1. Which guideline establishes standards for clinical laboratory testing of human subjects?
A) CLIA
B) CLSI
C) GCP
D) GLP
2. What process ensures traceability of samples and test results according to GCLP?
A) Unique labelling
B) Blinded analysis
C) Equipement calibration
D) Specimen inventory logs
3. Which document defines standard operating procedures for a clinical lab according to GCLP?
A) Quality manual
B) Training records
C) Equipment log
D) Method validations
4. What organization recommends international quality standards for medical laboratories?
A) FDA
B) WHO
C) ISO
D) ICH
5. Which quality control verifies accuracy of clinical equipment according to GCLP?
A) Preventative maintenance
B) Reagent expiration monitoring
C) Proficiency testing
D) Temperature monitoring
6. What individual is responsible for laboratory quality systems according to GCLP?
A) Lab director
B) Quality manager
C) Testing personnel
D) Principal investigator
7. Which SOP defines processes for reporting critical clinical lab values according to GCLP?
A) Specimen handling
B) Method validations
C) Equipment log
D) Critical value reporting
8. What document defines roles, responsibilities and training in a clinical lab according to GCLP?
A) Organization chart
B) Job descriptions
C) Quality manual
D) SOP index
9. Which GCLP process monitors for potential sample mix-ups?
A) Unique labelling
B) Split sample analysis
C) Temperature monitoring
D) Chain of custody logs
10. Under which regulations must clinical labs establish quality systems in the United States?
A) Clinical Laboratory Improvement Amendments (CLIA)
B) Good Laboratory Practices (GLP)
C) Good Manufacturing Practices (GMP)
D) Investigational New Drug (IND)
11. Which guidance recommends clinical reference ranges for laboratory assays?
A) CLSI
B) AACC
C) Validation guidance
D) Method SOPs
12. What GCLP process ensures traceability between samples received and results reported?
A) Unique identifier labeling
B) Blinded analysis
C) Double reads
D) Chain of custody forms
13. Which individual monitors proficiency testing participation for clinical laboratory staff?
A) Quality manager
B) Laboratory director
C) Specimen accessioning personnel
D) Testing technologists
14. Which guidance contains standards for clinical laboratory biosafety?
A) CDC
B) CLSI
C) WHO
D) CAP
15. Which process verifies accuracy of clinical instrumentation according to GCLP?
A) Calibration
B) Maintenance
C) Operator training
D) Proficiency testing
16. What document defines processes to ensure only validated methods are used in clinical testing?
A) Quality manual
B) SOP master list
C) Equipment and maintenance log
D) Method validation reports
17. Which system ensures safety when handling biological specimens in a clinical lab?
A) Chemical hygiene
B) Barrier nursing
C) Biosafety
D) Biological safety cabinets
18. What initials refer to standards-developing organization for clinical laboratory practices?
A) CLSI
B) USP
C) AABB
D) AMA
19. What term refers to a clinical laboratory’s compliance with regulatory standards?
A) Validation
B) Verification
C) Accreditation
D) Certification
20. Which individual establishes policies to maintain clinical laboratory confidentiality?
A) Medical director
B) Laboratory manager
C) Quality manager
D) All personnel
21. Which term refers to evaluating instrument performance before clinical use?
A) Verification
B) Calibration
C) Qualification
D) Validation
22. How should clinical laboratory equipment be checked to ensure specifications are met?
A) Installation check
B) Operational qualification
C) Performance qualification
D) Training records review
23. What level of personal protective equipment is required for handling biohazardous specimens?
A) Gloves
B) Gloves and gown
C) Gloves, gown and eye protection
D) Full protective body suit
24. How should analytical accuracy of clinical laboratory methods be confirmed?
A) Proficiency testing
B) Calibration verification
C) Internal quality control
D) Method cross-validation
25. Which guidance establishes good storage practices for clinical laboratory specimens?
A) CAP checklist
B) GCLP
C) Equipment SOPs
D) CLIA regulations
26. Which supplies must be managed using tracking logs in a clinical laboratory?
A) Reagents and calibrators
B) Pipette tips
C) Waste containers
D) All of the above
27. According to GCLP, what oversight evaluates overall laboratory quality systems?
A) Audits
B) Method validations
C) Training records
D) Management reviews
28. Which quality control process ensures specified analytes are reliably detected by instrumentation?
A) Calibration verification
B) Sensitivity testing
C) Analytical measurement range
D) Equipment maintenance
29. According to GCLP, who is responsible for preventing clinical laboratory errors?
A) All personnel
B) Quality manager
C) Laboratory director
D) Testing staff only
30. Which guidance recommends acceptable quality control practices for clinical laboratories?
A) CLIA
B) GCLP
C) CAP checklist
D) Manufacturers’ guidelines
31. What process tracks expiration dates for clinical laboratory reagents and supplies?
A) Inventory logs
B) Temperature monitoring
C) Maintenance records
D) MATERIAL SAFETY DATA SHEETS
32. Which initials identify US accrediting agency for clinical laboratory excellence?
A) COLA
B) AMBA
C) AABB
D) CAP
33. What term refers to establishing and verifying performance of a new clinical test?
A) Validation
B) Verification
C) Calibration
D) Accreditation
34. Which guidance contains categorization schemes for clinical laboratory errors?
A) CLSI
B) ISO
C) CAP
D) Laboratory SOPs
35. Which personnel according to GCLP are responsible for documenting all quality issues?
A) Testing staff
B) Quality manager
C) Laboratory management
D) All personnel
36. Which document defines processes for equipment servicings and repairs in a clinical lab?
A) Maintenance SOP
B) Equipment log
C) Training manual
D) Specimen accessioning SOP
37. Which record according to GCLP contains performance specifications for analytical tests?
A) Quality control plans
B) Method SOPs
C) Equipment logs
D) Performance records
38. Which guidance recommends standards for designing clinical laboratory facilities?
A) CDC
B) NFPA
C) JCI
D) CAP
39. What initials identify standards-developing organization for clinical and anatomic pathology?
A) CAP
B) COLA
C) CLIA
D) WHO
40. According to GCLP, which individual is responsible for medical direction of a clinical lab?
A) Technical Supervisor
B) Laboratory Director
C) Quality Manager
D) Testing Personnel