Draft One
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DATIA's Comments
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DRAFT Two
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A "trained tester" under the supervision of a Responsible Technician, (RT)
must perform point of collection tests (POCT).
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Certified Collectors/Testers can perform tests. No RT is needed at a POCT Provider.
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RT Requirement removed from guidelines. Collectors required to be certified
by an HHS-approved POCT Certification Program
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Oral fluid testing allowed for post accident and reasonable suspicion testing
only.
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Allow oral fluids for all test reasons (pre-employment, random, reasonable
suspicion, post accident, return to duty, follow-up).
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Oral fluid allowed for all testing reasons.
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Summary Reports sent on a quarterly basis.
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No need to require frequent summary reports to be sent.
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Summary reports sent only when requested by the agency.
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POCT Providers must employ a Responsible Technician to monitor analytical performance
of all controls and standards; document the validity, reliability, accuracy, precision,
and performance of each device used.
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No Responsible Technician needed by POCT Provider. Too expensive, very impractical
for industry.
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Requirement removed from guidelines.
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At least one negative and one positive (25% above cutoff level) quality control
sample tested daily
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Test quality control on device lots, not daily
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At least one negative and one positive (25% above cutoff level) quality control
sample tested daily OR a positive quality control sample tested after each presumptive
positive
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POCT Providers required to be certified by SAMHSA
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Do not need to certify POCT Providers since collectors/testers are certified,
and devices are FDA approved an on conforming products list
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Removed from guidelines
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POCT Providers required to be inspected by SAMHSA
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Not needed-costly and impractical. See above
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Removed from guidelines
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No training or certification requirements for Medical Review Officers
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Medical Review Officers, as the gatekeeper, should be certified
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Medical Review Officers required to be certified by an HHS-approved Certification
program
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