Title: Understanding Your Lab Tests
1Understanding Your Lab Tests
2The Black Box of Medical Laboratory Testing
- What You Dont Know Can Hurt You!
3The Black Box, revealed!
4amednews.com
5Ask your physician, nurse, pharmacist, biology
graduate about
- Vitamin C as an interference in glucose and
triglyceride testing - Causes of false positives in pregnancy testing
- WHO classifications for Hodgkin disease and
diagnostic criteria - Ways to test for swine flu (H1N1) and avian flu
(H5N1) - Genetic testing for cystic fibrosis
- Who is most likely to show antibodies to Kell
6Formal coursework training in medical laboratory
testing by
- Physicians
- Nurses
- Pharmacists
- PTs, OTs
- Biology graduates
- Medical laboratory scientists and technicians
- 1 (except those with pathology residency)
- 1
- 1
- 0
- 0
- 100
7Brief history of the medical laboratory in the US
- Pre-1900
- Diagnostic testing simple, mainly microscopic,
physician-performed - 1920s
- AMA survey 48 of US hospitals had medical
laboratories -
8250,000 medical laboratory professionals in the
United States
St. Michaels Hospital - WI
St. Elizabeth Med Ctr - NY
Clarian North Med. Ctr. - IN
9States requiring Personnel Licensure for doing
medical laboratory testing in the US
Note not in DE!
California (1937) Florida Nevada Tennessee Georgia
Hawaii Louisiana North Dakota Rhode
Island Montana West Virginia New York (2007)
No evidence that personnel licensure raises
salaries worsens the personnel shortage Plenty
of evidence that personnel licensure positively
affects patient safety recognizes the importance
of training provides an accurate number
10What is Medical Laboratory Science?
- Clinical Laboratory Science
- Medical Technology
11Medical Laboratory Science diagnostic
laboratory testing from A to Z
Centers for Medicaid and Medicare Services 7.25
billion tests performed annually in US 13
million tests performed in Delaware per
year over 171,000 medical laboratories
nationally 97,000 in physician offices
12Medical Laboratory Science diagnostic
laboratory testing from A to Z
Rodney Forsman, Mayo Clinic 75 of the
diagnostic and/or treatment decisions made by
healthcare professionals are based on clinical
laboratory testing results 94 of the objective
medical data in the patient record comes from the
laboratory
Clin Chem 42 813-816, 1995 Clin Leadersh Manag
Rev, 370-373. Nov/Dec 2002
13Medical Laboratory Science diagnostic
laboratory testing from A to Z
Over 1,200 different types of tests available
14(No Transcript)
15Can anyone do medical laboratory testing?
- can anyone build a bridge
- can anyone perform _____ surgery
- can anyone do your plumbing
- can anyone cut your hair
- with appropriate training and experience, yes!
- without that training/experience, dont let them
near me!
16NAACLS curricular requirements
- Instructional Areas
- Anatomy/physiology
- Immunology
- Genetics/molecular biology
- Microbiology
- Organic/biochemistry
- Statistics
17NAACLS curricular requirements
- Instructional Areas
- Principles and methodologies
- Clinical Chemistry
- glucose
- tumor markers
- cholesterol
- heart attack markers
- thyroid
- drugs..
18NAACLS curricular requirements
- Instructional Areas
- Principles and methodologies
- Hematology
- white blood cells red blood cells
- platelets blood clotting factors
19NAACLS curricular requirements
- Instructional Areas
- Principles and methodologies
- Microbiology
viruses (like swine flu!)
bacteria
fungi
parasites
immune response
20NAACLS curricular requirements
- Instructional Areas
- Principles and methodologies
- Immunohematology
- blood typing
- crossmatching blood
for
transfusion
21NAACLS curricular requirements
- Instructional Areas
- Principles and methodologies
- Genetics testing, phlebotomy, urinalysis, safety,
quality control
22NAACLS curricular requirements
- Instructional Areas
- Performance of assays
- Problem-solving, troubleshooting, techniques
- Interpretation of clinical procedures and results
- Statistical approaches to data evaluation
23Is it possible to get all that in an on-the-job
training situation?
- Can, if
- Sufficient experienced trainers available
- Limited to one clinical testing area
- Enough time (years!)
- Cannot, if
- Any of the above is unavailable
24Bureau of Labor Statistics
Gross estimate at best without personnel licensure
Average age 49
40 US workforce will retire in next 10 yrs
http//www.bls.gov/oco/ocos096.htmoutlook
25Bureau of Labor Statistics
- 155,822 CLS (baccalaureate) in 2004
- Note not all these graduates work in a clinical
laboratory - Projected need by 2014 73,846
- 7385/year
- 146,626 MLT (associate level) in 2004
- Projected need by 2014 76,310
- 7631/year
http//www.bls.gov/oco/ocos096.htmoutlook
26NAACLS Statistics
- 222 CLS programs (Baccalaureate)
- 202 MLT programs (Associate)
Need 15,000/year!
CLEC2008
27Wall Street Journal, 5/13/09
http//online.wsj.com/article/SB124217357954413095
.html
28Wage and vacancy survey
29If the general public only knew
30If the general public only knew
Where is the emphasis on patient care and safety?
Are these just button-pushers, and anyone can do
what they do?
Nursing and shutting down patient floors
31(No Transcript)
32Katrina
33How can so many tests get done per day?
You might be able to drive your car without
knowing how it works
14,000 tests per day!
We cannot run this instrumentation without
knowing how it works no button-pushers!
34(No Transcript)
35National Medical Laboratory Professionals Week
36Normal range
- No such thing!!
