specimen management in microbiology

1. Specimen management in diagnostic microbiology Dr.T.V.Rao MD Dr.T.V.Rao MD

2. NABH Standards for Hospitals • The programme is made to fulfill major objectives of the AAC.7 Clause C on Policies and procedures guide collection, identification, handling safe transportation, processing and disposal of Microbiology Specimens Dr.T.V.Rao MD

3. How do we achieve excellent performance in the laboratory? Dependent on quality systems Dr.T.V.Rao MD

4. Why specimen management is a important factor • The specimens are collected and handled may directly affect the outcome of microbiological analysis, appropriate specimen management is critical to ensuring laboratory effectiveness and an acceptable turnaround time. Specific guidelines on specimen collection are necessary for optimal use of microbiology services. Dr.T.V.Rao MD

5. Accurate results dependent on quality management of specimens • Microbiology laboratory results that are accurate, significant, and clinically relevant depend almost entirely on the specimen managementprocess Dr.T.V.Rao MD

6. The Quality Assurance Cycle Pre-Analytic Patient/Client Prep Sample Collection Personnel Competency Test Evaluations Reporting • Data and Lab Management • Safety • Customer Service Post-Analytic Sample Receipt and Accessioning Record Keeping Sample Transport Quality Control Testing Analytic Dr.T.V.Rao MD

7. Organization • Support from the top level of the organization • Involve all persons in the organization • Conform with any regulatory requirements Dr.T.V.Rao MD

8. Process Control:Specimen Management • Request forms • Specimen - identification throughout process • collection (including patient preparation) • receipt and accessioning • rejection criteria • processing • transport • storage Dr.T.V.Rao MD

9. The result of any laboratory test is only as good as the sample received in the laboratory Dr.T.V.Rao MD

10. Specimen Management • Specimen Collection • Specimen Transport • Specimen Handling • Specimen Referral • Specimen Storage • Specimen Disposal Dr.T.V.Rao MD

11. Organization Personnel Equipment Process Control (QC & EQA) & Specimen Management Purchasing & Inventory Occurrence Management Assessment Documents & Records Process Improvement Customer Service Facilities & Safety The Quality System Information Management Dr.T.V.Rao MD

12. What is a Sample/Specimen Management Strategy (SMS)? • Sample management strategies vary among organizations. Overall, the goal of an SMS is for the organization to leverage assets (samples) for future research, eliminate costly development time, ensure informed consents are properly associated with the appropriate samples, and build an organization-wide sample library to pull samples with multiple data points Dr.T.V.Rao MD

13. Essential to accurate laboratory diagnosis Directly affects patient care and patient outcome Influences therapeutic decisions Impacts patient length of stay, hospital costs, and laboratory costs Influences laboratory efficiency Impact of Specimen Management on Patient Care Dr.T.V.Rao MD

14. Verify completeness of test request Verify integrity of the specimen Determine adequacy of specimen Appropriately labeled, legible identification Determine if appropriate specimen was submitted for requested test Identifier of the collector, e.g., phlebotomist, patient Enforce procedures for handling sub-optimum specimens Specimen rejection criteria Specimen Collection: Laboratory Responsibilities Dr.T.V.Rao MD

15. Should include instructions for: Positively identifying the patient before collecting a specimen Required specimen for each requested test Preparation of patient Type of collection container, required volume, timing Preservation of specimen, e.g., transport media Proper specimen labeling Special handling instructions, e.g., refrigeration Specimen Collection Procedures Dr.T.V.Rao MD

16. Swabs for Specimen Collection • Bacteria, aerobic - cotton, Dacron, or alginate is usually acceptable • Bacteria, anaerobe - tissue or aspirate is recommended. Resist placing swabs into Surgery. Use only anaerobe transport. • Chlamydia - Dacron or alginate but not cotton. Cytobrush is specimen of choice. No wooden shafts • Fungi - swabs not recommended • Viruses - cotton or Dacron but not alginate. No wooden shafts or charcoal. Dr.T.V.Rao MD

17. Compilation of documents that must be made available to all specimen collection areas Must be understood by all laboratory staff Includes: Name and address of laboratory Contact names and telephone numbers Hours of operation List of available tests Specimen collection procedures Specimen transport procedures Expected turn around times (TAT) How stat requests are handled May be referenced in the Quality Manual Laboratory Handbook Dr.T.V.Rao MD

