1、August 2014 Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、07.100.10!%?ka“2287262www.din.deDDIN 58959-3Medical microbiology Quality management in medical microbiology Part 3: Requirements for request and report forms,English translation of DIN 58959-3:2014-08Medizinische Mikrobiologie Qualittsmanagement in der medizinischen Mikrobiologie Teil 3: Anforderung
3、en an Untersuchungsauftrag und Befundbericht,Englische bersetzung von DIN 58959-3:2014-08Microbiologie mdicale Management de la qualit en microbiologie mdicale Partie 3: Exigences pour la charge danalyse et le rapport mdical,Traduction anglaise de DIN 58959-3:2014-08SupersedesDIN 58959-3:1997-06www.
4、beuth.deDocument comprises 12 pagesIn case of doubt, the German-language original shall be considered authoritative.02.15 DIN 58959-3:2014-08 2 A comma is used as the decimal marker. Contents Page Foreword 3 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Table of abbreviations .6 5
5、Requirements .7 5.1 Content of lab service requests .7 5.1.1 General 7 5.1.2 Details about the sender/applicant 7 5.1.3 Details about the patient/subject .7 5.1.4 Clinical/pre-clinical data 7 5.1.5 Details about the specimen 8 5.1.6 Details about the desired investigation/type of analysis.8 5.2 Cont
6、ent of the medical laboratory report 8 5.2.1 General 8 5.2.2 Details about the investigating laboratory 8 5.2.3 Details from the lab service request 8 5.2.4 Data to be obtained in the medical microbiology laboratory 9 5.2.5 Details of the test results 9 5.2.6 Date of medical laboratory report . 10 5
7、.2.7 Additional information . 10 5.2.8 Details of the medical assessment and evaluation of the results . 10 5.3 Checking of report and validation. 10 5.4 Reporting format . 10 5.5 Reporting timeframe . 11 5.5.1 Time-critical laboratory examinations and results 11 5.5.2 Non-time-critical laboratory e
8、xaminations and results 11 5.6 Documentation of medical laboratory reports . 11 5.7 Eliminating risk of infection/Safety requirements . 11 Bibliography . 12 DIN 58959-3:2014-08 3 Foreword This standard (DIN 58959-3) has been prepared by Working Committee NA 063-05-13 AA Kulturmedien of the Normenaus
9、schuss Medizin (NAMed) (DIN Standards Committee Medicine). Particular consideration has been given to improvements in data processing relating to the lab service request and the medical laboratory report. This standard has been harmonized with MiQ 30 (Quality Standard No. 30 for the Microbiological
10、Diagnosis of Infectious Diseases issued by DGHM). Attention is drawn to the possibility that some elements of this document may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifying any or all such patent rights. DIN 58959 Medical microbiology Quality manageme
11、nt in medical microbiology comprises the following parts (supplements are not listed): Part 1: Requirements for the QM system Part 2: Requirements for sample collection, transport and acceptance of specimens Part 3: Requirements for request and report form Part 4: Requirements for investigations usi
12、ng light microscopes Part 6: Requirements for control strains Part 7: General requirements for the use of control strains Part 8: Requirements for the use of control strains for testing swabs, transport media, media of dip-slides and blood culture media Part 9: Requirements for the use of control st
13、rains for testing culture media Part 10: Requirements for the use of control strains for testing reagents, dyes and biological materials Part 11: Requirements for the use of control material for testing ready-to-use tests and test kits Part 12: Requirements for the use of control material for testin
14、g immunological reagent kits Part 14: Requirements for the use of control strains for susceptibility testing of aerobic bacteria Part 15: Requirements for the use of control strains for susceptibility testing of anaerobic bacteria Part 16: Requirements for the use of control strains for susceptibili
15、ty testing of special bacteria Part 17: Requirements for the use of control strains for the examination of mycobacteria Part 18: Requirements for the use of control strains for the examination of mycoplasms Part 19: Requirements for the use of control strains for the examination of fungi Part 20: Re
16、quirements for the use of control material for the examination of protozoae and microorganisms of higher order A list of supplements to the standards in the DIN 58959 series and an index are provided in DIN 58959 Supplement 1. DIN 58959-3:2014-08 4 Amendments This standard differs from DIN 58959-3:1
17、997-06 as follows: a) the standard has been reassigned from the now dormant Working Committee NA 063-05-12 AA Qualittsmanagement in der medizinischen Mikrobiologie to Working Committee NA 063-05-13 AA; b) the title has been changed from “Quality management in medical microbiology Part 3: Requirement
