CHT CHS Certification - Laboratory
Regulation 2025/2026 Exam Questions
with 100% Correct Answers | Latest
Update
Certificate of waiver inspection - 🧠 ANSWER ✔✔• when the agency has
substantial reason to believe lab operation poses an
imminent and serious risk to human health
• in response to complaints from the public
• on a random basis to determine whether the laboratory is following
manufacturer's instructions and handles waived tests only
Health and Human Services (HHS) - 🧠 ANSWER ✔✔A department of the
executive branch of the US Government
,There are 3 agencies within HHS :
• the Centers for Disease Control and Prevention (CDC)
• the Food and Drug Administration (FDA)
• the Centers for Medicare and Medicaid Services (CMS)
The CDC is well-known for: - 🧠 ANSWER ✔✔• monitoring disease
outbreaks
• implementing disease prevention strategies
CDC Centers for Disease Control and Prevention - 🧠 ANSWER ✔✔•
Administration of Agency for Toxic Substances and Disease registry
• Immunization services
• Environmental disease prevention
FDA Food and Drug Administration - 🧠 ANSWER ✔✔is a federal regulatory
agency that monitors the safety and effectiveness of food, drinks,
cosmetics, drugs, and medical devices
The FDA is organized into several "centers" - 🧠 ANSWER ✔✔Center for
Biological Evaluation and Research (CBER)
, • Vaccines and blood products are two examples of biologics
•Center for Devices and Radiological Health with its Office of In Vitro
Diagnostics Device Evaluation (OIVD)
• responsible for the classification of in vitro diagnostics methods and
instruments as Class I, Class II, or Class III
• determines whether a test will be classified as waived, moderately
complex, or highly complex
CMS Centers for Medicare and Medicaid Services - 🧠 ANSWER
✔✔administers Medicare, a federal healthcare coverage plan for the
elderly, those with severe kidney damage who require dialysis, and people
with certain disabilities
• Medicare is a federal insurance program, financed by salary deductions.
has authority for the regulation enforcement for CLIA '88 - the Division of
Laboratory Services is responsible for the certification and survey of clinical
laboratories
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED 3
Regulation 2025/2026 Exam Questions
with 100% Correct Answers | Latest
Update
Certificate of waiver inspection - 🧠 ANSWER ✔✔• when the agency has
substantial reason to believe lab operation poses an
imminent and serious risk to human health
• in response to complaints from the public
• on a random basis to determine whether the laboratory is following
manufacturer's instructions and handles waived tests only
Health and Human Services (HHS) - 🧠 ANSWER ✔✔A department of the
executive branch of the US Government
,There are 3 agencies within HHS :
• the Centers for Disease Control and Prevention (CDC)
• the Food and Drug Administration (FDA)
• the Centers for Medicare and Medicaid Services (CMS)
The CDC is well-known for: - 🧠 ANSWER ✔✔• monitoring disease
outbreaks
• implementing disease prevention strategies
CDC Centers for Disease Control and Prevention - 🧠 ANSWER ✔✔•
Administration of Agency for Toxic Substances and Disease registry
• Immunization services
• Environmental disease prevention
FDA Food and Drug Administration - 🧠 ANSWER ✔✔is a federal regulatory
agency that monitors the safety and effectiveness of food, drinks,
cosmetics, drugs, and medical devices
The FDA is organized into several "centers" - 🧠 ANSWER ✔✔Center for
Biological Evaluation and Research (CBER)
, • Vaccines and blood products are two examples of biologics
•Center for Devices and Radiological Health with its Office of In Vitro
Diagnostics Device Evaluation (OIVD)
• responsible for the classification of in vitro diagnostics methods and
instruments as Class I, Class II, or Class III
• determines whether a test will be classified as waived, moderately
complex, or highly complex
CMS Centers for Medicare and Medicaid Services - 🧠 ANSWER
✔✔administers Medicare, a federal healthcare coverage plan for the
elderly, those with severe kidney damage who require dialysis, and people
with certain disabilities
• Medicare is a federal insurance program, financed by salary deductions.
has authority for the regulation enforcement for CLIA '88 - the Division of
Laboratory Services is responsible for the certification and survey of clinical
laboratories
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY
STATEMENT. ALL RIGHTS RESERVED 3
