Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.07 - Medical Laboratories-Personnel
Section 10.10.07.01 - Permitted POL and POCL - Director and Associate Director
Universal Citation: MD Code Reg 10.10.07.01
Current through Register Vol. 51, No. 19, September 20, 2024
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.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
