1. Waived Testing and Collection of Non-Blood Specimens
Chapter 13
Waived Testing and Collection of Non-Blood Specimens

2. Learning Outcomes When you finish this chapter, you will be able to:
13.1 Explain how to collect various non-blood specimens.
13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Introduction
Phlebotomists may be required to collect specimens other than blood, such as throat cultures, or to give instructions for collection of various body fluids. Laboratory tests and procedures are classified into categories based on complexity of the test and the training required to perform the test. Phlebotomists may be specially trained to perform laboratory testing that is classified as “waived.”

3. NAACLS Competencies
4.00 Demonstrate understanding of the importance of specimen collection in the overall patient care system.
4.2 Describe the types of patient specimens that are analyzed in the clinical laboratory.
4.3 Define the phlebotomist’s role in collecting and/or transporting these specimens to the laboratory.
4.5 Explain the importance of timed, fasting, and stat specimens, as related to specimen integrity and patient care.
5.00 Demonstrate knowledge of collection equipment, various types of additives used, special precautions necessary, and instances that can interfere in clinical analysis of blood constituents.

4. NAACLS Competencies (cont.)
5.1 Identify the various types of additives used in blood collection, and explain the reasons for their use.
5.2 Identify the evacuated tube color codes associated with the additives.
5.4 Describe substances that can interfere in clinical analysis of blood constituents and ways in which the phlebotomist can help to avoid these occurrences.
7.00 Demonstrate understanding of requisitioning, specimen transport, and specimen processing.
7.2 Instruct patients in the proper collection and preservation of various samples, including blood, sputum, and stools.
7.6 Identify and report potential pre-analytical errors that may occur during specimen collection, labeling, transporting, and processing.

5. Key Terms 24-hour collection erythrocyte sedimentation rate (ESR)
catheter
Certificate of Waiver
expectorate
clean-catch midstream specimen
fecal occult blood
first morning void
Clinical Laboratory Improvement Advisory Committee (CLIAC)
glucose testing
hematocrit
high complexity
Clinical Laboratory Improvement Amendments (CLIA ’88)
human chorionic gonadotropin (hCG)
legal specimens
continence
microhematocrit
diabetes mellitus
moderate complexity
dipstick
nasal swabs

6. Key Terms (cont.) nasopharyngeal swabs suprapubic puncture
packed cell volume (PCV)
throat swabs
point-of-care testing (POCT)
urinalysis
provider-performed microscopy procedures (PPMP)
urine chemical screening
urine pregnancy tests
waived
reagents
rouleaux formation
semen
sputum
standard operating procedures (SOP)
stool specimens
strep screening

7. 13.1 Collection of Non-Blood Specimens
Throat Swabs
Sample taken from back of throat
Uses
Group A Streptococcus screening
Cultures of throat microorganisms
DO NOT use cotton-tipped swabs for throat cultures. The cotton may inhibit bacterial growth.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Throat swabs are samples taken from the back of the throat.
They are used for Group A Streptococcus screening as well as for growing cultures to identify pathogens such as Haemophilus influenzae and Nisseria gonorrhoeae.

8. Throat Swab Collection
Competency Check 13-1:
Throat Swab Collection
Identify the patient.
Explain the procedure. Determine if the patient has used an antiseptic mouthwash to gargle recently or is taking antibiotics. These actions could affect the results of the test.
Put on PPE including gloves, mask, and eye protection.
Obtain a tongue depressor.
Remove the sterile swab from its container (do not set it down).
Have the patient tilt his or her head back and stick out the tongue.
Hold the tongue down with the tongue depressor.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Before beginning the throat swab collection procedure, make sure that the room has sufficient lighting and all of the equipment you will need.
Gloves must always be worn when performing procedures on patients. When performing throat cultures, you should also wear a mask and eye protection since the patient may cough. Wearing all appropriate PPE is especially important to prevent the spread of pathogens.

9. Withdraw the swab, then the tongue depressor.
Competency Check 13-1:
Throat Swab Collection (cont.)
Rub the back of the throat and each tonsil with the swab using a rolling action. To minimize the gag reflex, avoid touching the uvula (the tissue that hangs between the oral cavity and the throat). Do not touch the sides of the mouth or teeth because these contain bacteria normally present and can make interpreting culture results confusing.
Withdraw the swab, then the tongue depressor.
Place the swab back into its sterile container and crush the media ampule, if applicable.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
To help prevent gagging, instruct patients to breath through the nose. This will help minimize movement of the uvula and make it easier for you to collect the specimen quickly.
After removing the sterile swab from the container, do not set it down. Doing so would compromise the sterility of the swab, and you would need to start over with a new sterile swab.
Collect the sample using a rolling action. To minimize the gag reflex, avoid touching the uvula.
To avoid collecting bacteria that are normally present in the mouth, do not touch the swab to the sides of the mouth or teeth.
Most culture swabs have an ampule of growth medium. After the sample has been collected and the swab has been reinserted into the sterile container, the ampule must be crushed to release the growth medium. This helps ensure that any microorganism present remains viable.

