Policy/Principle: | Certification: | Testing Prerequisites: | Specimen: | Materials: | Testing Procedure: | Testing During | Routine Charging | Deep Discharge | Results Derivation: | Expected Result(s) | Infection Control: | References:
The BiliChek Bilirubin test is CMS “Waived” status, obviating Equivalent QC and Calibration Verification as stated in CLIA regulations. The BiliChek test is performed as a definitive function to monitor the baby’s Total Bilirubin level. Results of the test could trigger therapeutic interaction without reflex laboratory analysis. The BiliChek works by directing white light into the skin of the newborn and measuring the intensity of the specific wavelengths, which are returned. By knowing the spectral properties of the components of the skin, one can subtract out the interfering components and determine the concentration of bilirubin. The light reflected from the skin of neonates, and collected by the BiliChek, is analyzed with a highly sophisticated, proprietary algorithm to generate a serum bilirubin measurement.
The major skin components, which impact the spectral reflectance in newborns, are dermal maturity, melanin, hemoglobin and bilirubin. The intensity of the reflected light is converted to absorbance units, Optical Density (OD) for analysis. The total OD at each measured wavelength is equal to the sum of the component ODs. By measuring the intensity of the reflected light at more than 100 individual wavelength bands across the visible spectrum, a spectral analysis can be performed. By normalizing against a reference standard located on the disposable tip, the variation over time of the bulb and the photo-detectors are eliminated. The peak absorption of the bilirubin is at approximately 460nm as measured by subtracting the absorption of the other components for the total skin absorption. The absorption of a molecule is proportional to its concentration. Therefore, the absorption of bilirubin, as calculated above, is proportional to the concentration of bilirubin in the subcutaneous capillary beds and subcutaneous tissue. By subtracting the contribution of the aforementioned components, the bilirubin absorbance can be quantified and is correlated to the laboratory total serum bilirubin levels.
1. Orientation, authorization and competency of staff and licensed practitioners performing POCT are provided by the director’s (named on the CLIA certificate) designee as indicated in the “Point of Care (POCT) Program” procedure.
2. BiliChek testing will be performed by Nursing Service personnel who have been specifically certified:
3. Requirements:
A. To be certified, the requirements of the BiliChek; POC Self-Instructional/Competency documentation packet must be completed.
B. Re-certification is required annually:
a. Re-certification for an individual may be required more often if deemed necessary. When an instructor observes improper technique, he/she may decertify the operator on the spot. Arrangements for re-certification of that individual must then be made through their immediate supervisor.
b. To be re-certified, an operator must successfully complete the BiliChek; POC Self-Instructional Competency documentation packet.
C. The certification record for operators and instructors will be maintained in the department.
4. Physicians performing waived testing are exempt from training and competency.2
1. A physician order is not required for BiliChek testing.
2. The only laboratory-sanctioned non-invasive POCT Bilirubin analyzer is the BiliChek from Respironics.
3. Charging for the BiliChek Testing:
At MHC BiliChek Testing is not charged.
1. The BiliChek test can be performed on babies older than 28 weeks gestation and 0-20 days post-natal.
2. Measurement is taken on the flat center part of the baby's forehead. Do not use any other body part.
3. Do not take measurements from sites on the forehead with bruising, birthmarks, hematomas or excessive hairiness.
4. The BiliChek is not recommended for use in patients undergoing exchange transfusions.
1. BiliChek Analyzer
2. BiliChek Tips (Respironics #800-50)
Store at room temperature in original plastic dispenser. Protect against exposure to excessive heat, acid or alkaline fumes. Stable until expiration date on the label.3. Neo-guard Thermal Reflector (CAS Medical Systems Inc. #4200)
1. Apply a new Disposable Tip to the BiliChek unit.
2. Press and release either F1 or F2. The unit will perform a self-test, momentarily displaying all LCD indicators, measurement status indicator (MSI), software revision, configuration screen and end at the home screen.
3. Press and release the Trigger button to start calibration. Three dashes (---) will flash in the display window and the MSI will be amber, indicating the system is ready to calibrate.
Note: If a Disposable Tip is not in place the MSI will be red and an E01 error message will be displayed.
4. Press and release the trigger button again. The dashed lines will stop flashing indicating the system is calibrating.
5. The display window will read "005" when the calibration measurement is complete.
Note: If a problem occurs during calibration an error message will be displayed. Refer to the Troubleshooting Section of the manual for instruction.
Note: This unit is equipped with a Critical Power-Off feature. After completing the calibration, the unit will sound an alarm if no measurement is performed within a preset period of time. The unit will power-off 20 seconds later if F1 or F2 is not pressed. If the unit automatically shuts off, it is necessary to perform another calibration after restarting.6. After performing the calibration, remove the protective covering from the Disposable Tip and dispose.
7. Press and release the trigger button. The unit is now activated and ready to take a measurement. Gently press the Disposable Tip flat against the infant's forehead. The measurement status indicator (MSI) on the display will change from amber to green when proper pressure is applied. Do NOT continue to increase pressure, this will result in an E04 error message and the MSI will turn red.
Warning: Do not point the BiliChek at eyes while taking a measurement.
Note: If an error is displayed, you do not need to calibrate the unit again. Press and release F1 and F2 at the same time to return to the previous measurement screen. Gently press the tip to the baby's forehead and take another measurement.8. The display will read "005" and will stop blinking when proper pressure has been applied. The measurement should take approximately one to three seconds.
