The Practice of Clinical Pathology A Quantitative Description of Laboratory Director Activities at a Large Academic Medical Center

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1 The Practice of Clinical Pathology A Quantitative Description of Laboratory Director Activities at a Large Academic Medical Center John A. Branda, MD, Anand S. Dighe, MD, PhD, Walter Dzik, MD, Mary Jane Ferraro, PhD,MPH, James Flood, PhD, Elizabeth Lee-Lewandrowski, PhD, MPH, Robert Makar, MD, PhD, Murali Mandokolathur, MD, Eric S. Rosenberg, MD, Susan Saidman, PhD, Patrick Sluss, PhD, Aliyah R. Sohani, MD, Christopher Stowell, MD, PhD, Elizabeth M. Van Cott, MD, and Kent B. Lewandrowski, MD From the Department of Pathology, Division of Laboratories and Molecular Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA. Key Words: Diagnostic testing; Laboratory testing; Laboratory director; Laboratory medicine; Clinical pathology Am J Clin Pathol August 2014;142: DOI: /AJCP3NU7AOPPKYWO ABSTRACT Objectives: The scope of activities performed by clinical laboratory directors is sometimes unfamiliar to other physicians or hospital administrators. Consequently, hospital leadership may undervalue the role and assume that many director level activities could be delegated to a professional manager. In this study, we sought to define the activities of academic laboratory directors, and to determine which activities require doctorate level medical or scientific expertise. Methods: We performed an audit of laboratory director activities at a large academic medical center by reviewing electronic calendars and other available records from the preceding 12 consecutive months. For episodic activities, the directors estimated the average number of hours devoted over the 1-year period. Results: On average, directors worked 54.9 hours per week and performed at least some service work 47.7 weeks per year. Administrative duties accounted for the greatest proportion of effort (47.1%), followed by clinical activities (33.1%) and academic activities (19.8%). Among administrative duties, those that required doctorate level medical or scientific expertise comprised 60.3% of the total administrative effort, whereas the remaining 39.7% (18.7% of total activity) could be performed by a professional manager.. Conclusions: Although the activities of clinical laboratory directors have been described elsewhere, this is the first study detailing the effort allocated to these various activities in quantitative terms. The study demonstrated that less than 20% of an academic laboratory director s effort involves administrative activities that could potentially be performed by a professional manager lacking doctorate level medical or scientific expertise. Frequently hospital administrators and nonpathologist physicians are unaware about the role and scope of activities of the clinical laboratory director. 1,2 Clinical laboratory directors are physicians trained in clinical pathology or doctoral scientists with advanced training in a laboratory specialty. Although some of the activities of clinical laboratory directors are directly reimbursed under Medicare part B payments or similar professional billing from third-party payers, the majority of the work performed by clinical laboratory directors is reimbursed indirectly through allocation of Medicare part A payments. Laboratory regulations stipulated by the Clinical Laboratory Improvement Amendments and accreditation standards of the College of American Pathologists, the Joint Commission, and other accrediting organizations describe a number of activities that are necessary for laboratory accreditation. However, directors also function in other roles necessary for the operation of the laboratory and the hospital that are not mandated by statute or accreditation requirements. Moreover, accreditation standards do not define the time commitment required from a director for these activities. Previous reports have listed physician activities in the clinical laboratory and activities involved in laboratory management. 1,3,4 However, these reports did not provide information on the proportion of time spent on each activity, or attempt to define which activities required the advanced medical and scientific training that sets directors apart from managers. Absent this information, hospital administrators tend to undervalue the role, and to assume that many director level activities are (or could be) delegated to a professional laboratory manager. In this study, we performed an audit of laboratory director activities among the faculty in the Division of Laboratories and Molecular Medicine at Massachusetts General Hospital (MGH; Boston, 144 Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO

