Laboratory Directors - Leading the Lab through Troubled Waters

On March 24, 1989, the oil tanker Exxon Valdez ran aground in the pristine waters of Prince William Sound off the Alaskan coast. The tanker’s side was slit open upon a reef, causing it to spill its cargo of over ten million gallons of crude oil. This led to one of the largest ecological nightmares in environmental history.
 
Captain Joseph Hazelwood was blamed for the accident, even though he was apparently not even on the bridge when this happened. He had left an inexperienced third mate in charge and had gone to his cabin. The third mate was trying to maneuver the ship in iceberg laden waters when he struck a reef. It was later determined that the third mate was not even certified to be piloting the tanker in these waters.
 
The fact that Captain Hazelwood was not present did not lessen his responsibility to take care of his ship.
 
Staying at the Helm

In many ways, a clinical laboratory can be compared to a ship at sea. A laboratory that is running smoothly, efficiently, and is performing quality testing probably has a laboratory director at the helm who is constantly involved with overseeing the laboratory activities. On the other hand, if the laboratory director is not involved, there is a good possibility that the lab will eventually “flounder.”
 
A laboratory director is not just the name listed on the CLIA certificate; this person must also make sure that all laboratory activities are taking place correctly, even if most of these activities have been delegated to someone else. A lab cannot be left in the care of “a third mate” with the expectation that it will continue to function smoothly, especially if the laboratory staff may be lacking in education or experience.
 
What makes a good laboratory director? Let’s start with the qualifications of a laboratory director, and then talk about how this person is responsible for the laboratory staff.
 
CLIA ’88 (the Clinical Laboratory Improvement Amendments of 1988) defines education and experience qualifications for all laboratory positions. The intent is to ensure quality patient testing by stating minimum staffing requirements.
 
Qualifications: Laboratory Director of a Moderate Complexity Lab
The captain of a commercial fishing boat may not have the training and certification to safely captain a huge oil tanker. Similarly, a laboratory director is not simply a licensed physician. He or she must fulfill one of these qualifications in order to direct a moderate complexity laboratory:

• Is a licensed MD, DO, or DPM and possesses a current license to practice in the state where the lab is located, AND possesses one of the following qualifications:

a. Board certified in anatomic or clinical pathology,
OR
b. Has one year of lab training or experience directing or supervising non-waived tests,
OR
c. Has at least 20 CME credits in lab practice about director responsibilities,
OR
d. Has the training through medical residency equivalent to at least 20 CME credits in
laboratory operation and supervision (such as board certification in hematology or
medical oncology).
 
•· OR has a Doctoral degree in a laboratory science AND
a. Board certified in Medical Microbiology, Clinical Chemistry, Bioanalysis, Medical Laboratory Immunology,
OR
b. 1 year experience directing or supervising non-waived tests.
 
• OR has a Master’s Degree in laboratory science, AND
a. 1 year laboratory training or experience, AND
b. 1 year supervisory experience in a non-waived laboratory.
 
• OR has a Bachelor’s Degree in laboratory science, AND
a. 2 years of laboratory training or experience in non-waived testing, AND
b. 2 years supervisory experience in a non-waived laboratory.
 
• OR has served and was qualified under state law as a laboratory director prior to Feb. 28, 1992.
[Please see CLIA Section 493.1405 for more details and exceptions.]
 
As you can see, there is much more to this position than just having “MD” or “DO” after your name. Not only must education requirements be met, but experience must be shown as well. If adequate experience cannot be shown, the “lab director” may be judged “unqualified.” If this is determined at the time of the lab’s initial survey, the lab faces closure until a qualified director can be found. So, it is important to ensure you have a qualified individual directing the laboratory when it opens.
 
A potential laboratory director of moderate complexity labs who lacks adequate experience can also take a prescribed number of continuing medical education credits in specific laboratory director topics (as approved by CMS) to fulfill this requirement.
 
But the job description doesn't end here. CLIA ’88 states that a lab director “is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures…and for assuring compliance with the applicable regulations.” The CLIA regulations list what this position’s responsibilities are (CLIA ’88, subpart M, section 493.1407). Many of the duties can be delegated to others, but the laboratory director is still responsible for the acceptable performance of these duties.
 
