| Monday, January 01, 0001
Laboratory Directors (LD) are the leaders of the laboratory, not only in quality management but in thought leadership. Information often travels from the top down in many facilities, and thus, it is critical for these administrators to stay informed and educated. Just as a lab staff is required to stay compliant with their certification and pursue Continuing Education (CE) opportunities, so, too, must the lab’s Director stay current on educational requirements.
As defined by COLA, the LD is “responsible for the overall operation and administration of the laboratory, and for assuring compliance with all applicable regulations. The LD must meet education and experience requirements to hold the position, and must meet all of the responsibilities associated with the position, including ensuring that there are sufficient personnel with adequate experience and training to conduct the work of the laboratory. He or she must also ensure that every position in the laboratory is filled by an individual qualified to hold the position and able to perform the tasks required of the position.
Indeed, much is required of LDs in terms of not only technical expertise but also communication, education and leadership. This means allotting sufficient time towards the completion of their CE as well as other forms of professional development. While there are certain courses focused solely on LD criteria, there also are many general education opportunities that can benefit LDs such as reviewing professional journals and magazines. Directors should avail themselves of as many of these opportunities as possible, not only to expand their own knowledge base, but to also understand what is being communicated to their staff.
For instance, if there is an increase in the number of errors for a certain procedure in a laboratory, the LD should review how the staff was trained and request competency assessment be performed on the procedure to troubleshoot any potential sources of error. Not only should the procedure be reviewed, but if changes are necessary, the LD must ensure that all staff has been retrained and competency assessed and documented on the revised procedure. CE should always be documented in employee records as well.
U.S. CLIA regulations require “that a physician licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; to qualify as a Laboratory Director for a Moderate Complexity Laboratory, beginning September 1, 1993, they must have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in §493.1407; or Interpretive Guidelines§493.1405(b)(2)(ii)(B)The 20 CMEs must be obtained prior to qualifying as a laboratory director. The CME courses must encompass preanalytic, analytic, and post analytic phases of testing, and be of such quality as to provide the physician with education equivalent to the experience described in§493.1405(b)(2)(ii)(A). Courses related to laboratory payment and CPT coding would not fulfill this requirement. For a list of CME providers, please see the CLIA web page atwww.cms.hhs.gov/clia.”
NOTE: Obtaining 20 CME credit hours is but one way that one can qualify as a Laboratory Director of a moderate complex laboratory. It is only required if other options cannot be met.
The rules also state that, “Where applicable, State Licensure includes Continuing Education Requirements for the physician Laboratory Director. In all of the United States, there are defined requirements for physicians to meet Continuing Medical Education requirements every 1-3 years. These requirements vary by State (the term "State" as used in this provision, includes The District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of Northern Mariana Islands, the Virgin Islands, Guam and American Samoa) licensure and may also be in conjunction with the American Medical Association Continuing Medical Education Guidelines.” ,
Some laboratory accrediting bodies are now requiring that LDs (regardless of whether they are a non-physician LD) maintain Continuing Education hours. Due to the significance of the CLIA-defined responsibilities of the Laboratory Director, COLA requires all Laboratory Directors, except those who have completed the qualifying requirements for this position within the last two years, to complete four education credits every two years.
While most LDs fully understand the importance of Continuing Education, many may be wondering “When will I have the time to do all of this?” The answer is simple: Devote the same time allotted for the lab staff to complete their Continuing Education. The same 24 hours are in each day, but the way that LDs manage them makes all the difference. LDs must also master time management in their daily activities, in addition to their other daily tasks. (It has been noted that the laboratories that have the most citations during surveys are the ones where the LD is not wholeheartedly involved.)
Time Management Tips
One way to complete the Continuing Education items on a task list is by incorporating them into overall daily activities. By scheduling CE as part of a weekly routine -- perhaps an hour a week or every two weeks -- LDs can stay well versed in the current issues of laboratory medicine. LDs should regularly research upcoming Calendars of Events and try to schedule time to attend webinars, workshops, conferences and symposia. If time or budget issues preclude traveling to such trainings, there are many online courses and webinars available. The Centers for Medicare and Medicaid Services lists has a list of CME Courses for Laboratory Directors of Moderate Complexity Laboratories on its website.  Some of the providers listed also offer Continuing Education credits under P.A.C.E. for non- Physician LDs.
Reading articles and current publications is another excellent way to stay current on laboratory medicine; LDs can circulate articles of interest to their staff as well.
Continuing Education, whether by requirement or voluntary, is a valuable way for LDs to maintain their educational edge. The LD should never stop learning and sharing information with their colleagues, peers and staff. They should periodically review the team’s employment records and see if everyone is current with their documentation and certifications. They should see what educational opportunities are available for everyone – including themselves -- and involve the laboratory staff in trainings. CE should not be seen as a chore but as a way to continuously ensure high quality laboratory medicine and quality patient care.
Maria S. Hardy is a Technical Writer for COLA’s Education subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel and allied health professionals. CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI Symposia for Clinical Laboratories and Workshops, providing live educational sessions and interactive seminars with leading industry organizations. For more information, visit their website at www.criedu.org, or call
 COLA Accreditation Manual (revised April 2014)
 CLIA Brochure #10 - What Do I Need to Do to Assess Personnel Competency? http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf
,4 CMS 493. 1405 Standard; Laboratory director qualifications. http://www.cms.gov/Regulations-and-
 Continuing Medical Education (CME) http://www.ama-assn.org/ama/pub/education-careers/continuing-medical-education.page?
 COLA Technical Bulletin “2014-3: New Survey Criteria - LDR 6 R”