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Chapter 14.3 : Laboratory Records

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Laboratory Records, Page 1 of 2

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Abstract:

“If it hasn’t been recorded, it hasn’t been performed.” This sentence summarizes the absolute requirement for detailed and accurate record retention for all aspects of the clinical microbiology laboratory. Records serve at least four purposes. (i) They document what has transpired without recourse to memory (they provide a paper or electronic audit trail), (ii) they serve as a point of reference for developing the facts regarding any incident, (iii) they assist in the recognition of trends and the resolution of problems, and (iv) they establish the laboratory’s credibility. The standards for record keeping and the length of time records must be maintained are established by the agencies presented in Appendix 14.3–1 . Federal guidelines should be considered minimum standards and are superseded by the standards established by the states or other certification agencies.

Citation: Leber A. 2016. Laboratory Records, p 14.3.1-14.3.19. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.3
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References

/content/book/10.1128/9781555818814.chap14.3
1. Federal Register. 2003. Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications; final rule. Fed Regist 68:13640-13714.
1. Federal Register. 1968. Clinical Laboratories Improvement Act of 1967. Fed Regist 33:1529715303.
2. Health Care Financing Administration. 1988. Medicare, Medicaid, and CLIA programs; revision of the clinical laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs. Fed Regist 53:2959029632.
3. Health Care Financing Administration. 1990. Medicare, Medicaid and CLIA programs; revision of laboratory regulations; final rule with request for comments. Fed Regist 55:1953819610.
4. Occupational Safety and Health Administration. 1989. Occupational exposure to bloodborne pathogens: proposed rule and notice of hearing. Fed Regist 54:2313423139.

Tables

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Table 14.3–1

Suggested guidelines for minimal time of retention for laboratory records

Citation: Leber A. 2016. Laboratory Records, p 14.3.1-14.3.19. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.3
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Untitled

Citation: Leber A. 2016. Laboratory Records, p 14.3.1-14.3.19. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.3
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Microbiology Laboratory Safety Checklist

Microbiology Laboratory Safety Checklist

Citation: Leber A. 2016. Laboratory Records, p 14.3.1-14.3.19. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.3
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Reportable Disease

Reportable Disease

Citation: Leber A. 2016. Laboratory Records, p 14.3.1-14.3.19. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.3

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