"The Crew": The Lab Director’s Responsibilities for Lab Personnel
Just as a ship should be manned with a qualified, well-trained crew, a laboratory should be staffed with qualified, well-trained personnel. It's the laboratory director’s duty to oversee the selection, training, and evaluation of laboratory personnel:
• The laboratory staff should be made up of qualified individuals. The lab director is responsible for seeing that the lab staff meets minimum CLIA qualifications. This means for example, that in moderate complexity labs, each staff person must be able to provide at least a high school diploma or transcript. Certificates of training from medical assistant schools, respiratory therapy programs, practical nursing programs, etc., are good supplemental documents, but a record of graduation from high school or GED (Graduate Education Development credential) must be in each person’s file. Of course, an associate, bachelor, or master degree can be substituted, if available.
• Each position should have a written job description that describes qualifications, specific duties, and what, if any, supervision is required for this position. The job description clarifies what is expected from each individual and what their evaluation will subsequently cover.
• Each person must be trained for each level of activity in the current lab. Even if they have learned similar tasks elsewhere, they should be oriented to this lab’s procedures. And don't assume that a certified medical assistant automatically knows how to operate all instrumentation and computer equipment. Use a training staff checklist to show documentation of training for the test methods in this laboratory.
• Make sure the staff is periodically evaluated (at least annually) for competence. This activity is commonly overlooked or is not documented. Also, evaluations are often “generic” and don’t specifically assess laboratory activities. In many cases, the laboratory director is also the person most involved and most qualified to be the evaluator. If competency is lacking, he or she should provide remedial training or look for more qualified staff.
• Employ enough personnel having the appropriate qualifications to carry out all aspects of laboratory activities (pre-analytical, analytical, and post-analytical) assigned to them. First of all, the lab director needs adequate numbers of staff to perform the assigned workload. If the staff is constantly rushing or putting in overtime to finish the work, mistakes may be made. Second, make sure they are qualified to perform the assigned tasks. An inexperienced medical assistant may not be capable or qualified to perform supervisory duties in a large laboratory. Most “supervisory duties” such as performance evaluation, quality control review, and quality assessment review fall under the responsibilities of the technical consultant. CLIA ’88 defines the positions of technical consultant and clinical consultant—these positions must also be filled with qualified individuals.
• The laboratory director, if qualified, may also perform the duties of technical consultant and clinical consultant. So in the smaller laboratory settings, the lab director may have to fill the role of “captain” as well as “first mate.” These duties may be delegated to others, but the laboratory director is still responsible for ensuring they are adequately performed. If a technical consultant has been employed to perform the supervisory duties of the lab, have regular meetings to address results and concerns, and document these discussions. Maintain strong communication avenues, so the lab director always knows what is happening within the laboratory.
• Be available to provide onsite, telephone, or electronic consultation to the laboratory as needed. Unfortunately, some laboratory staffers are left without and immediate resource of help or consultation, much like the third mate of the Exxon Valdez. When problems crop up, they are left to make their own decisions.
 
Keeping the Lab Ship-Shape

Simply stated, the laboratory director is ultimately responsible for everything that happens in the lab, even if others actually perform the activities. Unsatisfactory survey results with large numbers of deficiencies usually come from laboratories with un-qualified or poorly trained staff. In most of these cases, the laboratory director is cited for being “uninvolved” because these conditions persisted under his supervision. The comment, “I don’t know anything about the lab,” is a weak but commonly heard defense in many of these cases.
 
Be involved! If supervisory skills are lacking, seek education or enlist the help of a qualified technical consultant. A laboratory with a foundation of qualified, well-trained staff under the constant leadership of the laboratory director should have smooth sailing ahead.
 
Resources:
1. Clinical Laboratory Improvement Amendments of 1988, Sub-part M, Sections 493.1405-1407, Centers Disease Control and Prevention (CDC) website: http://www.phppo.cdc.gov/clia/regs/toc.aspx.
2. “Disasters: America’s Largest Spill”, the Exxon Valdez Oil Spill, http://www.boisestate.edu/history/ncasner/hy210/valdez.htm.
3. “On This Day: 24, March, 1989: Exxon Valdez creates oil slick disaster,
http://news.bbc.co.uk/onthisday/hi/dates/stories/march/24/newsid_

42310004231971.stm.