Quality control of test systems waived by the Clinical Laboratory Improvement Amendments of 1988. Perceptions and practices.

Abstract:

CONTEXT:Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. OBJECTIVE:To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. DESIGN AND SETTING:Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. RESULTS:Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. CONCLUSIONS:Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.

journal_name

Arch Pathol Lab Med

authors

LaBeau KM,Simon M,Steindel SJ

doi

10.1043/0003-9985(2000)124<1122:QCOTSW>2.0.CO;2

subject

Has Abstract

pub_date

2000-08-01 00:00:00

pages

1122-7

issue

8

eissn

0003-9985

issn

1543-2165

journal_volume

124

pub_type

杂志文章
  • Intestinal Buerger's disease.

    abstract::We describe a 50-year-old man who, at 26 years of age, underwent a hemicolectomy on the right side of the abdomen due to infarction of the right colon. At 35 years of age, a stenotic, ischemic segment of distal jejunum was resected. Later he had had intermittent claudication, migratory thrombophlebitis, and recurrent ...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Rosen N,Sommer I,Knobel B

    更新日期:1985-10-01 00:00:00

  • Necrobiosis lipoidica in a diabetic intravenous drug user.

    abstract::Necrobiosis lipoidica occurs most commonly on the lower extremities in patients with diabetes; lesions typically occur in the pretibial region. Although the pathogenesis of necrobiosis lipoidica remains unclear, both external trauma and vascular damage have been proposed as contributing to the development of this diso...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Jordan CD,Flotte TJ,Wright SW,MacKool B,Duncan LM

    更新日期:1997-10-01 00:00:00

  • Clinical Laboratory Quality Practices When Hemolysis Occurs.

    abstract:CONTEXT:Hemolyzed specimens delay clinical laboratory results, proliferate unnecessary testing, complicate physician decisions, injure patients indirectly, and increase health care costs. OBJECTIVE:To determine quality improvement practices when hemolysis occurs. DESIGN:We used the College of American Pathologists (C...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.5858/arpa.2014-0252-CP

    authors: Howanitz PJ,Lehman CM,Jones BA,Meier FA,Horowitz GL

    更新日期:2015-07-01 00:00:00

  • Changes of biochemical and biomechanical properties in Dupuytren disease.

    abstract:BACKGROUND:The major biochemical characteristic of Dupuytren disease is the progressive and irreversible deposition of excess fibrous collagen characterized by an enhanced type III collagen proportion. OBJECTIVE:To investigate the influence of changes of the collagen spectrum on the biophysical properties of the palma...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/0003-9985(2000)124<1275:COBABP>2.0.CO;2

    authors: Melling M,Karimian-Teherani D,Mostler S,Behnam M,Sobal G,Menzel EJ

    更新日期:2000-09-01 00:00:00

  • Death certification errors at an academic institution.

    abstract:CONTEXT:The correctly completed death certificate provides invaluable personal, epidemiologic, and legal information and should be thorough and accurate. Death certification errors are common and range from minor to severe. OBJECTIVE:To determine the frequency and type of errors by nonpathologist physicians at a unive...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/1543-2165(2005)129[1476:DCEAAA]2.0.CO;2

    authors: Pritt BS,Hardin NJ,Richmond JA,Shapiro SL

    更新日期:2005-11-01 00:00:00

  • Computerized image analysis of p53 and proliferating cell nuclear antigen expression in benign, hyperplastic, and malignant endometrium.

    abstract:CONTEXT:The endometrium is an intrinsically dynamic tissue with great capability for regeneration and proliferation; consequently, there is some overlap between features seen in benign, premalignant, and malignant lesions. This leads to marked intrabiopsy, interbiopsy, and interobserver variability. OBJECTIVE:We studi...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/0003-9985(2001)125<0872:CIAOPA>2.0.CO;2

    authors: Elhafey AS,Papadimitriou JC,El-Hakim MS,El-Said AI,Ghannam BB,Silverberg SG

    更新日期:2001-07-01 00:00:00

  • The efficiency of lactate dehydrogenase isoenzyme determination for the diagnosis of acute myocardial infarction.

