POC. 07520

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Hello all!


   I am doing my self-inspection for our CAP inspection next fall. My question is in regards to the following standard:


POC.07520


"If the laboratory performs test procedures for which control materials are not commercially available. there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded."


Does this pertain to waived Hemoccult card testing since there are no commercial controls, only an internal control? Our ER physicians perform Hemoccult testing. The standard suggests testing specimen in duplicate or split-sample testing, etc. to verify test system performance. I know these physicians are not going to run the specimen again, so if this pertains, I am not sure what exactly to do. Any thoughts are greatly appreciated!


Thank you

4 Replies

Hemoccult is a waived test; analyzing the internal controls are sufficient.  However, testing personnel must document that the internal controls are done.  We use a QC log. 


There are commercial QC as my physicians used to perform Hemoccult tape method. This is what they used to use:


Quantimetrix Dropper Urine Dipstick Controls - liquid, ready to use, store at refrigerator temperature (2-8°C)
until expiry date. Do Not freeze.


5 positive + 5 negative / pack.



1)     
For Quality Control testing-
apply two drops of the control to one side of the tape. Wait 3 to 5 minutes.



2)     
Turn the tape over.



3)     
Apply two drops of Hemoccult Developer to the
reverse side of the tape, directly behind the QC.



4)     
Read the results on the reverse side of the smear within 60 seconds
Any trace of blue on or at the edge of the smear is a positive result.


 


 


 



Kathy Andrews
MLT, RT


Point of Care Coordinator /
Coordinatrice des Analyses Hors Laboratoire


Moncton & Miramichi Area /
Régions de Moncton et Miramichi


Horizon Health Network / Reseau de Sante Horizon


Tel: (506)-857-5315    Fax: (506) 857-5325


kathy.andrews@horizonnb.ca                       


    Christmas



 




From: Ashlee By via POCT Listserv (Groupsite) [mailto:users+1245018@poct.groupsite.com]


Sent: December-06-19 2:25 PM

To: Andrews, Kathy (LAB) (HorizonNB)

Subject: [POCT Listserv] POC. 07520




 


ATTENTION! External email / courriel externe.



 


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reconnaissants de votre collaboration.


Another FYI….the physicians don’t particularly want to perform QC….It was the Nurse Manager whom I also trained that ran the controls and did the proficiency testing (CAP).


 



Kathy Andrews
MLT, RT


Point of Care Coordinator /
Coordinatrice des Analyses Hors Laboratoire


Moncton & Miramichi Area /
Régions de Moncton et Miramichi


Horizon Health Network / Reseau de Sante Horizon


Tel: (506)-857-5315    Fax: (506) 857-5325


kathy.andrews@horizonnb.ca                       


    Christmas



 




From: Ashlee By via POCT Listserv (Groupsite) [mailto:users+1245018@poct.groupsite.com]


Sent: December-06-19 2:25 PM

To: Andrews, Kathy (LAB) (HorizonNB)

Subject: [POCT Listserv] POC. 07520




 


ATTENTION! External email / courriel externe.



 


------- Horizon Health Network Disclaimer -------



This e-mail communication (including any or all attachments) is intended

only for the use of the person or entity to which it is addressed and may

contain confidential and/or privileged material. If you are not the intended

recipient of this e-mail, any use, review, retransmission, distribution,

dissemination, copying, printing, or other use of, or taking of any action in

reliance upon this e-mail, is strictly prohibited. If you have received this

e-mail in error, please contact the sender and delete the original and any

copy of this e-mail and any printout thereof, immediately. Your

co-operation is appreciated.



Le présent courriel (y compris toute pièce jointe) s'adresse uniquement à

son destinataire, qu'il soit une personne ou un organisme, et pourrait

comporter des renseignements privilégiés ou confidentiels. Si vous n'êtes

pas le destinataire du courriel, il est interdit d'utiliser, de revoir, de

retransmettre, de distribuer, de disséminer, de copier ou d'imprimer ce

courriel, d'agir en vous y fiant ou de vous en servir de toute autre façon.

Si vous avez reçu le présent courriel par erreur, prière de communiquer

avec l'expéditeur et d'éliminer l'original du courriel, ainsi que toute copie

électronique ou imprimée de celui-ci, immédiatement. Nous sommes

reconnaissants de votre collaboration.

Our policy states the following:


 


QUALITY CONTROL:


Two quality control mechanisms are used for this test:



  1. With each test, the built-in positive and negative control dot areas are utilized. If the expected reaction on these areas does not occur, do not report the results of this test. Obtain a new test card and test again.

  2. With each new box of Hemoccult Sensa occult blood cards use two fecal occult blood external control samples. These samples are prepared in-house using fecal control material. External control 1 is control material with no added hemoglobin and  should test negative on the Hemoccult Sensa test, while External control 2 has patient RBC's (hemoglobin) added and should test positive. If the expected reactions do not occur, test using other test cards. If the expected reactions still do not occur, set this kit aside and return to the vendor for credit. If the appropriate reactions occur, place a green "This Lot Ready For Use" label on the box to indicate that the test kit is satisfactory. Indicate in the Kit Test Log that the lot number has performed acceptably and is ready for use.


External quality control is performed with each new lot and each new shipment. Internal quality control is performed with each test.


Internal Quality control is recorded on the Daily Log with each patient test run.


 


Hope this helps


Alayna

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