10. Discard the tongue depressor.
Competency Check 13-1:
Throat Swab Collection (cont.)
Discard the tongue depressor.
While the patient is still present, label the specimen with all required patient and collection information, which is the same as for blood specimens.
Remove your PPE and wash your hands.
Thank the patient.
LO 13.1 Explain how to collect various non-blood specimens.

11. Competency Check 13-2: Nasal Swab Collection Identify the patient.
Explain the procedure.
Put on PPE including gloves, mask, and eye protection.
Remove the sterile swab from its container (do not set it down).
While seated, have the patient tilt his or her head back. Support the back of the head by placing the hand without the swab against the back of the patient’s head. Patients have a tendency to pull away during this procedure.
Insert the swab approximately 2 cm (about ¾ inch) into a naris.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
The nares are the cavities just inside the nasal opening.
Nasal swab: Used to collect a specimen from the cavities just inside the nose; also called the nares

12. Rotate the swab against the anterior nasal mucosa for 3 seconds.
Competency Check 13-2:
Nasal Swab Collection (cont.)
Rotate the swab against the anterior nasal mucosa for 3 seconds.
Using the same swab, repeat for other naris.
Place the swab back into the transport tube and crush the media ampule, if applicable.
Before leaving the patient, label the specimen with all required patient and collection information.
Remove PPE and wash your hands.
Thank the patient.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
The transport tube keeps the microorganisms in the sample moist during transport.

13. Nasopharyngeal Swab Collection
Competency Check 13-3:
Nasopharyngeal Swab Collection
Identify the patient.
Explain the procedure.
Put on PPE including gloves, mask, and eye protection.
Obtain nasopharyngeal swab, transport medium, and scissors.
Remove swab from its container (do not set it down).
While seated, have the patient tilt his or her head back. Support the back of the head by placing the hand without the swab against the back of the patient’s head. Patients have a tendency to pull away during this procedure.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Nasopharyngeal swabs are samples taken from the nasopharynx (the upper part of the throat behind the nose). They are collected for detection of influenza and respiratory virus infections.
Swab requirements:
Dacron-tipped swabs on a very thin wire
Do not use cotton or calcium alginate
Must be kept moist in viral transport medium
Dry swabs are not acceptable

14. Competency Check 13-3:
Nasopharyngeal Swab Collection (cont.)
Insert swab into one nostril straight back (not upwards) and continue along the floor of the nasal passage for several centimeters until reaching the nasopharynx (you will feel a resistance). Do not force the swab if obstruction is encountered before reaching the nasopharynx. Remove the swab and try the other side.
Rotate the swab gently for 5−10 seconds to loosen cells from the epithelial lining.
LO 13.1 Explain how to collect various non-blood specimens.

15. Remove PPE and wash your hands. Thank the patient.
Competency Check 13-3:
Nasopharyngeal Swab Collection (cont.)
Remove swab, open the viral transport medium, and immediately place it into the container. Use scissors to cut the wire enough below the swab handle to fit the transport medium container. Reattach the cap securely.
Before leaving the patient, label the specimen with all required patient and collection information.
Remove PPE and wash your hands.
Thank the patient.
Transport to the laboratory immediately. If immediate transport is not possible, the specimen must be refrigerated and kept refrigerated during transport.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Patients needing collection of a nasal swab or nasopharyngeal swab may have nasal discharge. Provide the patient with a non-scented tissue and ask him or her to attempt to clear the discharge by “blowing the nose” into the tissue. Children may need assistance with this.
Do not try to clear the nasal discharge with swabs. Attempting to do so might be excessively traumatic, especially for children.

16. Follow the protocols at your facility and your scope of practice
Other Swabs
Phlebotomists do not collect but may be asked to handle other types of swabs
Wound cultures
Vaginal cultures
Urethral cultures
Follow the protocols at your facility and your scope of practice
LO 13.1 Explain how to collect various non-blood specimens.

17. Diagnose disorders of respiratory tract Culture for pathogens
Sputum Specimens
Uses
Diagnose disorders of respiratory tract
Culture for pathogens
Collection
Rinse mouth with water
Ask patient to expectorate and spit into sterile container
Label specimen and deliver to laboratory
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Sputum: Mucus that collects in the air passages of the respiratory system
Expectorate: Generate a cough from deep within the lungs and bronchi
Having the patient rinse the mouth with water before collecting the specimen helps minimize contamination by bacteria in the mouth.

