Clinical Laboratory Divided into two main sections: Clinical Pathology Analysis of body fluids and tissues Anatomical Pathology Concerned with autopsies Cytological examinations from various sources including surgical.

Patient Care Clinical Laboratory Where Located? Hospitals POL Clinics PH departments HMOs Private Referral laboratories

Clinical Laboratory Director Pathologist (physician specially trained in the nature and cause of disease.) Clinical Laboratory Scientist with a doctorate degree.

Laboratory Staffing Trained Professionals Certified Medical Technologists (aka CLS in state of California) Baccalaureate degree Additional formal training National certification exam Continuing education with license renewal.

Laboratory Staffing Certified Medical Laboratory Technician (MLTs) Medical Laboratory Assistants (MLAs) Certified Medical Assistant (CMA) Laboratory Assistant Phlebotomist

MLTs; MLAs; CMAs and phlebotomists Qualifications MLTs; MLAs; CMAs and phlebotomists

Qualifications 1-2 year specialized training program Passed a registry examination CMA =CCBMA Refer to Table 51-1 Textbook

Conditions for Practice Certified Medical Assistants With the authorization of a licensed physician or podiatrist who is physically present in the facility: The following activities may be performed.

May Perform Perform electrocardiograms (ECGs), electroencephalograms (EEGs) and plethysomography test (except full-body). Collect specimens for testing, such as urine, sputum, semen, and stool, by noninvasive techniques. Assist patients in obtaining a specimen for testing.

May Perform Provide information and instructions to the patient, as directed. Collect and record basic information about present and previous tests. Perform simple laboratory and screening tests, but without interpreting testing results.

May Perform After successful completion of specified training, perform venipuncture or skin puncture to withdraw blood. Plethysomography The use of a plethysmograph to record changes in volume of an organ or extremity.

May Not Perform Perform arterial punctures. Administer intravenous medications. Insert urinary catheters. Analyze test results Advise patients about their condition. NOTE: Always check with your state scope of practice regulations.

Patient Care MA must know: Proper patient preparation Procedures for each test to be done Normal range of results of test Instructions for obtaining and labeling specimens to be sent to the reference lab. Maintain good communications among patients, office staff and laboratory.

Laboratory Testing Essential part of medical diagnosis Combined with health history; physical exam. Physician’s use testing to determine appropriate treatment. Help with medication decisions and also to monitor medications.

Testing Process Only health care practitioners can request laboratory tests. MD PA (Physician’s Assistant) CNP (Certified Nurse Practitioner) Laboratory tests are ordered using a Laboratory Requisition.

Requisition

Divisions of Clinical Laboratory Urinanalysis Hematology Chemistry Immuno-hematology / Serology Microbiology

Laboratory Testing Tests can be simple: Screening tests: Measures presence of a substance that may indicate the presence of disease state. Are not diagnostic for any particular disease only that it may exist. Tests are usually “Qualitative” Qualitative tests have no numeric value as their results….They are either positive or negative. An example of a qualitative test. Guaic test for occult blood in a stool specimen

Laboratory Testing Tests can be quantitative Units of measure are attached to numeric values. Represents the amount of “analyte” per given volume of “specimen”. Essential that the results be reported with the units of measure. Example: RBC = 5.0 x 106/mm3 or HgB =15gm/dl

Patient Care Lab Testing Used in conjunction with a thorough health history. Physical Examination Healthy body is when equilibrium exists in internal environment. State of equilibrium = homeostasis

Homeostasis Definition: Internal adaptions and change in response to environmental factors, multiple functions that attempt to keep the body’s function in balance…….Staying the same. Physical and chemical characteristics of body substances (fluids, excretions and secretions) are within a certain acceptable range…..Normal

Laboratory results Normal or Reference range……homeostasis Change in homeostasis = Abnormal or outside reference range either high or low. Panic value are results extremely too high or too low. A level that demands quick medical intervention to reverse.

Laboratory Results Abnormal test results may have more than one pathological reason. Example: Low HgB can be present in iron deficiency anemia, hyperthyroidism or cirrhosis of the liver. Conclusive diagnosis cannot be totally dependent on laboratory testing.

Laboratory Regulations Clinical Laboratory Improvement Act Congress passed law in 1988 Established quality standards for all laboratory testing Purpose to ensure the accuracy, reliability and timeliness of patient testing. Laboratory defined :any and all entities that perform laboratory testing on specimens derived from humans for the purpose of providing information about the diagnosis, prevention and treatment of disease or impairment of or assessment of health.

CLIA User funded: fees are levied according to the testing done and the number of tests performed by the user per year. All facilities that perform even 1 test even waived tests must meet certain federal requirements and must register as a laboratory.

CLIA CLIA categorization of commercially marketed “in-vitro” (outside of human body) diagnostic tests is the responsibility of the Food and Drug Administration (FDA). Three CLIA categories exist based on their potential risk to public health.

CLIA Categories Waived Tests: Procedures approved by FDA for home use. Simple laboratory procedures that have an insignificant risk of an erroneous result. Including those that are so simple and accurate that erroneous results are virtually not possible. Proposes no risk or harm to patient if performed incorrectly.

CLIA Categories Moderate –High Complexity Tests Must meet CLIA regulations and be subject to unannounced inspections every 2 years. Establish a system to maintain the integrity and identification of patient specimens throughout the testing process. (barcoding) Ensure accurate reporting of test results. Must have written Quality Control and Quality Assurance procedures. Participate in “Proficiency Testing” at least 3xs a year.

Proficiency Testing A form of External Quality Control. Laboratory tests samples provided by an approved proficiency testing agency using the same tests that the laboratory would use for testing patient samples.

Moderate-High Complexity CLIA regulations specify qualifications and responsibilities of personnel performing moderate and high complexity testing from director to testing personnel. Regulations are most stringent (strict) for High Complexity testing.

Testing Role of Medical Assistants May perform all CLIA waived testing May perform some moderate complexity testing dependent on the certification of the laboratory or POL. Cannot perform High Complexity testing. Responsible for collecting specimens for high complexity Preparing patient for testing Recording results on medical record.

Anatomic Pathology Laboratory Forensic Pathology (CSI) Autopsy (Coroner) Cytology Histology DNA Probe analysis (Chromosome Analysis)

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