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Fecal Occult Blood

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External Quality Control is not available for the Hemoccult. Internal Quality Control (positive and negative Performance Monitors) must be performed and

    Fecal Occult Blood Hemoccult RL.19.02 Michigan Regional Laboratory System August 2007

    Fecal Occult Blood - Hemoccult

    I. Purpose: To determine the presence of occult blood in fecal specimens which may be

    indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific

    disease.

    

    detection of occult blood: Hemoccult single slides, Hemoccult II triple slides, and

    Hemoccult tape. The laboratory must customize this procedure to identify the test

    system used in their laboratory. Material not used at this laboratory is to be deleted

    from the final procedure after customization is complete. Please send a final version of

    this procedure, plus a copy of the package insert, to your laboratory director for review

    and signature>

    II. Specimen: Fresh fecal material, less than 4 hrs old.

    A. The test requires a small fecal specimen which is promptly applied to the hemoccult slide.

     B. Specimen rejection criteria.

    1. Slides submitted within 3 days of collection.

    2. Slides submitted 14 days after collection.

    3. Slides stored at refrigerator temperature or frozen after collection.

III. Materials:

    A. Hemoccult slides (test cards) or tape (in plastic container) to determine occult blood.

    1. <Insert product name used at your clinic>, cat. no.

    Each box contains:

    a. Slides

    b. Applicator sticks

    c. Hemoccult developer

    B. Storage conditions

    1. Protect from heat, light and volatile chemicals. Store completed slides at controlled

    room temperature 15 - 30 degrees C (59-86F) in original packaging. Do not

    refrigerate of freeze. Protect from heat and light. Do not store wi volatile

    chemicals (e.g., iodine, chlorine, bromine, or ammonia.

    2. Hemoccult slides and developer, when stored as recommended, will remain stable

    until the expiration dates, which appear on each slide and developer bottles.

    3. Do not use expired supplies. Do not use reagents from different lots.

     4. Keep the slide’s cover flap sealed until ready for use. Page 1 of 6

    Fecal Occult Blood Hemoccult RL.19.02

     Michigan Regional Laboratory System August 2007

IV. Safety:

     Fecal specimens can harbor infectious agents. Wear gloves and use Universal Precautions.

     V. Quality Control

    1. External Quality Control is not available for the Hemoccult.

    2. Internal Quality Control (positive and negative Performance Monitors) must be

    performed and documented for all individual patient tests performed.

    3. Patient results may be reported only when both the Positive and Negative Performance

    Monitors give the expected results,

    4. Corrective action must be performed and documented whenever the Positive or

    Negative Performance Monitors fail to give expected results.

VI. Method

    A. Instructions for collection of the fecal specimens should be provided to the client prior

    to specimen collection. The client must be instructed to:

     1. Apply samples from bowel movements collected on three different days to slide.

     2. Not collect sample if blood is visible in the stool or urine (e.g., menstruation, active

    hemerrhoids, urinary tract infection).

     3. Collect each stool sample before contact with the toilet bowl water. The client may

    use any clean, dry container to collect the stool sample.

     4. Return completed slides to the laboratory no later than 14 days after the first sample

    collection.

     5. Protect slides from heat, light, and volatile chemicals (e.g., ammonia, bleach,

    bromine, iodine, and household cleaners).

     6. Remove toilet bowl cleaners from toilet bowl and flush twice before proceeding.

     7. Refer to the appendix for drug and diet guidelines.

    B. Specimen Collection

     1. Develop Hemoccult slides no sooner than 3 days after sample application

    2. Slides containing samples may be stored for up to 14 days at room temperature

    before developing.

    3. Samples should be collected from bowel movements on three different days.

    4. To further increase the probability of detecting occult blood, separate samples

    should be taken from two different sections of each fecal specimen.

    5. Return the cards to the laboratory no later than 14 days after the first sample

    collection.

    C. Test Procedure for Hemoccult Slides

    1. Identification a. Fill in patient name, age, address, phone number, sample collection date and Page 2 of 6

    physician name in space provided on front of each slide.

     2. Preparing the test

    Fecal Occult Blood Hemoccult RL.19.02

     Michigan Regional Laboratory System August 2007

     a. Collect small fecal sample on one end of applicator.

     b. Apply thin smear inside Box A.

    c. Reuse applicator to obtain second sample from a different part of feces.

    Apply thin smear inside Box B.

     d. Close cover.

     3. Developing the test

     a. If testing immediately, wait 3 - 5 minutes before developing. Otherwise,

    slides are best developed no sooner than three days after sample application.

     Slides may be stored as directed for up to 14 days as directed until ready to

    develop.

     b. Open flap in back of slide and apply two drops of Hemoccult developer to

    guaiac paper directly over each smear.

     c. Read results within 60 seconds. Any trace of blue on or at the edge of the

    smear is positive for occult blood.

     d. Document test results on the test log as well as the results of the internal

    control (see section VI.D.4).

    4. Developing the Performance Monitor (Quality Control).

     a. The Performance Monitor area must be developed on every slide.

     b. Apply one drop of Hemoccult Developer between the positive and negative

    Performance Monitor areas.

     c. Read results within 10 seconds.

     d. If the slide and developer are functional, a blue color will appear in the

    positive Performance Monitor area and no blue will appear in the negative

    Performance Monitor area.

     e. Document the results of both the positive and negative Performance

    Monitor areas on the client testing log for each sample tested.

    VII. Results

    A. Negative: No blue color. This is the expected normal result, when precautions are

    followed.

