is no clear paradigm for biomarker development, several principles are clear. Marker development should be driven by clinical needs, including early cancer detection, accurate pretreatment staging, and prediction of response to treatment, as well as monitoring disease progression and response to therapy. Development of a national repository that uses carefully preserved, well-annotated tissue specimens will facilitate new marker development. Reference standards will be an essential component of this process. Both hospital-based and commercial laboratories can play a role in developing biomarkers from discovery to test validation. Partnering of academe and industry should occur throughout the process of biomarker development. The National Cancer Institute is in a unique position to bring together academe, industry, and the Food and Drug Administration to (a) define clinical needs for biomarkers by tumor type, (b) establish analytic and clinical paradigms for biomarker development, (c) discuss ways in which markers from different companies might be evaluated in combination, (d) establish computational methods to combine data from multiple biomarkers, (e) share information regarding promising markers developed in National Cancer Institute-supported programs, and (f) exchange data regarding new platforms and techniques that can accelerate marker development.

Local INR calibration of the Owren type prothrombin assay greatly improves the intra- and interlaboratory variation

In 1999, a simplified procedure for calibration of the Owren prothrombin time (Owren PT) assay was introduced by a working group of the organisation for national quality assurance in laboratory medicine in Sweden. The new protocol allowed local calibration by means of only two lyophilised national plasma calibrators and expression of results as an international normalized ratio (INR). This is our report of a three-year follow-up involving the analysis of data from all laboratories, in hospitals (n=88 in 2002) and primary health care units (n=246 in 2002) that perform the Owren PT assay in Sweden. The interlaboratory variation was significantly improved after the introduction of the new calibration procedure. For the larger hospital-based laboratories, the mean coefficient of variation (CV) was reduced from 7.9% to 5.2% (p<0.0001) when analysing test materials with INR range 2-4. In the higher INR range (>4), the CV was reduced even further, from 10.4% to 6.8% (p<0.0001). The corresponding results from smaller laboratories in the primary health care units showed a similar decrease in CV from 8.2% to 5.7% in the INR range 2-4 (p<0.0001). At the INR range >4, the CV was reduced from 9.5% to 7.8%. The intralaboratory variation was also improved for both types of laboratory categories. This study shows an improved precision, with CV less than 6% at the therapeutic INR range, for both hospital-based laboratories and smaller laboratories in the primary health care system. The results indicate that the Owren PT assay is well suited for local INR calibration employing only two calibrant plasmas in a simplified procedure.

Customer satisfaction in anatomic pathology. A College of American Pathologists Q-Probes study of 3065 physician surveys from 94 laboratories.

Measurement of physicians' and patients' satisfaction with laboratory services has recently become a requirement of health care accreditation agencies in the United States. To our knowledge, this is the first customer satisfaction survey of anatomic pathology services to provide a standardized tool and benchmarks for subsequent measures of satisfaction. This Q-Probes study assessed physician satisfaction with anatomic pathology laboratory services and sought to determine characteristics that correlate with a high level of physician satisfaction. In January 2001, each laboratory used standardized survey forms to assess physician customer satisfaction with 10 specific elements of service in anatomic pathology and an overall satisfaction rating based on a scale of rankings from a 5 for excellent to a 1 for poor. Data from up to 50 surveys returned per laboratory were compiled and analyzed by the College of American Pathologists. A general questionnaire collected information about types of services offered and each laboratory's quality assurance initiatives to determine characteristics that correlate with a high level of physician satisfaction. Hospital-based laboratories in the United States (95.8%), as well as others from Canada and Australia. Ninety-four voluntary subscriber laboratories in the College of American Pathologists Q-Probes quality improvement program participated in this survey. Roughly 70% of respondents were from hospitals with occupied bedsizes of 300 or less, 65% were private nonprofit institutions, just over half were located in cities, one third were teaching hospitals, and 19% had pathology residency training programs. Overall physician satisfaction with anatomic pathology and 10 selected aspects of the laboratory service (professional interaction, diagnostic accuracy, pathologist responsiveness to problems, pathologist accessibility for frozen section, tumor board presentations, courtesy of secretarial and technical staff, communication of relevant information, teaching conferences and courses, notification of significant abnormal results, and timeliness of reporting). The database of 3065 physician surveys was derived from 94 laboratories. An average of 32.6 surveys (median 30) was returned per institution, with a range of 5 to 50 surveys per institution. The mean response rate was 35.6% (median 32.5%). The median (50th percentile) laboratory had an overall median satisfaction score of 4.4. The lowest satisfaction scores that were obtained all related to poor communication, which included timeliness of reporting, communication of relevant information, and notification of significant abnormal results. Statistically significant associations of customer satisfaction with certain institutional characteristics and laboratory performance improvement activities were identified. The importance of this satisfaction survey lies not in its requirement as an exercise for accrediting agencies but in understanding the needs of the customer (in this case the physician) to direct performance improvement in the delivery of quality anatomic pathology laboratory services.