18. Fecal hemoglobin screening Ova and parasite identification Collection
Stool Specimens
Uses
Stool culture
Fecal fat analysis
Fecal hemoglobin screening
Ova and parasite identification
Collection
Clean, dry, sealable, leakproof container
Instruct patient on procedure
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Stool specimen: Fecal matter that is waste discharged from the digestive system
The phlebotomist should give clear, practical instructions for collection of the stool specimen:
Follow special diet (if prescribed)
Do not contaminate specimen with urine or water

19. Stool Specimens (cont.) Specimens for certain tests
Specimens need to be transferred to vials
All vials be completely labeled
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
If the specimen is for the detection of occult blood or certain other tests, the phlebotomist may also need to instruct the patient on how to transfer a specimen to another container.
Fecal Occult Blood
Ova and Parasites

20. Evaluate infertility problems Verify vasectomy Collection
Semen Specimens
Uses
Evaluate infertility problems
Verify vasectomy
Collection
Patient obtains by masturbation
Include entire ejaculate
Label the specimen
Deliver to lab quickly
DO NOT use condoms for collection of specimens. They may contain spermicidal compounds.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Semen: Fluid produced by the male reproductive system containing sperm and some substances necessary for fertilization
Have the patient collect the specimen into a clean, wide-mouthed glass or plastic jar with a secure lid. The patient should not use a condom for collection because many condoms contain chemicals (spermicides or lubricants) that may interfere with test results. The most accurate results are obtained on semen specimens collected after a 48- to 72-hour continence (abstinence from sexual activity).
Semen analysis results can be affected by delayed delivery, so encourage the patient to provide the sample in the facility, if possible. Most facilities provide a private room for this purpose. If the patient collects the sample at home, instruct him to keep the specimen near body temperature and deliver it to the lab within 30 minutes.

21. Urine Specimens Collection Type Used for First morning void
Overall screening
Random void
General or routine assessment
Clean-catch midstream
Urine cultures
24-hour collection
Quantitation of proteins and other substances
Legal specimens
Drug screening
Catheterization
Collection when patient is unable to void
Suprapubic puncture
Collection from bladder when patient is unable to void
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Urine must be refrigerated if it is not tested within one hour of collection. Changes that may occur if it is left at room temperature include:
Changes in urine color and clarity
Bacterial growth
Increase in pH and nitrites
Decomposition of casts and cellular elements
Decrease in substances such as glucose, bilirubin, ketones, and urobilinogen (if they were initially present)
First morning void: Urine that is produced during the night and collected in the morning at the first void
Random void: Collected at any time of the day, usually requiring no special preparation
Clean-catch midstream specimen: Urine collection procedure for culture, which requires skin cleansing and collection of the mid-portion of the urine stream
24-hour collection: Specimen collection procedure that requires patients to collect urine for a 24-hour period of time
Legal specimen: Specimen requiring special handling for criminal investigation
Catheter: A hollow tube inserted into the bladder; used for urine collection
Suprapubic puncture: Urine collection procedure requiring the insertion of a needle through the area just above the pubic bone and directly into the bladder

22. Reasons for Urine Testing Screening Glucose Drugs or alcohol
General well-being
Measuring total amount of substances excreted in a 24-hour period
Assessment of urinary system
Screening for metabolic diseases
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Metabolic diseases that can be detected in the urine include:
Diabetes mellitus (a carbohydrate metabolism disorder)
Amino acid overflow
Proteinuria (the leakage of glucose, amino acids, and protein into the urine)

23. Urine Collection Containers Routine collection cups
Sterile collection containers
Evacuated tubes with preservatives
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Routine tests are performed on specimens in the original container (routine collection cup).
Urine for culture must be collected into a sterile cup and may need to be transferred into a tube that contains an additive. Some sterile container kits include towelettes for cleansing.
Urine preservative tube (yellow-topped)
Urine culture tube (gray-topped)
Care must be taken not to confuse the gray-topped urine tube with the gray-stoppered tubes containing sodium fluoride that are used for blood collection.

24. Female Clean-Catch Urine Specimen Collection
Competency Check 13-4:
Female Clean-Catch Urine Specimen Collection
Instruct the patient to follow these steps to clean the perineum.
Separate the skin folds (labia) and keep them separated throughout the cleaning and collection process. With one antiseptic towelette, wipe from front to back down one side of the skin folds and then discard the towelette.
With a second towelette, wipe down the other side of the skin folds from front to back; discard the towelette.
With a third towelette, wipe down the middle of the labia front to back and discard the towelette while keeping the skin folds open with the other hand.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Watch the video, “Collecting a Clean-Catch Midstream Urine Specimen,” for more information about this topic.

