Sec. 10.10.07.02. Permitted POL and POCL — General Supervisor and Consulting Supervisor

A. Primary Standard. A licensee operating a POL or POCL under a permit shall employ or otherwise engage a qualified general supervisor or consulting supervisor.

B. Standards.

(1) Requirement. A laboratory shall employ or otherwise engage a qualified general supervisor or consulting supervisor who shall act in concert with the laboratory director to ensure that the laboratory complies with the standards and requirements of this chapter.

(2) Qualifications - POL and POCL General Supervisor. To qualify as a laboratory supervisor in a permitted POL or POCL, an individual shall be a:

(a) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised;

(b) Technologist as defined in COMAR 10.10.01.03B and employed to perform tests at least 1 day a week in the lab being supervised; or

(c) Technician as defined in COMAR 10.10.01.03B and employed to perform tests on a full-time basis in the lab being supervised.

(3) Qualifications - Consulting Supervisor. To qualify as a consulting supervisor of a POL or POCL, an individual shall be a:

(a) Technologist as defined in COMAR 10.10.01.03B who possesses at least 2 years of work experience in a laboratory that:

(i) Operated under a permit; and

(ii) Performed testing services related to those offered by the laboratory to be supervised; or

(b) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised.

(4) Supervisory Duties and Responsibilities. A general supervisor or consulting supervisor shall:

(a) Implement and maintain the applicable laboratory standards and requirements set forth in this chapter;

(b) Ensure proper and reliable test performance, reporting, record keeping, and immediate general and technical supervision of testing personnel and laboratory services;

(c) Develop, implement, and oversee maintenance of an internal quality assurance program that includes:

(i) A working quality control program or system that determines and documents accuracy and precision of all tests performed;

(ii) Selection and use of quality control and standard materials for analysis;

(iii) Recording and documenting quality control data;

(iv) Ongoing analysis of quality control data; and

(v) Implementation and maintenance of a specimen documentation and management system;

(d) Prepare and maintain a SOPM;

(e) Ensure full participation in an external proficiency testing program approved by the Secretary as set forth in COMAR 10.10.05.03;

(f) Teach proper laboratory techniques, including the importance of quality control, quality assurance, and proficiency testing;

(g) Review proficiency testing results, determine sources of error, and work to correct any problems;

(h) Review proficiency testing results, analytical studies and evaluations, and survey reports with technical personnel to improve test performance and laboratory services;

(i) Maintain, as part of laboratory records, a log or other suitable record documenting monthly consultations with the director and all supervisory activities provided to the laboratory;

(j) Ensure that laboratory testing personnel:

(i) Possess the education, training, and experience required to perform and report laboratory test results accurately and promptly;

(ii) Are sufficient in number for the scope and complexity of the services provided;

(iii) Receive regular in-service training and continuing education appropriate for the scope and complexity of the services provided; and

(iv) Maintain competency in performing test procedures and reporting test results; and

(k) Perform other duties and responsibilities as delegated and authorized by the director that may include assisting in:

(i) Developing cost benefit data;

(ii) Identifying and recommending adjustments to a laboratory's scope of services; and

(iii) Recommending the purchase or replacement of test kits, reagents, and equipment.