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Patient Safety Focus: The Role of Lab Directors in Patient Safety

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The Role of Lab Directors in Patient Safety
An Interview with James Hernandez, MD

Disengagement of lab directors from the lab is an important latent error in lab medicine that can lead to catastrophic lab failures. In this interview, James Hernandez, MD, discusses the overall role of lab directors and how to hire a pathologist or PhD lab director who has the training necessary to run a high quality lab. Dr. Hernandez is assistant professor of Laboratory Medicine and Pathology, and director of Clinical Laboratories at Mayo Clinic Arizona in Scottsdale and Phoenix. He has more than 25 years of experience as an anatomic and clinical pathologist in the community hospital setting, as well as experience in managing small and large clinical labs. He has written and lectured extensively about lab management. Michael Astion, MD, PhD conducted this interview.

Q: Who can direct a clinical lab?
For labs performing high complexity testing, the lab director must be a medical doctor or a PhD with specialty training, for example in clinical chemistry. For hospital labs, pathologists who are board certified in both anatomic and clinical pathology are most often lab directors.

Q: What are the CLIA requirements regarding the duties of the lab director of a high complexity lab?
Under CLIA, there are seven responsibilities of a lab director that cannot be delegated. The lab director must:

  1. be accessible to provide consultation;
  2. ensure test systems provide quality service in all aspects of testing: pre-analytic, analytic, and post-analytic;
  3. employ a sufficient number of properly trained people;
  4. specify in writing the responsibilities of each person;
  5. ensure that the physical plant is adequate and safe;
  6. direct no more than five labs; and
  7. ensure that all delegated responsibilities are performed.

Responsibilities of a Medical Director According to CLIA

  • Be accessible to provide onsite, telephone, or electronic consultation.
  • Ensure test systems provide quality service in all aspects of testing: pre-analytic, analytic, and post-analytic.
  • Employ a sufficient number of properly trained people.
  • Specify in writing the responsibilities of each person.
  • Ensure that the physical plant is adequate and safe.
  • Direct no more than five laboratories.
  • Ensure that all delegated responsibilities are performed.

Q: Can you provide more detail regarding the onsite consultation requirement?
The director must be available for consultation with lab management and staff. In addition, the director must be available to consult with the physicians and nurses caring for patients.

Q: When you inspect a lab for CAP, do you ask about whether the director is fulfilling the obligation regarding on site consultation?
Yes. One of the questions on the lab director checklist is: Does your director give enough attention to the medical staff and the lab? When there is a deficiency here, it is usually because the director is not meeting the needs of the lab staff. It is more common that the director is meeting the needs of the medical staff, which the director considers his or her peers.

A disengaged lab director is like a ship losing its captain.

Q: You have experience both as a community pathologist and as a medical lab director of a large academic laboratory. What do lab workers want from a lab director?
I think lab workers want to know that they are doing the right thing for patients, and they want to hear about cases where the lab is having a positive impact on patients’ lives. A well managed lab can often do things efficiently, meaning they can do things right, but they are not necessarily effective, which means they may not be doing the right things. The lab director should ensure that lab staff are doing the right things and should be communicating to the employees that this is the case.

Q: Can you give an example of doing things right, but not doing the right thing?
A lab might do a great job of running tests that are now obsolete, like a bleeding time or a T3 resin uptake. If they were doing the right thing, they would not be running those tests at all. The director should be playing a central role in making sure the test menu is up-to-date and meeting the needs of the physicians that rely on the lab.

Q: Are most lab directors comfortable ensuring quality for all aspects testing?
Most lab directors are comfortable in the zone that is already best controlled, which is the analytic part of testing. They are least comfortable in the areas where they could have the greatest impact: preanalytic and post-analytic systems. Lab directors need to be comfortable helping with key pre-analytic projects like barcode-based patient identification systems and computerized provider order entry, as well as post-analytic projects like critical values reporting and interpretive reports. 

Contrary Incentives That Cause Community Pathologists to Disengage from Managing Clinical Labs They Direct

  • Financial incentives favor performing fee-for-service anatomic pathology case work.
  • Financial incentives favor directing the maximal number of labs allowed by CLIA.
  • Cultural incentive favoring anatomic pathology over clinical pathology.

Q: What are the short- and long-term implications to patient safety of having a suboptimal lab director?
The short-term harm can be relatively minor, but the long-term damage can be severe and even catastrophic. In fact, disengagement of the lab director has been fundamental to the catastrophic failures that have afflicted a handful of labs in the last decade. There are two metaphors that I use to describe the implications of having a disengaged medical lab director. The first is that a disengaged or incompetent lab director is like a ship at sea losing its captain. The ship may go on sailing without incident for awhile, but eventually it will slowly drift and run aground. During the period of drift, people on the inside may not even notice, until it is too late to avoid serious harm to patients. Similarly, loss of an active and competent medical director is like a car running out of oil. The car will run fine for awhile. By the time the oil loss disables the car, you end up having to do an expensive repair on the whole engine, or even replace it.

