Download presentation
Presentation is loading. Please wait.
Published byAshlee Black Modified over 8 years ago
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
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.