: Rebekah M. Martin
: 101 Topics for Clinical Microbiology Laboratory Leaders Accreditation, Verification, Quality Systems, and More
: ASM Press
: 9781683674474
: 1
: CHF 70.00
:
: Medizin
: English
: 256
: DRM
: PC/MAC/eReader/Tablet
: ePUB

Successfully manage your laboratory accreditation and compliance audits with this easily accessible how-to resource for clinical laboratories

101 Topics for Clinical Microbiology Laboratory Leaders: Accreditation, Verification, Quality Systems, and More by Rebekah M. Martin is your roadmap to achieving and maintaining excellence in clinical microbiology laboratory administration. This quick reference guide is designed to help laboratory professionals efficiently navigate the key aspects of accreditation, regulatory compliance, and quality management. This practical resource is perfect for both new and experienced laboratory leaders who need accessible, actionable information.

Inside, you'll find:

  • Regulatory Overview:Information on the Clinical Laboratory Improvement Amendments, test complexity categories, and the roles of key agencies like the Centers for Medicare& Medicaid Services, the Centers for Disease Control and Prevention, and the Food& Drug Administration in overseeing clinical laboratories.
  • Accr ditation Basics: Guidance on how to obtain and maintain laboratory accreditation, including what to expect during inspections and how to respond to deficiencies.
  • Test Verification& Validation: Essential tips on conducting verification and validation studies to ensure your laboratory's test systems are accurate, reliable, and compliant with regulatory standards.
  • Quality Management Essentials: Practical strategies for implementing and maintaining a quality management system, including process control, document management, and continuous improvement techniques that keep your lab running smoothly.

Present d in a user-friendly question-and-answer format,101 Topics for Clinical Microbiology Laboratory Leadersis your go-to resource for quick, reliable guidance on leading a compliant and high-performing clinical microbiology laboratory.

Rebekah M. Martin is currently a Medical Affairs Manager for Molecular Solutions at Becton, Dickinson and Company (BD). She completed a CPEP-accredited medical microbiology fellowship, is a Diplomate of the American Board of Medical Microbiology (ABMM), a former Associate Technical Director of Microbiology for a national reference laboratory and has been working in clinical microbiology for more than a decade.

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Clinical Laboratory Improvement Amendments (CLIA) and Regulatory Oversight


How is “clinical laboratory” defined?


The Code of Federal Regulations in the United States defines a laboratory as follows:

“…a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.” (42 CFR §493.2)(1)

Laboratories that operate as defined above are subject to regulation by the Clinical Laboratory Improvement Amendments (CLIA) and are often referred to as clinical laboratories. The term clinical laboratories will be used throughout this book to refer to laboratories regulated by CLIA.

There are some key aspects that help identify a clinical laboratory based on the definition above:

What is occurring in the laboratory? Laboratories must be involved in testing. If a location is handling specimens for other purposes but is not performing any testing, they are not considered a clinical laboratory.

What is being tested? The laboratory must examine human specimens, which refers to any materials that are obtained from humans. These include but are not limited to blood, body fluids and secretions, tissues, urine, stool, hair and nails, and swabs from various body sites. Human samples collected postmortem during an autopsy may also be tested in clinical laboratories(2).

What is the purpose of testing? The purpose of testing in the laboratory must be for patient management. This can include testing to assist in diagnosis, monitor disease progress, track treatment impact, engage in preventative care, or assess potential organ donors(3).

Other laboratories may perform testing on human samples, but not for the purposes of health assessment and patient management. These are not considered clinical laboratories and they are not subject to CLIA requirements. Examples of such laboratories include research laboratories, forensic laboratories, and laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMSHA) that perform only drug testing (other testing performed in SAMSHA certified laboratories may require a CLIA certificate)(4).

What is CLIA?


CLIA stands for Clinical Laboratory Improvement Amendments. When someone mentions “CLIA” they may be talking about either CLIA law or CLIA regulations. CLIA law refers to the Clinical Laboratory Improvement Amendments of 1988 (CLIA’88) (Public Law 100‐578), which were amendments to the Clinical Laboratories Improvement Act of 1967 (CLIA’67) and were signed into law in 1988. CLIA regulations, on the other hand, are requirements codified in the Code of Federal Regulations (42 CFR §493Laboratory Requirements). CLIA regulations were issued by the Centers for Medicare and Medicaid Services (CMS) in 1992 in order to enact CLIA’88. From 1992 to 1994, CLIA regulations were phased in. Amendments to these regulations have occurred periodically since then. For further information on CLIA regulations see sectionWhat is the Code of Federal Regulations (CFR)? The section here will discuss CLIA law.

The Clinical Laboratories Improvement Act of 1967 (Public Law 90‐174)


In 1967, a new section (Sec. 353) was added to the Public Health Service Act(5). TitledLicensing—Biological Products and Clinical Laboratories, the purpose of this addition was briefly