3604.1 Violation of the following provision shall be a Class 1 infraction: 22 DCMR § 301.1 (operating a tissue bank without a license).

3604.2 Violation of any of the following provisions shall be a Class 2 infraction:

1. (a) 22 DCMR § 300.3 (failure to manage and operate a tissue bank in accordance with good medical and public health practice);
2. (b) 22 DCMR § 302.1 (failure to have a physician as director and operator of the bank);
3. (c) 22 DCMR § 302.2 (failure to maintain a roster of authorized persons and to establish policies and procedures for operation of the bank);
4. (d) 22 DCMR § 302.4 (failure of a hospital licensee to designate a physician as director and operator of the bank);
5. (e) 22 DCMR § 303 (failure to comply with requirements concerning tissue acquisition, tissue withdrawal, and recordkeeping);
6. (f) 22 DCMR § 304 (failure to comply with physical and sanitary requirements);
7. (g) 22 DCMR § 305.2 (failure to cooperate in an inspection); or
8. (h) 22 DCMR § 306.1 (transporting tissue without the required record).

3604.3 Violation of any of the following provisions shall be a Class 3 infraction:

1. (a) 22 DCMR § 301.4 (failure to sign and certify application for license);
2. (b) 22 DCMR §302.3 (failure to provide policies and procedures for inspection upon request); or
3. (c) 22 DCMR § 302.6 (failure to notify of change in operator).

3604.4 Violation of the following provision shall be a Class 4 infraction:22 DCMR § 301.10 (failure to frame and post license).

SOURCE: Final Rulemaking published at 52 DCR 4998 (May 27, 2005).