Q: In the common case of a community hospital using a pathologist as lab director for both anatomic and clinical pathology, lab staff sometimes complain that the pathologists are disengaged from the clinical pathology part of their duties. What are some of the contrary incentives that lead pathologists to disengage from the labs they direct?
There are a few factors here. The financial incentives favor anatomic pathology because this is fee-for-service work. The more slides you can interpret, the more you can bill. In addition, financial incentives favor directing the maximum number five laboratories allowed by CLIA. This splitting of effort might not be optimal for any one of the labs. Lastly, there is a cultural incentive favoring anatomic pathology over clinical pathology. Historically, pathologists, especially in the community, view surgical pathology as more glamorous than clinical pathology, which is viewed as analytic and esoteric.

Macadamia nut farmers need time to reap the benefits of their labor; so do lab directors.

Q: What advice do you have for hospital lab leadership looking to hire a pathologist who will not abandon the clinical lab in favor of anatomic pathology duties?
In the community, most hospitals are looking for a person who is trained in both anatomic and clinical pathology. It is essential to closely examine a candidate’s clinical pathology training, because that is the area that is commonly weak. I would look for a pathologist who completed a residency program that has a good reputation for teaching clinical pathology and includes some training in management and leadership. I would ask candidates questions about their management experience, including knowledge about the lab director’s role and specific project experience. Lastly, I would ask candidates specific questions to test clinical pathology knowledge in a few domains, for example current tests in coagulation and in therapeutic drug monitoring.

Q: What are some specific questions you might ask to assess their management experience?
First I would ask the candidate to describe the role of the medical director. I would not expect the candidate to recite the whole list specified in CLIA, but I would expect him or her to understand the basic requirement, which is setting quality standards for the lab. I would also ask if he or she had ever been in charge of a lab. Then I would ask the candidate to tell me about his or her experiences with such issues as:

  1. choosing instruments or other technology for a clinical lab;
  2. evaluating the effectiveness of lab tests;
  3. changing the test ordering patterns of clinicians;
  4. preanalytic issues like phlebotomy services and patient identification issues; and
  5. post-analytic issues like interpretive reports and critical value policies and procedures.

Q: Are most pathology residency programs teaching leadership and management?
Yes. Surveys of training programs suggest that a large majority have formal training, in the form of didactics and experiences as an acting lab director.

Q: Is the training successful in producing pathologists with adequate skills to lead and manage a clinical lab?
The results are mixed. Objective testing of newly trained pathology residents show that they have learned a significant amount about key issues of management and leadership. In contrast, surveys of experienced pathologists, who have significant or sole responsibility for hiring pathologists, indicate that the vast majority feel that leadership and management training of newly trained pathologists is inadequate.

Q: How do you reconcile these results?
We might be teaching the wrong things to residents. Another possibility is that pathologists value real world experiences, and their expectation of what could be taught during training is too high. The experience they desire from candidates might require years of post-residency experience in the lab.

Q: For lab directors, how important is the ability to lead and manage relative to the importance of specific domain knowledge regarding lab testing?
Leadership and management abilities are roughly equal in importance to domain knowledge. Pathologists in the community, who are practicing both anatomic and clinical pathology, should view lab directorship as a three-legged stool consisting of anatomic pathology knowledge, clinical pathology knowledge, and the ability to lead and manage.

Q: Can you think of an analogy that describes what it takes to become a good lab director?
Being a good lab director is analogous to being a good macadamia nut farmer. The farmer has to work for about 6 years before a tree becomes productive. Similarly, a good lab director has to take the long view on running a high quality lab. Some of the projects that are necessary to be a truly great lab can take several years.

Q: Can you give us some take home points on what makes an ideal lab director?
The ideal lab director provides strategic guidance and innovative ideas to the clinical lab that he or she directs. The best lab directors push quality, in a quietly disruptive way. It is not sufficient to lead a good lab. Your leadership must ensure that the lab keeps getting better. Lab directors should believe in the Olympic motto: faster, higher, and stronger. One way to practice this is to stop comparing your lab to labs that are in worse shape, and start comparing your lab to labs that are ahead of yours.


CLIA personnel requirements. CDC website.

Hemmer PR, Karon BS, Hernandez JS, et al. Leadership and management training for residents and fellows: a curriculum for future medical directors. Arch Pathol Lab Med 2007;131:610–614.

Brimhall BB, Wright LD, McGregor KL, Hernandez JS. Critical leadership and management skills for pathology practice. Arch Pathol Lab Med 2007; 131:1547–54.

Gold crown macadamia association website. Accessed February 15, 2009.

Friedberg RC, Rauch CA. The role of the medical laboratory director. Clin Lab Med 2007;27:719–731.

Patient Safety Focus Editorial Board

Michael Astion, MD, PhD
Department of Laboratory Medicine
University of Washington, Seattle

Peggy A. Ahlin, BS, MT(ASCP)
ARUP Laboratories
Salt Lake City, Utah 
James S. Hernandez, MD, MS 
  Mayo Clinic Arizona
Scottsdale and Phoenix

Devery Howerton, PhD

Centers for Disease Control and Prevention
Atlanta, Ga.

Sponsored by ARUP Laboratories, Inc.