What is the Clinical Laboratory?

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1 What is the Clinical Laboratory? Clinical Laboratory Scientists: Who Are We & What Do We Do? Meredith Bell, BSMT(ASCP) Clinical Manager, Aurora Diagnostics GPA Laboratories

2 What is Clinical Laboratory Science? Welcome to the Aurora Diagnostics GPA Laboratories, Clinical Laboratory located in Greensboro, NC. Clinical Laboratory Science is the Nerve Center of medicine. Think about the last time you had a really bad sore throat or were running a fever If you went to the doctor, you probably had your throat cultured (the cotton swab rubbed on the back of your throat) and your blood drawn out of your arm to see if your white blood cell count was elevated. Or maybe you were asked to collect a urine specimen to determine if you had a urinary tract infection.

3 What is Clinical Laboratory Science continued: Your throat culture, tube of blood, and the urine specimen were then delivered to the lab and the Clinical Laboratory Scientist was the person who identified which bacteria was causing your sore throat, what your White Blood Cell count level was, and whether you had a urinary tract infection.. All samples taken by a Doctor, Nurse, or Phlebotomist are analyzed by a Clinical Laboratory Scientist. Without the Clinical Laboratory Scientist, Doctors would not be able to diagnose diseases properly or treat patients effectively.

4 Who are Clinical Laboratory Scientists? We perform laboratory tests in conjunction with pathologists and other physicians who specialize in Clinical Chemistry, Hematology studies, Coagulation therapy, Urinalysis, Microbiology, Blood Bank, Immunoassay, and various other test orders. Another name for a Clinical Laboratory Scientist (CLS) is Medical Technologist (MT) or Medical Laboratory Technician (MLT). This field of study can be obtained through a 2 year or 4 year degree program and avenues for certification are most commonly Clinical Pathologists (ASCP).

5 Who are Clinical Laboratory Scientists con t: The job of the Clinical Laboratory Scientist may consist of identification of organisms causing infections, counting and classifying blood cells, operating chemistry and immunoassay analyzers, performing immunological tests, or typing and crossmatching blood for transfusion. The Clinical lab also works in partnership with the Phlebotomy team. We have a large team of phlebotomists in client offices and patient service centers stations across North Carolina, Virginia, Maryland, and Michigan.

6 What is the Role of the Clinical Laboratory Scientist? Perform Laboratory analyses Evaluate and correlate test results Quality control measurement and correlations Instrument and result troubleshooting Communication with the healthcare team Result management and consulting Client and staff education

7 Clinical Laboratory Science Disciplines Hematology - the study of blood cells Hemostasis - the study of the clotting mechanisms of the blood Immunology - the study of the body s defense mechanisms Immunohematology - the immunology of blood cells. Involves providing compatible blood for transfusion Chemistry - the study of chemical constituents of the blood and other body fluids Microbiology - the study of microorganisms including bacteria, viruses, parasites, and fungi

8 What a Clinical Laboratory Scientist might see under the microscope: This is a picture of a blood smear slide from a Complete Blood Count with Differential (CBCD) order (CPT code: 85025). On this slide there are several red blood cells and one white blood cell. Red blood cells (pink discs seen here) are special cells that contain the protein hemoglobin, which allows them to pick up and transport oxygen from the lungs to release it deep into the tissues via our circulatory system. In this picture, the white blood cell called a Segmented Neutrophil is the large cell with the lobular purple nucleus (the nucleus is segmented, hence the name seg) and the cytoplasm is filled with rose- violet granules. CBCD testing is a common order placed by the clients that the GPA Clinical Laboratory services.

9 Under the Microscope: Bacterial Culture Gram Stain Slide This is a picture of a gram stain slide from a Bacterial Culture order (CPT code: 87070). In it you can see Segmented Neutrophils and Mononuclear white blood cells. There is also a type of bacteria present (gram positive rods) in chains present on the slide. The Clinical Laboratory Scientist would report the Gram Stain result out to the clinician as a preliminary report while the culture is incubated for bacterial growth, identification, and sensitivities to specific prescription drugs for treatment. Bacterial Cultures are another common test Performed by the GPA clinical laboratory.

10 Specimen Tubes: Spun vs. Unspun When a tube of blood is drawn on a patient the blood draw goes into the tube as a whole blood specimen. The rack of tubes shown below has whole blood specimens in it. These specimens are unspun. Some laboratory testing does require the use of whole blood (unspun) while others require the serum/plasma and the red cells to be separated from each other. The tubes with a clotting factor or serum separator (gel) must clot for a minimum of 15 minutes and then be spun down in a centrifuge for 15 minutes to look like the middle image below where the serum/plasma has been separated from the red cells. If the tube is not allowed to clot or is not spun down correctly the test results are adversely affected.

11 Do you know what percentage of all clinical orders are performed in our GPA Clinical Lab vs. send- out volume percent? 3 Guesses: a. 36 % in- house testing volume b. 65% in- house testing volume c. 90% in- house testing volume

12 In- house vs. Send- out Testing Volumes Did you know that 90% of the Clinical test orders are run in- house? Only 10% of our test volume consist of send- out tests to Quest. For FY2013 the clinical lab offering is currently comprised of 553 different test profiles which include both in- house and send- out test orders. A total of 175,725 profiles were ordered by our clients in the past year. 157,888 of these profile orders were in- house test orders. Only 17,837 profiles were send- out test orders. 6 send- out test profiles have a testing volume of >500 orders/year and comprise 32% of the send- out volume. They include the following profiles: Allergy testing, Fungus Culture, Hgb Electrophoresis, PSA Free, Quad Screen.