- More appropriately called a reference range
- At least 40 healthy individuals donate
specimens - Analysis by THAT method, on THAT instrumentation,
by THOSE clinical lab professionals
37Reference range
- Statistically represents what 95 of that
healthy population can be expected to have - You can be slightly outside that reference range
and still be within what 99 of that healthy
population can be expected to have
38Reference range
- Example
- Sodium reference range 135-153 mmol/L
- Your value 133 L
- Are you sick?
39Reference range
153
135
95 of healthy population
40Reference range
144
153
135
95 of healthy population
41Reference range
144
153
157.5
135
130.5
95 of healthy population
99 of healthy population
42Reference range
144
153
157.5
135
130.5
X
95 of healthy population
99 of healthy population
133 is within what 99 of that healthy
reference population got for sodium
43but my value is outside that 99 range
- Very rarely will a single, isolated lab test
result, high or low, point to a diagnosis - Usually, its the PATTERN of test results which
helps to rule a diagnosis in or out,
(a) from the same specimen and
(b) over time -
-
44- Its the PATTERN which the physician is looking
for when he/she orders a set of tests - Its the PATTERN (connecting disease to lab test
results) which insurance companies and Medicare
are using when they decide to pay or not pay for
the lab tests -
-
45Patterns and Panels
- Pattern of tests which will help to establish a
diagnosis panel
46Panels as defined by Centers for Medicare and
Medicaid Services
- Organ or Disease Oriented Panels
- Basic metabolic panel
- 8 tests
- Comprehensive metabolic panel
- 13 tests
- General health panel
- 18 tests
- Panels for liver function
- kidney function
- arthritis
- lipids.
47- Why is this particular test being done?
- has been linked to a particular diagnosis
- meets medical necessity requirement
- most likely paid for by insurance
48- Or phrased another way a diagnosis of _____
isnt likely without the _______ test showing
_______ - ICD10 codes
- 244.10 ____________________
49- Or phrased another way a diagnosis of _____
isnt likely without the _______ test showing
_______ - ICD10 codes
- 244.10 ____________________
50How long does it take to get a clinical lab test
result?
- Depends on
- Frequency of testing by the lab professionals
- Quality control decisions
- Sent to a reference lab?
- Courier
- Batching
- Sending results to your doctor
51Connecting lab tests to clinical conditions
- Diabetes mellitus
- Fasting glucose gt 126 mg/dL
- Random glucose gt 200 mg/dL
- HbA1c gt 6.5
- Pre-diabetes
- Fasting glucose between 100-125 mg/dL
- Random glucose gt 130 mg/dL
- HbA1c gt 6.0
52Connecting lab tests to clinical conditions
- Iron deficiency anemia
- Total iron
- Iron binding capacity
- Transferrin saturation
- Ferritin
- Red blood cells small and pale
53Error rates in lab tests
- Sensitivity the ability of a test to correctly
identify persons who have a disease (true
positives) - Specificity the ability of a test to exclude
those persons who do not have disease (true
negatives)
54How reliable is the xxx blood test in
determining the presence of cancer?
- determining the presence of cancer
- Not good at all, usually, if used alone!
- showing the effectiveness of therapy
- Excellent!
55Screening tests
- Useful when there is a statistically strong
connection between a condition and a lab test - Questionable usefulness otherwise!
56Screening tests
- Test/condition Recommending Age group Screening
- Group Recommendations
- Cholesterol AAP 2-20 if family history of
premature cardiovascular
disease - NHLBI gt20 every 5 yrs
- Lead state regs 2-12 varies
- Mammogram ACS 20-39 every 3 yrs
- 40-49 every 1-2 yrs
- 50 annual
- Tuberculosis all if at risk
- Pap test AAFP sexually active every 3 yrs
- ACS gt18 yearly
American Academy of Pediatrics National Heart,
Lung and Blood Institute American Cancer
Society American Academy of Family Physicians
57Screening tests
- Test/condition Recommending Age group Screening
- Group Recommendations
- Chlamydia USPSTF lt25, sexually active should be
screened - all women at risk
- CDC lt20 yearly
- gt20 with risk factors yearly
- Skin CA ACS 20-39 every 3 yrs
- 40 yearly
- Iron overload CAP gt18 routine med care
- children, sibs of every 5 years
- patient with iron ( trans sat, ferritin)
- overload
- Thyroid ATA 35 TSH every 5 yrs
US Preventive Services Task Force Centers for
Disease Control American Cancer Society College
of American Pathologists American Thyroid
Association
58Screening tests
- Test/condition Recommending Age group Screening
- Group Recommendations
- Colorectal CA ACS 50 FOBT yearly
- sigmoidoscopy every 5 yrs
- Prostate CA ACS 50 annual DRE, PSA
- (much controversy!)
- Endometrial CA ACS ?? Yearly pelvic exam
- Diabetes mellitus ADA 45 every 3 yrs
- ACE 30 every 3 yrs
- Osteoporosis NOF 65 should be screened
by bone density - (much controversy)
American Cancer Society American Diabetes
Association American College of Endocrinology
National Osteoporosis Foundation
59Lab Tests Online
http//www.labtestsonline.org
60http//www.ascls.org
61What can you do?
- Trifold helper for your lab test results
- Question who is doing the lab testing if your
blood sample is collected in a physician office
lab - Beware of direct access testing
- Blood tubes shaken like martinis!
- Do not believe everything TV tells you
- Support licensure for medical lab personnel in
Delaware!
62Over 750 medical laboratory professionals have
graduated from UD since 1950
Arent you glad?
..dont you wish there were more??
63www.udel.edu/medtech mclane_at_udel.edu