Works matching DE "PATHOLOGICAL laboratory laws"

Results: 164

Happy new year.

Published in:

Medical Laboratory Observer (MLO), 2025, v. 57, n. 1, p. 4

By:

Wichmann, Christina

Publication type:

Article

Have you heard about the (other) major regulatory change this year? CLIA changed its proficiency testing criteria -- and almost no one is talking about it.

Published in:

Medical Laboratory Observer (MLO), 2025, v. 57, n. 1, p. 6

By:

Westgard, Sten

Publication type:

Article

Personnel changes.

Published in:: Medical Laboratory Observer (MLO), 2024, v. 56, n. 9, p. 2
Publication type:: Article

Announcement of the re-approval of COLA under the Clinical Laboratory Improvement Amendments of 1988.

Published in:: Medical Laboratory Observer (MLO), 2024, v. 56, n. 4, p. 6
Publication type:: Article

Details from AMP on LDTs/LDPs.

Published in:

Medical Laboratory Observer (MLO), 2024, v. 56, n. 2, p. 35

By:

Wichmann, Christina

Publication type:

Article

Cause Analysis: The 5 whys method.

Published in:

Medical Laboratory Observer (MLO), 2023, v. 55, n. 7, p. 1

By:

Mathews, Carlyn

Publication type:

Article

Leveraging LIS tools to keep your lab inspection-ready.

Published in:

Medical Laboratory Observer (MLO), 2023, v. 55, n. 2, p. 8

By:

Futrell, Kim

Publication type:

Article

A leader in clinical laboratory consulting.

Published in:

Medical Laboratory Observer (MLO), 2023, v. 55, n. 2, p. 4

By:

Wichmann, Christina

Publication type:

Article

Five tips to cut lab inefficiencies, not lab revenue.

Published in:

Medical Laboratory Observer (MLO), 2022, v. 54, n. 11, p. 5

By:

Futrell, Kim

Publication type:

Article

Changes to the Clinical Laboratory Improvement Amendments (CLIA).

Published in:

Medical Laboratory Observer (MLO), 2022, v. 54, n. 8, p. 42

By:

Wichmann, Christina

Publication type:

Article

Understanding the difference between waived and non-waived testing.

Published in:: Medical Laboratory Observer (MLO), 2022, v. 54, n. 8, p. 12
Publication type:: Article

CMS addresses CLIA certification violations.

Published in:: Medical Laboratory Observer (MLO), 2021, v. 53, n. 5, p. 6
Publication type:: Article

Fostering a culture of continual preparedness in the laboratory.

Published in:

Medical Laboratory Observer (MLO), 2019, v. 51, n. 11, p. 18

By:

MacCormack, Jen

Publication type:

Article

Glucose meters: current regulatory guidance for manufacturers and providers.

Published in:

Medical Laboratory Observer (MLO), 2019, v. 51, n. 4, p. 8

By:

DuBois, Jeffrey A.

Publication type:

Article

The FDA reviews guidelines for capillary glucose testing in critically ill patients.

Published in:

Medical Laboratory Observer (MLO), 2018, v. 50, n. 7, p. 50

By:

DuBois, Jeffrey A.

Publication type:

Article

Accuracy of Diagnosing Heparin-Induced Thrombocytopenia.

Published in:

JAMA Network Open, 2024, v. 7, n. 3, p. e243786, doi. 10.1001/jamanetworkopen.2024.3786

By:

Larsen, Emil List;
Nilius, Henning;
Studt, Jan-Dirk;
Tsakiris, Dimitrios A.;
Greinacher, Andreas;
Mendez, Adriana;
Schmidt, Adrian;
Wuillemin, Walter A.;
Gerber, Bernhard;
Vishnu, Prakash;
Graf, Lukas;
Kremer Hovinga, Johanna A.;
Goetze, Jens P.;
Bakchoul, Tamam;
Nagler, Michael

Publication type:

Article

State Variation in Uptake of Pharmacy-Based CLIA-Waived Testing: Impact of Laws and Regulations.