25. Instruct the patient to follow these steps to obtain the specimen.
Competency Check 13-4:
Female Clean-Catch Urine Specimen Collection (cont.)
Instruct the patient to follow these steps to obtain the specimen.
Keeping the skin folds spread apart to avoid contamination, start to urinate into the toilet.
Place the cup under the flow of urine after it has begun and remove the cup before it has finished. Do not collect the first or last part of the stream of urine. Instead, collect the urine at midstream; this is why the phrase “clean-catch midstream” is used.
Once the patient is finished, place the lid on the cup. Ideally, the cup should be about three-fourths full.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
It is important not to collect the first or last part of the urine stream. Start the void, then place the cup under the flowing urine. Remove the cup before the urine flow stops.

26. Competency Check 13-4:
Female Clean-Catch Urine Specimen Collection (cont.)
Label the specimen (name, date of collection). Remember, your facility might require other identification on the specimen, so check with your supervisor.
LO 13.1 Explain how to collect various non-blood specimens.

27. Male Clean-Catch Urine Specimen Collection
Competency Check 13-5:
Male Clean-Catch Urine Specimen Collection
Instruct the patient to follow these steps to clean the penis.
Use an antiseptic towelette to clean the head of the penis.
Take a second towelette and wipe across the head of the penis. If uncircumcised, retract the foreskin before cleaning the penis.
Instruct the patient to follow these steps to obtain the specimen.
If uncircumcised, keep the foreskin retracted and urinate into the toilet. Place the cup under the flow of urine after it has begun and remove the cup before it has finished. Do not collect the first or last part of the stream of urine. Instead, collect the urine at midstream.
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Watch the video, “Collecting a Clean-Catch Midstream Urine Specimen,” for more information about this topic.
If the patient is uncircumcised, retract the foreskin before cleansing the penis and keep the foreskin retracted throughout the clean-catch procedure.

28. Competency Check 13-4:
Male Clean-Catch Urine Specimen Collection (cont.)
Once the patient is finished, place the lid on the cup. Ideally, the cup should be about three-fourths full.
Label the specimen (name, date of collection). Remember, your facility might require other identification on the specimen, so check with your supervisor or procedure manual for further instructions.
LO 13.1 Explain how to collect various non-blood specimens.

29. Infant Urine Collection Use pediatric collection unit
May transfer to collection cup or tube
If for urine culture, leave in collection bag
Transport to laboratory immediately
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Urine collection from an infant or small child is performed using a pediatric collection kit, which consists of a sterile plastic bag that has an opening to fit around genitalia. The bag is secured with an adhesive backing.
Always use the established procedure at your facility for collecting urine from an infant.

30. Twenty-Four-Hour Urine Specimen Collection
Competency Check 13-6:
Twenty-Four-Hour Urine Specimen Collection
Upon waking the morning of the collection, empty the bladder. Do not collect this urine. Record the time at which this urination occurs.
Collect all urine voided throughout the next 24 hours directly into the preservative container or into a urine collection cup and add to the container.
Use caution when adding the urine to the container because it contains an acid that may splash.
Be sure to add all the urine into the container; do not spill; do not contaminate the inside of the container.
LO 13.1 Explain how to collect various non-blood specimens.

31. Competency Check 13-6:
Twenty-Four-Hour Urine Specimen Collection (cont.)
Refrigerate the container, or keep it on ice, for the entire time of collection.
On the second morning, at exactly the same time as the previous day, collect a final void and add it to the container. Record this time.
Keep the specimen refrigerated or on ice, if necessary, until transported to the laboratory.
LO 13.1 Explain how to collect various non-blood specimens.

32. Measures total amount of substances excreted in 24 hours
24-Hour Urine Specimen
Measures total amount of substances excreted in 24 hours
Protein
Sodium
Hormones
Some collections require preservatives
Caustic chemicals
Wear PPE
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
Not all 24-hour urine collections require preservatives. For those that do, be aware that the chemicals may include strong acids or chloroform. Use a fume hood and wear appropriate PPE:
Gloves
Goggles
Rubber apron
Add acids slowly, and if water is also required, always add the acid to the water. Never add water to the acid.
Some specimens also require refrigeration or need to be placed on ice during the time of collection.

