LABORATORY: Russell County Hospital
DEPARTMENT: ALL
POLICY SUBJECT:
EFFECTIVE DATE: 5/1/06
Medical Director Responsibilities
Page 1 of 2
Written by: Lisa Johnson & Dr Lozano
Date issued:
Laboratory Director:
Date
Initials
Reviewed
Revised
Reviewed
Revised
Reviewed
Revised
Date
Reviewed
Revised
Reviewed
Revised
Reviewed
Revised
Initials
Date
Initials
Reviewed
Revised
Reviewed
Revised
Reviewed
Revised
SCOPE:
This policy applies to Russell County Hospital Laboratory
PURPOSE:
The Clinical Laboratory Improvement Act (CLIA) is very specific and defines the
qualifications of the laboratory medical director and assigns numerous
responsibilities to medical directors of moderate and high-complexity labs. CLIA
holds the director responsible for the “overall operation and administration of the
lab” and lists areas of responsibility included within that operation and
administration. The laboratory medical director must be accessible to the
laboratory to provide onsite, telephone or electronic consultation as needed.
PROCEDURE: Pathology and Cytology Laboratories, Inc. of Lexington, Kentucky, provide
Pathology, clinical laboratory services and consultation under contract.
Dr. Richard Lozano serves as Medical Director. Dr Lozano is available 24
hours per day, 7 days per week on an as needed Basis.
If Dr. Lozano is not available, another pathologist from Pathology
and Cytology Laboratories is assigned. The Medical Director’s involvement
in and oversight of operations will be documented Monthly.
QUALIFICATIONS:
DUTIES:
The laboratory medical director must meet the qualifications defined in
the standards issued by the Center for Medicare and Medicaid Services
(CMS). (See attached regulations).
The duties of the Laboratory Medical Director are listed below and may be
delegated to qualified individuals with oversight by the laboratory medical
director. The laboratory medical director is responsible for and will ensure that:
 There is effective communication of laboratory data
 He/She is directly involved in the selection of all laboratory equipment
and supplies
 Anatomic pathology procedures are appropriate
 The lab’s testing systems provide quality lab services and testing
methods used in the lab provide quality test results
 The lab uses verification procedures that adequately measure the
accuracy of its testing methods.
 He/She is actively involved in the design, implementation, and
oversight of the quality management system





















Staff perform tests as required to yield accurate and reliable results.
The lab is enrolled in a Department of Health and Human Services –
approved proficiency testing program and proficiency testing is
properly performed.
Proficiency testing reports are appropriately reviewed and necessary
corrective action is identified and implemented.
The lab has quality control and quality assessment programs.
Acceptable performance levels for each test system are established.
The lab takes and documents remedial action when performance
specifications go unmet.
The lab reports patient results only when systems work properly.
Test reports include all required information
The lab provides consultation to clients on test quality, medical
significance of laboratory data, and other test-related issues.
The lab employs sufficient numbers of qualified and competent
personnel with the experience needed to perform tests offered by
the lab.
Staff receives appropriate training for testing services offered.
Staff can demonstrate competency to perform tests offered and
report accurate results.
The lab establishes monitoring policies and procedures to ensure
that testing staff are competent and identify training needs.
A lab procedure manual is accessible to all staff. All new
procedures and changes in procedures are approved, signed, and
dated by the Medical Director.
The lab details the responsibilities of all staff, including consultants
and supervisors, in writing, including the activities each staff
member is authorized to perform and whether a review if required
before test results can be reported.
Directs the blood transfusion service.
Recommends reference laboratory services to the clinical staff.
Establishes an effective working relationship with the clinical staff,
the organization’s administration, and other departments/services.
Has an active role in the in-service educational programs.
Must ensure compliance with OSHA and state/local regulations, as
well as other applicable safety regulations and ensure that the lab is
a safe environment in which to work
Will review the lab’s organizational chart to ensure that He/She has
the authority to do the job of Medical Director.
2