Each participant has the responsibility to be in compliance, and to remain in compliance, with the regulations set out in this chapter. For the purpose of assuring initial and continued compliance, the Department will conduct inspections of participants. Participats must allow such inspections which includes allowing access to and the copying of records
005.01RESULTS OF INSPECTIONS. Notifications will be made in writing to the participant.005.01(A)NOTIFICATION OF IMMINENT DANGER. If notified that the violations would create an imminent danger of death or serious physical harm or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must cease participation in the program immediately.005.01(B)NOTIFICATION OF NON-IMMINENT DANGER. If notified that the violations do not create an imminent danger of death or serious physical harm to the patients of the participant and no direct or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must correct any deficiencies noted in the inspection within 30 days after receiving the inspection results.005.01(C)CORRECTIVE ACTION. Participants that are not fully in compliance with these regulations within 30 days after receiving the inspection results will no longer be allowed to participate in the program.181 Neb. Admin. Code, ch. 7, § 005
Amended effective 12/23/2020