Distant directors cause concerns
Q The director of
our physician office laboratory (POL) is a staff physician who meets the
CLIA qualifications on paper, but he does not seem to know how to
interpret or troubleshoot quality-control or proficiency-testing issues.
He does not know what his responsibilities are for the lab and only gets
involved when he absolutely has to. As supervisor of the lab, how should
I approach him regarding his lack of participation and possible lack of
Q Our laboratory
is located in a medical-arts building serving several practices. The
contracted director requires us to send him our procedure manual cover
sheets and procedures for his review, but he is not familiar at all with
the day-to-day issues of the lab. He rarely visits the laboratory and is
generally not available to help. As supervisor of the lab, how can I
make him understand that we need him to come here in person to see what
really goes on in the lab, not just see what is written on a report?
A Your worry about your
director’s involvement in laboratory activities is a legitimate concern —
one shared by others in your position. It is even more critical during your
accreditation or licensure survey. The surveyors are focusing on evidence
that the director is actively involved in the laboratory and are citing
deficiencies for the lack thereof, especially if the survey results are less
Perhaps you could find a journal article on the
responsibilities of the laboratory director and give it to him with a note,
“I thought you might find this article interesting.” You could later discuss
with the director which of those responsibilities should be delegated to
him, you, or other staff members.
Take specific questions or concerns to him and offer
your answers or solutions. By asking his opinion on your thoughts, you are
giving the director information without patronizing him and allowing him to
participate in decision making. An example would be a Levy-Jennings graph
showing a shift or a trend, pointing out the problem, and suggesting some
possible causes and corrective actions.
—M. Ann Bachman, BS,
Laboratory Supervisor, Generalist
of Physician Offices and Laboratories
The surveyors are focusing on evidence that the director is
actively involved in the laboratory and are citing deficiencies for the
A You cannot “make” your
director understand, but you can certainly help him to do so. Invite him to
visit your laboratory. Explain that you would like your staff to meet him —
then he can get to know the staff for which he, ultimately, is responsible.
Point out the benefits of seeing instruments for which he has signed off and
viewing the procedures he has approved. Let him know you would like to
discuss job descriptions — assuming you have them. (If not, use this visit
to start to develop them.) Job descriptions should be available for each
position and reviewed annually as part of the performance-management
This type of meeting can be a positive way for you to
discuss and clarify the needs and expectations you have for one another and
as a management team. Use this dialogue to come to an agreement on directing
and supervising your laboratory. This meeting can serve as the starting
point for more visits. Include having scheduled visits in your discussion of
expectations. Last, and most importantly, use this meeting to open and
establish a dialogue regarding laboratory operations. The goal of this visit
is to establish better relations, a shared management vision, and improved
—Martha Casassa, MS,
Braintree Rehabilitation Hospital
A Unfortunately, I do not
have enough information on your particular circumstances to know how many
laboratories he contracts as the director, what kind of help you would like
from him, or the level of involvement you would like him to have in your
My first recommendation would be for you to determine
exactly what type of assistance you need from him. What is it that you
really want him to see that he cannot see on the report? Are you having
staffing issues with which you would like his help? Budgeting problems?
Next, take a minute to assess what you know of his
responsibilities, understanding that you are probably only aware of a small
portion of them. Is he the director of multiple labs? Are the laboratories
large or small? Once you know what you need and have thought about his
responsibilities, you should contact him.
Let him know that you do understand he has other
responsibilities, but you value his input. Be sure to have the list of
specific concerns ready with how much time you will need for him to be at
the laboratory to observe the issues. Schedule dates and times for him to
come to the laboratory, and then ask for a follow-up meeting to discuss his
observations and recommendations.
Patient Relations Specialist
Medical Practice Services
State Volunteer Mutual Insurance Co.
