Day 4 Pre – Examination Processes

1. Day 4 Pre – Examination Processes Dr. Viral Patel

2. The result of any laboratory examination is only as good as the sample received in the laboratory Sample Management-Module 5

3. Goodsamplemanagement Sample Management-Module 5

4. 5.4 Pre Examination Processes

5. 5.4 Pre-examination processes • 5.4.1General • 5.4.2Information for patients and users • 5.4.3Request form information • 5.4.4Primary Sample collection and handling • 5.4.4.1General • 5.4.4.2 Instructions for pre collection activities • 5.4.4.3Instruction for collecting activities • 5.4.5 Sample transportation • 5.4.6Sample reception • 5.4.7 Pre examination handling, preparation and storage

6. 5.4 Pre-examination processes (The clause is substantially rewritten) 5.4.1General • The laboratory shall have documented procedures and information for pre-examination activities to ensure the validity of the results of examinations.

7. 5.4.2Information for patients and users Amended • The laboratory shall have information available for patients and users of the laboratory services. The information shall include as appropriate: • the location of the laboratory; • types of clinical services offered by the laboratory; • hours of operation of the laboratory;

8. the examinations offered by the laboratory, including • information concerning samples required, • primary sample volumes, • special precautions, • turnaround time, (which may also be provided in general categories or for groups of examinations), • biological reference intervals, and • clinical decision values; • instructions for completion of the request form; • instruction for preparation of the patient; • instructions for patient-collected samples;

9. 5.4.2Information for patients and users (Continued)... • instructions for transportation of samples, including any special handling needs; • any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals if referral is required); • a list of factors known to significantly affect the performance of the examination or the interpretation of the results;.

10. 5.4.2Information for patients and users (Continued)... • availability of clinical advice on ordering of examinations and on interpretation of examination results; • the laboratory’s policy on protection of personal information; and • the laboratory’s complaint procedure . • The laboratory’s criteria for sample acceptance and rejection

11. 5.4.2Information for patients and users (Continued)... • The laboratory shall have information available for patients that includes an explanation of any clinical procedure to be performed to enable informed consent. Importance of provision of patient and family information, where relevant (e.g. for interpreting genetic examination results), shall be explained to the patient.

12. 5.4.3Request form information Amended The request form or an electronic equivalent shall allow space for the inclusion of, but not be limited to, the following: • unique identification, including • gender and • date of birth, and • the location/contact details of the patient;

13. 5.4.3Request form information Amended • name or other unique identifier of • clinician, healthcare provider, or other person • legally authorised to • request examinations or • use medical information, • together with • the destination for the report and • contact details;

14. 5.4.3Request form information Amended • type of primary sample and, • where appropriate, the anatomic site of origin; • examinations requested; • clinically relevant information about • the patient and the request, • for examination performance and • result interpretation purposes; • date and, where appropriate, • time of primary sample collection, and

15. 5.4.3Request form information Amended • date and time of sample receipt. • The laboratory shall have a documented procedure concerning verbal requests for examinations that includes • providing confirmation by request form or • electronic equivalent within a given time. • The laboratory shall be willing to cooperate with users or their representatives in clarifying the user’s request.

16. 5.4.4Primary Sample collection and handling Significant Editorial 5.4.4.1General • The laboratory shall have documented procedures for • the proper collection and • handling of primary samples. • The documented procedures shall be available to those responsible for primary sample collection whether or not the collectors are laboratory staff.

17. 5.4.4Primary Sample collection and handling 5.4.4.1General Where the user requires • deviations and exclusions from, or • additions to, the documented collection procedure, these shall be recorded and included in all documents containing examination results and shall be communicated to the appropriate personnel New.

18. 5.4.4.2 Instructions for pre collection activities The laboratory's instructions for pre collection activities shall include the following: • completion of request form or electronic request; • preparation of the patient (e.g. instructions to caregivers, phlebotomists, sample collectors, and patients); • type and amount of the primary sample to be collected; • special timing of collection, if required; and • clinical information relevant to or affecting sample collection, examination performance, or result interpretation (e.g. history of administration of drugs).

19. 5.4.4.3Instruction for collecting activities The laboratory’s instructions for collection activities shall include the following: • determination of positive identification, in detail, of the patient from whom a primary sample is collected; • verification that the patient meets pre examination requirements (e.g., fasting, etc.) • instructions for collection of primary sample (e.g. phlebotomy, skin puncture, blood and non-blood samples), with descriptions of the primary sample containers and any necessary additives;

20. 5.4.4.3Instruction for collecting activities • In situations where the primary sample is collected as part of clinical practice, information and instructions regarding suitable specimen containers, any additives needed and any necessary processing and sample transport conditions shall be determined and communicated to the appropriate clinical staff New.

21. 5.4.4.3Instruction for collecting activities • instructions for labelling of primary samples in a manner that provides an unequivocal link with the patients from whom they are collected; • recording of the identity of the person collecting the primary sample and the collection date, and recording of the collection time, where applicable; • instructions for proper storage conditions before collected samples are delivered to the laboratory; and • safe disposal of materials used in the collection.

22. 5.4.5 Sample transportation • The laboratory’s instructions for post collection activities shall include packaging of samples for transportation. • The laboratory shall monitor the transportation of samples to the laboratory such that they are transported • within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned; • within a temperature interval specified for sample collection and handling and with the designated preservatives to ensure the integrity of samples; and

23. 5.4.5 Sample transportation continue… • in a manner that ensures the integrity of the sample and the safety for the carrier, the general public, and the receiving laboratory, in compliance with established requirements. Note: • In such an instance, the signature of that person taking responsibility for the primary sample identification should be recorded on, or traceable to, the request form. • If this requirement is not met for any reason, the person responsible should be identified in the report if the examination is carried out. • Samples to be set aside for future examination (e.g., viral antibodies, metabolites relevant to the clinical syndrome) should also be identifiable.