2 MA). The purpose was to delineate the time commitment required of the directors to perform their various duties, and to determine which, if any, of these duties could reasonably be performed by a professional manager without advanced clinical or scientific training. Materials and Methods MGH is a 1,051-bed tertiary care academic medical center in Boston, MA. The MGH Division of Laboratories and Molecular Medicine (LMM) in the Department of Pathology provides laboratory and blood transfusion services to the inpatient medical, surgical, pediatric, obstetric, and burn and trauma services of the hospital, and to extensive primary care and specialty outpatient practices on campus and in the greater Boston community. The clinical laboratories include the core laboratory (chemistry, hematology, coagulation), microbiology, the transfusion medicine service, and various specialty laboratories (eg, immunology, histocompatibility, diabetes, and affiliated health center laboratories). The laboratories perform approximately 10 million tests per year, collect and process over 27,000 units of blood components per year, and distribute for transfusion over 61,000 units of blood components. The blood transfusion service also performs a number of direct patient care procedures including transfusions, infusions, plasmapheresis, cytapheresis, photopheresis, stem cell collections, and therapeutic phlebotomy. The LMM clinical faculty includes 12.8 full time equivalent (FTE) positions distributed as shown in Table 1. In 2011, our department performed an audit of clinical laboratory director activities in an effort to determine the activities and time commitments of a laboratory director. The audit was based on a review of electronic calendars and other available staff records from the preceding 12 consecutive months. For episodic activities, the directors estimated the average number of hours devoted over the 1-year period. Administrative activities were then further subdivided into five subcategories as follows: 1. Administrative activities requiring clinical expertise Table Administrative activities requiring scientific or technical expertise. For example, evaluating a new test platform or troubleshooting an assay. Choosing a new test platform requires knowledge and interpretation of the related scientific literature and familiarity with the performance characteristics of alternative methods. Once a new assay has been chosen, one must then design and interpret the findings of a verification or validation protocol activities that require many judgments, such as determining the number and type of specimens to include, or determining acceptable performance in comparison with the Table 1 Laboratory Director Full Time Equivalents (FTE) at Massachusetts General Hospital Laboratory Degree FTE Core laboratory Director and Director of Informatics MD, PhD 1.0 Associate Director, Chemistry PhD 1.0 Associate Director, Special Chemistry PhD 1.0 Medical Director, Hematology MD 0.35 Medical Director, Coagulation MD 1.0 Medical Director, Immunology MD 1.0 Codirector, Research Core PhD Microbiology Director PhD 0.85 Codirector MD 0.5 Associate Director MD 1.0 Blood transfusion service Director MD, PhD 1.0 Codirector MD 1.0 Associate Director MD, PhD 1.0 Director, Histocompatibility PhD 1.0 Overall operation Director of Clinical Laboratories MD 1.0 Total 12.8 reference method. These judgments are best made by an expert in the field who can lend perspective based on familiarity with the assay s expected performance, the composition of the patient population being served, the clinical implications of inaccurate or imprecise results, and training in statistical analysis. Similarly, troubleshooting an assay requires a detailed understanding of potential pitfalls in the method being applied and any instrumentation involved, and often broader expertise and experience not directly related to the assay itself particularly after obvious sources of error have been ruled out (eg, clerical errors, nonadherence to protocol, etc). For example, if a laboratory is seeing an increase in imipenem-nonsusceptible Proteus isolates, appropriate analysis would require knowledge of the wild-type minimal inhibitory concentration or disk zone size distributions around the susceptibility breakpoints, knowledge of recent changes in susceptibility breakpoints for the relevant drug class, an understanding of the expected rate of nonsusceptibility and mechanisms known to be active in the species that may lead to nonsusceptibility, familiarity with the stability of carbapenems when stored as reagents for in vitro testing and variables that might affect it, the potential effect of swarming growth by Proteus isolates on disk zone interpretation in other words, advanced knowledge that goes beyond familiarity with the test procedure itself. 3. Administration requiring director level (doctorate level) status. For example, directing off-site laboratories or performing certain committee work such as representing the clinical laboratories on the hospital committee that sets medical policy. Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO 145

3 Branda et al / The Practice of Clinical Pathology Table 2 Examples of Administrative Activities Requiring Clinical Expertise Clinical Pathology Discipline Example Activity Clinical chemistry Coagulation Histocompatibility Laboratory hematology Laboratory immunology Medical microbiology Transfusion medicine 4. Administration requiring business or financial expertise. For example, preparing a budget or a business plan. 5. Other general administration, including activities related to quality assurance or quality control, regulatory compliance, human resource management, or interdepartmental activities. For the purposes of this study, we considered the first three subcategories (numbers 1-3 above) to entail activities that could not be performed by a professional manager lacking director level scientific or medical training, whereas a subset of the remaining activities (numbers 4-5 above) could potentially be handled by a professional (non doctorate level) administrator. Results On average, the clinical laboratory