Role of the hospital-based microbiology laboratory in preparation for and response to a bioterrorism event.

Many hospital-based clinical microbiology laboratories were called upon by local first responders (law enforcement, hazardous-material teams, and emergency medicine service personnel) to perform testing on powdery and miscellaneous environmental substances during the anthrax outbreak of September

Comparison of Serum and Heparin-Plasma Samples in Different Generations of Dimension Troponin I Assay

An editorial in the June issue of the Journal pointed out the usefulness of plasma instead of serum for cardiac troponin I (cTnI) determinations. However, because some analytical systems yield significant differences between serum and plasma troponin concentrations, the author of the editorial advocates more peer-reviewed studies before new assays are implemented in hospital-based laboratories (1). In September 2001 and March 2002, we carried out two comparison studies of cTnI measurements in plasma and serum samples, using different generations of the same assay (Cardiac Troponin-I Flex; Dade Behring). Both serum and plasma samples have been reported as suitable for cTnI determinations in the first (2) and second (3) generations of the assay. We collected two different series of 39 blood samples from patients admitted to the intensive care unit of our hospital during each month. …

Expression of progesterone receptors A and B and insulin-like growth factor-I in human myometrium and fibroids after treatment with a gonadotropin-releasing hormone analogue

Objective: To determine mRNA and protein expression of the progesterone receptor (PR) and insulin-like growth factor-I (IGF-I) in myometrium and fibroids. Design: Retrospective clinical study. Setting: Hospital-based and university-affiliated research laboratories. Patient(s): Twelve women in the proliferative phase and six women treated with GnRH analogue (GnRH-a). Intervention(s): Blood sampling and collection of myometrium and fibroids. Main Outcome Measure(s): PR and IGF-I mRNA levels in fibroids and myometrium were analyzed by solution hybridization and in situ hybridization whereas the proteins were localized by immunohistochemistry. Result(s): Fibroids and myometrium from women in the proliferative phase showed significantly higher PR mRNA than the corresponding tissues from GnRH-a-treated women. The amount of cells positively stained for PR-AB and PR-B in fibroids and myometrium decreased after GnRH-a treatment compared with in the proliferative phase. The IGF-I mRNA in both fibroids and myometrium in the proliferative phase was significantly higher than those after GnRH-a treatment. The immunostaining of IGF-I showed no difference between the two tissues. There was weaker immunostaining in the GnRH-a-treated group compared with in the proliferative phase group. Conclusion(s): The shrinkage of fibroids after steroid deprivation is associated with alterations in PR and IGF-I expression.

Q-tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking.

Continuous monitoring of key laboratory indicators of quality by hundreds of laboratories in a standardized measurement program affords an opportunity to document the influence of longitudinal tracking on performance improvement by participants focused on that outcome. To describe the results of the first 2 years of participation in a unique continuous performance assessment program for pathology and laboratory medicine. Participants in any of 6 modules in the 1999 and 2000 College of American Pathologists (CAP) Q-Tracks program collected data according to defined methods and sampling intervals on standardized input forms. Data were submitted quarterly to CAP for statistical analysis. Interinstitutional comparison reports returned in 6 weeks provided each laboratory with its performance profile of key indicators and its percentile ranking compared with all participants in that quarter. This also included longitudinal comparisons of performance during previous cumulative quarters. Control charts graphically displayed data with flags identifying performance points that were out of statistical control. Hospital-based laboratories in the United States (98%), Canada, and Australia. Voluntary subscriber laboratories in the CAP Q-Tracks performance measurement program: roughly 70% from hospitals of 300 occupied beds or fewer, 65% from private, nonprofit institutions, slightly more than half located in cities, one third from teaching hospitals, and 20% with pathology residency training programs. Each module measured several major and additional minor quality indicators and unbenchmarked individualized data for internal use. Participants in 4 of 6 Q-Tracks continuous monitors demonstrated statistically significant performance improvement trends in 1999 and 2000, which were most marked for laboratories that continued participation throughout both years. These monitors were wristband patient identification, laboratory specimen acceptability, blood product wastage, and intraoperative frozen section consultation. Key continuous indicators chosen on the basis of a decade's experience in the CAP Q-Probes quality improvement program are useful measurement and benchmarking tools for laboratories to improve performance. In general, measures in which there is a broad range of demonstrable performance initially are most optimal for subsequent improvement using continuous monitoring. These studies have shown that quality is not static, but rather is a moving benchmark of performance as seen in the redefinition of benchmarks over time by participants in the first 2 years of the CAP Q-Tracks program.

