10.50.01.06

.06 Permits.

A. General.

(1) Permit Requirement. A person shall hold a permit issued by the Secretary before the person may:

(a) Operate a tissue bank in this State; or

(b) Represent or service in this State a tissue bank that is:

(i) In this State; or

(ii) Outside this State.

(2) Operating Without a Permit.

(a) Unless a person has a permit issued by the Secretary to operate, represent, or service a tissue bank in this State, a person may not:

(i) Operate a tissue bank in this State; or

(ii) Represent or service in this State a tissue bank that is in this State or outside this State.

(b) A permit holder may not operate, represent, or service a tissue bank class other than that authorized in the permit.

B. Issuance.

(1) Permit and Provisional Permit.

(a) Content. A permit and provisional permit shall state:

(i) The name of the tissue bank;

(ii) The name of the tissue bank's technical directors;

(iii) The name of the tissue bank's owner or owners; and

(iv) The class or classes of tissue bank.

(2) Permit. The Secretary may issue a permit that is valid for a 2 -year term.

(3) Provisional Permit.

(a) The Secretary may issue a provisional permit before or after an initial inspection.

(b) A provisional permit:

(i) Is valid for 180 days or a lesser period as determined by the Secretary; and

(ii) May not be renewed.

C. Expiration and Renewal.

(1) Expiration.

(a) Permit. At least 1 month before a permit expires, the OHCQ shall send to the permit holder, by first class mail to the last known address of the holder, a renewal notice that states the:

(i) Date on which the current permit expires;

(ii) Date by which the renewal application must be received by the OHCQ for the renewal to be issued; and

(iii) The amount of the renewal fee set forth in §D of this regulation.

(b) Provisional Permit. A provisional permit shall automatically expire without notice on the date set for its expiration.

(2) Renewal Applications. Before a permit expires, the permit holder may renew the permit for an additional 2-year term, if the permit holder:

(a) Pays to the Department the renewal fee set forth in §D of this regulation;

(b) Submits a renewal application on the form that the Secretary requires; and

(c) Complies with the requirements of this chapter.

(3) Failure to Renew a Permit. The Department shall interpret the failure on the part of a tissue bank permittee to complete and submit renewal forms and fees as intent not to operate.

D. Fees.

(1) Requirement. An applicant for a permit to operate a tissue bank in this State or represent or service in this State a tissue bank that is in this State or outside this State shall pay the appropriate fee as set forth in §D(2) of this regulation.

(2) Amounts.

(a) Fee to apply for a permit — $200;

(b) Fee to renew a permit — $200;

(c) Permit or provisional permit fee for each class of tissue bank — $200;

(d) Fee to amend an unexpired permit or provisional permit — $50;

(e) Fee to replace a provisional permit with a permit — $50; and

(f) Fee to replace a lost permit or provisional permit — $50.

(3) Refunds and Credits. The Secretary may not issue a refund or credit or return any permit fee to an applicant or permit holder that:

(a) Withdraws a permit application; or

(b) Voluntarily or involuntarily ceases to operate or reduces or limits classes of tissue or services before a permit expires.

E. Change of Director, Name, or Location of a Tissue Bank. A tissue bank undergoing a change in medical director, name, or location shall:

(1) Notify the OHCQ 10 days before a change occurs; and

(2) Apply to the OHCQ for an amended permit or provisional permit within 30 days after a change takes place.

F. Nontransferability. A permit or provisional permit may not be transferred from one owner or tissue bank to another.

G. Denial, Suspension, Revocation — Causes. The Secretary may deny, suspend, or revoke a permit or provisional permit if the tissue bank or the tissue bank's technical director, medical director, or both fail to meet requirements of this chapter, including, but not limited to:

(1) Failure within a specified time to correct a cited deficiency identified during an inspection;

(2) Repetitive or consistent errors;

(3) Deliberate falsehood; or

(4) Failure to apply for an amended permit or provisional permit within 30 days after a tissue bank undergoes a change in tissue bank class, medical director, name, or location.

H. Denial, Suspension, and Revocation — Hearing Requirement.

(1) When the Secretary denies an application for a permit or a renewal of a permit, the Secretary shall inform the permit applicant or holder in writing:

(a) Of the date the denial takes effect;

(b) Of the reason for the denial; and

(c) That the permit applicant or holder has an opportunity for a hearing on the matter under State Government Article, §10-226, Annotated Code of Maryland.

(2) Unless the Secretary finds that a danger to public health, safety, or welfare summarily requires that emergency action be taken to correct a deficiency, the Secretary shall inform the permit holder or provisional permit holder, in writing:

(a) Of the date a suspension or revocation of the permit or provisional permit takes effect;

(b) Of the reason for the suspension or revocation; and

(c) That the permit holder or provisional permit holder has an opportunity for a hearing on the matter before the suspension or revocation takes effect, under State Government Article, §10-226, Annotated Code of Maryland.

(3) When a finding is made that the public health, safety, or welfare summarily requires that emergency or immediate action be taken, the Secretary shall inform the permit holder or provisional permit holder in writing:

(a) Of the date a suspension or revocation of the permit or provisional permit takes effect;

(b) Of the reason for the suspension or revocation; and

(c) That the permit holder or provisional permit holder has an opportunity for a hearing on the matter, after the suspension or revocation takes effect, under State Government Article, §10-226, Annotated Code of Maryland.

(4) Reapplication After Revocation. A tissue bank that has had its permit or provisional permit revoked may apply for a new permit 30 days after revocation and upon presentation to the Secretary of evidence of capability and intention to comply with the standards and requirements of this chapter.

I. Return of Permit. If a tissue bank's permit is amended, suspended, or revoked, the original permit is void and the tissue bank's technical director shall return the permit to the Secretary.