CLC CLC Laboratory Accreditation & Certification Processes 2 — Questions and Answers
Question 1: When a laboratory's CLIA certificate is due for renewal, how often must the renewal occur?
- Annually
- Every 2 years (Correct answer)
- Every 3 years
- Every 5 years
Correct answer: Every 2 years
CLIA certificates must be renewed every two years, with the laboratory demonstrating continued compliance with applicable standards.
Question 2: A consultant helps a laboratory prepare for a Joint Commission laboratory accreditation survey. Which TJC program covers hospital-based laboratories?
- Laboratory Accreditation Program (LAP)
- Hospital Accreditation Program (HAP) (Correct answer)
- Ambulatory Health Care Program
- Behavioral Health Care Program
Correct answer: Hospital Accreditation Program (HAP)
Hospital-based laboratories are assessed under The Joint Commission's Hospital Accreditation Program (HAP), which includes laboratory standards.
Question 3: Which CLIA certificate is required for a physician office laboratory that performs only provider-performed microscopy procedures (PPMP)?
- Certificate of Waiver
- Certificate for Provider-Performed Microscopy Procedures (Correct answer)
- Certificate of Compliance
- Certificate of Accreditation
Correct answer: Certificate for Provider-Performed Microscopy Procedures
The Certificate for Provider-Performed Microscopy Procedures (PPMP) is specifically designed for labs where a clinician performs microscopy examinations during patient visits.
Question 4: During a laboratory accreditation survey, inspectors observe a staff member performing a test without documented competency assessment. This finding most likely represents a deficiency in which CLIA requirement?
- Proficiency testing participation
- Personnel qualifications and competency assessment (Correct answer)
- Quality control documentation
- Test method validation
Correct answer: Personnel qualifications and competency assessment
CLIA requires that laboratory directors ensure all personnel have documented competency assessments for each test they perform.
Question 5: A laboratory consultant is assisting a lab in achieving deemed status. What does 'deemed status' mean in the context of laboratory accreditation?
- The lab is exempt from all inspections
- An accrediting organization's standards are accepted as meeting CLIA requirements (Correct answer)
- The lab director is deemed qualified
- State licensure replaces federal requirements
Correct answer: An accrediting organization's standards are accepted as meeting CLIA requirements
Deemed status means CMS recognizes that an accrediting organization's standards and inspection processes are equivalent to or exceed CLIA requirements.
Question 6: Which accreditation body is specifically known for accrediting reference and independent laboratories through its laboratory accreditation program separate from hospital programs?
- The Joint Commission
- College of American Pathologists (CAP) (Correct answer)
- AABB
- ASHI
Correct answer: College of American Pathologists (CAP)
CAP's Laboratory Accreditation Program (LAP) accredits a wide range of laboratory types, including independent and reference laboratories, using peer inspection teams.
CLC CLC Laboratory Accreditation & Certification Processes 2
When a laboratory's CLIA certificate is due for renewal, how often must the renewal occur?