18. Accepting every specimen ???. • This occurs mainly because laboratorianseither are afraid or have no support to say “no” to a physician or to reject the specimen that was inappropriately selected, collected, or transported. This indicates that there is little support for promoting quality in microbiology and that someone other than the microbiology- Dr.T.V.Rao MD

19. Accepting every transportdevice. • A swab is not the collection device of choice for many specimens, and for some specimens special swabs will be necessary. The laboratory must receive a specimen that is representative of the disease process. Specimens submitted for the diagnosis of otitis media should not be sent on swabs since the flora on the swab will likely be that of the external ear canal. The specimen of choice is an aspirate from a tympanocentesis Dr.T.V.Rao MD

20. Sites of Infection Where the Specimen is Likely to Become Contaminated During Collection • Middle ear ……………. External ear canal • Lower respiratory tract. Oropharynx • Nasal sinus…………….Nasopharynx • Bladder……………..… Urethra and perineum • Endometrium…………. Vagina • Superficial wounds…… Skin and membranes • Fistulae………………… GI tract Dr.T.V.Rao MD

21. Train personnel in appropriate safety and packaging procedures Package and preserve specimens appropriately Transport specimens at appropriate temperature Determine acceptable transport time Determine mode of transport Courier, ambulance, clinic/lab staff Adhere to the International Air Transport Association (IATA) regulations Specimen Transport Dr.T.V.Rao MD

22. Specimen Storage • Establish policy • What should be stored? • Determine retention time • Determine storage location • Consider ease of access • Assure proper storage conditions • Indexing of specimens • By day of receipt or accession number Dr.T.V.Rao MD

23. Specimen Storage Serum Banks: • Establish tracking procedures • Encourage use of information technology • Maintain an organized, accessible storage system • Monitor freeze/thaw cycles

24. Unlabeled specimen Insufficient patient information Hemolyzed specimen Wrong tube drawn Wrong specimen submitted Inadequate volume for the amount of preservative Insufficient quantity Prolonged transport Specimen Rejection Criteria: Dr.T.V.Rao MD

25. Be Prepared to say “No”(professionally) • Specimen management manual- spend the time to write what you really need; then follow it! • QC policy- remember, specimens can be out of control. You should never report out-of-control results! • References - document your position! • Read-Read-Read! - budget time to keep up! Dr.T.V.Rao MD

26. Specimen Handling • Handle all specimens as if infectious • Use tracking system for all specimens: • Accession / logging process • Confirm actual receipt of specimens • Date and time of specimen receipt • Track aliquots – traceable to the original sample Dr.T.V.Rao MD

27. Establish procedures for handling: Stat / urgent requests Delayed testing, e.g., storage, separation of serum/plasma from cells Leaking containers Contaminated forms Preservation of specimens Specimen Handling Dr.T.V.Rao MD

28. Working with ideal sample ???? • Providing appropriate support in the preanalytical, analytical, and postanalyticalphases of the laboratory testing process in microbiology requires working only with appropriate specimens Dr.T.V.Rao MD

29. Types of Collection Errors • Patient Identification • Phlebotomy Technique • Test Collection Procedures • Specimen Transport • Specimen Processing Dr.T.V.Rao MD

30. Transport of blood specimens in the proper manner after collection ensures the quality of the sample Timing Some specimens must be transported immediately after collection, for example Arterial Blood Gases. Specimens for serum or plasma chemistry testing should be centrifuged and separated within two hours Blood Specimen Transport Errors

31. Temperature Specimens must be transported at the appropriate temperature for the required test On ice—ABGs, Ammonia Warmed --98.6 degrees (37 C), cryoglobulins Avoid temperature extremes if transported from via vehicle from other collection site Transport Container Some samples need to be protected from light, for example, bilirubin Transport in leak-proof plastic bags in lockable rigid containers Transport Errors

32. The Dangerous Goods Regulations • Covers: • Packaging • Labelling Packages • Packing Instructions • Documentation • Training • Are updated annually by IATA Dr.T.V.Rao MD

33. Record: Tests / specimens referred Date of referral Name of person referring test Monitor / Track, and Record: Turnaround time Results delivery (from referral lab, to requestor) Problems with referral Specimen Referral Dr.T.V.Rao MD