Recent approaches in standardization of cardiac markers

The development of commercial assays for the determination of new cardiac proteins has been one of the most important innovations in the field of cardiovascular diagnostics in the last decade. This significant and sudden advancement has however led to some analytical and interpretative problems. There are problems in test standardization, imprecision, interference and preanalytical variability. We also need to standardize utilization of biomarkers in diagnosis and management of acute cardiac syndromes and clearly define decision thresholds. Powerful tests, such as cardiac markers, on which critical decisions will rest, need highly reliable methods. The feeling is that some assays are inadequately appraised prior to their introduction in clinical use. More studies are needed to implement new devices in the laboratory routine, and only well documented assays should be used in hospital-based laboratories. The technology to address many analytic problems is at hand, but commitment on the part of manufacturers and their customers in the laboratory community is essential.

Surgical pathology-based outcomes assessment of breast cancer early diagnosis: a College of American Pathologists Q-Probes study in 199 institutions.

To develop breast cancer outcomes data relating pathologic tumor variables at diagnosis with clinical method of detection. Anatomic pathologists assessed 30 consecutive breast cancers at each institution, resulting in an aggregate database of 4232 breast cancers. Hospital-based laboratories from the United States (98%), Canada, Australia, and Belgium. One hundred ninety-nine laboratories in the 1999 College of American Pathologists Q-Probes voluntary quality improvement program. Pathologic variables indicative of favorable outcomes included percentage of carcinomas detected at the in situ stage, tumors < or = 1 cm in diameter, and invasive cancers with lymph nodes negative for metastases. All outcomes measures, including percent in situ carcinomas (26.9% vs 13.8%), tumor size < or = 1 cm (57.8% vs 36.5%), and lymph node-negative status (77.8% vs 64%), were more favorable when tumors were detected by screening mammography (P <.001) compared to all other detection methods. This study demonstrates an opportunity for pathologists to develop outcomes information of interest to health care organizations, providers, patients, and payers by integrating routine oncologic surgical pathology and clinical breast cancer detection data. Such readily obtained interim outcomes data trended and benchmarked over time can demonstrate the relative clinical efficacy of preventive breast care provided by health care systems long before mortality data are available.

Follow-up of infants of hepatitis B-infected women after hepatitis B vaccination, Connecticut, 1994 to 1997.

Follow-up of infants of hepatitis B-infected women after hepatitis B vaccination, Connecticut, 1994 to 1997.

Infectious disease testing related to organ and tissue transplantation: Results from a national laboratory survey

Background: The purpose of this national survey in the United States was to determine laboratory practices and policies related to infectious disease testing of tissue and organ donors. Methods: Supplementary questions were asked of the laboratories that subscribe to the College of American Pathologists’ 1996 Donor Center (DC-B) and Viral Markers (W1-B and W2-B) surveys. Only the laboratories that perform infectious disease testing for the purposes of organ and tissue transplantation were asked to respond to the survey. Results: A total of 1563 laboratories participated in the 1996 DC-B, W1-B, and W2-B surveys. A total of 203 (13.0%) laboratories indicated that infectious disease testing was performed for purposes of tissue and organ transplantation. The majority (81.1%) of respondents were hospital-based laboratories or regional blood centers. Variances existed in policies regarding type of testing, turnaround times, maintenance of frozen samples, confirmatory testing of positive screening tests, and the reporting of results. Conclusions: Various policies and procedures are practiced by laboratories that perform infectious disease testing related to transplantation, and standard guidelines do not currently exist. More data is needed to assess the variability of infectious disease testing of organ donors, as well as the need for standard guidelines. (AJIC Am J Infect Control 1999;27:275-8)