13 High Volume In- house Test Offerings: Women's Health Testing: Prenatal- Blood Type/Antibody Screen, Beta HCG, Glucose Tolerance Infectious Disease - Hepatitis A, Hep B, Hep C, HIV, RPR, Rubella, HSV Hormone Levels- Estradial, Testosterone, FSH, Progesterone, Vit D OSTEO- Calcium, BUN, Vitamin D Amenorrhea- FSH, LH, Beta HCG, Prolactin

14 High Volume In- house Test Offerings con t: Dermatology Testing: Accutane- Cholesterol, Triglycerides, CMP, CK, CBCD, Serum Pregnancy General Testing- Hepatitis B Core, Hep B Surface, Hep C, CBCD, CMP, ALT, AST, Cholesterol, Triglycerides Cultures- Anaerobic, Bacterial

15 High Volume In- house Test Offerings con t: Urology: General Testing- PSA Total, Urine Culture, Total Testosterone, BMP, Hepatic Function Panel, CBC, CBCD Gastroenterology: General Testing- Hepatitis C Antibody, Hepatitis B Surface Antigen, CBCD, CMP, Lipase, Amylase, Sedimentation Rate, Lipase, PT/INR, Iron and IBC, Folate, Ferritin, Hepatic Function Panel Internal Medicine: 99% test orders are run in- house General Testing- CBC/CBCD, BMP, CMP, Glucose, PT/INR, PTT, Bacterial culture, Hepatitis, HIV, Hepatic Function Panel, Lipid Panel, Urinalysis, Urine Drug Screen, etc.

16 All About Cultures: In- house Testing The GPA Clinical lab performs testing for 23,212 in- house cultures/year. In- house Cultures = 15% of in- house testing volume Anaerobic = 72 hr TAT Bacterial = hr TAT Genital = 48 hr TAT Group B Strep = 48 hr TAT Respiratory = 48 hr TAT Urine = hr TAT Yeast = 48 hr TAT Preliminary reporting for Bacterial ID = 24 hrs

17 All About Cultures: Sendout Testing GPA Clinical lab sends out 3,070 cultures/year to Quest. Sendout Cultures = 17% of sendout testing volume Acid Fast = 46 day TAT Clostridium Difficile = 5 day TAT Mycobacterium = 7 day TAT Fungus = 4-6 week TAT Herpes Simplex Virus = 5 day TAT Ova and Parasite = 7 day TAT Stool Culture = 72 hr TAT Varicella Zoster = 48 hr TAT Viral Culture Profile = 4-6 day TAT

18 Average In- house vs. Send- out Testing Result TATs In- house TAT from time of receipt in Clinical lab = 1-4 hours with the exception of Micro cultures = hours In- house TAT from time of draw at client to receipt in Clinical lab = <24 hours Send- out TAT from time of receipt at Quest = 24 hrs- 5 days with the exception of fungal cultures = 4-6 weeks. Send- out TAT results from time of draw at client to receipt at Quest = 48 hrs 6 days

19 Common Lab Equipment and Supplies for a Laboratory: Automated instrumentation Specimen centrifuges Specimen incubators Specimen Tubes, Swabs, and Containers Reagents and Quality Control Materials Specimen, Reagent Refrigerators and Freezers Phlebotomy Supplies Specimen rockers, rotators, and vortexers Microscopes Pipettes

20 Common Client Office Clinical Supplies: Needle Holders and Needles for Phlebotomy Draws Specimen Tubes Sterile Specimen Cups Urine Culture Tubes Sterile Swabs for Micro Centrifuge Clinical Requisitions

21 Why a Clinical Sales Relaunch Now? Currently the Greensboro Pathology Clinical Laboratory is the only Aurora lab that has all the laboratory disciplines all under one roof: Histology, Cytology, Molecular, and Clinical. We are proud to the hub of clinical and are looking to promote the use of the clinical laboratory Aurora wide. The Aurora sales teams are launching a sales blitz to promote clinical to our existing and new clients. This allows Aurora to be a one stop shop. A few reasons why now is the best time to promote the use of the clinical lab to our clients are listed below: The Clinical LIS upgrade that went live in October 2013 has enhanced the clinical offering through offering increased functionality: a. Partial Reporting- specific test profile groups can be resulted to the clinician while other tests results are still pending. b. Preliminary Reporting- Microbiology test results including gram stain and organism identification can be reported to the clinician while the prescription drug sensitivities are still pending.

22 Why a Clinical Sales Relaunch Now Con t: c. SuperPanels- client based custom panels that can be tailored to the specific client s needs. This allows a multitude of profiles to be ordered under a single customized profile name. New testing has been insourced over the past year to include: T3, HSV 1 IgG, and HSV 2 IgG. Vitamin D testing is being performed on the Gold Standard instrument of the laboratory industry- the DiaSorin Liaison. All Clinical instrumentation has been interfaced with the Psyche LIS system to improve quality of result reporting and virtually eliminate the possibility of manual result entry errors.

23 Contact Information for Webinar Questions: Please questions to Meredith Bell at or call (336)

24 Thank You for Your Time!!!!

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