34. Develop policy for disposal of medical waste Establish and follow disinfection procedures Comply with local regulations Include policy of disposal of rejected specimens Appoint someone with oversight responsibilities Establish a schedule to review all stored specimens Specimen Disposal Dr.T.V.Rao MD

35. Information Management • Managing incoming and outgoing information • Standardization of information capture • Privacy and confidentiality of patient information • Competency in relevant computer skills • Word processing • Spreadsheet • Database Dr.T.V.Rao MD

36. Laboratory Information Management System ( LIMS) and Computer System • IMS is an compliant system that performs integrated control and operation system, from order receipt entry to report writing. With the use of computer networks, it deals with a large number of samples in a speedy and precise manner. It also supports e-mail distribution to customers and realizes customer request with higher satisfaction through appropriate delivery management system. Dr.T.V.Rao MD

37. Summary: Avoiding Pitfalls • Remember good laboratory practice • Patients first! • Train all personnel responsible for collecting, handling, storage, transport of specimens • Monitor rejection log • Routinely communicate with customers • Update handbook, procedures when methods change Dr.T.V.Rao MD

38. Error Prevention • Phlebotomy Education • Phlebotomists should have completed a standard academic course in phlebotomy and undergo thorough on-the-job training under the supervision of a senior phlebotomist • Continuing Education • Phlebotomists should participate in regular educational competency assessments (written and observational) • Professional Licensure • Phlebotomy Staffing • Adequate staffing to maintain collection standards • Technology • Use of barcode scanners for patient identification Dr.T.V.Rao MD

39. Occurrence Management The process of dealing with laboratory problems and errors as they occur • Perform in a timely manner • Provide information to those affected by the problem or error Dr.T.V.Rao MD

40. Occurrence Management:How? • Collect information about systematic problems • Establish a process to detect all problems • Analyze the problem, take corrective action • Keep records Dr.T.V.Rao MD

41. We Microbiologists are responsible major issues ……….. • We are responsible for all phases of the testing cycle • Our Job Is To Educate Clinicians Using Our Services • In pre analytic phase of testing cycle: selection, collection and transport Dr.T.V.Rao MD

42. Key to accurate laboratory diagnosis Directly affects patient care and patient outcome Influences therapeutic decisions Impacts hospital infection control Impacts patient length of stay, hospital costs, and laboratory costs Influences laboratory efficiency Impact of Specimen Management on Patient Care

43. Who is responsible for Quality? • EVERYONE IN THE LABORATORY! • Laboratory management must commit to meeting quality needs • Laboratory personnel must follow all quality assurance procedures Dr.T.V.Rao MD

44. Consequences of Laboratory Errors • When errors occur at any point in this specimen management process, regardless of who might be responsible for the error, the result can be a negative outcome for the patient, such as misdiagnosis, extended length of stay and/or inappropriate therapy Dr.T.V.Rao MD

45. Laboratories need the support of physicians for a greatr success • The microbiology laboratory needs the support of its client physicians, not just that of laboratory management, to optimize the information coming from it. Laboratorians must be charged with the critical task of evaluating specimen quality and this report must be transmitted to the submitting physician in order for an accurate interpretation of specimen results to be accomplished Dr.T.V.Rao MD

46. Motivation to Say “NO” • Good laboratory practice - patients first! • Following the law - CLIA ‘88 • 493.1211 - The procedure manual must include requirements for specimen collection and processing, and criteria for rejection. • 493.1109 - Must indicate on the report any information regarding the condition and disposition of specimens that do not not meet the laboratory criteria for acceptability. Dr.T.V.Rao MD

47. Specimen Disposal important part of specimen management

48. Biosafety Precaution Dr.T.V.Rao MD All the Technical staff should follow the Universal and other Biosafety Precautions while handling and Disposing the Microbiology Specimens

49. Sources of Laboratory QA Guidance and Information • World Health Organization (WHO) • International Organization for Standardization (ISO) • NCCLS • CDC guidelines • Professional & accrediting organizations • National standards & regulations Dr.T.V.Rao MD

50. Programme created by Dr.T.V.Rao MD for Laboratory Personal in the Developing World Email doctortvrao@gmail.com Dr.T.V.Rao MD