VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE Routine Screening Test for Fecal Occult Blood The Point of Care Testing (POCT) program at Vanderbilt University Medical Center (VUMC) is overseen and coordinated by the POCT Steering Committee as chartered by the Medical Center Medical board. The POCT Steering Committee administers the program with the primary goal of meeting clinical needs in the most cost-efficient manner possible. In order to provide for both regulatory compliance and appropriate utilization of POCT, any clinical area wishing to perform POCT must be approved by the POCT Steering Committee and must maintain acceptable performance according to criteria set forth in Hospital Policy 20-23. I. PRINCIPLE: The Hemoccult test is based on the oxidation of guaiac by hydrogen peroxide to a bluecolored compound. The heme portion of hemoglobin, if present in the fecal specimen, has peroxidase activity which catalyzes the oxidation of alpha guaiaconic acid (active component of the guaiac paper) by hydrogen peroxide (active component of the developer) to form a highly conjugated blue quinone compound. II. PURPOSE: The Beckman Coulter Hemoccult test is a qualitative screening method for detecting fecal occult blood, which may be indicative of gastrointestinal disease. It is not a test for specific diseases. III. SCOPE OF PRACTICE: Stool occult blood testing may be performed by RN’s, LPN’s, Patient Care Partners/Technicians, OR Technicians, and Nursing Externs working in areas/units approved by the POCT Steering Committee to perform point of care stool occult blood testing. To maintain this privilege, testing must be performed in accordance with VUMC hospital POCT policy. All staff performing testing must attend POCT orientation, annual retraining, read procedure annually and follow established testing protocol. IV. SPECIMEN COLLECTION: A. Conditions for Patient Preparation 1. Refer to current package insert for collection procedure and patient preparation. 2. Samples should not be collected during periods of active bleeding (e.g., menstruation, active hemorrhoids, urinary tract infection). 3. Remove toilet bowl cleaners from toilet tank and flush twice before proceeding with sample collection. Hemoccult Procedure revised 2-2006 Page 1 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE 4. For seven days before and during the stool collection period, avoid nonsteroidal anti-inflammatory drugs such as ibuprofen, naproxen or aspirin (more than one adult aspirin a day). 5. For three days before and during stool collection period, avoid vitamin C in excess of 250mg a day from supplements, and citrus fruits and juices. 6. For three days before and during stool collection period, avoid red meats (beef, lamb, and liver). 7. Eat a well balanced diet including fiber such as bran cereals, fruits and vegetables. 8. Collect samples over a 3 day period. B. Specimen Type 1. Small amount of fecal specimen 2. Do not test samples containing visible blood 3. Collect sample in a clean, dry container, before contact with toilet bowl water. 4. Gastric or vomitus specimens are not recommended C. Handling Conditions Use Standard Precautions 1. Specimen is applied to guaiac paper of Hemoccult test card as THIN SMEAR using provided applicator stick 2. Apply samples form bowel movements collected on three different days to test card. 3. Separate samples should be taken from two different sections of each fecal specimen. 4. Hemoccult test cards are best developed no sooner than 3 days after sample application. 5. Slides containing samples may be stored up to 14 days at controlled room temperature 15-30°C before developing. V. REAGENTS AND SUPPLIES: 1. Hemoccult test cards (guaiac paper) 2. Hemoccult developer (Stabilized aqueous solution. <5% hydrogen peroxide, 75% denatured alcohol) 3. Applicator sticks (optional) 4. Collection tissues (optional) VI. STORAGE AND STABILITY: 1. Store product at controlled room temperature 15 to 30C (59 to 86F) in original packaging. Do not refrigerate or freeze. 2. Protect from excessive heat and light. 3. Do not store Hemoccult test cards or developer with volatile chemicals. Hemoccult Procedure revised 2-2006 Page 2 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE VII. 4. Hemoccult slides and developer, stored as recommended, are stable until printed expiration dates if quality control is acceptable. 5. All reagents must be labeled with staff initials, and valid expiration date (including box and developer bottles). CALIBRATION: N/A VIII. QUALITY CONTROL (QC): 1. The positive and negative Performance Monitors (quality controls) built into each Hemoccult test card must be developed each time a Hemoccult test card is used for patient testing. 2. These Performance Monitors (quality controls) check the function and stability of the test card and the developer. 3. DO NOT apply developer to Performance Monitor areas before interpreting patient test results. 4. The Positive Performance Monitor area contains a hemoglobin-derived catalyst, which will turn blue within 10 seconds after application of developer. The negative Performance Monitor does not contain the catalyst and should not turn blue after application of developer. IX. TEST PROCEDURE: Observe Standard Precautions A. Preparing and Developing PATIENT Test 1. 2. 3. 4. Properly label test card with patient information Collect sample on applicator stick. Apply thin smear to card side A. Obtain another sample from different part of specimen and apply a thin smear to card side B. 5. Close cover and wait 3 to 5 minutes. 6. Open back flap and apply (2) drops developer over each smear. 7. Read within 60 seconds. Any trace of blue on or at the edge of the smear is positive for occult blood. Any blue color originating from the positive Performance Monitor area should be ignored when reading the patient sample results. B. Developing Performance Monitors (quality controls): 1. Apply (1) drop of Hemoccult developer between the positive and negative Performance Monitors. They are located in the orange rectangle below the patient testing area. Hemoccult Procedure revised 2-2006 Page 3 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE 2. Read the results within 10 seconds. 3. If the test card and developer are functioning correctly, the positive Performance Monitor will turn blue in color (positive result), and the negative Performance Monitor will remain white with no blue color visible (negative result). If the Performance Monitors do not react as expected after applying the developer, regard patient results as invalid. Follow the corrective action steps. B. Corrective Action: 1. Check expiration date of Hemoccult test cards and developer being used. 2. If supplies not expired, retest patient sample using a different test card from the kit. 3. If needed, retest patient sample with test card and developer from a different box of Hemoccult supplies. If Performance Monitors yield expected results with test card from the second box of supplies, discontinue use of test cards and developer from the original box. Notify POCT Support Center for pick-up of bad supplies. 