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Name of Policy: Cidex OPA Solution Test Strips Policy Number: 3364-135-028 Department: Radiology Approving Officer: Chief Executive Officer - UTMC Responsible Agent: Interim Chairman & Professor, Radiology Scope: Radiology HEALTH THE UNIVERSITY OF TOLEDO Effective Date: 5/1/2017 Initial Effective Date: 5/8/2014 D New policy proposal X Minor/technical revision of existing policy D Major revision of existing policy Reaffirmation of existing policy (A) Policy statement It is imperative to use Cidex OPA test strips in order to assure the accurate concentration levels of the Cidex OPA solution. (B) Purpose of policy Quality control procedures will be performed to test positive and negative controls of Cidex OPA test strips with each newly opened bottle. OPA strips are to be used to provide a means of testing concentration levels of ortho-phthaladehyde in Cidex OPA solution. (C) Quality Control Procedure 1. Note the date that the Cidex OPA strips bottle was opened and an expiration date 90 days from the opening date in the spaces provided on the bottle. 2. Precautions: Do not leave the test strip bottle open for more than 30 minutes. Keep cap closed tightly. Store bottle at controlled room temperature of 15-30 degrees C (59-86 degrees F) and in a dry place. Do not use after 90 days of opening the bottle or bottle expiration date. 3. To prepare the positive and negative control solutions for testing, first verify the expiration date for the Cidex OPA solution is appropriate. This solution may be used as a positive control. To prepare the negative control, dilute one part of the full strength solution with one part of water. Label each control solution appropriately. 4. Following the directions for use, submerge three test strips in each of the above solutions for one second each. Remove. The three strips dipped in the diluted negative control

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Page 1: Name of Policy: HEALTH - University of Toledo3364-135-028 Cidex OP A Solution Test Strips Page 2 should either remain completely blue or exhibit color change to purple when read at

Name of Policy: Cidex OPA Solution Test Strips

Policy Number: 3364-135-028

Department: Radiology

Approving Officer: Chief Executive Officer - UTMC

Responsible Agent: Interim Chairman & Professor, Radiology

Scope: Radiology

HEALTHTHE UNIVERSITY OF TOLEDO

Effective Date: 5/1/2017Initial Effective Date: 5/8/2014

D New policy proposal X Minor/technical revision of existing policy

D Major revision of existingpolicy

Reaffirmation of existing policy

(A) Policy statement

It is imperative to use Cidex OPA test strips in order to assure the accurate concentrationlevels of the Cidex OPA solution.

(B) Purpose of policy

Quality control procedures will be performed to test positive and negative controls ofCidex OPA test strips with each newly opened bottle. OPA strips are to be used toprovide a means of testing concentration levels of ortho-phthaladehyde in Cidex OPAsolution.

(C) Quality Control Procedure

1. Note the date that the Cidex OPA strips bottle was opened and an expiration date 90 daysfrom the opening date in the spaces provided on the bottle.

2. Precautions: Do not leave the test strip bottle open for more than 30 minutes. Keep capclosed tightly. Store bottle at controlled room temperature of 15-30 degrees C (59-86degrees F) and in a dry place. Do not use after 90 days of opening the bottle or bottleexpiration date.

3. To prepare the positive and negative control solutions for testing, first verify theexpiration date for the Cidex OPA solution is appropriate. This solution may be used as apositive control. To prepare the negative control, dilute one part of the full strengthsolution with one part of water. Label each control solution appropriately.

4. Following the directions for use, submerge three test strips in each of the above solutionsfor one second each. Remove. The three strips dipped in the diluted negative control

Page 2: Name of Policy: HEALTH - University of Toledo3364-135-028 Cidex OP A Solution Test Strips Page 2 should either remain completely blue or exhibit color change to purple when read at

3364-135-028Cidex OP A Solution Test StripsPage 2

should either remain completely blue or exhibit color change to purple when read at 90seconds.

(E) Testing Cidex OPA soaking solution concentration levels

1. Obtain test strip and submerge in solution for 1 second and remove.2. Remove excess solution by standing the strip upright on a paper towel. Do not

shake strip after removal.3. Read results 90 seconds after test strip is removed from the solution. Do not read

the pad after 2 minutes. Follow strip color chart on the bottle.4. Record results in logbook.5. If reading is not at the highest level, discard the soaking solution.6. Discard the Cidex OPA soaking solution after 14 days.

Approved by:

- , 7. fC^M Ir •<#>"//> 5/1 / / 7^ilailnam Elsamaloty, MD | Date

Interim Chairman & Professor, Radiology

O r~2 \^<£~- ((^ £^-U_ Gt twbj Ic^q

Daniel Barbee, RN, BSN, MBA DateChief Executive Officer - UTMC

Review/Revision Completed by:Haitham Elsamaloty, MD

Next Review Date: 5/1/2020