Am Fam Physician. 2001 Jan 1;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.
Categories of testing complexity
Certification requirements and application process
Types of certification
Application and inspection fees
Name of tests
Volume of tests h. Qualification of personnel
Proficiency testing requirement
Notification of changes
Federal and state inspections
Assessment of facilities
Selection of representative samples
An expanded sample
Legal implications for noncompliance with CLIA standards
College of American Pathologists
Testing systems and equipment
Selecting a reference laboratory: service, quality, price
Log of equipment
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
Traditional laboratory terms
Specimen collection and integrity
Problems related to specimens
CLIA assessment of specimen integrity
Assessment of skills of testing and surveying personnel
Assessment of equipment and supplies
Qualifications of laboratory director
Overall operation and administration
Choosing competent personnel
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
Quality assurance and quality control program
Policies and standards
Specimen collection and handling
Qualitative testing (i.e., pregnancy test)
Semiquantitative testing (i.e., urine dipstick)
Quantitative testing (i.e., creatinine)
Proficiency testing and results
Definition and terminology
Selecting a proficiency testing program
Processing and handling patient samples
Interpretation of results
Maintenance of records
Review by director
Written policies and procedures
Name of test
Specimen collecting, handling and rejection
Limitations of procedure, interfering substances
Reference range, panic values
Signed and dated by director, then reviewed annually
Ways to resolve problems in testing process
Physical plant and laboratory safety management
Blood-borne pathogen regulations
Hepatitis B vaccination
Postexposure evaluation and follow-up
Communication of hazards to employees
Occupational exposure to hazardous chemicals in the laboratory
Permissible exposure limits (PEL)
Exposure and monitoring
Use and care of the microscope
Red blood cells
White blood cells
Specific gravity, pH
Complete blood count
Manual white blood cell count/red blood cell count
Automated procedures not requiring operator interaction
Gram stain test
Cocci vs. rods vs. coccobacilli
Diplococci, tetrads, etc.
Potassium hydroxide and wet mount
White blood cells and bacteria
Rapid streptococcus test
Urine/serum pregnancy test
Fecal occult blood
Chemistry analyzer tests
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.
Stepp CA, Woods MA. Laboratory procedures for medical office personnel. Philadelphia: Saunders, 1998.
Davis BG, Mass D, Bishop ML. Principles of clinical laboratory utilization and consultation. Philadelphia: Saunders, 1999.
Jacobs DS. Laboratory test handbook. Hudson: Lexi-Comp, 1996.
COLA. A voluntary education and accreditation program for physicians' office laboratories. 9881 Broken Land Parkway, Columbia, MD 21046. E-mail: info@COLA.org; Web site: http://www.cola.org/.
Centers for Disease Control and Prevention. Regulations for implementing Clinical Laboratory Improvement Amendments of 1988: a summary. JAMA. 1992;267:1725–7,1731–4.
AAFP-PT site for POLs, retrieved September, 2000 from: http://www.aafp.org/pt/.
CLIA-related publications from the Federal Register and Code of Federal Regulations, retrieved September, 2000 from: http://www.phppo.cdc.gov/dls/clia/chronol.asp.
Bloodborne pathogens regulations, retrieved September, 2000 from: http://www.osha-slc.gov/SLTC/bloodbornepathogens/index.html.
HCFA's page on the CLIA program, retrieved September, 2000 from: http://www.hcfa.gov/medicaid/clia/cliahome.htm.
Online CME for the POL, retrieved September, 2000 from: http://www.vh.org/Providers/CME/CLIA/CLIAHP.html.
Copyright © 2001 by the American Academy of Family Physicians.
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