33. All legal specimens require chain-of-custody procedures
Alcohol and drug testing
Employee physical exams
Insurance company screening
Place specimen in specimen transfer bag with permanent seal
LO 13.1 Explain how to collect various non-blood specimens.
Notes:
When chain-of-custody procedures are required, the phlebotomist must fill out the appropriate paperwork to show:
Specific identification
Who obtained and processed the specimen
Date
Location
Patient signature

34. 13.2 Levels of Laboratory Testing
Clinical Laboratory Improvement Act of 1988
High complexity tests
Moderate complexity tests
Provider-performed microscopy procedures (PPMP)
Waived tests
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
The Clinical Laboratory Improvement Act of (CLIA ’88) identified three levels of complexity for medical laboratory tests. Provider-performed microscopy procedures (PPMP) was added to this law in 1997 as a subcategory of moderate complexity tests.
The following slides describe each type of test.

35. Require close attention to detail
High Complexity Tests
Require close attention to detail
Require specialized training and substantial experience
Involve manual manipulation of complex equipment and reagents
Require interpretation and troubleshooting skills
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
High complexity tests: Classification of laboratory tests that require close attention to detail and specialized training
Reagents: Lab test chemicals
Examples of high complexity tests:
Manual DNA extraction procedures
Special staining procedures
Complex analyzers that require detailed setup or operator interaction

36. Moderate Complexity Tests
Steps not highly complex but require formal training
Require little manual manipulation
Personnel required to have proper training and experience
May require direct supervision
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
Moderate complexity tests: Classification of laboratory tests that fall between low (waived) and high complexity tests with respect to the complexity of the test and the training required
Examples of moderate complexity tests: Tests that involve running simple automated instruments

37. Provider-Performed Microscopy Procedures
Subcategory of moderate complexity testing
Tests performed by healthcare providers only for their own patients
Examples
Direct wet mounts
Potassium hydroxide (KOH) preparations
Pinworm examinations
Fern tests
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
Provider-performed microscopy procedures: Subcategory of moderate complexity testing that allows healthcare providers to perform certain tests only for their own patients
Additional examples:
Post-coital qualitative tests
Urine sediment examinations
Nasal smears for granulocyte
Fecal leukocyte examinations
Qualitative semen evaluation

38. FDA-approved for home use
Waived Tests
Simple procedures
FDA-approved for home use
Pose no reasonable risk of harm if performed incorrectly
Require less training than higher complexity tests
On-the-job training possible
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
Waived tests: FDA-approved laboratory tests that are minimally complicated and pose little risk of harm to the patient
Examples:
Blood glucose levels by glucose monitoring devices cleared by the FDA specifically for home use
Erythrocyte sedimentation rate—non-automated
Fecal occult blood
Spun microhematocrit (manual procedure for determining hematocrit that requires only a small amount of blood)
Urine chemical testing
Urine pregnancy tests—visual color comparison tests; the testing of urine for the presence of human chorionic gonadotropin, indicating pregnancy

39. Regulatory Compliance
All medical laboratories must comply with CLIA ’88
Certificate of Accreditation (COA)
Certificate of Compliance (COC)
Certificate of Registration (COR)
Certificate for Provider-Performed Microscopy Procedures
Certificate of Waiver
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
A Certificate of Accreditation (COA) is awarded to laboratories that perform moderate and/or high complexity testing and meet the standards of a private not-for-profit accreditation program. These labs must be surveyed every other year.
A Certificate of Compliance (COC) is awarded to laboratories that perform moderate and/or high complexity testing after inspectors find that the laboratory is in compliance with all applicable CLIA requirements. These labs must also be surveyed every other year.
A Certificate of Registration (COR) is granted to laboratories that have applied for either COA or COC and enables the laboratory to perform moderate and/or high complexity testing until it has been inspected and verified to meet all requirements for COA or COC.
A Certificate for Provider-Performed Microscopy Procedures is granted to laboratories at facilities where physicians, mid-level practitioners, or dentists perform only certain microscopy procedures.
A Certificate of Waiver must be granted before a laboratory can perform waived tests. These labs must submit to random inspections and investigation if indicated.
The Clinical Laboratory Improvement Advisory Committee (CLIAC) has made several recommendations for good practice in a Certificate of Waiver laboratory.

40. Waived Testing Regulations
Follow federal, state, and local regulations
Perform waived tests only
Follow manufacturer instructions
Do not modify instructions
Allow random inspections
Establish laboratory safety plan that follows OSHA guidelines
Have a designated area with adequate space and conditions
Have enough personnel and train them appropriately
Have written documentation of each test performed
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
Facilities that perform waived laboratory tests must have a designated person—usually a physician or experienced laboratory supervisor—that is responsible for laboratory supervision. All personnel must follow the guidelines, regulations, and requirements listed here.

