High Complexity Laboratories

(Specific qualifications are required for each specialty or subspecialty.)

For Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or Immunohematology:

1. Licensed MD/DO, certified by the American Board of Pathology or the American Osteopathic Board of Pathology
2. Licensed MD/DO/DPM AND 1 year laboratory training or experience, or both in high complexity testing for the applicable specialty
3. Have a Doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology AND 1 year laboratory training or experience, or both, in high complexity testing within the applicable specialty
4. Have a Master’s degree in a chemical, biological, clinical or medical laboratory science or medical technology AND 2 years laboratory training or experience, or both, in high complexity testing within the applicable specialty
5. Have a Bachelor’s degree in a chemical, biological, clinical or medical laboratory science or medical technology AND 4 years laboratory training or experience, or both, in high complexity testing within the applicable specialty

For Bacteriology, Mycobacteriology, Mycology, Parasitology, or Virology:

1. Licensed MD/DO, certified by the American Board of Pathology or the American Osteopathic Board or Pathology
2. Licensed MD/DO/DPM AND have 1 year laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty
3. Have earned a Doctoral degree in chemical, biological, clinical, or medical laboratory science, or medical technology AND 1 year of training of experience or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the applicable microbiology subspecialty
4. Have earned a Master’s degree in a chemical, biological, clinical, medical laboratory science, or medical technology AND have 2 years of training or experience or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the applicable subspecialty
5. Have earned a Bachelor’s degree in a chemical, biological, clinical, medical laboratory science, or medical technology AND have 4 years of training or experience or both in high complexity testing with the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the applicable subspecialty

Requirements

1. Must be available to provide needed consultation either on-site, by telephone, or electronically
2. Selects test methodology appropriate for the clinical use of the test menu
3. Verifies procedures for testing performed and establishes the laboratory’s performance criteria, including accuracy and precision of each test and test system
4. Enrolls the laboratory in an approved PT program commensurate with services offered
5. Establishes a quality control program appropriate for the testing performed, establishes the acceptable levels of analytic performance, and ensures these levels are maintained throughout the testing process
6. Resolves technical problems and ensures corrective actions are taken when- ever test systems deviate from  the laboratory’s established performance specifications
7. Ensures patient test results are not reported until all corrective action has been taken and the test system is functioning properly
8. Identifies training needs and ensures testing personnel receive regular in-service training
9. Evaluates the competency of all testing personnel on an ongoing basis
10. Evaluates and documents Testing Personnel’s performance at six months and twelve months during the first year of employment and yearly thereafter. Performance is reevaluated (prior to reporting patient test results) if test methodology or instrumentation changes. The evaluation must include the use of the new test methodology or instrumentation