/policies/,/policies/clinical/,/policies/clinical/uwhc-clinical/,/policies/clinical/uwhc-clinical/department-specific/,/policies/clinical/uwhc-clinical/department-specific/point-of-care/,/policies/clinical/uwhc-clinical/department-specific/point-of-care/fecal-occult-hemoccult/,

/policies/clinical/uwhc-clinical/department-specific/point-of-care/fecal-occult-hemoccult/1595p041.policy

201710275

page

100

UWHC,UWMF,

Policies,Clinical,UWHC Clinical,Department Specific,Point of Care,Fecal Occult Hemoccult

Fecal Occult (Guaiac) Hemoccult® (1595.P041)

Fecal Occult (Guaiac) Hemoccult® (1595.P041) - Policies, Clinical, UWHC Clinical, Department Specific, Point of Care, Fecal Occult Hemoccult

1595.P041

UWHC Clinical Laboratories Original Date: September 2010
Point of Care Current Version Date: March 2017
Document Title: Fecal Occult (Guaiac) Hemoccult®
Document ID: 1595.P041 Page 1 of 5



Effective Date: 4/5/2015
Faculty Director Date Manager Date Technical Reviewer Date
David Yang, MD 8/23/2017 Leanne Preston 9/25/17 Beth Urban 8/22/2017






CSC Medical Director Date East Medical Director Date
University Station
Medical Director Date
Diane Norback, MD 8/23/2017 Diane Norback, MD 8/23/2017 Diane Norback, MD 8/23/2017







The American Center
Medical Director

Date West Medical Director Date
Joseph Connor, MD 9/13/2017 Diane Norback, MD 8/23/2017







I. Purpose
To perform point of care diagnostic testing on fecal specimens for the presence of
occult blood using the guaiac (Hemoccult®) method.

II. Policy
A. This test may only be performed on units/clinics that have been approved to
perform this test, that perform the required quality control checks, and maintain
the necessary training and competency assessments. The list of units/clinics
approved to perform this point of care test will be maintained by the Point of Care
Testing Coordinators in the Clinical Laboratories.
B. If a unit/clinic is not approved to perform this test, the unit/clinic should prepare
and label a test kit and send the kit to the Clinical Labs to complete the testing.
The kit used must match the order placed by the ordering provider.
1. For Occult Blood (Guaiac), Diagnostic, Stool (FOCBM) smear a small
amount of feces on Hemoccult® slide. Transport slide to UWHC Core
Laboratory for testing.
2. For Occult Blood (Immunoassay), IFOBT or IFOBTM, collect a specimen
for immunochemical fecal occult blood (iFOB) test using the collection
guidelines available on UConnect in the UWHC Test Directory. Transport
collection tube to UWHC Core Laboratory for testing.

III. Specimen

UWHC Clinical Laboratories Original Date: September 2010
Point of Care Current Version Date: March 2017
Document Title: Fecal Occult (Guaiac) Hemoccult®
Document ID: 1595.P041 Page 2 of 5


A. Remove Hemoccult® slide from box. Only 1 box of slides should be open at a
time.
B. Check back of Hemoccult® Fecal Occult Blood Slide and Developer® for
expiration date. Do not use if past the manufacturer expiration date noted on the
container. Opening the bottle does not change the expiration date. Discard
expired slides and developer.
C. Identify the patient using 2 patient identifiers. Acceptable identifiers are full name
and medical record number or birthdate. Room and bed numbers are not
acceptable identifiers.
D. Collect a fecal sample. If testing is not performed at the patient's bedside or
treatment room where the specimen was collected, the specimen container must
be labeled with 2 patient identifiers in the presence of the patient.

IV. Reagents (or Media), Standards, Supplies and Equipment
A. Hemoccult® Fecal Occult Blood Slide Storage and Handling
1. Do not use after expiration date listed.
2. Keep cover flap of slide sealed until ready to use. Protect from heat, light,
and volatile chemicals.
3. Store at room temperature in original packaging. Do not refrigerate or
freeze.
B. Hemoccult® Developer Storage and Handling
1. Do not use after expiration date on bottle.
2. Protect from heat and light. Keep bottle tightly capped when not in use.
3. Store at room temperature. Do not refrigerate or freeze. Do not store with
volatile chemicals.
4. Avoid contact with skin and eyes. Should contact occur, rinse promptly
with water and consult a physician.
C. Applicator stick
D. Protective barrier devices as needed (gown, gloves, etc.).

V. Procedure
A. Apply small amount of fecal sample on 1 end of the applicator stick. Using the
Hemoccult® Fecal Occult Blood Slide, apply a thin smear inside box A.
B. Reuse applicator, using a clean side, to obtain a second sample from a different
part of the stool.
C. Apply a thin smear to box B.
D. Close the cover and wait 3-5 minutes before developing.
E. Note: This test is visually read and requires color differentiation. It should not be
interpreted by individuals with blue color deficiency (blindness).
F. Open the flap on the back of the slide and apply 2 drops of Hemoccult®
Developer to the guaiac paper directly over each smear in box A and B. Read
results within 60 seconds.
G. Any trace of blue on or at the edge of the smear is positive for occult blood.
Always develop the test and determine whether the fecal sample is positive or
negative before developing the Performance Monitor® feature. Do not apply the
developer to the Performance Monitor® area before interpreting test results.
H. Some specimens with a high bile content appear green. A distinct green color
(not blue), appearing on or at the edge of the smear within 60 seconds after

UWHC Clinical Laboratories Original Date: September 2010
Point of Care Current Version Date: March 2017
Document Title: Fecal Occult (Guaiac) Hemoccult®
Document ID: 1595.P041 Page 3 of 5


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.
I. Conduct steps for Performance Monitor® as outlined below. Performance
Monitor® must be performed and documented with each patient test to ensure
results are accurate and reliable.