41. Standard Operating Procedure
Required for laboratories performing waived tests
Applies to all steps in the testing process
Pre-examination
Examination
Post-examination
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
Standard operating procedure (SOP): Requires the person performing waived testing to follow designated steps during all phases of the testing process

42. Confirm written test orders Establish procedure for patient ID
SOP: Pre-Examination
Confirm written test orders
Establish procedure for patient ID
Give pre-test instructions and determine whether patients followed them
Collect specimens according to package insert instructions
Label specimens appropriately
Never use expired reagents or test kits
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
These are guidelines for standard operating procedure during the pre-examination phase (before the test).

43. Perform quality control testing
SOP: Examination
Perform quality control testing
Correct problems discovered during QC testing before testing patient samples
Establish policy for control testing frequency
Follow test-timing recommendations
Interpret test results as directed
Record test results according to office policy
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
These are guidelines for standard operating procedure during the examination phase (during the test).

44. SOP: Post-Examination
Report test results to the physician in a timely manner
Follow package insert recommendations for follow-up or confirmatory testing
Follow OSHA regulations for disposing of biohazardous waste
LO 13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
Notes:
These are guidelines for standard operating procedure during the post-examination phase (after the test).
To help ensure the quality of testing, Certificate of Waiver laboratories are also required to participate in quality assurance/assessment programs for each test they perform.

45. 13.3 Waived Testing Erythrocyte sedimentation rate Fecal occult blood
Microhematocrit
Strep screening
Urine pregnancy testing
Urine chemical screening
Point-of-care testing
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Point-of-care testing: Testing at or near the patient’s location, such as at a hospital bedside or in a physician’s office
Although phlebotomists typically do not perform waived tests, they may be trained to do so in smaller facilities or in rural communities. Some states, including California, have licensure laws to regulate testing, so phlebotomists may not be allowed to perform them. It is important to know the laws in your state.

46. Erythrocyte Sedimentation Rate (ESR)
Rate at which RBCs settle in whole blood
Screens for inflammation
Methods
Wintrobe
Westergren
Modified Westergren
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Erythrocyte sedimentation rate (ESR): Rate at which red blood cells settle in whole blood; measured as the distance, in millimeters, that RBCs fall in one hour when allowed to settle in a calibrated tube
This is a nonspecific test that screens for inflammation:
When inflammation is present, plasma proteins such as albumin and globulin are increased.
Increased plasma proteins cause RBCs to come closer and may result in rouleaux formation, in which the RBCs stick to each other.
Several cells sticking together sink faster than a single RBC does, so an elevated sedimentation rate indicates inflammation.

47. Erythrocyte Sedimentation Rate Testing
Competency Check 13-7:
Erythrocyte Sedimentation Rate Testing
Transfer the blood from an appropriate specimen to the diluent vial and fill it to the mark on the vial (amounts vary by manufacturer).
Replace the vial cap and gently mix the blood with the diluent by inversion.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
The equipment needed for a simple ESR test include:
Specimen transfer pipettes
ESR kit
ESR vials containing a premeasured amount of diluent (usually saline)
Calibrated ESR tubes
ESR testing rack
The amount of blood needed for the test varies by kit manufacturer. Be sure to fill the diluent vial to the mark on the vial.

48. Label the ESR tube or vial with the patient’s identification.
Competency Check 13-7:
Erythrocyte Sedimentation Rate Testing (cont.)
Insert a calibrated ESR tube through the vial cap and into the blood-diluent mixture; adjust the tube until the blood is even with the 0-mm mark.
Place the ESR tube in the testing rack (it should be absolutely level).
Label the ESR tube or vial with the patient’s identification.
Allow the blood to settle for 1 hour.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.

49. Competency Check 13-7:
Erythrocyte Sedimentation Rate Testing (cont.)
After 1 hour, read the level to which the red blood cells have fallen and record this information as millimeters per hour.
Consult the manufacturer’s instructions for the proper interpretation of the results. Normal values vary by method and may vary by gender.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Other factors that may affect ESR results:
Testing time
Temperature
Tilting
Vibrations

50. Fecal Occult Blood Testing
Cardboard holder contains paper impregnated with guaiac
Apply stool to cardboard
Apply hydrogen peroxide
Presence of hemoglobin in blood makes guaiac paper turn blue
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Fecal occult blood is blood that is found in the feces/stool and may not be visible (therefore occult).
Guaiac is a chemical that turns blue when blood (hemoglobin) is present.
Several portions of the stool sample are usually processed in order to maximize blood detection.
False-positive fecal occult blood results may occur if patients have ingested:
Fish
Heme-laden meat (such as beef and lamb)
Fruits that contain peroxidase (bananas, cantaloupe, pears, plums)
Vegetables that contain peroxidase (broccoli, cauliflower, horseradish, turnips)