Published in:

Journal of Pharmacy Technology, 2025, v. 41, n. 2, p. 95, doi. 10.1177/87551225241306678

By:

Adams, Alex J.;
Klepser, Donald G.;
Klepser, Michael E.

Publication type:

Article

General Applicability of Existing College of American Pathologists Accreditation Requirements to Clinical Implementation of Machine Learning--Based Methods in Molecular Oncology Testing.

Published in:

Archives of Pathology & Laboratory Medicine, 2025, v. 149, n. 4, p. 319, doi. 10.5858/arpa.2024-0037-CP

By:

Furtado, Larissa V.;
Kenji Ikemura;
Benkli, Cagla Y.;
Moncur, Joel T.;
Huang, Richard S. P.;
Zehir, Ahmet;
Stellato, Katherine;
Vasalos, Patricia;
Sadri, Navid;
Suarez, Carlos J.

Publication type:

Article

Estimation of Numbers of Testing Personnel and Test Volume in the Clinical Laboratory Improvement Amendments of 1988 Certificate of Accreditation and Certificate of Compliance Laboratories in the United States.

Published in:

Archives of Pathology & Laboratory Medicine, 2024, v. 148, n. 4, p. 443, doi. 10.5858/arpa.2022-0345-OA

By:

Yang Xia;
Taylor Jr., Thomas H.;
Jufu Chen;
Hsia, Jason

Publication type:

Article

Most Frequently Cited Accreditation Inspection Deficiencies for Clinical Molecular Oncology Testing Laboratories and Opportunities for Improvement.

Published in:

Archives of Pathology & Laboratory Medicine, 2022, v. 146, n. 12, p. 1441, doi. 10.5858/arpa.2021-0448-CP

By:

Sidiropoulos, Nikoletta;
Daley, Sarah K.;
Briggs, Marian;
Fernandes, Helen;
Lockwood, Christina M.;
Mahmoud, Amer Z.;
Merker, Jason D.;
Vasalos, Patricia;
Wielgos, Lynnette M.;
Moncur, Joel T.;
Farkas, Daniel H.

Publication type:

Article

Genotype and Phenotype Concordance for Pharmacogenetic Tests Through Proficiency Survey Testing: An Update.

Published in:

Archives of Pathology & Laboratory Medicine, 2020, v. 144, n. 9, p. 1057, doi. 10.5858/arpa.2019-0478-CP

By:

Moyer, Ann M.;
McMillin, Gwendolyn A.;
Long, Thomas A.;
Gandhi, Manish J.;
Mao, Rong;
Smock, Kristi J.;
Halley, Jaimie G.;
Weck, Karen E.

Publication type:

Article

Regulating Artificial Intelligence for a Successful Pathology Future.

Published in:

2019

By:

Allen, Timothy Craig

Publication type:

Editorial

Accreditation and Regulatory Implications of Electronic Health Records for Laboratory Reporting.

Published in:

Archives of Pathology & Laboratory Medicine, 2015, v. 139, n. 3, p. 328, doi. 10.5858/arpa.2013-0713-SO

By:

Castellani, William J.;
Sinard, John H.;
Wilkerson, Myra L.;
Whitsitt, Mark S.;
Henricks, Walter H.

Publication type:

Article

Verifying Performance Characteristics of Quantitative Analytical Systems.

Published in:

Archives of Pathology & Laboratory Medicine, 2014, v. 138, n. 9, p. 1173, doi. 10.5858/arpa.2013-0051-CP

By:

Killeen, Anthony A.;
Long, Tom;
Souers, Rhona;
Styer, Patricia;
Ventura, Christina B.;
Klee, George G.

Publication type:

Article

Prospective and Retrospective Review of Gynecologic Cytopathology: Findings From the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference Working Group 2.

Published in:

Archives of Pathology & Laboratory Medicine, 2013, v. 137, n. 2, p. 175, doi. 10.5858/arpa.2012-0178-OA

By:

Brainard, Jennifer A.;
Birdsong, George G.;
Elsheikh, Tarik M.;
Hartley, David A.;
Naik, Kalyani;
Neal, Margaret H.;
Souers, Rhona J.;
Henry, Michael R.

