confirmatory referral guidelines - tti -...

CONFIRMATORY REFERRAL GUIDELINES 1

CONFIRMATORY REFERRAL GUIDELINES

ANNEX 1: INSTRUCTIONS FOR CONFIRMATORY REFERRAL OF BLOOD SPECIMENS

FOUND REACTIVE TO TRANSFUSION TRANSMISSIBLE INFECTIONS (HIV/HBV/HCV/MALARIA)

Effectivity: February 22, 2014 | Revision Date: May 1, 2016 | Version: 4

1. PURPOSE This document provides instructions for the confirmatory referrals of blood specimens found reactive to HIV, HBV, HCV and Malaria. It also provides instructions for the testing performance validation of blood service facilities.

2. METHOD a. SCOPE

All blood units and components found reactive to HIV, HBV, HCV and Malaria shall be sent to the RITM TTI-NRL

i. Segregate and label all reactive blood units and components found reactive to HIV, HBV, HCV and Malaria in a clearly designated and safe area. Keep refrigerated at 2-4°C.

ii. For components which has already been separated, send only the bag containing the plasma (i.e. platelet concentrate, fresh frozen plasma, cryoprecipitate)

iii. In the event of an unconscionable delay in shipment, freeze an aliquot of 10 mL plasma at -20°C or lower and send within two (2) weeks (within the National Capital Region) or within one (1) month (for regional blood centers)

iv. For Malaria confirmation, send a Dried Blood Spot. (See Annex 6. Preparation of Dried Blood Spot)

v. HBV Samples tested using the following kits with an optical density (OD) or sample/cut off value (S/Co), which exceeds the set cut-off points, should no longer be sent for confirmation (Table 1). (See Annex 1: Department Circular No. 2012-0198) Table 1. HBV Cut-Off Points

ASSAY REAGENT KIT CUT-OFF POINT Abbott AxSYM HBsAg (S/Co) ≥ 34.9 Roche cobas Elecsys HBsAg (S/Co) ≥ 20.46 Abbott Architect HBsAg (S/Co) ≥ 34.32 BIO-RAD Monolisa HBsAg ULTRA (OD/COV ≥ 20.1125

1. Blood service facilities using these kits should accomplish and submit the HBV Quarterly Referral Report form. (See Annex 2: HBV Quarterly Report Form)

2 CONFIRMATORY REFERRAL GUIDELINES

vi. Blood units that have been screened reactive to Syphilis should no longer be sent for confirmatory testing. (See Annex 3: Department Circular No. 2013-0132)

vii. Blood units that have been tested reactive by methods that do not conform to the guidelines herein shall not be accepted for confirmatory testing. (See Annex 3: Department Circular No. 2013-0132)

viii. All referring blood service facilities are required to accomplish and submit the TTI Quarterly Report Form. (See Annex 4: TTI Quarterly Report Form)

b. DOCUMENT REQUIREMENTS PRIOR TO SHIPMENT i. A completely filled-out Confirmatory Request Form should accompany each

specimen for proper documentation. (See Annex 5: Confirmatory Request Form) 1. Ensure that the information on the confirmatory request form matches

the information on the blood unit and dried blood spot.

c. SAMPLE REJECTION CRITERIA i. Specimens are UNACCEPTABLE for confirmation if they fall under any of the

following criteria (NOTE: TTI-NRL shall NOT test rejected samples): 1. General Criteria

a. Discrepant samples Aliquoted sample or blood bag labels SHOULD be IDENTICAL to the information provided in the confirmatory request form. Table 2. Example of Discrepant Labels CORRECT INCORRECT SAMPLE LABEL

2012-123456789 2012-123456789

REQUEST FORM

2012-123456789 12-123456789

SAMPLE LABEL

J.D.C J.D.C

REQUEST FORM

J.D.C Juan dela Cruz

SAMPLE LABEL

12345 (MGH) NVBSP 12345 (MGH) NVBSP

REQUEST FORM

12345 (MGH) NVBSP (MGH) NVBSP 12345

b. Sample labels not clear. (Refer to section 2-E-II-3 for Proper

Sample Labeling) c. Illegible handwriting on Confirmatory Request Form. (Write

legibly in BOLD letters) d. Samples with an optical density reading that exceeds the set cut-

off value. (Refer to section 2-A-IV)


2. Blood Units and Components a. Spilled or damaged during storage and transport. (Refer to

section 2-E for proper sample packaging) b. Contaminated samples as a result of spillage or improper

storage. c. Aged samples (i.e. stored at 4°C for more than 1 month prior to

receipt) d. Blood units with intact needles.

