Waived tests and testing

Clinical Microbiology Newsletter

Volumn 28, Issue 12, 2006, Pages 89-93

  Campbell, Sheldon ^a   Klein, Roger D ^b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL ANTIGEN; BACTERIUM ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; RESPIRATORY SYNCYTIAL VIRUS ANTIBODY; VIRUS ANTIGEN;

ARTICLE; CERTIFICATION; DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; DIAGNOSTIC TEST; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HEALTH PRACTITIONER; HELICOBACTER PYLORI; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 2; INFECTION; INFLUENZA VIRUS A; INFLUENZA VIRUS B; LABORATORY; MEDICAL SERVICE; MEDICARE; PATIENT CARE; RESPIRATORY SYNCYTIAL PNEUMOVIRUS; STREPTOCOCCUS GROUP A; UNITED STATES;

EID: 33646926433     PISSN: 01964399     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clinmicnews.2006.05.003     Document Type: Article

References (14)

1. Centers for Medicare and Medicaid Services. How to Apply for a CLIA Certificate: Form CMS-116. http://www.cms.hhs.gov/clia/cliaapp.asp accessed 9/7/05
2. 42 U.S.C. sec. 263a(a); 42 C.F.R secs. 493.2,3
3. 42 USC §§263a-a7 (2001); 42 CFR §493.1-493.2001 (2003).
4. US DHHS, CMS. Provider-Performed Microscopy Procedure. Accessed at http://www.cms.hhs.gov/clia/ppmplst.asp on 9/7/05
5. 42 U.S.C. § 263a(c)(2).
6. 42 U.S.C 263a(d)3); 42 C.F.R. sec. 493.15(b).
7. US DHHS, FDA, CDR. Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA. Released March 1, 2001. Accessed at http://www.fda.gov/cdrh/ode/guidance/1147.pdf on 6/1/05
8. US DHHS, FDA, CDR. Draft Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications;. Released September 7, 2005. Accessed at http://www.fda.gov/cdrh/oivd/guidance/1171.pdf on 9/7/05
9. US DHHS, CMS. CLIA Home Page. accessed at http://www.cms.hhs.gov/clia/ on 9/7/05
10. College of American Pathologists, Commission on Laboratory Accreditation. 2002. Point-of-Care-Testing Checklist.
11. CMS. CMS Certificate of Waiver and Provider Performed Microscopy Procedures Pilot Project (2005). accessed at http://www.cms.hhs.gov/clia/cowppmp.asp on 9/9/05
12. Nadel M.R., et al. Ann. Int. Med. 142 (2005) 86-95
13. Bulterys M., et al. Rapid HIV-1 testing during labor. JAMA 292 (2004) 219-223
14. Bodenheimer T. The Oregon Health Plan - lessons for the nation. N. Engl. J. Med. 337 (1997) 720-723