Institution Laboratory Name Location Head/Responsible Person

Institution Code: Laboratory name Standard Operating Procedure (SOP) Version: no. Location Date: of release Head/Responsible person Sample reception and accessioning Page: 1 of 5

1. Sample Reception and Accessioning – Study specific sample flow procedures

2. Objectives and scope

This SOP will describe the receipt and accessioning of samples in laboratory. This will help maintain patient confidentiality, prevent sample mix up, ensure sample integrity, and overall quality handling of specimens. It is imperative that this SOP is followed appropriately by all personnel in the laboratory. This procedure is the first step in preparing patient specimens for processing, storage, and transfer to appropriate parts of the laboratory for testing. The SOP also describes study specific sample flow procedures by use of flow diagrams.

This SOP is applicable to all technical employees of the laboratory.

3. Abbreviations, definitions and terms

• N.A. Not applicable • QM Quality Manual • SOP Standard Operating Procedure • LRFR Laboratory Request Form Reconciliation form

4. Tasks, responsibilities and accountabilities

Task Responsible Accountable Unpacking and reception of Lab tech at reception bench Lab Manager samples Accessioning of samples in Lab tech at reception Lab Manager the database bench Ordering of tests in the Lab tech at reception bench Lab Manager database Rejection of samples Lab tech at reception bench Lab Manager

Following the sample flow Lab tech at reception bench Lab Manager

5. Safety and environment

 For safety measures use Personal Protective Equipment  All contaminated materials must be placed in biohazard bags/containers during working. No contaminated waste should be thrown on the floor.

6. Procedure

6.1 Reagents and Materials

• Laboratory Register Book • Pens; black and red • Fine tip Markers • Gloves

Source: GLI Stepwise Process towards TB Laboratory Accreditation Institution Code: Laboratory name Standard Operating Procedure (SOP) Version: no. Location Date: of release Head/Responsible person Sample reception and accessioning Page: 2 of 5

• Laboratory Coat • Sample racks • Laboratory Request Form file • Database • Disinfectantant • Rejection forms

6.2 Stepwise procedure

1. Biological specimens such as sputum and aspirates are collected via standard techniques and are delivered to the laboratory. 2. The samples must be shipped to the laboratory under conditions that are appropriate for subsequent processing, culture and testing. 3. Each sample MUST be accompanied by a laboratory requisition form or its equivalent for research samples. 4. Unpack the patient samples and the requisition forms. Match each sample with the corresponding request form and make sure that the identifiers on the sample containers match those on the request form. • If there is an inconsistency between the sample label and request form, a Laboratory Request Form Reconciliation (LRFR) form (appendix 1) should be sent to the clinic to clarify the label on the tube. Keep a copy of the request form and the reconciliation forms. • If the distance from the laboratory to the clinic is big, the health unit may be notified by phone about the inconsistence and corrections made. In this case the LRFR will be completed at the laboratory on behalf of the person answering the call. • Try to complete reception of samples while the person who delivered them is still present so that he can carry back some information if available. • Documentation of any corrections made should be noted on the lab requisition form and the LRFR form. 5. The date and time that the samples were received at laboratory and the initials of the personnel handling the samples, sample appearance and volume are noted on the lab requisition form. The volume should be at least 0.5 ml 6. Log on into the database and proceed to the accessioning window. Accession the sample in the database; a database generated laboratory serial number is allocated to the sample. 7. Record the Laboratory serial number from the database on the request form and the corresponding specimen containers. 8. Record the sample laboratory number and the patient’s information in the laboratory register book in which subsequent monitoring will be done. 9. Put all received samples on a suitable rack and transfer them to the fridge from where the person processing or testing will pick them up (notify this person when samples are ready for testing). 10. If urgent samples or considerable number of samples have been received, notify the processing personnel accordingly to start processing them directly. 11. If specimens have been received later in the evening, store appropriately till the next morning. Transfer samples to the fridge at 2 - 8°C overnight. 12. Dispose packing waste (cotton wool, gauze etc.) in the biohazard bag/container under the table.

6.2 Sample Rejection Criteria

The laboratory shall reject specimens, when it is really necessary, to minimize the inconveniences associated with such. It is however important to note that under certain circumstances, it may be dangerous to patients or laboratory staff or both to proceed with analysis of samples. Under such conditions the laboratory will take the painful option of rejecting the specimen. 1. A sample will be rejected if it meets one or more of the following criteria: a. Sample container is broken, damaged, or leaking. Do not try to rescue such a sample as it may expose you to infection risks. b. Sample container is not labeled or there is not enough information on the container to match with the laboratory request form. c. Information on laboratory request form does not match sample label. d. Sample was not accompanied by a request form. e. Sample collected in an inappropriate container (antibiotic bottles, narrow-necked bottle, or in toilet tissue) f. Sample volume is too little and container appears empty. Note: A comment will be made on the report that the sample volume may have compromised the results if testing is done anyway. 2. The Sample Rejection Form (see Appendix 2) must be completed whenever a sample is rejected, photocopied and the original sent to the health center where the sample came from while the photocopy is filed at the laboratory. 3. The request form of the rejected sample shall be written across “SAMPLE REJECTED” and stapled together with the sample rejection form. A copy of rejected request form shall be kept together with the copy of the sample rejection form.

7. Related documents

SOP Sample Collection and Transport

8. Related forms

9. References

CAP General checklist ISO 15189 Medical Laboratories – Particular requirements for quality and competence

10. Attachments / Annexes

Laboratory Request Form Reconciliation (LRFR) Form

Laboratory Tech. Name Signature

Person who requested the test TO DATE

Health Unit

Patient Name/ID

Dear Sir/Madam/Dr/Prof. Please note that there was a problem with your laboratory request form for the above patient as explained below;

SECTION FOR PERSON CORRECTING THE PROBLEM Correct the problem or fill in the missing information on the laboratory request form. If corrections involve crossing out, do so using a single line across text, put your initials and date below. Sign this form after fixing the problem and insert comments if any.

Comments of person correcting the problem

Name Signature & Date

***Photocopy the request form before sending it back for reconciliation.

SAMPLE REJECTION FORM

Patient Name/ Sample ID Date collected

Date and Time sample Received at laboratory

The above sample has not met the criteria of a good specimen for the tests requested and processing this sample will give unreliable results. Therefore we cannot submit the specimen for further analysis.

You are advised to collect another specimen from the patient if possible. REASON FOR SAMPLE REJECTION Criteria for Sample Reception* Criteria for Sample Reception Met Not Met (reason for rejection) Sample collected in proper container Sample properly sealed/not leaking Sample properly labeled at least with name/patient ID and Date of collection Sample delivered is appropriate for tests requested Volume of samples requiring culture must be at least 0.5ml and above (ideal volume is 5ml) Sample was delivered with a request form At least patient name on both request form and sample container should be in agreement

*** For each of the criterion, tick the appropriate column if it has been met or not met We apologize for any inconvenience this has caused.

laboratory Tech. Name/Signature: Date:

NB: Photocopy this form and the Laboratory Request form, staple the copies and keep in laboratory file while the originals are sent back to the clinic/person that sent the sample.

Source: GLI Stepwise Process towards TB Laboratory Accreditation