3. Aliquoted Samples a. Broken glass test tube container. (The container may break

during transport especially when packed improperly) b. Insufficient amount of plasma. (Aliquoted samples are required

to be at least 10 mL) 4. Dried Blood Spot (See Annex 6: Preparation of Dried Blood Spot for

Malaria Confirmation) a. Insufficient quantity of blood.

b. Damaged blood sport (scratched or abraded filter paper).

c. Insufficiently dried prior to mailing.

d. Appears hemolyzed, discolored or contaminated.

d. TIMING OF SHIPMENT TO RITM

As the quality of confirmatory testing is dependent on sample age, these should be send to RITM within one (1) week after screening tests are done.

i. Blood units and components tested for HIV using an antigen-antibody combination test kit should be sent within five (5) days as HIV antigen deteriorates on storage. However, if a considerable delay is anticipated, freeze an aliquot of 10 mL plasma at -20°C or lower and send within two (2) weeks.

ii. For regional blood centers, specimens may be sent within one (1) month; however, in this case, separate an aliquot of 10 mL plasma and keep samples frozen at -20°C or lower.

Module 14: EQA – Dried Blood Spots 8 Participant Manual 2005

Valid DBS Specimen

On the card with MB/KP/120, the blood is spreading from one circle to another due to the anemia (anemic blood is more fluid). This is still considered a valid specimen. Blood has completely filled the circle. Notice that the third and fifth circles have been punched (hence the white area in the middle).

Invalid DBS Specimen

This specimen is invalid because quantity of blood is insufficient for testing. This may have been caused by::

• Removing filter paper before blood has completely filled circle or before blood has soaked through to the other side

• Applying blood to filter paper with a capillary tube

• Filter paper coming in contact with gloved or ungloved hands or substances such as hand lotion or powder, either before or after blood specimen collection


This specimen is invalid because it appears scratched or abraded. This may have been caused by applying blood with a capillary tube or other device.


This specimen is invalid because the specimen was not dry before mailing. DBS must dry a minimum of 4 hours before packaging and shipping.


Valid DBS Specimen












Valid DBS Specimen













This specimen is invalid because the specimen appears clotted or layered. This may have been caused by:

• Touching the same circle on the filter paper to blood drop several times

• Filling circle on both sides of filter paper

The volume of specimen will not be uniform between spots resulting in errors during the testing process.


This specimen is invalid because the specimen appears hemolyzed, discolored, or contaminated. This may have been caused by:

• Squeezing or “milking” of area surrounding the puncture site

• Allowing filter paper to come in contact with glove or ungloved hands or substances either before or after blood collection

• Exposing blood spots to direct heat


This specimen is invalid because the specimen exhibits serum rings – in other words, serum becomes separate from cells. This may have been caused by:

• Not allowing alcohol to dry at puncture site before making skin puncture

• Allowing filter paper to come in contact with alcohol, hand lotion, etc.

• Squeezing area surrounding puncture site excessively

• Drying specimen improperly



e. SAMPLE PACKAGING The blood bank staff must ensure that the specimens are properly packed during transport so that it will arrive in good condition and will not pose any hazard to human health and the environment. Blood units and aliquoted samples should be arranged according to the requested examination (HIV first followed by HBV, HCV and Malaria). The Confirmatory Request Forms should also be arranged according to the order the blood units/aliquoted samples were packed to facilitate a better, faster, safer and orderly receipt.

i. Blood Units and Components 1. Make sure that the needle has been removed from the blood units and

that the tubing is tightly sealed to prevent possible leakage. 2. Place each blood unit or component in a plastic bag and seal tightly.

