Document control practices in 120 clinical laboratories

Archives of Pathology and Laboratory Medicine

Volumn 133, Issue 6, 2009, Pages 942-949

  Valenstein, Paul N ^a   Stankovic, Ana K ^b   Souers, Rhona J ^c   Schneider, Frank ^d   Wagar, Elizabeth A ^e  

^a ST JOSEPH MERCY HOSPITAL   (United States)

^b Preanalytical Systems   (United States)

^c North Carolina   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLOOD TRANSFUSION; CLINICAL LABORATORY; CLINICAL PRACTICE; HEALTH CARE POLICY; HEALTH SERVICE; HUMAN; MEDICAL AUDIT; MEDICAL DOCUMENTATION;

HUMANS; LABORATORIES, HOSPITAL; LABORATORY TECHNIQUES AND PROCEDURES; RECORDS AS TOPIC;

EID: 67049158479     PISSN: 00039985     EISSN: 15432165     Source Type: Journal    
DOI: None     Document Type: Article

References (13)

1. Valenstein P, ed. Quality Management in Clinical Laboratories: Promoting Patient Safety Through Systematic Risk Reduction. Northfield, IL: College of American Pathologists; 2005.
2. Health Insurance Portability and Accountability Act of 1996, Pub L No. 104-191, 120 Stat 1884-1962 (1996).
3. College of American Pathologists (CAP). Laboratory General Checklist: Laboratory Accreditation Program. Northfield, IL; 2008. CAP publications GEN.20375, GEN.20376, GEN.20377.
4. Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: JCAHO; 2008.
5. Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing. Oakbrook Terrace, IL: JCAHO; 2008.
6. Clinical Laboratory Standards Institute (CLSI). Application of a Quality Management System Model for Laboratory Services; Approved Guidelines. 3rd ed. Wayne, PA: CLSI; 2004. NCCLS document GP26-A3.
7. International Organization for Standardization (ISO). Medical Laboratories - Particular Requirements for Quality and Competence. Geneva, Switzerland: ISO; 2007. ISO Standard 15189:2007, 4.3.
8. American Association of Blood Banks (AABB). Policies, processes and procedures. In: Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB; 2006. Standard 1.3.
9. American Association of Blood Banks (AABB). Document and records. In: Standards for Blood Banks and Transfusion Services. 24th ed. Bethesda, MD: AABB; 2006. Standards 6.0, 6.1, 6.2.
10. Laboratory requirements: standard - procedure manual. Fed Regist. 2004;42(3):1035-1036. To be codified at 42 CFR §493.1251.
11. Laboratory requirements: standard-retention requirements: test procedure. Fed Regist. 2004;42(3):1030-1031. To be codified at 42 CFR §493.1105(2).
12. Howanitz PJ. Quality assurance measurements in departments of pathology and laboratory medicine. Arch Pathol Lab Med. 1990;114:1131-1135. (Pubitemid 20365591)
13. Garcia F, Harrison E, Wise C, Wolk DM. Is your document control out of control?: complying with document control regulations. Clin Leadersh Manag Rev. 2003;17:255-262.