directors reported working 54.9 hours per week on all activities. They also reported working a mean of 47.7 weeks per year, during which they were responsible for at least some clinical laboratory activities. The percentage of time allocated to each individual activity is shown in Table 3. Administrative activities required the largest effort proportionately (47.1%), followed by clinical activities (33.1%), research activities (12.9%), and efforts devoted to trainee education (6.9%). Separating the administrative activities into subcategories showed that administrative duties requiring director level status or Utilization management review of tests sent to outside reference laboratories, to eliminate tests of limited clinical utility and to identify tests that require clinical pathologist approval Developing laboratory testing algorithms for hypercoagulation, lupus anticoagulant, or prolonged PT and/or aptt, and interpreting test results Determining which tests to offer for platelet function testing or for managing new anticoagulant therapies, and providing interpretation Developing an algorithm (method and frequency) for HLA antibody testing of transplantation candidates and recipients Deciding the appropriate method(s) and resolution needed for HLA typing in various kinds of patients based on clinical requirements Evaluating the clinical utility of novel parameters available on a new automated CBC/differential platform, in the context of the medical center s patient population Interpreting tests for evaluating the monoclonal gammopathies such as SPEP, immunofixation, and serum free light chains Defining a laboratory algorithm for the evaluation of a positive ANA or for celiac disease Deciding which antimicrobial agents should be tested and reported for a given infectious agent Choosing a laboratory diagnostic algorithm for an infectious disease (eg, syphilis) Developing clinical guidelines for the use of blood components and derivatives (eg, clotting factors, intravenous immunoglobulin, etc) Developing clinical guidelines for therapeutic apheresis procedures Monitoring utilization of blood components and derivatives and addressing misuse ANA, antinuclear antibodies; aptt, activated partial thromboplastin time; CBC, complete blood count; HLA, human leukocyte antigen; PT, prothrombin time; SPEP, serum protein electrophoresis. expertise comprised 60.3% of all administrative activity, and thus the majority of administrative activities performed by laboratory directors could not be performed by personnel with administrative skills only. Some laboratory director administrative activities do not require either medical or technical/scientific expertise, or director level status. These include oversight of some aspects of regulatory compliance, some of the oversight of quality assurance and quality control activities, management of human resources, and budgeting. Together, these activities accounted for 39.7% of administrative activities performed by the directors, or 18.7% of their total effort on average. Therefore, we estimate that up to 18.7% of our laboratory directors activities (2.39 of 12.8 FTE) could potentially be assumed by a professional administrator with expertise in laboratory finance, human resources, and regulatory compliance, but without clinical or technical/scientific expertise. Collectively, direct patient-care activities, including both nonreimbursed and reimbursed duties, require 33.1% of our directors effort. Nonreimbursed clinical activity primarily involves informal clinical consultations requested by physicians from other departments, utilization management and gatekeeper activities, and nonreimbursed provision of direct patient care on the Transfusion Medicine service. Common types of nonreimbursed consultations include providing assistance with choosing tests or interpreting test results, assisting with the appropriate use of blood products, or the management 146 Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO

4 Table 3 Allocation of Clinical Laboratory Directors Effort Collective Full-Time Activity Percentage of Collective Effort Equivalent Administration General administration 16.0 Quality assurance/control 6.5 Regulatory compliance 3.3 Other 3.3 Human resources 2.9 Activities requiring director level status 12.3 Interdepartmental activities 4.9 Departmental committee work 3.1 Directing off-site laboratories 2.4 Hospital committee work 1.5 Hospital network committee work 0.4 Activities requiring scientific or technical expertise 8.7 Activities requiring clinical expertise 7.4 Activities requiring financial expertise 2.7 Patient care Nonreimbursed 16.4 Reimbursed 8.3 Clinical conference preparation 3.3 Attending hospital clinical conferences 3.1 Attending outside clinical conferences 2.0 Research Funded 4.7 Unfunded 4.5 Assisting other investigators 3.7 Trainee education of complex transfusion situations such as massive transfusion, urgent reversal of anticoagulation, or platelet refractoriness. Reimbursed clinical activities accounted for 8.3% of the total effort. Reimbursed clinical activities within the laboratories include serving as attending physician for therapeutic procedures on the Transfusion Medicine service and providing patient-specific interpretation of tests in Special Coagulation, Immunology, Transfusion Medicine, or Hematology (protein and hemoglobin electrophoresis). Of note, review of abnormal peripheral blood smears and bone