Specimen management in Microbiology


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Specimen management in Microbiology

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Specimen management in Microbiology

  2. 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 safetransportation, processing and disposal of Microbiology SpecimensDR.T.V.RAO MD 2
  4. 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 4
  5. 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 managementDR.T.V.RAO MD process 5
  6. 6. The Quality Assurance Cycle Patient/Client Prep Sample Collection Personnel Competency Reporting Test Evaluations •Data and Lab Management •Safety •Customer Service Sample Receipt and Accessioning Record Keeping Quality Control Sample Transport TestingDR.T.V.RAO MD 6
  7. 7. ORGANIZATION• Support from the top level of the organization• Involve all persons in the organization• Conform with any regulatory requirementsDR.T.V.RAO MD 7
  8. 8. PROCESS CONTROL: SPECIMEN MANAGEMENT• Request forms• Specimen - identification throughout process • collection (including patient preparation) • receipt and accessioning • rejection criteria • processing • transport • storageDR.T.V.RAO MD 8
  9. 9. The result of any laboratory test is only as good as the sample received in the laboratoryDR.T.V.RAO MD 9
  10. 10. SPECIMEN MANAGEMENT • Specimen Collection • Specimen Transport • Specimen Handling • Specimen Referral • Specimen Storage • Specimen DisposalDR.T.V.RAO MD 10
  11. 11. THE QUALITY SYSTEM Organization Personnel Equipment Process Purchasing Control Information (QC & EQA) & & Inventory Specimen Management Management Documents Occurrence Assessment & Records Management Process Customer Facilities & Improvement Service SafetyDR.T.V.RAO MD 11
  12. 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 pointsDR.T.V.RAO MD 12
  13. 13. IMPACT OF SPECIMEN MANAGEMENT ON PATIENT CARE• 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 DR.T.V.RAO MD 13
  14. 14. SPECIMEN COLLECTION: LABORATORY RESPONSIBILITIES• 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 DR.T.V.RAO MD 14
  15. 15. SPECIMEN COLLECTION PROCEDURES• 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., refrigerationDR.T.V.RAO MD 15
  16. 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 16
  17. 17. LABORATORY HANDBOOK• 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 DR.T.V.RAO MD 17
  18. 18. ACCEPTING EVERY SPECIMEN ???.• This occurs mainly because laboratorians either 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 18
  19. 19. ACCEPTING EVERY TRANSPORT DEVICE.• 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 tympanocentesisDR.T.V.RAO MD 19
  20. 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 tractDR.T.V.RAO MD 20
  21. 21. SPECIMEN TRANSPORT• 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 DR.T.V.RAO MD 21
  22. 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 numberDR.T.V.RAO MD 22
  23. 23. SPECIMEN STORAGESerum Banks:• Establish tracking procedures • Encourage use of information technology• Maintain an organized, accessible storage system• Monitor freeze/thaw cycles 23
  24. 24. SPECIMEN REJECTION CRITERIA:• Unlabeled specimen• Insufficient patient information• Hemolyzed specimen• Wrong tube drawn• Wrong specimen submitted• Inadequate volume for the amount of preservative• Insufficient quantity• Prolonged transport DR.T.V.RAO MD 24
  25. 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 25
  26. 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 sampleDR.T.V.RAO MD 26
  27. 27. SPECIMEN HANDLING• 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 DR.T.V.RAO MD 27
  28. 28. WORKING WITH IDEAL SAMPLE ????• Providing appropriate support in the preanalytical, analytical, and postanalytical phases of the laboratory testing process in microbiology requires working only with appropriate specimensDR.T.V.RAO MD 28
  29. 29. TYPES OF COLLECTION ERRORS• Patient Identification• Phlebotomy Technique• Test Collection Procedures• Specimen Transport• Specimen ProcessingDR.T.V.RAO MD 29
  30. 30. BLOOD SPECIMEN TRANSPORT ERRORS• 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
  31. 31. TRANSPORT ERRORS• 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
  32. 32. THE DANGEROUS GOODS REGULATIONS• Covers: • Packaging • Labelling Packages • Packing Instructions • Documentation • Training• Are updated annually by IATADR.T.V.RAO MD 32
  33. 33. SPECIMEN REFERRAL• 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 DR.T.V.RAO MD 33
  34. 34. SPECIMEN DISPOSAL• 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 DR.T.V.RAO MD 34
  35. 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 • DatabaseDR.T.V.RAO MD 35
  36. 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 36
  37. 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 changeDR.T.V.RAO MD 37
  38. 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 identificationDR.T.V.RAO MD 38
  39. 39. OCCURRENCE MANAGEMENTThe 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 errorDR.T.V.RAO MD 39
  40. 40. OCCURRENCE MANAGEMENT: HOW?• Collect information about systematic problems• Establish a process to detect all problems• Analyze the problem, take corrective action• Keep recordsDR.T.V.RAO MD 40
  41. 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 transportDR.T.V.RAO MD 41
  42. 42. IMPACT OF SPECIMEN MANAGEMENT ON PATIENT CARE• 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
  43. 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 proceduresDR.T.V.RAO MD 43
  44. 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 therapyDR.T.V.RAO MD 44
  45. 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 accomplishedDR.T.V.RAO MD 45
  46. 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 46
  48. 48. BIOSAFETY PRECAUTION • All theTechnical staff should follow the Universal and other Biosafety Precautions while handling and Disposing the Microbiology SpecimensDR.T.V.RAO MD 48
  49. 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 & regulationsDR.T.V.RAO MD 49
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