A First, take the time to
build a relationship with him. Begin by scheduling an appointment with him
to discuss the role of the laboratory director. Be open to his perspective
while taking the opportunity to share yours. Keep the conversation focused
on service and patient care/safety. Have specific examples of why it is
important for him to come to the lab on a regular basis, and set up specific
times for him to come and participate in the running of the lab.
Ask him what he sees as obstacles to coming to the
lab and how you can work together to eliminate them. The keys are frequency
of meetings and the discussion of issues. Perhaps you can set up routine
meeting times in his office and, over time, change the meeting location to
the lab. Have specific items for discussion and review, as this will help
him realize his importance to the daily lab operations.
Director Laboratory Operations
Christiana Care Health System
A A laboratory director (LD)
must demonstrate active involvement in the laboratory’s operation and be
available to the laboratory staff, as needed. If this is not the case at
your facility, you should make an appointment to talk to the LD. Keep in
mind that while the LD is responsible for the overall operation and
administration of the laboratory — including personnel competency,
equipment, safety, policies, quality assurance, proficiency testing, and
reporting and delivery of results — the LD need not perform all of these
responsibilities personally. Some responsibilities can be delegated to other
staff members. The LD, however, is in charge of making sure those duties are
performed properly and remains responsible for the overall operation and
administration of the lab to ensure quality patient-care services are
Of course, remaining actively involved in the
operations of the laboratory is the best way to ensure others are performing
the delegated duties appropriately. Perhaps your LD is new on the job and is
not aware of what duties have been delegated to members of his staff.
Give your LD a copy of CLIA’s brochure “What are my
responsibilities as a laboratory director” (available at
www.cms.hhs.gov/CLIA/downloads/brochure7.pdf ). This brochure
provides an assortment of reminders, tips, and answers to questions to help
both LDs and staff members understand what is expected of the LD.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA
’88) define the responsibilities of the Laboratory Director (LD).
CLIA’s Top 10 tips for LDs:
- Learn CLIA (www.cms.hhs.gov/clia);
understand the laboratory director delegations and monitor them.
- Review policies, procedures, and processes (i.e., quality system).
- Review problem log and corresponding corrective actions. Learn from
- Are the laboratory’s panic values appropriate for the patient
- Notify the state department of health and the accrediting
organization, if applicable, of any change in laboratory director.
- Review and evaluate the laboratory’s quality-assessment (QA) plan
and indicators, and continuously monitor.
- Review the laboratory’s proficiency testing (PT) enrollment and
performance, corrective actions for all missed challenges, and speak to
the staff about what constitutes intentional referral of PT.
- Learn what equipment and test systems are used in the laboratory,
the quality control and validation protocols utilized, and the tests’
applicability to the patient population.
- Understand the supervisory and testing personnel array for the
laboratory; confirm their training and competency record and that there
are adequate numbers of the right personnel for each discipline.
- Ensure the laboratory is customer-focused.
Martinez Medlab Consulting
Los Angeles, CA
Bottom line: The Clinical Laboratory
Improvement Amendments of 1988 (CLIA ’88) define the responsibilities of
the Laboratory Director (LD). LD is defined in the CLIA regulations with
specific requirements for qualifications and responsibilities. Ensure
the LD has a copy of them as written in the CLIA Surveyor Guidelines
www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf. This version
provides the information relevant to delegating some of the LD
responsibilities to other CLIA-defined positions.
If you have a contract with this LD, consider
making payment contingent upon compliance with the CLIA
responsibilities. The CLIA inspector can cite deficiencies if your LD is
not compliant. If he is contracted, it is up to you to specify
conditions for payment. That could include monthly face-to-face meetings
to review PT and QA activities.
COLA, a physician-led clinical laboratory
accreditation organization, also has educational information available
for LDs and laboratory staff available at
A word of caution — be careful what you ask for;
your LD may get too involved!
Anne Pontius is a senior medical practice
consultant with State Volunteer Mutual Insurance Co. in Brentwood, TN,
and president of CLMA. Send questions to Ms. Pontius at