Table of Contents
Laboratory directors | Operational responsibilities | Proficiency testing | Personnel | General responsibilities | Delegation | Tips | Joint Commission compliance tools | Additional referencesCite this page: Olea S. Laboratory director. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/managementlabdirectgeneral.html. Accessed April 19th, 2024.
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
- Technical consultant must meet one of these requirements:
- 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
- General supervisor must meet one of these requirements:
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
- Standards Online Question Form, Standards Interpretation Group at 630-792-5900, 8:30 a.m. - 5:00 p.m. Central Time