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Chapter 8 laboratory management reading Questions and Answers $12.99
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Chapter 8 laboratory management reading Questions and Answers
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Chapter 8 laboratory management reading Questions and Answers According to this law, all sites handling "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." must abide by the regulations laid out in Clinical...

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  • December 26, 2024
  • 5
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • chapter 8 laboratory management reading questions
  • providing analysis research and technical assist
  • according to this law all sites handling materia

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  • Laboratory management
  • Laboratory management

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Chapter 8 laboratory management
reading Questions and Answers
According to this law, all sites handling "materials derived from the human body for the
purpose of providing information for the diagnosis, prevention, or treatment of any
disease..." must abide by the regulations laid out in - answer Clinical laboratory
improvements amendment of 1988 (CLIA)

who enforces CLIA - answer the Center for Medicare and Medicaid Services (CMS),
the Food and Drug Administration (FDA), and the Centers for Disease Control and
Prevention (CDC)

providing analysis, research, and technical assistance
developing technical standards and laboratory practice guidelines
conducting laboratory quality improvement studies
monitor proficiency testing - answer CDC

CMS - answer publishing of CLIA rules and regulations
conducting CLIA inspections and enforcing regulatory compliance
issuing CLIA certificates (which permit a lab to conduct lab testing at a certain level)
collecting the user fees

categorizing tests based on their complexity (to ensure the appropriate level of expertise
and quality assurance practices are in place)
developing guidelines for complexity categorization
reviewing requests for Waivers by Application (A manufacturer may submit these
applications to request a test be categorized waived, if that test could be considered for
home use) - answer FDA

The FDA is focused on - answer Test complexity (difficulty in performing the test
method)

Two types of lab testing are - answer waived and nonwaived testing

A __________________ is an easily-performed, simple test with a low risk of erroneous
or inaccurate results and poses no reasonable risk of harm to the patient, as long as the
test is performed correctly
Urine chemistry strip (dipstick) [non-automated] for: bilirubin, glucose, hemoglobin,
ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, and urobilinogen.
Fecal occult blood
Ovulation testing [visual color comparison tests for luteinizing hormone]
Urine pregnancy tests [visual color comparison tests]
Erythrocyte sedimentation rate [non-automated]

, Hemoglobin-copper sulfate [non-automated]
Blood glucose [FDA-cleared, home-use glucose monitoring devices]
Spun microhematocrit
If a laboratory only performs waived testing, such laboratory must seek a CLIA
Certificate of Waiver and must follow manufacturers requirements for each test under
that certificate. - answer waived

Another general category of tests is _________________(PPM). PPM procedures are
moderate complexity tests that are performed by the provider while patient is visiting an
office in the outpatient setting. These procedures do not meet the waiver criteria
because they require a substantial amount of training and skill to correctly perform the
test. PPM testing is restricted to only nine microscopic procedures using bright-field or
phase-contrast microscopy. - answer Provider-Performed microscopy A CLIA
Certificate for Provider-Performed Microscopy (PPM) is required for medical offices
performing these methods and only certain providers can perform these limited number
of tests which include physicians, dentists, physician assistants, nurse practitioners, and
other mid-level providers

PPM - answer Direct wet mounts [to detect bacteria, fungi, parasites, and human
cellular elements]
Potassium hydroxide (KOH) preparations [to detect fungal elements]
Pinworm testing
Fern tests [to detect amniotic fluid in vaginal secretions]
Direct smears, vaginal or cervical mucus [qualitative only]
Urine sediment microscopy
Nasal smears [to detect granulocytes]
Fecal leukocyte examinations
Semen analysis [qualitative only - presence/absence of sperm & motility]

Nonwaived Testing There are two types of non waived name testing them - answer
There are two types of nonwaived testing: moderate and and high complexity

Laboratories that perform these tests must have one of three CLIA certificates: a
Certficate of Registration, Certificate of Compliance, or Certificate of Accreditation. -
answer Nonwaived testing

Moderate complexity test: total score ≤ 12
High complexity test: total score >12 - answer

______________________ are only those tests that are approved for home use or
waived in accordance with the federal regulation - answer waived test

_____________________signifies the laboratory (not a diagnostic test, a laboratory)
has been licensed or approved by a state where CMS reviewed the requirements and
decided that they are more stringent than CLIA. In that case, state licensure program
must be approved by CMS

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