marrow aspirates is performed by the Anatomic Pathology service in our department. Also, some of our laboratory directors hold dual appointments in Pathology and in the Department of Medicine. Clinical activities performed by these physicians in other departments (and not addressed in this study) include serving as attending physician on the Inpatient Medical service, the Hematology Consultation service, the Infectious Diseases service, or the Allergy-Immunology service. Interdepartmental activities accounted for 4.9% of overall director activity. In addition, the directors reported devoting 1.5% of their effort toward standing hospital committee work, as outlined in Table 4. Table 4 does not include participation in transient (ad hoc) committees that convene for a limited duration of time, nor committees that are entirely within the Department of Pathology. Service on these standing interdepartmental committees requires director status and/or clinical and technical expertise. Beyond formal committee work, the majority of interdepartmental duties involve participation in several key activities requiring director level status and clinical expertise, including: 1. Directing appropriate utilization of laboratory tests and blood components (as described by Kim et al 5 ). 2. Determining the need for, and supporting the implementation of, new clinical services. 3. Participation in interdepartmental clinical and process improvement efforts. 4. Participation in the development of clinical practice guidelines and standardized order templates. Funded and unfunded research projects led by the laboratory directors required 9.2% of their total effort. Funding sources include the National Institutes of Health, private foundations, and industry. An additional 3.7% of the directors time (0.47 FTE) was spent assisting outside research investigators, as clinical and translational researchers from other departments and institutions frequently require the support of laboratory scientists. Finally, 6.9% of laboratory director effort was devoted to training medical students, residents, and fellows. Included in this activity are training program administration, direct teaching activities such as delivering lectures or leading teaching discussions, and supervising trainees on their various laboratory medicine rotations. Clinical sign-out with trainees is also a teaching activity, but this was tallied under clinical activities in this study. Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO 147

5 Branda et al / The Practice of Clinical Pathology Table 4 Participation by Clinical Laboratory Directors on Standing Hospital and Hospital System Committees Committee leadership Cochair, Emergency Department Laboratory Task Force Chair, Clinical Laboratory Advisory Committee Chair, Transfusion Committee Cochair, High Performance Medicine Team: Improving the Reporting of Clinically Significant Results Chair, Advanced Clinical Training Committee Director, Clinical Research Education Unit Director, Advanced Curriculum in Clinical Investigation Committee membership Quality Oversight Committee Quality and Patient Safety Committee Infection Control Committee Cardiac Surgery Care Redesign Committee Orthotopic Liver Transplant Care Redesign Committee Argatroban Utilization Committee Committee on Dabigatran Utilization Transplant Center Operations Committee Office for Women s Careers Committee Transport Systems Committee Infection Control Committee Infectious Disease, Pharmacy, and Microbiology Antibiotic Review Committee Biothreats Preparedness Committee Biorepository Executive Committee Antimicrobial Approval Committee Biorepository Task Force, Executive Council of Research Information Technology Committee, Center for Personalized Genetic Medicine Ambulatory Laboratory Committee Antithrombotic Medications Stewardship Committee Provider Order Entry Steering Committee Discussion In this article we describe the professional activities of clinical laboratory directors at a large academic medical center. Directors reported working an average of 54.9 hours per week and were responsible for at least some laboratoryrelated activities 47.7 weeks per year. This represents an important distinction from other medical specialties (including Anatomic Pathology), in which academic physicians are either on- or off-service a certain number of weeks per year. Although some of the laboratory directors clinical activities, such as directing interpretive services or providing direct patient care on the blood transfusion service, can be managed by rotation among the directors, the majority occur more or less continuously throughout the year, irrespective of the service assignments. This reflects the basic nature of clinical laboratory directorship, which requires a continuous commitment throughout the year and is not amenable to a clear distinction between on- and off-service. Among the various activities reported by the laboratory directors, administrative functions accounted for the greatest time allocation proportionately (47.1% of the overall collective effort). However, when administrative activities were substratified to distinguish those that could be performed only by an individual with director level status or doctorate level clinical or scientific expertise from those that could reasonably be performed by a professional manager without these qualifications, only a minority fell into the latter category (up to 39.7% of the