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11.18 How long must a laboratory retain a specimen?

11.19 How long must a laboratory retain records?

11.20 Can a laboratory store records electronically?

11.21 What summary report must a laboratory provide to a Federal agency?

11.22 What information is available to the donor?

11.23 What type of relationship is prohibited between a laboratory and an MRO?

11.24 What information must a certified laboratory provide to its private sector clients?

Subpart L – Point of Collection Test (POCT)

12.1 What is a point of collection test?

12.2 What types of POCT devices are there?

12.3 What are the requirements for a POCT device?

12.4 Who may conduct a POCT?

12.5 What are the qualifications for the person who performs a POCT?

12.6 What are the responsibilities of a responsible technician?

12.7 Which specimen types may be tested using a POCT?

12.8 What are the cutoff concentrations when using a POCT?

12.9 May the donor observe the POCT being performed?

12.10 What are the requirements for conducting a POCT?

12.11 What are the quality control requirements when conducting a POCT?

12.12 What are the application requirements for a POCT provider?

12.13 What are the qualitative and quantitative specifications for PT samples that are used to evaluate a POCT provider?

12.14 What are the inspection requirements for a POCT provider?

12.15 Who may inspect a POCT provider?

12.16 What happens if a POCT provider does not satisfy the minimum inspection requirements?

12.17 Where is a list of “recognized” POCT providers published?

12.18 Is a POCT provider allowed to conduct any additional tests on a specimen?

12.19 How long must a POCT provider retain a specimen?

12.20 How long must a POCT provider retain records?

12.21 Can a POCT provider store records electronically?

12.22 What summary report must a Federal agency receive from a POCT provider?

12.23 What type of relationship is prohibited between a POCT provider and a Medical Review Officer?

12.24 What type of relationship can exist between a POCT provider and an HHS certified laboratory?

12.25 What security measures must a POCT provider maintain?

12.26 What information is available to the donor?

12.27 What is the minimum specimen volume for a POCT?

12.28 What action may a Federal agency take when a POCT is positive?

12.29 How is the POCT result reported to the Medical Review Officer?

Subpart M -Instrumented Initial Test Facility

13.1 What is an instrumented initial test facility?

13.2 Are laboratories that perform only initial tests allowed?

13.3 What is an instrumented initial test?

13.4 What types of initial tests are there?

13.5 What are the requirements for an instrumented initial test facility?

13.6 Why must the instrumented initial test device be calibrated?

13.7 Who may conduct an instrumented initial test?

13.8 What are the qualifications for the person who performs an instrumented initial test?

13.9 What are the responsibilities of a responsible technician?

13.10 Which specimen types may be tested using an instrumented initial test?

13.11 What are the cutoff concentrations when using an instrumented initial test?

13.12 What are the quality control requirements when conducting an instrumented initial test?

13.13 What are the application requirements for an instrumented initial test facility?

13.14 What are the qualitative and quantitative specifications for PT samples that are used to evaluate an instrumented initial test facility?

13.15 What are the inspection requirements for an instrumented initial test facility?

13.16 Who may inspect an instrumented initial test facility?

13.17 What happens if an instrumented initial test facility does not satisfy the minimum inspection requirements?

13.18 Where is a list of “recognized” instrumented initial test facilities published?

13.19 Is an instrumented initial test facility allowed to conduct any additional tests on a specimen?

13.20 How long must an instrumented initial test facility retain a specimen?

13.21 How long must an instrumented initial test facility retain records?

13.22 Can an instrumented initial test facility store records electronically?

13.23 What summary report must a Federal agency receive from an instrumented initial test facility?

13.24 What type of relationship is prohibited between an instrumented initial test facility and a Medical Review Officer?

13.25 What type of relationship can exist between an instrumented initial test facility and an HHS certified laboratory?

13.26 What security measures must an instrumented initial test facility maintain?

13.27 What is the minimum specimen volume collected for an instrumented initial test?

13.28 What action may a Federal agency take when an instrumented initial test is reported as a non-negative?

13.29 How is the instrumented initial test result reported to the Medical Review Officer?

Subpart N – Medical Review Officer (MRO)

14.1 Who may serve as an MRO?

14.2 What are the responsibilities of an MRO?

14.3 What type of relationship is prohibited between an MRO and a laboratory, POCT provider, or an instrumented initial test facility?

Subpart O – Single Specimen Retests and Split Specimen Tests

15.1 When may a single specimen or primary specimen be retested?

15.2 When may a split specimen be tested?

15.3 How does a laboratory handle the retesting of a single specimen

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