Laboratory Administration & Management of Pathology Practices
Lab director
Lab Director


Topic Completed: 1 October 2013

Minor changes: 30 June 2020

Copyright: 2002-2019, PathologyOutlines.com, Inc.

PubMed Search: laboratory director[title]

Stacy Olea, M.B.A.
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Cite this page: Olea S. Lab Director. PathologyOutlines.com website. http://www.pathologyoutlines.com/topic/managementlabdirectgeneral.html. Accessed July 10th, 2020.
Laboratory directors
  • Responsible for:
    • The overall operation and administration of the laboratory
    • Employment of personnel who are competent to perform test procedures
    • Recording and reporting test results promptly, accurately, and proficiently
    • Assuming compliance with the regulations
  • Moderate complexity
    • Technical consultant must meet one of these requirements:
      • MD, DO with current medical license in state of lab’s location AND certified in anatomic and/or clinical pathology by ABP or AOBP or equivalent qualifications
      • MD, DO, or DPM with current medical license in state of lab’s location AND 1 year laboratory training/experience in the designated specialty/subspecialty or responsibility
      • PhD in chemical, physical, biological or clinical laboratory science or medical technology AND 1 year laboratory training/experience in the designated specialty/subspecialty of responsibility
      • Masters in chemical, physical, biological or clinical laboratory science or medical technology AND 1 year laboratory training/experience in the designated specialty/subspecialty of responsibility
      • Bachelors in chemical physical, biological or clinical laboratory science or medical technology AND 2 years laboratory training/experience in the designated specialty/subspecialty of responsibility
    • Clinical consultant must meet one of these requirements:
      • MD, DO with current medical license in state of lab’s location AND certified in anatomic and/or clinical pathology by ABP or AOBP or equivalent qualifications
      • MD, DO, DPM with current medical license in state of lab’s location AND laboratory training/experience consisting of (only one):
        • 1 year directing or supervising non-waived tests
        • 20 CME credit hours in laboratory practice commensurate with director responsibilities (effective 08/02/1993)
        • Equivalent laboratory training (20 CMEs) obtained during medical residency
      • PhD in chemical, physical, biological or clinical laboratory science AND certification by ABMM, ABCC, ABB, ABMLI
      • MD, DO, DPM with current medical license in state of lab’s location
  • High complexity
    • General supervisor must meet one of these requirements:
      • Qualify as laboratory director of high complexity testing
      • Qualify as technical supervisor of high complexity testing
      • MD, DO, DPM with current medical license in state of lab’s location AND 1 year training in high complexity testing
      • PhD in clinical laboratory science or chemical, physical, biological science AND 1 year training/experience in high complexity testing
      • Masters in clinical laboratory science, medical technology, or chemical, physical, biological science AND 1 year training/experience in high complexity testing
      • Bachelors in medical technology or chemical, physical, biological science AND 1 year training/experience in high complexity testing
      • Associate Degree in laboratory science or medical laboratory technology AND have at least 2 years of laboratory training or experience, or both, in high complexity testing
      • Education and training equivalent to an associate degree in laboratory science or medical laboratory technology AND have at least 2 years laboratory training or experience, or both, in high complexity testing
      • Education
        • 60 semester hours including either 24 semester hours of medical laboratory courses or 24 semester hours of science courses (6 hours chemistry; 6 hours biology)
        • 12 hours in chemistry, biology, or medical laboratory technology, or any combination
      • Training
        • Either completion of an approved/accredited clinical laboratory or medical laboratory training program
        • May be included in the 60 semester hours specified above or three months of documented laboratory training in each specialty in which the individual performs high complexity testing
      • For blood gas analysis, earned an associate degree related to pulmonary function AND have at least 2 years of laboratory training or experience, or both, in blood gas analysis
    • Technical supervisor must meet one of these requirements:
      • MD, DO with current medical license in state of lab’s location AND certified in anatomic and/or clinical pathology by ABP, AOBP, or equivalent qualifications
      • MD, DO, DPM with current medical license in state of lab’s location AND certified in clinical pathology by ABP, AOBP, or equivalent
      • MD, DO, DPM with current medical license in state of lab’s location AND 1 year training/experience in high complexity testing in the respective specialty
      • PhD in clinical laboratory science, chemical, physical, biological science AND 1 year training/experience in high complexity testing in the respective specialty