24. 5.4.6Sample reception The laboratory’s procedure for sample reception shall ensure that the following activities take place. • Samples are unequivocally traceable, by request and labelling, to an identified patient or site. • Laboratory-developed and documented criteria for acceptance or rejection of samples are applied.

25. 5.4.6Sample reception continue… • Where there are • problems with patient or sample identification, • sample instability due to delay in transport or • inappropriate container(s), insufficient sample volume, or • when the sample is clinically critical or irreplaceable and the laboratory chooses to process the sample, the final report shall indicate the nature of the problem and, where applicable, that caution is required when interpreting the result.

26. All primary samples received are recorded in an accession book, worksheet, computer or other comparable system. The date and time of receipt and/or registration of samples shall be recorded. Whenever possible, the identity of the person receiving the sample shall also be recorded. • Only authorised personnel • systematically review requests and samples and • decide which examinations are to be performed and • the methods to be used in performing them..

27. 5.4.6Sample reception continue… • Where relevant, there are instructions for the receipt, labelling, processing and reporting of those primary samples specifically marked as urgent. The instructions shall include • details of any special labelling of the request form and primary sample, • the mechanism of transfer of the primary sample to the examination area of the laboratory, • any rapid processing mode to be used, and • any special reporting criteria to be followed.

28. 5.4.6Sample reception continue… • All portions of the primary sample shall be unequivocally traceable to the original primary sample.

29. 5.4.7 Pre examination handling, preparation and storage • The laboratory shall have procedures and appropriate facilities for securing patient samples and avoiding deterioration, loss or damage during pre examination, handling, preparation and storage. • Laboratory procedures shall include instructions (e.g., time limits, etc.) for requesting additional examinations or further examinations on the same primary sample

30. Components LaboratoryPSMPolicies & Practices Sample Management-Module 5

31. The Laboratory Handbook contains information needed by those who collect samples available to all sample collection areas must be understood by all laboratory staff referenced in the quality manual Sample Management-Module 5

32. Laboratory Handbook Contents name and address of laboratory contact names and telephone numbers hours of operation list of tests that can be ordered sample collection procedures sample transport procedures expected turn around times (TAT) how urgent requests are handled Sample Management-Module 5

33. The Laboratory’s Responsibilities Provide appropriate containers and supplies Provide sample collection informationWhat- When- How Define a good labeling system Assess all samples -preexamination Sample Management-Module 5

34. Test Requisition • patient ID • tests requested • time and date of sample collection • source of sample, when appropriate • clinical data, where indicated • contact information of requesting physician or authorized individual Sample Management-Module 5

35. Sample Management-Module 5

36. Collection Requirements patient preparation patient identification type of sample required type of container needed labeling special handling safety precautions Sample Management-Module 5

37. Provide sample collection information Sample Management-Module 5

38. Labeling Each sample should be labeled with: patient’s name patient’s unique ID number test ordered time and date of collection collector’s initials Use computer-generated bar codes when possible Sample Management-Module 5

39. Nurse from different ward Nurse not familiar with task Regular staff off sick Wrong blood group given Cross-match sample mislabeled Verbal instruction given LaboratoryHandbook not easy to locate Nursing station re-organized Shift changepatient admit Delay in admitting dept Two patients collected Samples taken to nursing station Sample labelling error example Samples not labeled at bedside major transfusion reaction Switched samples Sample Management-Module 5

40. Outcomes of Improper Collection delays in reporting test results unnecessary re-draws/re-tests decreased customer satisfaction increased costs incorrect diagnosis / treatment injury death Sample Management-Module 5

41. Preexamination Steps Verify completeness of test request appropriateness of sample information on label Record in register or log Enforce sample rejection criteria Sample Management-Module 5

42. Labeled samples, completed requisitions Spilled urine sample, a cause for rejection Sample Management-Module 5

43. Actions for Rejected Samples inform authorized person request another sample record rejected samples retain rejected sample based on preset criteria extraordinary circumstances may require testing suboptimal samples Sample Management-Module 5

44. Sample Register or Log A register should include: • date and time of collection • date and time of receipt • sample type • patient name • demographics as required • laboratory assigned identification • tests to be performed Sample Management-Module 5

45. Sample Tracking-Manual confirm receipt of samples, include date and time label samples appropriately; keep with the test requisition until laboratory ID is assigned track aliquots–traceable to the original sample Sample Management-Module 5

46. Sample Tracking-Computer Database entries include: identification number patient information collection date and time type of sample tests to be performed name of health care provider location of patient, e.g., ward, clinic, outpatient diagnostic test results time and date results are reported Sample Management-Module 5

47. Sample Handling Handle all samples as if infectious Sample Handling Universal Precautions Sample Management-Module 5

48. Sample Storage-Written Policy describe samples to be stored determine retention time determine location describe proper conditions establish method of organizing samples Sample Management-Module 5

49. Sample Retention set policy for retention monitor stored samples, including freeze/thaw cycles maintain an organized, accessible system establish a schedule to review all stored samples establish tracking procedures Sample Management-Module 5

50. Sample Referral Record: samples referred date of referral name of person referring test Monitor / Track, and Record: turnaround time results delivery (from referral laboratory, to requestor) problems with referral Sample Management-Module 5