The transfusion service is an integral and important component of the hospital and should not be outsourced

Hospitals are under increased pressure to decrease operating costs. Hospital-based laboratories, blood banks (transfusion services), increasingly face the potential of being outsourced as hospitals try to survive the current waves of managed care. A number of complicated and unique services are provided by the hospital-based transfusion service and physician. Clinical consultation, complicated immunohematological procedures, apheresis, participation in a complex array of patient-care services, clinical research, ever increasing regulatory issues, and quality assurance activities are only a few of the challenges in today's transfusion medicine environment. This paper will focus on the hospital-based transfusion service, and the transfusion medicine physician, and present arguments as to why this service should remain close to the patient's bedside and not be outsourced.

New findings concerning early bone grafting procedures in patients with cleft lip and palate: Keese E.; Schmelzle R.J. Cranio-Maxillo-Fac. Surg. (Deu) (1995) 23/5 (296–301)

Antistaphylococcal penicillins (ASPs) are recommended as first-line treatment for invasive infections caused by methicillin-susceptible Staphylococcus aureus (MSSA). Cefazolin is an alternative option, but there is theoretical concern about its use as some MSSA strains produce beta-lactamases active against cefazolin. The study compared the outcomes in patients with MSSA infections treated with flucloxacillin and cefazolin.We analysed data from The Australia and New Zealand Co-operative Outcomes of Staphylococcal Sepsis (ANZCOSS) observational study, which included all consecutive unique episodes of Staphylococcus aureus bacteraemia from 27 hospital-based or independent microbiology laboratories from January 2007 to September 2013. In this retrospective analysis of prospectively collected data, we compared 30-day all-cause mortality in patients with MSSA bacteraemia treated with flucloxacillin to that in patients treated with cefazolin.We included data from 7312 episodes of MSSA bacteremia and found no difference in 30-day mortality in those treated with flucloxacillin (731/6520 [11.2%, 95% CI 10.9–12.5%]) compared to cefazolin (83/792 [10.7%, 95% CI 8.4–12.8%]), OR 0.93 (95% CI 0.72–1.17). In a propensity-adjusted analysis, mortality remained non-significantly lower in the cefazolin group (aOR 0.86 [95% CI 0.65–1.14]).This study supports the results from previous observational studies from other regions, while extending them to Australasia and to a much larger number of patients. Although this observational study indicates cefazolin is likely to have equivalent or superior outcomes to ASPs for MSSA bacteraemia, this can only be convincingly proven by a properly designed randomised controlled trial.

Federal reimbursement to laboratories

The change from a predominately fee-for-service payment environment to managed care has significantly reduced revenues for many clinical laboratories. Medicare is rapidly becoming the most favorable payor in areas with high managed-care penetration. This trend has not gone unnoticed by Congress, and congressional and regulatory initiatives are rapidly moving to reduce federal laboratory reimbursement. The efforts by both the private and public payors to further restrict payments could have a profound effect on the scope of testing offered by hospital-based laboratories. On-site nonemergent testing capability will be dependent on the cost to provide the service and the level of reimbursement. Laboratory providers have an opportunity to influence the extent of laboratory cost-reducing initiatives. To effect congressional or regulatory change requires an understanding of the federal Medicare payment system and a well-organized effort.

CRYPTOSPORIDIUM TESTING PRACTICES AMONG CLINICAL LABORATORIES IN THE UNITED STATES

CRYPTOSPORIDIUM TESTING PRACTICES AMONG CLINICAL LABORATORIES IN THE UNITED STATES

Factors affecting the labor efficiency of hospital-based blood bank laboratories.

A variety of financing mechanisms and managerial innovations have been developed in the past decade to control hospital costs. Some evidence suggests that those changes have not produced substantial improvements in labor efficiency among employees in the hospital's technical level, such as in the blood bank laboratories. This study measured labor efficiency in 40 hospital-based blood bank laboratories in Southern California during the year from July 1989 to June 1990 and explored the impact of financial, managerial, and operational factors on labor efficiency. With standardized output measures used in all blood bank laboratories, a wide variation of labor efficiency was found. Multivariate analyses indicate that the labor efficiency of blood bank employees was not influenced by organizational financial incentives, but was affected by the managerial styles of blood bank managers. Interpretation of the findings suggests that labor efficiency is affected by operational designs intended to improve responses to variable workloads and reduce slack time.