      • Masters in medical technology, clinical laboratory science, chemical, physical, or biological science AND 2 years training/experience in high complexity testing in the respective specialty
      • Bachelors in medical technology, chemical, physical, or biological science AND 4 years training/experience in high complexity testing in the respective specialty
    • Clinical consultant must meet one of these requirements:
      • MD, DO with current medical license in state of lab’s location AND certified in anatomic and/or clinical pathology by ABP or AOBP or equivalent qualifications
      • MD, DO, or DPM with current medical license in state of lab’s location AND 1 year laboratory training during medical residency
      • MD, DO, DPM with current medical license in state of lab’s location AND 2 years experience in directing/supervising high complexity testing
      • PhD in chemical, physical, biological or clinical laboratory science AND certification by ABMM, ABCC, ABB, ABMLI, or other board deemed comparable by HHS
      • MD, DO, DPM with current medical license in state of lab’s location
Operational responsibilities
  • Testing systems provide quality laboratory services, both existing and new
  • Physical plant and environment conditions are appropriate size, contain required components and are safe
  • Test methodologies provide the quality of results required for patient care
  • Verification procedures are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method
  • QC and Quality Assurance programs are established, documented and maintained
  • Establish and maintain acceptable levels of analytic performance for each test
  • All remedial actions are taken and documented
  • Test reports include pertinent information required for interpretation
  • Consultation is available
  • Current, approved procedure manual is available
  • Specify in writing the responsibilities of each consultant, supervisor, and person engaged in the performance of the pre-analytic, analytic, and post analytic phases of testing
    • Identifies which procedures they are authorized to perform, including competency assessment
    • Whether supervision is required for processing, test performance, or result reporting
    • Whether consultant, supervisor, or director review is required prior to reporting patient test results
  • General Supervisor provides on-site supervision of high complexity test performance by qualified testing personnel as required by CLIA
Proficiency testing
  • Enrolled in a CLIA approved PT program for all regulated analytes
  • PT samples are tested as required under CLIA regulations Part 493, subpart H
  • Results are returned within the timeframe established by the PT provider
  • Reports are reviewed by appropriate staff to evaluate performance and to identify any problems that require corrective action
  • The approved corrective action plan is followed when results are unacceptable or unsatisfactory
    • Includes educational challenges and ungraded results
Personnel
  • Perform test methods as required for accurate and reliable results
  • Provides a sufficient number of lab personnel with appropriate education and experience or training
  • Prior to testing patient specimens, all personnel have the following:
    • Education and experience
    • Appropriate training
    • Demonstrated proficiency of all testing operations
  • Test methods performed as required for accurate and reliable results
General responsibilities
  • If qualifications are met per regulations, the same person can be the Technical Supervisor, General Supervisor, Technical Consultant, Clinical Consultant, and Testing Personnel
    • No limit to number of roles
    • Recommended to designate qualified personnel in above categories regardless of title to ensure redundancy
  • Must be accessible to the lab to provide onsite, telephone, or electronic consultation as needed or required
  • If the testing is being performed under your CLIA certificate, then you are responsible (includes POCT, Blood Gases)
  • May direct no more than 5 labs per regulations
Delegation
  • The Laboratory Director still remains responsible for ensuring all duties are properly performed even when delegated
  • Duties must be delegated to qualified individuals:
    • Technical Consultant
    • Technical or General Supervisor
    • Clinical Consultant
  • These can also be delegated:
    • New Hires - Completed orientation and have demonstrated competency
    • Assessing competency of existing employees
    • Review of PT report
    • Quality Control review and Quality Assurance Programs
    • Process Improvement
    • Method Validations
    • Correlations
    • Calibration Verification
    • Once every two year policy and procedure review
  • CANNOT delegate approval of new and revised procedures
Tips
  • Document delegation in writing
  • Complete a laboratory-wide organization chart and show qualified roles on chart
  • Use the resources provided by your accrediting organization to document personnel
Joint Commission compliance tools
  • Leading Practice Library
    • Procedures shared by other laboratories and hospitals
  • Standards FAQS on website
  • Online Question options for Standards (see below)
  • Lab Central Connect™
    • Portal for test menu, personnel, and other compliance information
Additional references
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