    abstract::Values for total lactate dehydrogenase (LDH; EC 1.1.1.27) activity and LDH isoenzymes 1 and 2 were determined in 80 patients with acute myocardial infarction (AMI) and in 40 without AMI every 24 hours up to 15 days after admission, when total serum LDH level returned to normal. The sensitivity, specificity, and effici...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Rotenberg Z,Davidson E,Weinberger I,Fuchs J,Sperling O,Agmon J

    更新日期:1988-09-01 00:00:00

  • Intracytoplasmic filamentous inclusions in the peripheral blood of a patient with chronic lymphocytic leukemia. A bright-field, electron microscopic, immunofluorescent, and flow cytometric study.

    abstract::Intracellular inclusions in lymphoproliferative disorders are not common. Multiple different types of inclusions have been reported in chronic lymphocytic leukemia (CLL), including vacuoles, crystals, and pseudocrystals. Most of the reported cases were seen in the bone marrow lymphocytes, and the majority of these on ...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/0003-9985(2003)127<0618:IFIITP>2.0.CO;2

    authors: Dorion RP,Shaw JH

    更新日期:2003-05-01 00:00:00

  • Beta-endorphin, steroids, and prolactin. Immunoassay in breast cysts and blood.

    abstract::Circulating levels and cyst fluid concentrations of beta-endorphin (beta-EP), estradiol, progesterone, and prolactin were measured by radioimmunoassays in 10 premenopausal women with gross breast cysts. In addition, aspirates and frozen tissue sections from cystic lesions were investigated immunocytochemically for a p...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Schön HJ,Schurz B,Wenzl R,Knogler W,Kubista E

    更新日期:1993-03-01 00:00:00

  • Adrenal cortical carcinoma with adenosquamous differentiation. Report of a case with immunohistochemical and ultrastructural studies.

    abstract::We report the case of an adrenal cortical carcinoma with glandular and squamous differentiation, demonstrated by light and electron microscopy as well as by immunohistochemical studies. The patient was a 63-year-old man presenting with a large adrenal mass and markedly increased 24-hour urine metanephrine, initially s...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Drachenberg CB,Lee HK,Gann DS,Wong-You-Cheong J,Papadimitriou JC

    更新日期:1995-03-01 00:00:00

  • Primary hepatic marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type in a patient with primary biliary cirrhosis.

    abstract::Primary lymphoma of the liver is rare. Recently, marginal zone B-cell lymphomas of mucosa-associated lymphoid tissue (MALT) type have been described in the liver. Most of these cases occurred without known underlying liver disease, while others were seen in patients with chronic hepatitis. A case of primary hepatic MA...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/0003-9985(2000)124<0604:PHMZBC>2.0.CO;2

    authors: Ye MQ,Suriawinata A,Black C,Min AD,Strauchen J,Thung SN

    更新日期:2000-04-01 00:00:00

  • Immunohistochemical localization of S100 protein in benign and malignant conditions of the breast.

    abstract::A peroxidase--antiperoxidase technique for S100 protein has been applied to 122 breast lesions from 122 patients. These included 35 cases of fibrocystic disease, 16 cases of sclerosing adenosis, 24 cases of papilloma and papillomatosis, 43 intraduct carcinomas, and four intralobular carcinomas. In fibrocystic disease,...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Egan MJ,Newman J,Crocker J,Collard M

    更新日期:1987-01-01 00:00:00

  • Experimentally induced bleomycin sulfate pulmonary toxicity: histopathologic and ultrastructural study in the pheasant.

    abstract::Morphological alterations in the lungs of pheasants after prolonged high-dosage administration of bleomycin sulfate were studied by light and electron microscopy. Nontreated birds acted as controls, and their lungs showed no abnormalities. Lungs of bleomycin-treated pheasants revealed collapse alternating with overexp...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Bedrossian CW,Greenberg SD,Yawn DH,O'Neal RM

    更新日期:1977-05-01 00:00:00

  • Granulomatous encephalitis caused by Bipolaris hawaiiensis.

    abstract::We describe a case of granulomatous encephalitis caused by Bipolaris (Drechslera) hawaiiensis in an immunocompetent patient. An 18-year-old man with a seven-month history of seizures and right leg weakness was found by computed tomographic scan to have a left frontoparietal enhancing lesion. Biopsy of the lesion revea...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Morton SJ,Midthun K,Merz WG

    更新日期:1986-12-01 00:00:00

  • Laboratory determination of hereditary susceptibility to breast and ovarian cancer.