51. Measured as packed cell volume (PCV)
Microhematocrit
Measured as packed cell volume (PCV)
Can be performed directly from puncture or from EDTA tube
Blood placed in capillary tube
Centrifuged to pack RBCs
Hematocrit determined using reading device
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Hematocrit: The percentage of whole blood that is made up of red blood cells
Measured as packed cell volume (PCV) of red blood cells (percentage of red blood cells in whole blood)
Used as a screening test for anemia

52. Microhematocrit Procedure
Fill the capillary tubes Directly from dermal puncture:
Wipe away first drop
Touch a red-tipped capillary tube to the edge of the next blood drop without touching the skin
Keep the capillary tube angled upward to avoid air bubbles
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Microhematocrit procedure uses capillary tubes, which are narrow-diameter tubes that take up blood by capillary action.
Avoid air bubbles because they may cause erroneous results.

53. Microhematocrit Procedure (cont.) From EDTA tube:
Remove the cap from an EDTA tube filled with blood
Tilt the specimen tube slightly and insert one end of the capillary tube
Keep the capillary tube angled upward to avoid air bubbles
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Fill two capillary tubes three-quarters full.
Because microhematocrit/capillary tubes are very slender and are usually made of glass, they break easily. For safety, some tubes are either plastic or have a plastic coating. However, always use caution when handling capillary tubes. A broken sharp edge can cause a break in the glove and skin, exposing the phlebotomist to blood.

54. Microhematocrit Procedure (cont.)
Place gloved finger over dry end of capillary tube
Hold tube horizontal so no blood can spill out
Embed clean end of tube in clay sealant and remove finger
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Some microhematocrit tubes are self-sealing and do not require sealing clay. Refer to the manufacturer’s directions.

55. Microhematocrit Procedure (cont.)
Place filled and sealed capillary tubes into microcentrifuge (with sealed end toward outer rim)
After centrifugation, remove tubes from centrifuge and read on hematocrit scale
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
A microhematocrit centrifuge is used to spin the capillary tubes, and then the packed cell volume is read using a microhematocrit reading device. Many microhematocrit centrifuges have these reading devices built in.

56. Reading a Microhematocrit Place bottom of RBC layer at 0% mark
Adjust scale so top of plasma layer is at 100% mark
Read hematocrit value at top of RBC layer on scale
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Correct placement of the tube on the hematocrit scale is critical to obtaining an accurate result. The bottom of the RBCs should be placed on the “0” mark. The top of the plasma should be placed on the “100” mark, NOT the top of the tube. The hematocrit is the line at the top of the RBCs.
Watch the video, “Measuring Hematocrit Percentage after Centrifuge,” for more information about reading a hematocrit result accurately.

57. Determines presence of Group A Streptococcus
Strep Screening
Determines presence of Group A Streptococcus
Waived testing labs use strep test kits with built-in controls
Procedures vary with manufacturer
Read instructions carefully
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Strep screening is used to determine if a patient’s sore throat is caused by the bacteria Group A Streptococcus. Detection is important because untreated Streptococcus infections can lead to rheumatic fever and autoimmune disease.
Testing devices contain:
Antibodies to Group A Strep
A color developer
Built-in controls
General procedure for the test kits used in Certificate of Waiver laboratories:
Swab specimen is taken from back of throat.
Swab is placed in a vial that contains premeasured amounts of extraction reagent to remove the bacteria from the swab.
Vial is set onto a testing device treated with antibodies to the bacterial antigens and color developers.
Results are read after a specified period of time, usually less than 10 minutes.
For the results to be valid, the control (“C” in the tests shown on this slide) must show a positive result.

58. Confirms or rules out pregnancy
Urine Pregnancy Test
Confirms or rules out pregnancy
Tests for human chorionic gonadotropin (hCG)
Tests vary by manufacturer
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Human chorionic gonadotropin (hCG): Hormone produced by the placenta
General procedure for the test kits used in Certificate of Waiver laboratories:
Place required number of drops of urine onto the testing device.
Read the results according to the manufacturer’s directions. (The test shown on this slide is negative.)
Built-in control verifies that the test has been performed correctly.

