Regulations and Quality Assurance in Laboratory Medicine: USA Experience
In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, per...
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| Format: | Article |
| Language: | English |
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De Gruyter
2006-12-01
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| Series: | Türk Biyokimya Dergisi |
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| Online Access: | http://www.turkjbiochem.com/2006/161.pdf |
| _version_ | 1797924363710758912 |
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| author | Sharon S. Ehrmeyer |
| author_facet | Sharon S. Ehrmeyer |
| author_sort | Sharon S. Ehrmeyer |
| collection | DOAJ |
| description | In the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, performance requirements or safeguards are designed to prevent testing errors. The U.S. Institute of Medicine found that testing processes fail as a result of human error, lack of documentation and lack of test management. To ensure quality, we must focus on all three phases of the testing process – pre-analytical, analytical, post-analytical. We can no longer just hope that quality will happen as a result of following a series of prescribed protocols – rules, regulations, good laboratory practices, etc. Quality laboratory test results requires planning, leadership and oversight. |
| first_indexed | 2024-04-10T15:00:19Z |
| format | Article |
| id | doaj.art-d1e746365dcc413a9c37ee94aef83a10 |
| institution | Directory Open Access Journal |
| issn | 0250-4685 1303-829X |
| language | English |
| last_indexed | 2024-04-10T15:00:19Z |
| publishDate | 2006-12-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Türk Biyokimya Dergisi |
| spelling | doaj.art-d1e746365dcc413a9c37ee94aef83a102023-02-15T16:07:07ZengDe GruyterTürk Biyokimya Dergisi0250-46851303-829X2006-12-01314161163Regulations and Quality Assurance in Laboratory Medicine: USA ExperienceSharon S. EhrmeyerIn the U.S., all clinical laboratory testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA). CLIA links test quality and adherence to a body of testing regulations intended to ensure accurate, reliable and timely patient test results.CLIA regulations with specific minimum, performance requirements or safeguards are designed to prevent testing errors. The U.S. Institute of Medicine found that testing processes fail as a result of human error, lack of documentation and lack of test management. To ensure quality, we must focus on all three phases of the testing process – pre-analytical, analytical, post-analytical. We can no longer just hope that quality will happen as a result of following a series of prescribed protocols – rules, regulations, good laboratory practices, etc. Quality laboratory test results requires planning, leadership and oversight.http://www.turkjbiochem.com/2006/161.pdfClinical Laboratory Improvement Amendments (CLIA)laboratory qualityregulationsmedical errorsqualityquality controlquality assessment |
| spellingShingle | Sharon S. Ehrmeyer Regulations and Quality Assurance in Laboratory Medicine: USA Experience Türk Biyokimya Dergisi Clinical Laboratory Improvement Amendments (CLIA) laboratory quality regulations medical errors quality quality control quality assessment |
| title | Regulations and Quality Assurance in Laboratory Medicine: USA Experience |
| title_full | Regulations and Quality Assurance in Laboratory Medicine: USA Experience |
| title_fullStr | Regulations and Quality Assurance in Laboratory Medicine: USA Experience |
| title_full_unstemmed | Regulations and Quality Assurance in Laboratory Medicine: USA Experience |
| title_short | Regulations and Quality Assurance in Laboratory Medicine: USA Experience |
| title_sort | regulations and quality assurance in laboratory medicine usa experience |
| topic | Clinical Laboratory Improvement Amendments (CLIA) laboratory quality regulations medical errors quality quality control quality assessment |
| url | http://www.turkjbiochem.com/2006/161.pdf |
| work_keys_str_mv | AT sharonsehrmeyer regulationsandqualityassuranceinlaboratorymedicineusaexperience |