4. If still unable to obtain expected results of the Performance Monitors, notify POCT Support Center at phone # 3-5707. X. REPORTING RESULTS: Patient test results and quality control test results are reported/recorded as positive or negative for occult blood XI. DOCUMENTATION: The following information is required to be documented with patient results in the permanent medical record: a. b. c. d. e. f. XII. Date and Time of patient testing Comments or corrective action taken Hemoccult test card lot number and expiration date Hemoccult developer lot number and expiration date Results of positive and negative performance monitor. Identification of staff performing testing QUALITY ASSESSMENT: The manager or designee has oversight of the following requirements: All POCT performed in patient care areas have been approved by the Diagnostic Laboratories and the State of Tennessee. Testing is performed only by staff approved by the Diagnostic Laboratories and Hemoccult Procedure revised 2-2006 Page 4 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE the State of Tennessee. All staff are trained prior to testing, and assessed for competency annually. Individuals responsible for staff training and /or compliance review, (quality control and patient documentation); have attended appropriate training sessions provided by the POCT Support Center. Initial training records, current annual competency records and “designated” trainer records must be accessible. Notification to the POCT Support Center of any changes or transfer of testing personnel. Current testing procedures and accessible to all testing staff. Quality control and maintenance procedures are performed, documented and reviewed for compliance by the manager or designee at least weekly, and are accessible for two years following review. Any corrective action is noted, and filed with records. Routine review of random patient medical records by manager or designee to verify compliance with patient test result documentation as described in testing procedures. Examples must be available for inspections. All testing supplies are stored and labeled according to instructions found in individual testing procedures. CAP proficiency testing, as required, is performed according to accompanying instructions and results and requested information returned to the POCT Support Center within specified time frame. Diagnostic Laboratories POCT Support Center Provides: Technical support Training Content of training materials and testing procedures Validation and implementation of testing methodologies Assistance with request for testing privileges The POCT Steering Committee is chartered by the VUMC Medical Board and has the authority to revoke testing privileges. XIII. INTERFERING SUBSTANCES: A. Some specimens have a high bile content, which causes feces to appear green. A distinct green color appearing on or at the edge of the smear within 60 seconds after adding developer should be interpreted as negative. A blue or blue-green color should be interpreted as positive for occult blood. B. Substances, which can cause false-positive test results include: 1. Red meat 2. Antiseptic preparations containing iodine. Hemoccult Procedure revised 2-2006 Page 5 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE 3. Aspirin (greater than 325 mg/day) and other non-steroidal antiinflammatory drugs such as ibuprofen, indomethacin and naproxen. 4. Alcohol in excess C. Substances, which can cause false negative test results: 1. Ascorbic acid in excess of 250 mg/day. 2. Excessive amounts of vitamin C enriched foods (citrus fruits and juices) 3. Iron supplements which contain quantities of vitamin C in excess of 250 mg per day XIV. SAFETY: 1. Observe standard precautions. 2. Treat all patient specimens as potentially infectious and dispose of with proper precautions. 3. Developer is an irritant. Avoid contact with skin and eyes. 4. Developer is flammable and subject to evaporation. XV. LIMITATIONS OF PROCEDURES: 1. This test is read visually and requires color differentiation. It should not be interpreted by staff with blue color blindness. 2. Hemoccult tests are designed for preliminary screening as an aid to diagnosis. They are not intended to replace diagnostic procedures. 3. Blood, if present, may not be distributed evenly in feces consequently; a test result may be negative even when disease is present. 4. False positives can occur due to low but detectable levels of blood loss common to healthy adults. 5. Positive results can be obtained from patients free of polyps and colorectal cancers due to other causes of bleeding. 6. Negative results can be obtained from patients with polyps and colorectal cancers when there is no bleeding, intermittent bleeding and when the blood is not distributed uniformly in the fecal specimen. 7. The Hemoccult test should not be used to test gastric specimens. 8. Rehydration of guaiac test card with water is not recommended. XVI. PROCEDURE NOTES: 1. Fecal specimen should not be collected if hematuria or obvious rectal bleeding, such as from hemorrhoids is present. Pre-menopausal women must be instructed to avoid collecting fecal specimens during or in the first three days after a menstrual period. 2. Since bleeding from gastrointestinal lesions may be intermittent, fecal specimens for testing should be collected from three bowel movements Hemoccult Procedure revised 2-2006 Page 6 of 7 VANDERBILT UNIVERSITY MEDICAL CENTER POINT OF CARE TESTING HEMOCCULT (Fecal Occult Blood Test) PROCEDURE closely spaced in time. To further increase probability of detecting occult blood, separate samples should be taken from two different sections of each fecal specimen. 3. Neither the intensity nor the shade of blue from the Positive Performance Monitor area should be used as a reference for the appearance of positive test results. 4. Any blue originating from the Positive Performance Monitor area should be ignored when reading the sample test results. 5. If Hemoccult testing is not available due to lack of supplies, untrained staff, or any other problem that prevents accurate testing, alternative hospital laboratory testing must be done. XVII. REFERENCES: 1. 2. Hemoccult product insert #462478.E; Beckman Coulter, Inc.; 4300 N. Harbor Blvd., Fullerton, CA 92834-1300. Rev. September 2003. VUMC Point of Care Support Center Hemoccult Procedure revised 2-2006 Page 7 of 7