59. Urine Chemical Screening Part of a complete urinalysis
Physical Component
Chemical Component
Microscopic Component
Color pH
Casts
Clarity
Specific gravity
Cells
Blood
Crystals
Bilirubin
Glucose
Ketones
Leukocytes
Nitrite
Protein
Urobilinogen
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Urine chemical screening: The testing of urine for various chemicals, most not normally present in the urine; part of a urinalysis
Urinalysis: The testing of urine for physical, chemical, and microscopic characteristics

60. Urine Chemical Screening
Competency Check 13-8:
Urine Chemical Screening
Double check that the specimen is correctly identified and matches the chart where you will record the results.
Allow the urine to come to room temperature; then mix the urine thoroughly.
Remove the reagent strip from the bottle and replace the cap.
Remove the cap from the urine container and dip the reagent strip into the urine, making sure that all the reagent pads come into contact with the urine.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Use all appropriate PPE as required by your facility.
For quality assurance, follow these precautions:
Keep strips in tightly closed containers in a cool, dry area.
Never remove strips from the container until immediately before testing.
Never touch the pads on the strip with your fingers or gloved hands.
Examine strips for discoloration before use; discard discolored strips.
Check the expiration date on the bottle; do not use strips that have expired.
Use strips within six months of opening the container.
Every time you open a new supply of reagent strips, run control samples to check for proper operation. Write the date opened on the bottle.

61. Begin timing immediately.
Competency Check 13-8:
Urine Chemical Screening (cont.)
Remove the reagent strip immediately (drag the strip across the top of the container to prevent dripping). Some facilities suggest removing excess urine by touching the side edge of the reagent strip to an absorbent material. Never blot the tops of the pads on the strip and do not allow urine from one pad to run over onto another.
Begin timing immediately.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.

62. Competency Check 13-8:
Urine Chemical Screening (cont.)
Compare the colors of the reagent pads to those of the color chart on the reagent strip bottle at the time designated by the manufacturer to avoid erroneous results.
Record the test result for each chemical component in the patient’s medical record.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Watch the video, “Performing a Reagent Strip Test,” for more information about this topic.

63. Point-of-Care Testing (POCT) Designed to: Reduce healthcare costs
Enhance patient care
Sample tested immediately after collection at patient’s side
Typically requires small amount of blood from dermal puncture
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Typical POCT tests:
Glucose
Hemoglobin
Electrolytes (sodium, potassium, chloride, bicarbonate)
Ionized calcium
Cholesterol
Blood ketones
Blood gases
Coagulation studies (such as prothrombin time)
Urine dipstick (plastic strip with reagent pads containing chemicals for urine or blood testing)
Urine pregnancy
Fecal occult blood
Strep screening
Watch the video, “Point of Care Testing,” for more information about this topic.

64. Glucose Point-of-Care Testing
Competency Check 13-9:
Glucose Point-of-Care Testing
Properly identify the patient.
Use PPE appropriate to the procedure and as required by your facility.
Assemble the dermal/capillary puncture equipment.
Verify that controls have been run on the glucose instrument and are in range.
Prepare the glucose instrument for testing (insert strip).
Perform a routine dermal/capillary puncture.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.
Notes:
Glucose testing: Screening for abnormal glucose levels and to monitor glucose levels in patients with diabetes mellitus
This is a representative procedure. Be sure to follow the procedure required at your facility.

65. Testing should begin automatically.
Competency Check 13-9:
Glucose Point-of-Care Testing (cont.)
Wipe away the first drop (the first drop may contain fluid from the tissue and give elevated results).
Apply a drop of blood to the test strip (following the manufacturer’s requirements).
Testing should begin automatically.
Provide post-puncture patient care.
Properly dispose of biohazards.
After the test is complete, read and record the results.
LO 13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.

66. Chapter Summary
Phlebotomists may need to collect, or instruct patients about how to collect, non-blood specimens.
Each non-blood specimen has a unique method of collection and unique specimen containers.
The Clinical Laboratory Improvement Amendments of (CLIA ’88) identified three levels of complexity for medical laboratory tests: waived tests, moderately complex tests, and high complexity tests. A subcategory of provider-performed microscopy procedures was later added to the moderately complex level.
13.1 Explain how to collect various non-blood specimens.
13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.

67. Chapter Summary (cont.)
A Certificate of Waiver is needed for facilities wishing to perform waived testing.
Phlebotomists and other healthcare workers may perform waived tests, including point-of-care testing (POCT), where licensure regulations allow.
Some waived or POCT tests include erythrocyte sedimentation rates, fecal occult blood testing, microhematocrit, strep screening, urine pregnancy testing, urine chemical screening, and bedside glucose testing.
13.2 Differentiate among waived tests, moderately complex tests, and high complexity testing.
13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.

68. Chapter Summary (cont.)
Each waived procedure must be performed according to standard operating procedures, which include the performance of quality control checks prior to patient testing.
13.3 Describe procedures for various waived and point-of-care tests that a phlebotomist may be asked to perform, including quality controls.