Label the plastic bag with the name of the referring blood service facility and requested confirmatory test. (HIV, HBV, HCV, Malaria)

3. Place in a cold transport container and surround with an adequate amount of frozen ice packs depending on the size of the transport box to maintain a refrigerated environment (2-4°C) during transport. Extra care should be taken to prevent hemolysis.

4. Place the Confirmatory Request Form/s in a separate plastic bag to

prevent it from being soiled or contaminated. If possible, collate the Confirmatory Request Form/s and place them inside a brown envelope and attached securely outside the transport box.

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5. Document the shipment including the blood unit information, date sent,

name of referring blood service facility, name of shipper, name of consignee, acknowledgement of courier and receipt at RITM.

ii. Aliquoted Samples 1. Ensure that the sample volume is at least 10 mL. 2. Secure the cap of the specimen tubes tightly and seal with a plastic

paraffin film to prevent leakage.

3. Ensure that the labels or markings will remain securely attached under all

conditions of storage and transport and these are clearly and legibly labeled with the following information:

a. Blood bag identification/code b. Serial number c. Blood type d. Collection date e. Requested confirmatory test

4. Insert specimen tubes in appropriate test tube racks to prevent the

specimens being in disarray during transport.


5. Place the specimens in a double plastic bag with enough absorbent material (e.g. paper towel, gauze pads, etc.). Label with the name of the referring blood bank and date of referral.

6. Place in a cold transport container and surround with an adequate amount of frozen ice packs depending on the size of the transport box to maintain the temperature of 2-4°C during transport.

7. Place the Confirmatory Request Form/s in a separate plastic bag to

prevent it from being soiled and contaminated. If possible, collate the Confirmatory Request Form/s and place them inside a brown envelope and securely attached outside of the transport box.

8. Document the shipment including the blood unit information, date sent, name of referring blood service facility, name of shipper, name of consignee, acknowledgement of courier and receipt at RITM.

iii. Dried Blood Spot for Malaria Confirmation 1. Place labeled dried blood spot filter paper into a sealable bag with a

desiccant. If multiple specimens are to be submitted, stack the filter papers between sheets of paper to prevent cross-contamination. Use a sealable bag that should be just the right size to hold the filter paper. Avoid using bags that are too big to prevent shuffling of the filter paper.

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2. Ensure that the bags are properly sealed to prevent moisture from

entering.

3. Label the outside of the sealed bag with the following information: a. Blood bag identification/code b. Serial number c. Blood type d. Collection date

4. Place the Confirmatory Request form/s and dried blood spot package in

the same envelope.

5. Keep packaged dried blood spot (in sealable plastic bags) cool and dry

until transport to the TTI-NRL. (Stability: 1 month stored at refrigerated temperature; >3 months stored at -20°C).

f. TRANSPORT TO RITM i. Label the shipment container legibly with a permanent marker and ensure that

the label is clear and not covered or obscured by any part or other attachments. 1. For blood banks in the National Capital Regions, blood specimens may

be sent directly to RITM during weekdays between 0800H – 1700H. Refrain from sending specimens beyond working hours, Fridays, weekends and holidays. Only authorized laboratory personnel of referring blood service facility are allowed to transport/deliver samples to RITM for referral.


2. For regional blood banks, ship the blood specimens through any accredited courier service that can guarantee delivery to RITM within 24 hours.

ii. Address the shipment to: TRANSFUSION TRANSMISSIBLE INFECTIONS - NRL Research Institute for Tropical Medicine 9002 Research Drive, DOH Compound, Filinvest Corporate City Alabang, Muntinlupa City 1781

iii. Transport boxes should be fastened securely inside the transport vehicle. A spill kit containing absorbent material, disinfectant, gloves, mask and disposal container (or biohazard bag) should be present inside.

g. INQUIRIES Please contact: TRANSFUSION TRANSMISSIBLE INFECTIONS NATIONAL REFERENCE LABORATORY Telephone: + 632 807 2628 local 229 Telefax: + 632 808 2552 Mobile: +63 998 459 5982 (Smart) | +63 916 639 3402 (Globe)

TRANSFUSION TRANSMISSIBLE INFECTIONS - NRL Research Institute for Tropical Medicine 9002 Research Drive, DOH Compound, Filinvest Corporate City Alabang, Muntinlupa City 1781

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