Publication type:

Article

Quality Improvement Opportunities in Gynecologic Cytologic-Histologic Correlations: Findings From the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference Working Group 4.

Published in:

Archives of Pathology & Laboratory Medicine, 2013, v. 137, n. 2, p. 199, doi. 10.5858/arpa.2012-0250-OA

By:

Crothers, Barbara A.;
Jones, Bruce A.;
Cahill, Leigh Ann;
Moriarty, Ann T.;
Mody, Dina R.;
Tench, William D.;
Souers, Rhona J.

Publication type:

Article

Clinical Implementation of KRAS Testing in Metastatic Colorectal Carcinoma.

Published in:

Archives of Pathology & Laboratory Medicine, 2012, v. 136, n. 10, p. 1298, doi. 10.5858/arpa.2011-0478-RA

By:

Ross, Jeffrey S.

Publication type:

Article

Test Verification and Validation for Molecular Diagnostic Assays.

Published in:

Archives of Pathology & Laboratory Medicine, 2012, v. 136, n. 1, p. 11, doi. 10.5858/arpa.2011-0212-ED

By:

Halling, Kevin C.;
Schrijver, Iris;
Persons, Diane L.

Publication type:

Article

Gynecologic Cytology Proficiency Testing Failures: What Have We Learned? Observations From the College of American Pathologists Gynecologic Cytology Proficiency Testing Program.

Published in:

Archives of Pathology & Laboratory Medicine, 2011, v. 135, n. 11, p. 1442, doi. 10.5858/arpa.2010-0681-SA

By:

Ducatman, Barbara S.;
Bentz, Joel S.;
Fatheree, Lisa A.;
Souers, Rhona;
Ostrowski, Saula;
Moriarty, Ann T.;
Henry, Michael;
Laucirica, Rodolfo;
Booth, Christine N.;
Wilbur, David C.

Publication type:

Article

Point of care blood glucose devices in the hospital setting.

Published in:

Critical Reviews in Clinical Laboratory Sciences, 2023, v. 60, n. 4, p. 290, doi. 10.1080/10408363.2023.2170316

By:

Tran, Nam K.;
LaValley, Clayton;
Bagley, Berit;
Rodrigo, John

Publication type:

Article

CLIA, Stark II are headed for revision.

Published in:

Urology Times, 1995, v. 23, n. 6, p. 1

By:

Gatty, Bob

Publication type:

Article

Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing.

Published in:

NPJ Digital Medicine, 2024, v. 7, n. 1, p. 1, doi. 10.1038/s41746-024-01369-1

By:

Herman, Daniel S.;
Reece, Jenna T.;
Weissman, Gary E.

Publication type:

Article

Establishing and Communicating Critical Laboratory Values: The Mayo Clinic Approach.

Published in:

Journal of Health & Life Sciences Law, 2012, v. 6, n. 1, p. 173

By:

Zehe, Sharon

Publication type:

Article

Impact of anti–squamous cell carcinoma antigen antibodies on serum squamous cell carcinoma antigen levels measured by chemiluminescent immunoassay and chemiluminescent enzyme immunoassay.

Published in:

Laboratory Medicine, 2024, v. 55, n. 3, p. 341, doi. 10.1093/labmed/lmad088

By:

Oyabu, Chinami;
Sato, Itsuko;
Yamamoto, Mari;
Imanishi, Takamitsu;
Sendo, Sho;
Yano, Yoshihiko

Publication type:

Article

Pathology – The Beginnings of Laboratory Medicine: Second in a Series.

Published in:

Laboratory Medicine, 2023, v. 54, n. 5, p. e141, doi. 10.1093/labmed/lmac164

By:

Robinson, Angela Tomei

Publication type:

Article

Lean Principles to Improve Quality in High-Throughput COVID-19 Testing Using SwabSeq: A Barcoded Sequencing-Based Testing Platform.

Published in:

Laboratory Medicine, 2022, v. 53, n. 1, p. e8, doi. 10.1093/labmed/lmab069

By:

Jones, Janae;
Saul, Rosita;
Sathe, Laila;
Xie, Joanna;
Marquette, Dawn;
Arboleda, Valerie A

Publication type:

Article

A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.

