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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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  1. Use and care of the microscope

  2. Urinalysis

    Chemical reactions

    Microscopic

    Crystals

    Red blood cells

    White blood cells

    Epithelial casts

    Quality control

    Specific gravity, pH

  3. 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

  4. Chlamydia testing

  5. Gram stain test

    Staining procedure

    Gram-negative

    Gram-positive

    Morphology

    Cocci vs. rods vs. coccobacilli

    Diplococci, tetrads, etc.

  6. Vaginal smears

    Potassium hydroxide and wet mount

    Clue cells

    Yeast

    Trichomonas vaginalis

    White blood cells and bacteria

  7. Pinworm preparation

  8. Skin scrapings

    Yeast

    Fungal elements

    Mites

  9. Immunochemical assays

    Rapid streptococcus test

    Methodology

    Procedure

    Quality control

    Mononucleosis test

    Urine/serum pregnancy test

    Other

    Influenza tests

    Chlamydia

  10. Sedimentation rate

  11. Fecal occult blood

  12. Cultures

    Gonorrhea screens

    Plating

    Incubator protocol

    Interpretation

    Throat

    Urine

    Colony counts

    Susceptibility testing

  13. 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.

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