18、s for request and report form” to “Medical microbiology Quality management in medical microbiology Part 3: Requirements for request and report form”; c) the standard has been adapted to correspond with MiQ 30; d) the normative references have been revised; e) terms relating to technical and medical
19、validation have been defined; f) a table of abbreviations has been included. Previous editions DIN 58941-4: 1986-01 DIN 58959-3: 1997-06 DIN 58959-3:2014-08 5 1 Scope This standard applies to all lab service requests sent to medical microbiology laboratories as defined in DIN EN 12128 and to the rep
20、orts compiled in these laboratories to communicate the results of patient-related analyses. 2 Normative references The following documents, which are referenced in this document either in part or in whole, are required for the application of this document. For dated references, only the edition cite
21、d applies. For undated references, the latest edition of the publication referred to (including any amendments) applies. DIN 58959-1, Quality management in medical microbiology Part 1: Requirements for the QM system DIN 58959-2, Quality management in medical microbiology Part 2: Requirements for sam
22、ple collection, transport and acceptance of specimens DIN EN 12128, Biotechnology Laboratories for research, development and analysis Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements Biostoffverordnung (BioStoffV Ordinance on Safety and Heal
23、th Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance) Infektionsschutzgesetz (IfSG German law on preventing and combating infectious diseases) 3 Terms and definitions For the purposes of this document, the terms and definitions in DIN 58940-1, DIN EN 12128 and DIN 589
24、59-1 apply. NOTE Terms from the field of medical microbiology that are assumed to be understood are not defined in this standard. 3.1 medical laboratory report*)list that contains: details about the information provided in the lab service request submitted by the sender, data obtained and methods us
25、ed in the medical microbiology laboratory, test results, other observations and additional comments relating to the findings, and the medical interpretation and evaluation of the results 3.2 susceptibility testing in vitro testing of the efficacy of antimicrobial agents 3.3 identification differenti
26、ation examination to identify a microorganism grown from a single colony *) Translators note. Referred to as “report form” in the title of this standard. DIN 58959-3:2014-08 6 3.4 lab service request*)written or electronic note that accompanies the sample sent for examination and can be unambiguousl
27、y assigned to the sender and to the patient and that contains a clinically based examination request as well as all information necessary for a proper clinical laboratory examination to be conducted 3.5 validation a technical and medical plausibility check with subsequent release or non-release 3.5.
28、1 technical validation verification of correct preanalytical procedures, technical plausibility check to confirm that quality criteria are met, and release of test results by medical technical staff at the laboratory Note 1 to entry: Refers to those preanalytical parameters that can be checked in th
29、e laboratory. 3.5.2 medical validation acceptance of technical validation, checking test results for medical plausibility, evaluation and interpretation of the results in terms of the overall medical context, and release of test results by the physician or scientist at the clinical microbiology labo
30、ratory with responsibility for the medical laboratory report 3.6 active substance chemically defined compound (molecule) with a defined molecular weight that constitutes the active component(s) of an anti-infective drug 4 Table of abbreviations Abbreviation Meaning ESBL Extended-spectrum beta-lactam
31、ase HIV-1 Human immunodeficiency virus type 1 HIV-2 Human immunodeficiency virus type 2 IfSG Infektionsschutzgesetz CFU Colony-forming unit MRE Multidrug-resistant pathogens MRSA Methicillin-resistant Staphylococcus aureus PCR Polymerase chain reaction *) Translators note. Referred to as “request fo
32、rm” in the title of this standard. DIN 58959-3:2014-08 7 5 Requirements 5.1 Content of lab service requests 5.1.1 General Every sample for investigation (specimen) shall be accompanied by a lab service request that is either in writing and signed by the sender/applicant and protected from leakage or
33、 contamination, or is stored on a data storage device, or is transmitted electronically as a computerized order entry. The lab service request shall contain: a) details about the sender/applicant in accordance with 5.1.2; b) details about the patient/subject in accordance with 5.1.3; c) clinical/pre