    B. Positive: Any recognizable blue color. A positive result requires follow-up with

    physician.

    C. Neither the intensity nor the shade of the blue from the Positive Performance Monitor

    should be used as a reference for the appearance of positive test results. D. Any blue originating from the positive Performance Monitor area should be ignored

    when reading the sample test results.

    VIII. Limitation of method

     A. Since bleeding from gastrointestinal lesions may be intermittent, fecal samples for Page 3 of 6 testing should be collected from three consecutive bowel movements or three bowel

    movements closely spaced in time. To further increase the probability of detecting

    occult blood, separate samples should be taken from two different sections of each

    Fecal Occult Blood Hemoccult RL.19.02

     Michigan Regional Laboratory System August 2007

     fecal specimen.

    B. Bowel lesions, including some polyps and colorectal cancers, may not bleed at all or

    may bleed intermittently. Also, blood, if present, may not be distributed uniformly in

    the fecal specimen. Consequently, a test result may be negative even when disease is

    present.

    C. Foods which contain peroxides and hemen may leave residues in the feces that may

    interfere with the test. See attached client dietary information sheet.

D. Interfering substances

     1. Substances that cause false-positive test results.

     a. Red meat (beef, lamb, and liver)

     b. Aspirin (greater than 325 mg/day) and other non-steroidal

    anti-inflammatory drugs such as ibuprofen, indomethacin, and naproxen.

     c. Corticosteroids, phenylbutazone, reserpine, anticoagulants, antimetabolites,

    and cancer chemotherapeutic drugs.

     d. Alcohol in excess

     e. The application of antiseptic preparations containing iodine.

     2. Substances which can cause false-negative test results.

     a. Ascorbic acid (vitamin C) in excess of 250 mg per day.

     b. Excessive amounts of vitamin C enriched foods (citrus fruits and juices)

     c. Iron supplements which contain quantities of vitamin C in excess of 250 mg

    per day.

     3. Substances that will not affect test results

     a. Dietary iron supplements

     b. Acetaminophen

    IX. Procedure Notes

    A. Serial fecal specimen analysis is recommended when screening asymptomatic patients. B. The Hemoccult test is not recommended for use with gastric specimens.

    C. Occasionally, a light blue discoloration may be notices on the Hemoccult test paper. This

    discoloration does not affect the accuracy or performance of the test when it is developed

    and interpreted according to this procedure. When developer is added directly over the

    fecal smear on a discolored slide, the blue background color migrates outward. A blue

    ring forms at the edge of the wetted area, leaving the Hemoccult slide around the fecal

     smear off-white in color. Any blue on or at the edge of the smear is positive for occult Page 4 of 6 blood. Proper storage of Hemoccult slides will help prevent blue discoloration. D. Some specimens have high bile content, which cause the feces to appear green. A distinct

    green color (no blue), appearing on or at the edge of the smear within 60 seconds after

    Fecal Occult Blood Hemoccult RL.19.02

     Michigan Regional Laboratory System August 2007

    adding Hemoccult developer should be interpreted as negative for occult blood. A blue

    or blue-green color should be interpreted as positive for occult blood.

    E. Because this test is read visually and requires color differentiation, it should not be

    interpreted by individuals with blue color blindness.

    F. Problems with performance of the assay should be directed to SmithKline Diagnostics

    Technical Support, 1-800-877-6242.

    III. References:

    SmithKline Diagnostics, Inc. - Hemoccult SENSA, 1991

***********************************************************************************

    This material reviewed and approved for use without modification:

Review Date/Signature: ______________________________________________________________

Review Date/Signature: ______________________________________________________________

Review Date/Signature: ______________________________________________________________

Review Date/Signature: ______________________________________________________________

Review Date/Signature: ______________________________________________________________

Review Date/Signature: ______________________________________________________________

RL.19.02

    Rev. 8/2007

     Page 5 of 6

Fecal Occult Blood Hemoccult RL.19.02

     Michigan Regional Laboratory System August 2007

     Addendum, Occult Blood Procedure

     Client Information

     Special Diagnostic Diet

Foods to Eat:

    ? Well-cooked pork, poultry, and fish

    ? Any cooked fruits and vegetables

    ? High fiber foods (e.g., whole wheat bread, bran cereal, popcorn)

Drug Guidelines

     For seven days before and during the stool collection period, avoid non-steroidal

    anti-inflammatory drugs such as ibuprofen (Motrin, Advil), naproxen, or aspirin (more

    than one adult asparin a day).

     Acetaminophen (Tylenol) can be taken as needed.

     For three days before and during the stool collection period, avoid vitamin C in excess of

    250 mg a day from supplements, and citrus fruits and juices.

Diet Guidelines

     For three days before and during stool collection period, avoid red meats (beef, lamb,

    and liver).

     Eat a well balanced diet including fiber such as bran cereals, fruits, and vegetables.

     NOTE:

    1. Patients are encouraged to discuss any questions they may have regarding the Special

    Diagnostic Diet with their doctors. If some patients have difficulty with strict adherence

    to the diet, the following modifications may be made:

     Optional items that may be included in the diet:

    ? Moderate amounts of alcoholic beverages may be consumed

    Moderate amounts of these raw fruits and vegetables:

     apples lettuce raisins 0 apricots oranges raspberries

    bananas peaches strawberries

    celery pears

    tomatoes plums Page 6 of 6

    2. Patients are encouraged talk to their doctor or pharmacist to discuss any questions about

    medications taken regularly.

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