VI. Method Specification
A. Interfering Substances
Patients should not ingest red meat, vitamin C enriched foods, drugs or other
substances which can cause false-positive or false-negative results for at least
48 hours before and continuing through the test period.

1. Substances that can cause false-positive results include
a. Red meat (beef, lamb, and liver)
b. Substances which can irritate the gastrointestinal tract such as aspirin,
ibuprofen, corticosteroids, indomethacin, naproxen, phenylbutazone,
reserpine, anticoagulants, antimetabolites, cancer chemotherapeutic
drugs and excess alcohol
c. Application of antiseptic preparations containing iodine to the anal area
2. Substances that can cause false-negative results include
a. Ascorbic acid (vitamin C) intake of more than 250 mg/day
b. Excessive amounts of vitamin C enriched foods
c. Iron supplements that contain quantities of vitamin C which exceed
250mg/day

B. Limitations and/or Exceptions
1. Bowel lesions, including some polyps and colorectal cancers, may bleed
intermittently or not at all and blood may not be distributed uniformly in the
fecal specimen causing a negative test result when disease is present.
2. A test result may be positive on specimens from healthy patients due to
interfering substances in the diet, medications, or low but detectable levels of
blood loss.
3. Hemoccult® tests are designed for preliminary screening and are not
intended to replace other diagnostic procedures such as sigmoidoscopy,
colonoscopy, barium enema or other x-ray studies.
4. Do not test on breast/nipple discharge specimens.
5. The Hemoccult® test should not be used to test gastric specimens.

VII. Result Reporting and Interpretation
A. Result Review and Data Entry
1. Record test results in patient's medical record, either on an approved form
with reference ranges, by using the POC electronic result entry program or
by use of the Smartphrase order set. If results are positive, notify physician.
B. Reference Intervals
1. Expected Results: Negative

VIII. Safety


UWHC Clinical Laboratories Original Date: September 2010
Point of Care Current Version Date: March 2017
Document Title: Fecal Occult (Guaiac) Hemoccult®
Document ID: 1595.P041 Page 4 of 5


All reagents have been reviewed for risk including reproductive toxicity, acute
toxicity, and carcinogenic potential. None were found.

IX. Quality Assurance
A. Apply 1 drop of Hemoccult® Developer between the positive and negative
performance areas on the back of the slide according to the manufacturer’s
recommendations.
B. Read results within 10 seconds. If the slide and developer are functional, a blue
color will appear in the positive (+) Performance Monitor® area, while no blue will
appear in the negative (-) Performance Monitor® area.
C. If the Performance Monitor® areas do not react as expected, the test results
should be regarded as invalid. Repeat test and Performance Monitor® with
another slide from same box.
D. If Performance Monitor® still does not react as expected, record this occurrence
in Quality Control Log and discard entire box of slides. Repeat test and
Performance Monitor® with new box of slides.
E. Routine quality control testing is performed weekly, based upon the
organization’s experience with test, by staff who routinely test patient samples.
1. One slide is removed from each open box of Hemoccult® slides.
2. Performance Monitor® is performed as outlined in steps 1 and 2.
3. Results are recorded in the Quality Control Log for each open box of
slides.
F. Clinical Nurse Manager or designee must review and sign quality control sheets
at least monthly.
G. Quality Control records are stored in a designated area for 2 years.
H. Training and Competency Assessment
1. All staff is trained and competent before performing patient testing. Initial
training is documented and records are retained.
2. After their first year of testing, all staff is required to complete an annual
competency assessment.
3. Any unsatisfactory competency assessment will be followed up with
retraining. The staff member will not perform any patient testing until
acceptable competence is achieved.
4. Copies of these competency records will be kept in nursing education or
at the testing site.

X. Alternate Testing and/or Down Time Procedures
A. Send the specimen to the main lab.

XI. References
A. Material Safety Data Sheet (MSDS), Hemoccult® Developer, March 2014
B. Product instruction insert from Hemoccult® Routine Screening Test for Fecal
Occult Blood, Beckman Coulter, Inc., March 2014

XII. Appendices & Forms
A. 1595.P041.F1 Point of Service Testing Competency Verification, April 2015

UWHC Clinical Laboratories Original Date: September 2010
Point of Care Current Version Date: March 2017
Document Title: Fecal Occult (Guaiac) Hemoccult®
Document ID: 1595.P041 Page 5 of 5


B. 1595.P041.F2 Quality Control Log – Fecal Occult Blood Performance Monitor
Check, April 2015

XIII. Author and/or Revised By
Elizabeth Urban, MLS (ASCP) Point of Care Testing Coordinator
Sarah Emond, MLS (ASCP)CM Point of Care Testing Coordinator

XIV. Coordination and/or Review
Point of Care Testing Coordinators, UWHC Clinical Laboratories
CLIA Laboratory Director UWHC Point of Care Testing
Nursing Patient Care Policy And Procedures Committee