.10 Tissue Bank Standards — Personnel.

A. General Requirements. A tissue bank shall employ a technical director, medical director, and sufficient staff to:

(1) Provide accurate and reliable services;

(2) Meet all operational needs; and

(3) Meet all statutory and regulatory requirements and standards.

B. Medical Director.

(1) Qualifications. The medical director:

(a) Shall be a physician licensed to practice medicine by the:

(i) Maryland Board of Physicians; or

(ii) Appropriate agency in the state where the tissue bank is located; and

(b) Shall be qualified by training and experience in evaluating and determining donor suitability, particularly with regard to infectious diseases.

(2) Serving as Technical Director. The medical director may serve also as the technical director if the medical director remains at the tissue bank site during the tissue bank's regular hours of operation.

(3) Responsibilities. The medical director shall:

(a) Establish donor suitability criteria;

(b) Evaluate and determine each donor's acceptability;

(c) Review and approve the standard operating procedures, quality assurance policies, and quality control records for medical efficacy;

(d) Approve exceptional or extraordinary releases of tissue as specified in the tissue bank's standard operating procedure manual;

(e) Establish policies and procedures regarding adverse outcomes that include requiring that all potential adverse outcomes are:

(i) Investigated;

(ii) Documented;

(iii) Reviewed; and

(iv) Reported as required by applicable federal, State, or local law;

(f) Notify the living donor or, for a cadaveric donor, the cadaveric donor's physician for any legally allowed counseling of next of kin, of confirmed positive infectious disease test results;

(g) Notify the OHCQ in writing or electronically of each fatal adverse outcome related to:

(i) Transplantation;

(ii) Transfusion;

(iii) Transfer; or

(iv) Implementation of tissue; and

(h) Establish look back and recall procedures when tissue is determined to:

(i) Be defective; or

(ii) May potentially cause an adverse outcome.

C. Technical Director.

(1) Qualifications. The technical director shall:

(a) Hold an earned bachelor's or higher degree in medical technology or a biological science from an accredited college or university and be qualified by training and experience for the scope of activities conducted by the tissue bank; or

(b) Hold an earned bachelorís degree in a discipline other than medical technology or a biological science from an accredited college or university and have 5 years of experience overseeing all technical aspects of tissue bank operations under the supervision of a medical director.

(2) Responsibilities. The technical director shall:

(a) Provide on-site supervision of tissue bank operations and personnel during the tissue bank's regular hours of operation; and

(b) Participate in and actively supervise the tissue bank's:

(i) Planning;

(ii) Organization;

(iii) Staffing;

(iv) Training and continuing education;

(v) Staff competency;

(vi) Quality control and quality assurance;

(vii) Standard operating procedures (SOPs);

(viii) Facilities;

(ix) Donor selection;

(x) Equipment;

(xi) Products;

(xii) Records;

(xiii) Services; and

(xiv) Compliance with the requirements and standards of this chapter.

D. Technical Staff.

(1) Qualifications.

(a) Technical staff shall possess the education, experience, and training necessary and sufficient to assure that assigned tasks are performed in accordance with the tissue bank's established procedures and the standards set forth in this chapter.

(b) The technical director and medical director shall train individual staff to accurately and reliably:

(i) Perform tissue bank services such as collection, retrieval, processing, packaging, and cryopreservation; and

(ii) Document that training in the individual's employee training file.

(2) Responsibilities.

(a) Technical staff shall implement, maintain, and follow the policies and procedures established by the medical director and technical directors.

(b) A technical director shall list and describe the duties and responsibilities of technical staff in written job descriptions.

(c) Technical staff shall initially, and at least annually thereafter, demonstrate documented competency in the tasks to which the staff person is assigned.

(d) Technical staff shall participate in documented training and continuing education to maintain technical competency in the duties described in their written job descriptions.