34、-clinical data in accordance with 5.1.4; d) details about the specimen in accordance with 5.1.5; e) details about the desired investigation/type of analysis in accordance with 5.1.6. 5.1.2 Details about the sender/applicant a) Name of the sender/applicant, including department/institution if applica
35、ble; b) address of sender/applicant, including telephone/fax/e-mail/pager if applicable; c) signature of sender/applicant, or electronic signature. 5.1.3 Details about the patient/subject a) Surname, given name(s) of patient/subject; b) date of birth; c) sex; d) address; e) identification number, if
36、 applicable; f) payment guarantor/details about insured person; g) type of treatment: outpatient/inpatient. 5.1.4 Clinical/pre-clinical data The lab service request should include the following information, insofar as it is relevant for the laboratory examination: a) clinical symptoms (e.g. fever, s
37、tiffness of the neck); b) suspected clinical diagnosis; c) date of onset of illness; d) prior treatment with anti-infective drugs; e) immunosuppression; f) vaccination status, if relevant; g) prior antibody treatment, if relevant; h) week of gestation, if relevant; i) risk factors (e.g. details of p
38、atients/subjects social contacts and travel history, associated diseases); j) suspected clustering of cases in the patients surroundings (e.g. food poisoning). DIN 58959-3:2014-08 8 5.1.5 Details about the specimen a) Type of specimen; b) Precise location of specimen, specified in accordance with th
39、e requirements in DIN 58959-2; c) Date and time of specimen collection; d) Method of specimen collection used, if relevant; e) Designation as urgent specimen, if applicable. 5.1.6 Details about the desired investigation/type of analysis Details about the desired laboratory examination(s) shall be sp
40、ecified together with, where appropriate, the test procedures to be used. If targeted testing for specific microorganisms is to be carried out, the microorganisms shall be stated explicitly (e.g. screening for multidrug-resistant pathogens (MDR pathogens such as MRSA, ESBL), Clostridium difficile).
41、5.2 Content of the medical laboratory report 5.2.1 General The medical laboratory report shall contain all relevant information from the lab service request, the test results and their clinical interpretation. If the test results were obtained using standardized test procedures, any specifications s
42、et out in those standards regarding the medical laboratory report shall be taken into account. 5.2.2 Details about the investigating laboratory a) Name and address of laboratory with telephone/fax/e-mail; b) name of laboratory manager; c) name of physician with responsibility for medical validation
43、with his/her written signature or electronic signature. 5.2.3 Details from the lab service request a) Name and address of the sender/applicant; b) other recipients of the report, if applicable; c) surname, given name(s) of patient/subject; d) date of birth of the patient/subject; e) type of specimen
44、; f) location of specimen, if applicable; g) date and time of specimen collection; h) designation as urgent specimen, if applicable; i) Suspected clinical diagnosis and relevant symptoms; j) Specification of desired laboratory examination(s). DIN 58959-3:2014-08 9 5.2.4 Data to be obtained in the me
45、dical microbiology laboratory 5.2.4.1 Details about the specimen In addition to the details taken from the lab service request, the following information relating to the submitted specimen shall also be recorded: a) date and time specimen was received by the laboratory; b) laboratory number; c) spec
46、ial observations (unusual macroscopic appearance due to decomposition or other changes, if of significance for the findings). 5.2.4.2 Details regarding the implementation of the test procedures Details about the type of any microbiological examination performed shall include the method used, for exa
47、mple: a) microscopy investigation; b) culture tests; c) susceptibility testing (antibiogram) specifying the method and rating the sensitivity to the tested antimicrobial substances as “susceptible”, “intermediate” or “resistant”; d) serological assay/immunoassay; e) molecular genetic test, if perfor
48、med, specifying the method, e.g. HIV-1 and HIV-2 assays using PCR; f) laboratory log number(s) from previous findings, if necessary. 5.2.5 Details of the test results The results of qualitative assays shall be reported as: a) positive, negative or marginal/indeterminate (e.g. antigen assay, antibody assay, toxin assay); b) description of the microscopy results (e.g. details about cells, spores, particles found, staining results); c) microbial growth; d) results of microbial identification (e.g.
