1. Technical requirements in medical laboratories Chapter 5 – ISO 15189:2012 Miroslawa Pietruczuk Lodz, Poland 2015

2. „5.1 Personnel”  „Documented procedure for personnel management and maintain records for all personnel to indicate compliance and requirements”  Responsibilities, authorities and task for all personnel

3. „5.1 Personnel”  Personnel qualification for each position:  Laboratory diagnostic assistants (are able to authorize lab results)  Technicians in medical labs (they accept result only on the technical level)  Medical secretary (without contact with biological material)

4. „5.1 Personnel”  Head of lab: requirements according to the profile of medical lab: eg Hematology Medical Laboratory  Specialist in hematology laboratory diagnostics, 10 years experience in hematology field  eg. Medical Laboratory  Specialist in medical laboratory diagnostics, 10 years experience in this field

5. „5.1 Personnel”  Education (eg Medical Unversity, Laboratory Medical Faculty – certificate with number  Training (eg in Transfusiology individual certificate is required)

6. „5.1 Personnel”  Experience in medical field (eg. bone marrow examination)

7. „5.1 Personnel”  New staff  „The laboratory shall have a program to introduce new staff to the organization”

8. New staff training procedure

9. „5.1 Personnel”  Training  „The laboratory shall provide training for all personnel which includes the following areas:  The quality management system  Lab staff understand the mission of lab or organization if the medical lab is a part eg. of a hospital  Lab staff work in quality management system

10. „5.1 Personnel”  „Work processes and procedures”  In medical laboratories this requirement include pre-examination, examination and post examination procedures  Its also important that medical lab staff know how to write procedures

11. „5.1 Personnel”  „Laboratory information system”  It is important to prepare a special comments which can be added to the results:  How to keep a safe LIS  eg. Data and time of taking blood is unknown, and laboratory interpretation is imposible (concentrations of cortisol in serum, where reference values depends on time of day)

12. „5.1 Personnel”  „health and safety”  Medical lab staff must know the main toxic/ infectious biological agents  „and effects of adverse incidents”  „Ethics”  The benefit and health of patients are the main task for lab staff

13. „5.1 Personnel” „Confidentiality of patients information” Clear rules how and to whom the lab results are sent To whom lab assistants may give the lab interpertation of the patient results

14. „Competence assessment”  „Laboratory shall assess the competence of each person……  according to the established criteria”  Criteria, eg.  Number of positive examined blood smears (skills and knowledge)  Results of external quality control (skills and knowledge)  Check for theoretical knowledge of medical field (test)

15. „ 5.1.8 Continuing education an professional development”  eg. Activity at Laboratory or Clinical Societies  Courses in medical fields  Undergraduate specialization programs

16. „5.2 Accomodation and environmental conditions”  „The laboratory should have space for the performance of its work”  „Access control should take into consideration safety, confidentiality, quality and prevailing practices”  Who can be at the area of medical lab  Responsibilities include:  „energy sources, lighting, ventilation, noise, water, waste disposal, enviromental condition”  In medical labs temperature and pressure, are mainly monitored (requirement for analysers)

17. „5.3 Laboratory equipment, reagents, and consumables”  Most of medical labs meet these technical requirements in this field.

18. „5.4 Pre-examination processes”  „The laboratory shall have procedures and information for pre- examination activities to ensure the validity of the results of examinations.”

19. „5.4.2 Information for patients and users”  „Practical information about the laboratory”  eg. list of lab tests, working hours, contact with lab

20. „5.4.2 Information for patients and users”  Request form and instruction how to fill it up.  (optionally electronical/ or paper form /or oral form ! (procedure)

24. „5.4.2 f) instruction for preparation of the patient”  Most of the lab tests requirements are:  Period of fasting (8-12 h)  eg. especially  Morphology (WBC)  Glucose concentration (FGL)  Lipids profile (TG, but not CH)  Not obligatory: PT/INR

25. 5.4.2 f) instruction for preparation of the patient”  Hold medication that may affect test results  eg.  Immunosupressive treatment and Ig level  Heparin treatment and hTs level

26. 5.4.2 f) instruction for preparation of the patient”  Conclusion:  The best solution is to describe which important clinical information are expected based on the type of lab test

27. Glycemia 1.Fasting plasma glucose test  Blood is drawn from a vein in the patient’s arm after a period at least 8-14 hours when the patient has not eaten  70 -99 mg/dl  3,4 – 5,5 mmol/l  Normal glucose tolerance (NGT)

28. Urine analysis Because of the potential (particularly in women) to contaminate urine with bacteria and cells from the surrounding skin, it is important to first clean the genital organs. Men should wipe the tip of the penis Women should spread the labia of the vagina and clean from front to back. As you start to urinate, let the urine fall into the toilet, then collect a sample of urine in the container provided.

29. 5.4.2 g) instructions for patients collected samples”  WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy:  „Closed systems for blood sampling are preferable because they have proven to be safer than open systems.”

