# COMAR Title 10 — Maryland Department of Health

## Subtitle 50 — Tissue Banks

### Chapter 01 — Tissue Banks

#### Regulation .06 Permitting Procedure.

*COMAR 10.50.01.06*

A. Application. An application is not complete until the OHCQ has received the completed permit application and all required documents.

B. Initial Inspection. The OHCQ shall inspect or have an inspection conducted by an accreditation organization for each tissue bank when an initial Maryland permit to operate is sought.

C. Issuance of a Permit. The Secretary shall issue a permit to an applicant who meets the requirements of this chapter to:

  (1) Operate a tissue bank in the State; or

  (2) Represent for service in the State a tissue bank that is inside the State or outside the State.

D. Issuance of a Permit and Provisional Permit.

  (1) Permit and Provisional Permit Content. A permit and provisional permit shall state:

    (a) The name of the tissue bank;

    (b) The name of the tissue bank's medical director;

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

    (d) The class or classes of the tissue bank.

  (2) 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 calendar days or a lesser period as determined by the Secretary;

      (ii) May not be renewed; and

      (iii) Shall automatically expire without notice upon the sooner of the date set for its expiration or upon issuance of a permit.

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

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

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

    (a) In this State; or

    (b) Outside this State.

F. Operating Without a Permit.

  (1) 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:

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

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

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

G. Cessation of Operations.  If a tissue bank ceases operation for 180 calendar days, then:

  (1) The OHCQ will void the permit to operate a tissue bank in the State; and

  (2) The tissue bank shall return the permit to the OHCQ.

H. Permit Application Administratively Closed.

  (1) After 180 calendar days from the date of initial receipt, the OHCQ may deem an incomplete permit application inactive and administratively close the application.

  (2) An applicant whose application is administratively closed may reapply for a permit by submitting a new application.

I. Change of Medical 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 calendar days before a change occurs; and

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

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

K. 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 calendar days after a tissue bank undergoes a change in tissue bank class, medical director, name, or location.

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

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

    (a) Of the date the denial takes effect;

    (b) Of the reason for the denial; and

    (c) That the permit applicant has an opportunity for a hearing on the matter in accordance with 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, in accordance with 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 corrective 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, in accordance with 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 calendar 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.

M. 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 OHCQ.