Sec. 10.10.07.01. Permitted POL and POCL — Director and Associate Director

A. Primary Standard. The licensee of a permitted POL or POCL shall employ or otherwise engage the services of a qualified director or associate director and a laboratory supervisor or consulting supervisor.

B. Standards.

(1) Qualifications.

(a) POL. The director of a permitted POL shall be:

(i) A physician licensed by the Board of Physicians to practice medicine in the State and a member or employee of the practice operating the laboratory; or

(ii) An employee or contractor of the practice who possesses the training and experience set forth in Regulation .05 of this chapter.

(b) POCL. The director of a permitted POCL shall be:

(i) A physician of the medical care facility who possesses the applicable training and experience set forth in Regulation .05 of this chapter;

(ii) An individual who qualifies as a director under 42 CFR §493.1443, and who possesses the applicable training and experience set forth in Regulation .05 of this chapter; or

(iii) An individual who meets the definition of a technologist as set forth in COMAR 10.10.01.03B.

(2) Duties and Responsibilities.

(a) A director of a permitted POL or POCL shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations to the extent necessary to ensure compliance with this chapter.

(b) A director's duties and responsibilities include:

(i) When applicable, employing or otherwise engaging the services of a qualified general supervisor or consulting supervisor;

(ii) Ensuring that the general supervisor or consulting supervisor spends sufficient time performing the supervisory duties and responsibilities;

(iii) Completing and submitting to the OHCQ forms, supplied by the OHCQ, that document a general or consulting supervisor's education, training, and experience in laboratory practice;

(iv) Recruiting qualified and competent technical personnel;

(v) Obtaining or providing and documenting initial training and continuing education for technical personnel;

(vi) Reviewing with the laboratory supervisor or consulting supervisor all laboratory procedures and policies and all evaluative material, including proficiency testing results, pertinent to the operation and performance of the laboratory;

(vii) Serving as a liaison between the physicians of the practice or medical care facility and the laboratory supervisor or consulting supervisor and other technical personnel to communicate situations such as test interpretations, timeliness of reports, reporting abnormal test results, and new or changing laboratory procedures and policies affecting patient care;

(viii) Ensuring that all application forms, documents, and other materials required under this chapter are submitted to the OHCQ within the appropriate time periods; and

(ix) Designating an associate director, when applicable.

(3) Associate Director. An associate director shall:

(a) Meet the same qualifications as set forth in §B(1) of this regulation; and

(b) Act as laboratory director when the laboratory director is away from the laboratory for a period of more than 30 days.

(4) Supervisory Consultation. A director of a permitted POL or POCL shall:

(a) Consult with the laboratory supervisor in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory; and

(b) Conduct an on-site visit to each directed laboratory at least once a month.

(5) Director Limitation. A POL director may not serve as director or associate director, or both, of more than five medical laboratories at the same time.

(6) Changes in Employment or Service. A director shall notify the OHCQ within 30 days of any change in the director's service or employment as a laboratory director.

(7) Director Disqualification. A director or associate director may be disqualified to direct a permitted POL for failing to comply with the applicable standards and requirements of this chapter.