    abstract::Inherited mutations in the genes BRCA1 and BRCA2 are associated with a significantly increased risk of breast cancer, particularly before the age of 50 years, as well as an increased risk of ovarian cancer. Patients with early-onset breast cancer or ovarian cancer at any age with a family history of either disease are...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1043/0003-9985(1999)123<1023:LDOHST>2.0.CO;2

    authors: Frank TS

    更新日期:1999-11-01 00:00:00

  • Use of immunohistochemistry in routine workup of prostate needle biopsies: a tertiary academic institution experience.

    abstract:CONTEXT:Diagnostic use of immunohistochemistry has been extensively studied in prostate needle biopsy, but its use in routine practice and the quality assurance and associated cost have not been previously addressed. OBJECTIVE:To examine the routine use of immunohistochemistry in prostate biopsies in a tertiary academ...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.5858/arpa.2012-0145-OA

    authors: Watson K,Wang C,Yilmaz A,Bismar TA,Trpkov K

    更新日期:2013-04-01 00:00:00

  • Jejunal gastrointestinal stromal tumor: a cause of obscure gastrointestinal bleeding.

    abstract::In cases of obscure gastrointestinal bleeding, when a source for blood loss is not apparent from examination of the colon and upper gastrointestinal tract, the small bowel usually becomes the focus of investigation. A tumor with interesting pathologic features was found in a patient who presented with recurrent episod...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.1043/1543-2165(2004)128<214:JGSTAC>2.0.CO;2

    authors: Sass DA,Chopra KB,Finkelstein SD,Schauer PR

    更新日期:2004-02-01 00:00:00

  • Sialadenoma papilliferum of the adenoids in a 2-year-old child.

    abstract::We report a case of sialadenoma papilliferum arising in the adenoids in a 2-year-old child. The tumor demonstrated papillary and adenomatous proliferations, suggestive of minor salivary gland origin. A review of the literature indicated no reported cases of this neoplasm arising in individuals this young. The location...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Masi JD,Hoang KG,Sawyer R

    更新日期:1986-06-01 00:00:00

  • An algorithmic approach to the diagnosis of pancreatic neoplasms.

    abstract:CONTEXT:The pancreas gives rise to an array of distinct neoplasms that can be solid, cystic, or intraductal and can recapitulate the various lines of differentiation present in the normal gland. OBJECTIVE:To develop an algorithmic approach to the diagnosis of pancreatic neoplasms that simplifies their pathologic evalu...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1043/1543-2165-133.3.454

    authors: Klimstra DS,Pitman MB,Hruban RH

    更新日期:2009-03-01 00:00:00

  • The role of the Ito cell in perivenular and intralobular fibrosis in alcoholic hepatitis.

    abstract::The role of the Ito cells in perivenular and intralobular scarring in alcoholic liver disease was examined morphologically. There was a substantial decrease in the number of Ito cells in the midzone of the hepatic lobule in both fatty liver and alcoholic hepatitis as judged by light microscopy. By electron microscopy,...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Okanoue T,Burbige EJ,French SW

    更新日期:1983-09-01 00:00:00

  • The role of platelets in infections. I. Observations in human and murine malaria.

    abstract::The interaction between platelets and microorganisms may be underestimated. Our in vivo studies support a direct role of thrombocytes in malarial infections. We have found intrathrombocytic parasites of Plasmodium vivax (in 10% of men naturally infected) and P berghei (in 53% of mice experimentally infected); these we...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Fajardo LF

    更新日期:1979-03-01 00:00:00

  • Multimodality Technologies in the Assessment of Hematolymphoid Neoplasms.

    abstract::Accurate assessment of tissues for hematolymphoid neoplasms requires an integrated multiparameter approach. Although morphologic examination by light microscopy remains the mainstay of initial assessment for hematolymphoid neoplasms, immunophenotypic analysis by immunohistochemistry and/or flow cytometry is essential ...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.5858/arpa.2016-0260-SA

    authors: Li S,Jaye DL,Bradley KT,Zhang L,Saxe D,Deeb G,Hill CE,Mann KP

    更新日期:2017-03-01 00:00:00

  • Emerging targeted therapies for lymphoid malignancies.

