Managing Laboratories in Critical Access Hospitals and Underserved Communities

A cost-saving and quality improvement essential

I. Laboratory Director Responsibilities

Key Points

• The Laboratory Director must not only ensure the responsibilities of the Technical and General Supervisors are fulfilled, but also the responsibilities of a Clinical Consultant and Testing Personnel.

• If training of technical personnel is included as one of the duties in any of the supporting positions, then that position takes the role of a Technical Supervisor and requires at least a bachelor of science degree.

• The majority of the duties of the Laboratory Director are performed by the Laboratory Manager or Laboratory Technologists.

Identifying the person who actually provides oversight and direction in a clinical laboratory is elusive. The federal government through Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulates this role to be the sole responsibility of the Laboratory Director. For a laboratory performing high complexity testing, this role can only be held by a person who has a doctor of medicine, doctor of osteopathy or a doctorate degree in a chemical, physical, biological or clinical laboratory science. However, the Laboratory Director may delegate some of their duties to the Technical Supervisor and General Supervisor. These roles are also strictly regulated in which specific qualifications must be met according to 42 CFR Part 493 Subpart M. The role of Laboratory Director is often split into multiple positions. Titles of positions that support the role of Laboratory Director include Medical Director, Clinical Pathologist, Assistant Laboratory Director, Administrative Laboratory Director, Laboratory Manager, Laboratory Supervisor, Chief Laboratory Coordinator, Quality Assurance Specialist, Lead Technologist. Though the responsibility still remains with the CLIA-approved Laboratory Director, the duties of the Laboratory Director shift heavily towards these supporting positions that are non-doctorate degree holders as the number of beds in the hospital or test volume increases. Significant cost savings and quality improvements can be made by enhancing the technical and managerial skills of these supporting positions.

Significant cost savings and quality improvements can be made by enhancing the technical and managerial skills of Laboratory Director supporting positions. 

There are certain duties of the Laboratory Director in a high complexity laboratory that need to be performed an individual who comprehends advanced scientific methods or a physician. 42 CFR 493.1445 (e) specifies 15 responsibilities that a Laboratory Director must fulfill. 12 of these responsibilities can be reasonably delegated to the Technical Supervisor. The Technical Supervisor must have at least a bachelor of science degree to oversee instrument validation, establishing a quality control program, and evaluating competency of technical staff. The remaining 3 responsibilities may be reasonably delegated to the General Supervisor. The General Supervisor must have at least an associate of science degree to ensure a safe environment, ensure consultation is available to laboratory clients and ensure approved procedure manual is available to all personnel. 42 CFR 493.1451 and 1463 further specifies the responsibilities of a Technical Supervisor and General Supervisor, respectively.

Moreso, the Laboratory Director must not only ensure the responsibilities of the Technical and General Supervisors are fulfilled, but also the responsibilities of a Clinical Consultant and Testing Personnel. The Clinical Consultant must have a doctor of medicine, doctor of osteopathy or a doctorate of science degree to provide consultation to the laboratory’s clients, assist in ensuring appropriate tests are ordered to meet the clinical expectations and ensure reports of test results include pertinent information required for specific patient interpretation (42 CFR 493.1457). Testing personnel must have at least an associate of science degree to perform high complexity testing such as blood typing, manual differential and interpreting gram stain slides.

If training of technical personnel is included as one of the duties in any of these positions, then the minimum qualification is a bachelor of science degree.

In a hospital setting, the Laboratory Director responsible for the high complexity lab is designated to the Medical Director or Pathologist, but most if not all the duties are delegated to the Assistant Laboratory Director or Laboratory Manager. These positions may have Specialists, Lead Scientists and Laboratory Technologist or Technicians reporting to them. The number of personnel must meet CLIA’s minimum requirement of testing personnel which depends on test volume and hours of operation. If training of technical personnel is included as one of the duties in any of these positions, then the minimum qualification is a bachelor of science degree. A certification as a Medical Laboratory Scientist (MLS) through an accreditation agency such as American Society of Clinical Pathology (ASCP) or American Medical Technologist (AMT) is often required by the hospital, but this is not a requirement by CLIA. Thus, the majority of the technical duties of the Laboratory Director are performed by the Laboratory Manager or Laboratory Technologists.