administrative effort; up to 18.7% of total effort). This finding will not be surprising to those in our field, but provides a quantitative rebuttal to those outside clinical pathology who tend to conflate laboratory administration at the director level with management activities more familiar to them, such as human resources management or budgeting. Although these more generic management tasks are part of the laboratory director s role, we found that they amounted to 18.7% of total effort at most. Furthermore, laboratory director expertise is valuable even for such administrative tasks for example, to ensure that quality assurance oversight is clinically relevant, or to ensure that a business plan optimizes the test menu to provide medically important tests and discontinue outdated methods. To the extent that such administrative tasks involve interfacing with clinicians, laboratory director status can be invaluable in bridging the gap between the laboratory technologists and the providers. For example, clinicians frequently contact representatives of the laboratory to request an explanation or voice displeasure when limits are placed on test utilization. A technologist, even one in a managerial role, may not fully understand the rationale for the utilization strategy, and may also receive incentives to refuse requests for exceptions, as these generate more work leading to suboptimal guidance and service. In contrast, a director level expert can best communicate the evidence behind the utilization strategy, and will understand when legitimate grounds for exceptions exist. In fact, we documented that the efforts of a clinical pathologist working in an academic medical center are wellbalanced among administrative (47.1%), clinical (33.1%), and academic activities such as research and teaching (19.8%). The clinical activities performed by our laboratory directors were quite diverse, including serving as attending physician on medical services, oversight of patient procedures in the blood transfusion service, providing formal and informal consultations or interpretive services, participating in hospital conferences related to individual patient management, and joining key departmental or interdepartmental committees. The majority of these activities (75% based on effort) are not directly reimbursed, and thus can be undervalued at the departmental or hospital level, because their value is less tangible. This report provides numerical evidence of the effort devoted by laboratory directors (4.24 of 12.8 FTE at our institution) in direct support of patient-care activities in the hospital. A few potential limitations to our study require discussion. First, our directors are fully funded by the hospital, and consequently the component reported for funded research may be substantially less compared with institutions that require their faculty to fund a portion of their salary through grants. Secondly, our institution is an academic medical center 148 Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO

6 that requires the faculty to engage in duties such as teaching, research, and other scholarly activities not related directly to oversight of the laboratory. The effort devoted to these activities may be much less for laboratory directors in nonacademic setting. Finally, some of our data were derived from electronic calendars and other personal records. This approach has inherent inaccuracies and therefore our numbers represent general estimates. In conclusion, we have reported on the professional activities of clinical laboratory directors at a large academic medical center. To our knowledge, this is the first study in which the time allocation for different laboratory director activities has been reported. Our results demonstrate that directing a large hospital laboratory represents a full-time commitment, and that the director must be on service continuously throughout the year. While a minimal fraction (up to 18.7%) of the activities performed by our directors could theoretically be assumed by a professional manager, the large majority of activities require either clinical expertise or scientific/technical training. The academic premium for participation in research, teaching, or other academic activities represents approximately 19.8% of director effort. Our results are not reflective of the laboratory director s role in smaller, nonacademic community hospitals, where the laboratory director must always be available but spends the majority of his/her time on surgical pathology. Address reprint requests to Dr Kent Lewandrowski: Massachusetts General Hospital, Gray 5 Chemistry, 55 Fruit St, Boston, MA 02114; klewandrowski@partners.org. References 1. Laposata M. What we are doing or should be doing in clinical pathology. Am J Clin Pathol. 1996;106: Laposata M. Education by the experts: what many of us are doing or should be doing in clinical pathology. College of American Pathologists webinar Available at: vmc_011105_projection.pdf. Accessed May 21, Wiess R, Mckenna B, Lord-Toof M, et al. A consensus curriculum for laboratory management training for pathology residents. Am J Clin Pathol. 2011;136: Winkelman J, Brugnara C. Management training for pathology residents. Am J Clin Pathol. 1994;101: Kim J, Dzik W, Dighe A, et al. Utilization management in a large urban academic medical center: a 10 year experience. Am J Clin Pathol. 2011;135: Am J Clin Pathol 2014;142: DOI: /AJCP3NU7AOPPKYWO 149