Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 10 - LABORATORIES › Chapter 10.10.07 - Medical Laboratories-Personnel › Section 10.10.07.02 - Permitted POL and POCL - General Supervisor and Consulting Supervisor

Current through Register Vol. 51, No. 14, July 12, 2024
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
				  10.10.01.03BB and
				  employed to perform tests at least 1 day a week in the lab being supervised;
				  or
(c) Technician as defined in
				  COMAR 10.10.01.03BB 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
				  10.10.01.03BB 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
				  10.10.05.03B;
(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.