9. Take 5 measurements by lifting and then placing the Disposable Tip on the center of the infants forehead. Press and release the trigger button before each measurement. The current measurement being taken will be indicated on the display (005...004...003...002...001) and the unit will beep one time for each measurement successfully completed.
10. Upon completion of the five measurements, a beep will sound and the test results will be displayed with the current time and date.
11. Record the results in the patient's chart.
12. Remove and dispose of the Disposable Tip.
13. Place protective cover onto the BiliChek. The BiliChek will turn OFF automatically after 120 seconds.
VII. Testing During Phototherapy:
1. Select the site at which the BiliChek measurement will be taken. The preferred site is the flat area of the forehead between the infant's eyebrows.
2. A photo-opaque material must be placed over the measurement site on the forehead prior to the start of phototherapy. Any necessary precautions should be taken to ensure that the material does not move in such a way as to expose the measurement site to the phototherapy lights.
3. All phototherapy lights should be turned off while a BiliChek measurement is taken. Ensure that the preferred measurement site is still covered.
Note: If the site has become uncovered the BiliChek cannot be used for Bilirubin measurement. In this case a Lab Bilirubin will have to be performed.
Remove the light blocking material and take the BiliChek measurement from the preferred site. Replace the light blocking material and continue the phototherapy as indicated.4. Leave the adhesive skin patch in place after phototherapy has been discontinued to ensure that the same site is used for subsequent BiliChek measurements.
Note: Clinical studies indicate that as many as 48 hours may be required before the skin treated by phototherapy returns to the Bilirubin level of an unexposed site.
VIII. Routine Charging the BiliChek Device:
The charger base contains two wells, "A" and "B". "A" is for the BiliChek device, and "B" is for the spare battery pack. The two small lights on the front of the charger base indicate the operation of the battery charger and battery charge status.
Green indicates that the battery pack is fully charged.
1. The BiliChek is placed in the "A" well with the display window facing the operator.
2. The spare battery pack is placed in the "B" well with the latch up and facing the operator.
Note: The BiliChek unit will not fit in well "B" of the charger base. The battery pack can fit into well "A", but may not make the correct connection to the charger base.
IX. Deep Discharge of BiliChek Device:
In order to maintain optimal battery performance, the battery packs should be fully drained of power on a monthly basis. The charger base has the ability to manually drain the battery by using the "Charge/Deep Discharge" switch located on the bottom of the charger base. It is recommended by the manufacturer to discharge each battery pack every month.
1. To drain a battery pack of power, place the Deep Discharge switch in the right position and place one of the BiliChek battery packs in the "B" position of the charger base. The discharge/recharge cycle will take approximately 4.6-9.2 hours depending on the amount of charge in the battery pack.
Note: When Deep Discharging the battery pack, the light will blink amber then become a constant amber color when charging.2. The green light will illuminate when the battery pack has completely discharged and then recharged.
3. Use this battery pack on the BiliChek, and perform a Deep Discharge on the other battery pack.
4. After both battery packs have been discharged, place the Deep Discharge switch in the left position.
5. Document that the Deep Discharge was performed on the BiliChek Maintenance log.
1. Analytical range is 0 - 20 mg/dl.
2. If acceptable precision is obtained on the 5 measurements, the average of the 5 measurements is displayed on the BiliChek Analyzer in mg/dl.
3. If a measurement obtained is greater than 20mg/dl, the BiliChek display window will present E05-HIGH. If this occurs, have a laboratory Bilirubin drawn immediately and notify the patient's physician.
4. Small changes in successive transcutaneous bilirubin measurement of less than 2.0mg/dl (increase or decrease) should not be interpreted as definite trends.
XI. Expected Result(s) and/or Critical Values:
Full term infant:
1. 24 hours: < 5.8 mg/dl4
2. 48 hours: < 8.2 mg/dl4
3. 3-5 days: < 11.7 mg/dl4
1. Staff will wear a fresh pair of gloves while performing the test and will wash their hands after the procedure using established protocol.
2. BiliChek tips and gloves will be disposed of in accordance with the hospital's approved waste management policy.
1. BiliChek™ Non-Invasive Bilirubin Analyzer User Instruction Manual. Respironics. Kennesaw, GA. PN H 577-0148-00 Rev. E.
2. Susie McBeth, JCAHO Regional Agent. JCAHO Division of Research. Oakbrook Terrace, IL. 60181. (630)792-5000 4/9/2001
3. Steve Raymond, Technical Director; Pathology Associates, Dubuque, IA.
4. Pediatric Reference Ranges, Second Ed. Steven J. Soldin, Carlo Brugnara, Kurt C. Gunter, Jocelyn M. Hicks. AACC Press. Washington, D.C. 1997.
i. April 2002 L. McGovern/S. Raymond
ii. March 2007 L. McGovern/S. Raymond (Revised: XI.; XIII.4. added)
iii. October 2009 L. McGovern, S. Raymond (Revised: II.1. added)
Comprehensive Review:
Medical Director; P.A.:
Technical Director; P.A.:
Representative: Nursing Service Mercy
Representative: Nursing Service Finley
Interim Review: January 2011 L. McGovern (no changes)
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