Am Fam Physician. 2001;63(1):165-168
This document has been endorsed by the American Academy of Family Physicians and was developed in cooperation with the Association of Departments of Family Medicine, the Association of Family Practice Residency Directors and the Society of Teachers of Family Medicine.
Laboratory testing in the physician's office improves efficiency and quality of patient care because test results can be available at the time the patient is seen. Laboratory technology has produced systems that are reliable, simple to use and inexpensive.
Residents should obtain the knowledge and skills required to maintain a high-quality laboratory for their patients. In addition, residents should be able to qualify to direct a laboratory in compliance with federal and state regulations.
An understanding of federal regulations such as Clinical Laboratory Improvement Amendment (CLIA-88), the role of the laboratory director and the elements of quality assurance and quality control are essential. In addition, residents should learn about the requirements of the physical plant, equipment, laboratory needs, written policies and procedures, including an understanding of the role of the Commission on Office Laboratory Accreditation (COLA), Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and Occupational Safety and Health Administration (OSHA) safety requirements.
Residents should also be able to evaluate the feasibility of performing tests, considering laboratory space, office staff and financial implications. Test volumes, equipment and reagent costs, technician time, cost of quality control, testing liability and charge to the patient should also be considered.
Knowledge
CLIA-88
Categories of testing complexity
Certification requirements and application process
Types of certification
Application process
Application and inspection fees
Requested information
Name of tests
Methodology
Volume of tests h. Qualification of personnel
Laboratory agreements
Inspection
Record availability
Proficiency testing requirement
Notification of changes
Federal and state inspections
Fees
Entrance interview
Assessment of facilities
Selection of representative samples
Criteria used
An expanded sample
Legal implications for noncompliance with CLIA standards
Accreditation options
COLA
JCAHO
College of American Pathologists
Testing systems and equipment
Selecting a reference laboratory: service, quality, price
Instrument maintenance/function:
Calibration
Instrument documentation
Log of equipment
Instrument troubleshooting
CLIA requirements for maintenance performance
Selecting qualitative test kits
Factors to consider in test kit instrument selection
Ease of performance/CLIA test complexity
Cost per billable test
Space for testing and storage
Accuracy, sensitivity and specificity
CLIA requirement for initiating a new test
Precaution before using test kits
Evaluation of sample kits: group A beta streptococcus kits, Chlamydia, urine, chorionic gonadotropin
Starting a new test
Method selection
Method verification
Traditional laboratory terms
Sensitivity
Specificity
Precision
Accuracy
Bias
Specimen collection and integrity
Specimen collection
Blood
Microbiology
Urine
Specimen processing
Specimen storage
Problems related to specimens
Improper labeling
Insufficient quantity
Improper collection
Deterioration
Specimen tracking
CLIA assessment of specimen integrity
Collection
Assessment of skills of testing and surveying personnel
Assessment of equipment and supplies
Laboratory personnel
Laboratory director
Qualifications of laboratory director
Responsibilities
Overall operation and administration
Job descriptions
Choosing competent personnel
Supervisor
Testing supervision
Evaluation of personnel performance
Need for continuing education
Maintaining personnel file
Minimum personnel requirements
Testing personnel and requirements for certification
Medical technologists, bachelor of science degree, experience
Medical laboratory technician, two years of college, experience
Medical assistant, high school, experience and/or training
Typical tasks of personnel
Average salaries of medical technologists and medical laboratory technicians
Regional salaries
National salaries
Consultants
Quality assurance and quality control program
Components
Procedure manual
Policies and standards
Specimen collection and handling
Specimen tracking
Calibration
Quality control
Qualitative testing (i.e., pregnancy test)
Semiquantitative testing (i.e., urine dipstick)
Quantitative testing (i.e., creatinine)
Record keeping
Proficiency testing and results
Safety requirements
OSHA
Blood-borne pathogens
Hazardous materials
Inspections
Problem log
Proficiency testing
Definition and terminology
Enrollment
Selecting a proficiency testing program
Processing and handling patient samples
Interpretation of results
Acceptable performance
Unacceptable performance
Documentation
Maintenance of records
Review by director
Written policies and procedures
Procedure manual
Standard format
Name of test
Specimen collecting, handling and rejection
Materials
Procedures (step-by-step)
Interpretation
Quality control
Calibration procedure
Limitations of procedure, interfering substances
Reference range, panic values
References
Signed and dated by director, then reviewed annually
Ways to resolve problems in testing process
Documentation
Record retention
Physical plant and laboratory safety management
Laboratory design
Space requirements
Administrator
Equipment fee
Electric design
Lighting
Plumbing
Fire safety
Waste storage
Blood-borne pathogen regulations
Exposure
Universal precautions
Hepatitis B vaccination
Postexposure evaluation and follow-up
Communication of hazards to employees
Warning signs
Occupational exposure to hazardous chemicals in the laboratory
Permissible exposure limits (PEL)
Exposure and monitoring
Hazard identification
Skills
Use and care of the microscope
Urinalysis
Chemical reactions
Microscopic
Crystals
Red blood cells
White blood cells
Epithelial casts
Quality control
Specific gravity, pH
Complete blood count
Manual white blood cell count/red blood cell count
Hemoglobin
Peripheral smear
Manual differentiation
Morphology
Platelet estimate
Automated procedures not requiring operator interaction
Spun microhematocrit
Chlamydia testing
Gram stain test
Staining procedure
Gram-negative
Gram-positive
Morphology
Cocci vs. rods vs. coccobacilli
Diplococci, tetrads, etc.
Vaginal smears
Potassium hydroxide and wet mount
Clue cells
Yeast
Trichomonas vaginalis
White blood cells and bacteria
Pinworm preparation
Skin scrapings
Yeast
Fungal elements
Mites
Immunochemical assays
Rapid streptococcus test
Methodology
Procedure
Quality control
Mononucleosis test
Urine/serum pregnancy test
Other
Influenza tests
Chlamydia
Sedimentation rate
Fecal occult blood
Cultures
Gonorrhea screens
Plating
Incubator protocol
Interpretation
Throat
Urine
Colony counts
Susceptibility testing
Chemistry analyzer tests
Methodology
Procedure
Quality control
Calibration
Maintenance
Implementation
The minimal educational experience required by CLIA is 20 hours of didactic and laboratory workshops. It is suggested that the experience be divided into approximately 15 hours of didactic training and at least five hours of laboratory skills. The 15 hours of didactic time could meet the CLIA certification for laboratory director if the following times are allocated:
Regulations: 1 hour
Physical plant: 1 hour
Testing systems and equipment: 3 hours
Quality assurance: 3 hours
Quality control: 3 hours
Laboratory personnel: 2 hours
Written policies, procedures and individual performance responsibilities: 2 hours
The guidelines can be accomplished on a longitudinal basis or through an in-depth, intense experience utilizing family practice and laboratory educators.