30. Blood, urine, body fluids are infectious materials !!!

31. Morphology/HbA1c coagulology PLT (trombocytophenia) Glucose

32. ESR Acid base balance ABO and RhD blood groups Clinical chemistry

33. „5.4.2 h) Instruction for transportation of samples”  Special requirements  Time: CSF, acid-base balance, lactate level (30 min)  hsTnT –TAT 1h  Temperature

34. „5.5 Examination processes”  „5.5.1 Selection, verification and validation of examination procedures”  !!! In medical labs validation in laboratory condition must be done

35. „5.6 Ensuring quality of examination results”  „Quality control material”  and internal quality procedures  (the levels and frequency in each lab parameter)

36. „5.7 Post-examination process”  „5.7.1 Review of results”  What is important:  adequate number of lab staff according to number and type of lab tests  adequate number of qualified authorizing staff

37. „5.8 Reporting of results”  „5.8.1. General  The results of each examination shall be reported  accurately,  clearly,  unambigously  and in accordance with any specific instruction  and examination procedures.”

38. „5.8 Reporting of results”  „The laboratory shall define the format and medium of the raport”  1. National requirements  2. Recomendations in the medical fields

39. According to national requirements

40. According to recommendation in medical fields Reactive (positive) Non reactive (negative) National Health Institute Polish Group of HCV infections Polish Virusology Association Polish Haematology and Transfusiology Association

41. „The medium of the raport”  According to the national rights  eg. ABO blood group results, RhD blood group antigens: paper form (fax but not electronical form)  Common form: electronical form (LIS and CIS are required)  Electronic signature  (positive: S(short)TAT,  negative: sometimes one authorizing person for many labs)

42. „5.8.2. Report attributes”  „comments on a sample quality”  if it influences the result, and it s clinically important  eg. I group:  Hemolysis and K+, AST activity …  Icteric sample and spectrophometry method (eg. AST, LDH, urea, creatinine,…..  Lipemic sample like above

43. II group  The quality of the sample restricted the lab test, eg:  Small urine volume (eg. anuria) and specific gravity of urine by urometer

44. III group  It is a basic clinical information, eg.:  The presence of blood in CSF  (differentiation between bleeding from venous and subarachnoid hemorrhage) erytrophage

45. „5.8.2. Report attributes”  b) acceptance/rejection criteria of sample  eg.  Clot in morphology or coagulology samples  Problem with unambiguous identification of sample, especially in labs which do not use unique sample coding system

46. „5.8.2. Report attributes”  Problem with obligatory data for the results interpretation eg.  Cortisol serum concentration without time of blood collection.

47. „5.8.2. Report attributes”  c) list of critical values  Its important to prepare this values with phisicians who order lab tests.  Sometimes there are different for different group of patients.

48. „5.8.2. Report attributes”  „Interpretive comments on results, where applicable”  (automatically selected =„technical acceptance level”)

49. !!! Reactive lymphocytes with large, irregular nuclei and rich cytoplasm (atypical lymphocytes)

50. Mononucleosis/ Mononucleosis syndrome/ Lymphoma WBC – 26 x 10 3 /μl Neu – 11% Atypical Ly– 47% Ly – 33 Mo – 9% Atyp LUC/ LIC Blast CD8+ cytotoxic Lymphocyte (flow cytometry)

51. Neutrophilia with Left shift Erytrocytosis with microcytosis and hypochromasia Thrombocytosis

54. Macrocytic hyperchromic anemia ! ! Hypersegmented neutrophils

55. Lymphocytosis (CLL?)

56. Chronic lymphocytic leukaemia WBC – 126,4 x 10 3 /μl Neu – 5% Ly – 77%, Prolym – 12 Lfbl - 3 Mo – 3% Blast AtyLy

57. CLL According to IWCLL i NCI -Working Group Guidelines: total lymphocyte count > 5.0x 10 9 /l Imunophenotype: CD19+, CD5+, CD23+, FMC-7 minus.

58. „5.8.3. Report content, shall include, but not be limited to..”  b) The identification of the laboratory  (a referal laboratory if the test has been done there)  d) Patients identification and patients locations (on each page)  e) Name or other unique identifier and request contact details  National requirements

59. „5.8.3 Report content”  „a) a clear, unambigous identification of the examination”  eg.:  Blood morphology with leukocyte differentiation  Complete blood morphology  5 diff morphology

60. „5.8.3 Report content”  „f) date and time when is clinically important”  Are there some types of lab tests, which do not depend on the time of sample collection?

61. „5.8.3 Report content”  g) type of primary sample  eg.: blood, serum, plasma, CSF, bronchoalveolar lavage (BAL), urine sputum,….  Reference values depend on the type of sample

62. „5.8.3 Report content”  „i) examination results in SI units or other applicable units”  eg:  Glucose level in plasma….

63. WHO 2014  Normal fasting plasma glucose level  70 -99 mg/dl  3,4 – 5,5 mmol/l

64. Glycemia  fasting P.G.L.:  100-125 mg/dl  (5,6-6,9 mmol/l)  signals prediabetes  (Impaired fasting glucose IFG)

65. Glycemia  >126 mg/dl (7,0 mm/l)  signals diabetes  (2x + clinical symptoms)

66. „5.8.3 Report content”  k) interpretation of results where appriopriate

67.  Total Cholesterol :  Target value  < 5 mmol/L, < 190 mg/dl  (< 175 mg/dL < 4,5 mmol/L)  In patients with diabetes

68. „5.8.3 Report content”  „Identification the person who is reviewing the results and authorizing”

69. „5.9 Release of results”  Who may release results and to whom  How lab staff inform physicians about „critical values”  Interim reports and Final reports

70. References  ISO 15189:2012