Published in:

Laboratory Medicine, 2021, v. 52, n. 4, p. 315, doi. 10.1093/labmed/lmaa086

By:

Graden, Kevin C;
Bennett, Shannon A;
Delaney, Sarah R;
Gill, Hillary E;
Willrich, Maria A V

Publication type:

Article

Clinical and Anatomic Pathology Test Volume by Specialty and Subspecialty Among High- Complexity CLIA-Certified Laboratories in 2011.

Published in:

Laboratory Medicine, 2013, v. 44, n. 2, p. 163, doi. 10.1309/LMPGOCRS216SVDZH

By:

Wians, Frank H.;
Gill, Gary W.

Publication type:

Article

Measuring the Application of Quality System Essentials in Vermont Clinical Laboratories.

Published in:

Laboratory Medicine, 2011, v. 42, n. 3, p. 151, doi. 10.1309/LML7NIALOXGPCIFJ

By:

Blumen, Steven R.;
Naud, Shelly;
Palumbo, Mary Val;
McIntosh, Barbara;
Wilcke Jr., Burton W.

Publication type:

Article

Compliance with the Clinical Laboratory Improvement Amendment of 1988 for hemoglobin screening...

Published in:: MMWR: Morbidity & Mortality Weekly Report, 1996, v. 45, n. 20, p. 419
Publication type:: Article

Effects of CLIA '88 on the physician office laboratory: A survey of midsized pediatric practices...

Published in:

Clinical Pediatrics, 1996, v. 35, n. 3, p. 125, doi. 10.1177/000992289603500303

By:

Benjamin, John T.

Publication type:

Article

Effect of legislation (CLIA'88) on setting quality specifications for US laboratories.

Published in:

Scandinavian Journal of Clinical & Laboratory Investigation, 1999, v. 59, n. 7, p. 563, doi. 10.1080/00365519950185364

By:

Ehrmeyer, S. S.;
Laessig, R. H.

Publication type:

Article

Emergence and evolution of standardization systems in medical biology laboratories.

Published in:

Advances in Laboratory Medicine / Avances en Medicina de Laboratorio, 2024, v. 5, n. 3, p. 261, doi. 10.1515/almed-2024-0014

By:

Khattar, Rita B.;
Nehme, Maha E.

Publication type:

Article

Continuous Reproductive Surveillance.

Published in:

Journal of Law, Medicine & Ethics, 2023, v. 51, n. 3, p. 570, doi. 10.1017/jme.2023.107

By:

Ulrich, Michael R.;
Fowler, Leah R.

Publication type:

Article

Biobanking Research and Privacy Laws in the United States.

Published in:

Journal of Law, Medicine & Ethics, 2016, v. 44, n. 1, p. 106, doi. 10.1177/1073110516644203

By:

Harrell, Heather L.;
Rothstein, Mark A.

Publication type:

Article

Developing Your Individualized Quality Control Plan.

Published in:

Clinical Leadership & Management Review, 2014, v. 28, n. 3, p. 23

By:

Inglis, Katheryn

Publication type:

Article

How to Win and Influence Your Legislator.

Published in:

Clinical Leadership & Management Review, 2014, v. 28, n. 2, p. 22

By:

Inglis, Katheryn;
Miller, Patty;
Williammee, Tim

Publication type:

Article

Quality Control Based on Risk Management - A Concept Whose Time Has Arrived.

Published in:

Clinical Leadership & Management Review, 2014, v. 28, n. 2, p. 18

By:

Anderson, Marcy

Publication type:

Article

Clinical Lab Equipment Validation — Simplify and Be Compliant.

Published in:

Clinical Leadership & Management Review, 2013, v. 27, n. 2, p. 26

By:

Satyadi, Caroline

Publication type:

Article

Digital Pathology.

Published in:

Clinical Leadership & Management Review, 2013, v. 27, n. 2, p. 10

By:

Corona, Robert J.

Publication type:

Article