    abstract:CONTEXT:Our understanding of molecular events in the pathogenesis of hematologic malignancies has evolved substantially. The research data gathered in the past 3 decades have led to the definition of neoplastic disorders based on specific genetic and molecular alterations, which is reflected in the current World Health...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.5858/arpa.2010-0391-RA

    authors: Pozdnyakova O,Kutok JL,Rodig SJ

    更新日期:2012-05-01 00:00:00

  • Adult Fanconi syndrome in kappa light chain myeloma.

    abstract::Distinctive morphological features in both the marrow infiltrate and the kidney were seen in a 52-year-old woman with kappa light chain-producing plasma cell myeloma, diagnosed on the basis of multiple osteolytic lesions, the presence of atypical plasma cells in the bone marrow, and monoclonal immunoglobulin productio...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Chan KW,Ho FC,Chan MK

    更新日期:1987-02-01 00:00:00

  • Iron deposits surrounding multiple sclerosis plaques.

    abstract::Autopsy samples from cerebral areas of five brains from patients with multiple sclerosis (MS) and from six control brains were stained with Perls acid ferrocyanide to detect nonheme iron present as hemosiderin. Positive iron reactions were observed only in MS sections surrounding demyelinated plaques. Myelinated white...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Craelius W,Migdal MW,Luessenhop CP,Sugar A,Mihalakis I

    更新日期:1982-08-01 00:00:00

  • Genomics, transcriptomics, proteomics, and numbers.

    abstract:OBJECTIVE:To review the advances in clinically useful molecular biologic techniques and to identify their applications in clinical practice, as presented at the 11th Annual William Beaumont Hospital DNA Symposium. DATA SOURCES:The 8 manuscripts submitted were reviewed, and their major findings were compared with liter...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1043/1543-2165(2003)127<1089:GTPAN>2.0.CO;2

    authors: Kiechle FL,Holland-Staley CA

    更新日期:2003-09-01 00:00:00

  • Mucinous Tubular and Spindle Cell Carcinoma: A Review of Histopathology and Clinical and Prognostic Implications.

    abstract::Mucinous tubular and spindle cell carcinomas are rare kidney tumors with generally indolent behavior. As the name suggests, classic histomorphology reveals bland spindle cells, tubules, and mucinous stroma. Uncommon histologic features include mucin-poor stroma, high nuclear grade, cellular pleomorphism, and presence ...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.5858/arpa.2017-0506-RS

    authors: Nathany S,Monappa V

    更新日期:2020-01-01 00:00:00

  • Histochemical staining. Its use for detection of glyceraldehyde-3-phosphate dehydrogenase in skeletal muscle.

    abstract::Histochemical staining of glyceraldehyde-3-phosphate dehydrogenase activity in fresh-frozen muscle tissue may be performed using a beta-nicotinamide adenine dinucleotide (beta-NAD) reduced-dehydrogenase tetrazolium-reductase linked reaction. The phosphate-buffered incubating medium contains glyceraldehyde-3-phosphate,...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:

    authors: Brumback RA,Susag ME,Gerst JW

    更新日期:1981-08-01 00:00:00

  • Granulomatous dermatitis due to Malassezia sympodialis.

    abstract::A 67-year-old man, with multiple skin lesions that appeared over 2 years, had biopsies that disclosed granulomatous dermatitis with associated small yeasts. The urinary antigen test results were negative for Histoplasma infection; cultures from the biopsies did not grow any fungi or other potential pathogens. The ches...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.5858/2010-0588-CRR.1

    authors: Desai HB,Perkins PL,Procop GW

    更新日期:2011-09-01 00:00:00

  • Loss of expression of DNA mismatch repair proteins is rare in pancreatic and small intestinal neuroendocrine tumors.

    abstract:CONTEXT:Two recent studies have identified a high rate of microsatellite instability (MSI) in pancreatic neuroendocrine tumors (pNETs). Microsatellite instability is rare in small intestinal neuroendocrine tumors (NETs). It is unclear why there is discordance in the frequency of MSI in the 2 studies of pNETs and why th...

    journal_title:Archives of pathology & laboratory medicine

    pub_type: 杂志文章

    doi:10.5858/arpa.2010-0560-OA

    authors: Arnason T,Sapp HL,Rayson D,Barnes PJ,Drewniak M,Nassar BA,Huang WY

    更新日期:2011-12-01 00:00:00