ORGANIZATION: CLINICAL CHEMISTRY DEPARTMENT INSTITUTION: UNIVERSITY

should be a defined role for the laboratory in the validation, assessment and quality control of near patient and point of care testing. The repertoires should be adjusted regularly and be part of the medical audit.<br><br> 1.1. SCOPE 1.2. AIMS To fulfil the requirements of the following clauses: ISO 15189ISO 9000: 2000ISO 17025 5.4.<br><br> Pre-examination procedures. 5.4.3. 5.5.<br><br> Examination procedures. 5.5.6. 1.3.<br><br> PUBLICATION CREDITS EC4 WG 1.4. REFERENCES 1. Jansen RTP, Blaton V, Burnett D, Huismann W, Queraltó JM, Zérah S, Allman B.<br><br> European Communities Confederation of Clinical Chemistry: Essential criteria for quality systems of medical laboratories. Eur J Clin Chem Clin Biochem 1997; 35(2): 123-132. 2.<br><br> ISO/FDIS 15189, Quality management in the medical laboratory (December 1998). 5.4.3. and 5.5.6.<br><br> 7.1. USER INFORMATION 7.2. CONSULTATION 7.4.<br><br> REQUEST 7.6. SPECIMEN COLLECTION 7.9. SAFETY AND CONFIDENTIALITY 7.7.<br><br> SPECIMEN TRANSPORTATION 7.5. PATIENT PREPARATION 7.3. REPERTOIRE MPD 0202-0-0711 PROCEDURE FOR USER INFORMATION MPD 0202-0- 0713 REPERTOIRE MPD 0202-0-0715 LABORATORY USERS 9 HANDBOOK MPD 0202-0- 0741 REQUESTING FORMS MPD 0202-0-0702 HANDBOOK OF SPECIMEN COLLECTION MPD 0202-0-0751.<br><br> PROCEDURE FOR TEST REQUESTING MPD 0202-0-0761 PROCEDURE OF SPECIMEN OBTENTION MPD 0202-0-0765 PROCEDURE FOR SPECIMEN PREPARATION CODE) DOCUMENT: QMM07 (INSTITUTION): EC4 UNIVERSITY HOSPITAL (CODE) SECTION: QMM07-S03 (CHAPTER TITLE): PRE-ANALYTICAL PHASE (DATE): 21/10/01 PAGE 4 OF 8 (SECTION TITLE): REPERTOIRE EC4 CLINICAL CHEMISTRY DEPARTMENT AUTHORVERSIONAPPROVED BYDATE 3. Jansen RTP, Bank CMC, Huisman W, Penders TJ. NVKC Model quality manual.<br><br> 2 nd rev. Ed. Utrecht: NVKC 1996.<br><br> 1.5. RELATED DOCUMENTS QM 09-04 Reference values MPD 0202-0-0713 Analytical services repertoire MPD 0202-0-0761 Procedure for specimen collection MPD 0202-0-0765 Procedure for specimen preparation MPD 0202-0-0702 Handbook of specimen collection MPD 0202-0-0715 Laboratory users 9 handbook MPD 0202-0-0911 Biological reference values 1.6. ABBREVIATIONS 1.7.<br><br> RELATED DEFINITIONS measurable quantity: (measurable property, quantity) attribute of a phenomenon, body, or substance that may be distinguished qualitatively and determined quantitatively. NOTE 1: Phenomenon, body, or substance corresponds to the concept of system as used in clinical laboratory sciences. Qualitatively refers to the need to define a quantity before it can be measured.<br><br> NOTE 2: Measurable quantity is described by three concepts, here called kind-of-quantity, component , and system . NOTE 3: " quantity " is often used as a short term. measurand: particular quantity subject to measurement.<br><br> EXAMPLE Vapour pressure of a given specimen of water at 20 °C. NOTE The specification of a measurand may require statements about other quantities such as time, temperature and pressure. quantity: short term of measurable quantity .<br><br> sample: one or more parts taken from a system and intended to provide information on the system, often to serve as a basis for a decision on the system or its production. EXAMPLES: A volume of serum taken from a larger volume of serum; a simple random subset of measured values of a measurable quantity taken from a set of such values. NOTE 1: The single part forming a cohesive entity and taken from one place and at one time is also called a "sampling unit" or an "item".<br><br> NOTE 2: Unless otherwise specified, the sample is assumed to be representative of a "static system", that is a system having no appreciable change in relevant measurable quantities during the time of consideration. NOTE 3: When a "dynamic system" is concerned, as is often the case in the clinical laboratory sciences, the calendar time of sampling is a mandatory item of specification to the system of interest. Such a special type of sample has been called a " specimen ", but this term is not used here.<br><br> The term specimen has also been used in laboratory medicine as a synonym for a sample, as defined here, of biological origin, or for an entire macroscopic parasite. NOTE 4: The system from which a sample is taken may not be of the same type as that of the measurand. EXAMPLE: A given blood sample may serve for measurement of pH in plasma and haemoglobin concentration) in erythrocytes.<br><br> NOTE 5: The definition given above covers a sample from any type of system. ISO gives two definitions that apply more to data and materials respectively. (a) sample: One or more sampling units taken from a population and intended to provide information on the population; (b) sample: Representative quantity of material extracted from a batch of reference material).<br><br> NOTE 6: In some countries the term specimen is used for primary sample (or a subsample of it) which is the sample prepared for sending to or as received by the laboratory and intended for measurement. sampling: process of drawing or constituting a sample. sampling procedure: operational requirements and or instructions relating to the use of a particular sampling plan, that is the planned procedure of selection, withdrawal, and preparation of one or more samples from an inspection lot to yield knowledge of the characteristic(s) of the lot.<br><br> NOTE: In laboratory medicine, the "inspection lot" usually is a person. specimen: in some countries the term specimen is used for primary sample. system: demarcated part or phenomenon of the perceivable or conceivable universe, material or immaterial, that may be regarded as a set of elements and a set of relationships between these elements.<br><br> (INSTITUTION): EC4 UNIVERSITY HOSPITAL (CODE) DOCUMENT: QMM07 (CHAPTER TITLE): PRE-ANALYTICAL PHASE (CODE) SECTION: QMM07-S03 (DATE): 21/10/01 EC4 CLINICAL CHEMISTRY DEPARTMENT (SECTION TITLE): REPERTOIRE PAGE 5 OF 8 AUTHORVERSIONAPPROVED BYDATE 2. LIST OF THE STAT REPERTOIRE The analytical services offered by the Clinical Chemistry Department are listed in the document MPD 0202-0-0713 Analytical services repertoire which includes the following items: TestRequired specimen and specimen volume Special precautionsTurn- around time Reference ranges Laboratory pH BLOOD GASESblood gas syringe filled with arterial blood, transported in iced water to be tested immediately20 minutes General Chemistry Laboratory PYRUVATEspecial tube, see appropriate test procedure 35 minutes General Chemistry Laboratory, by arrangement PROCAINAMIDE LEVEL 2 tubes of whole blood, seal send no. 29, obtain specimen before intake of food/drink 2 hTDM &&&&&& 3.<br><br> LIST OF THE 24 HOURS REPERTOIRE TestRequired specimen and specimen volume Special precautionsTurn- around time Reference ranges Laboratory PNF1 tube of whole blood send no. 01, completed form PORPHYRINurine collected over a 24-hour period store in a cool, dark place, deliver before noon. To be tested immediately Special Test Laboratory PRECIPITINES1 tube of whole blood, seal Protein Chemistry Laboratory PREGNANETRIOLurine collected over a 24-hour period measure volume and prepare 100-ml specimen Urine Laboratory &&&&&& 4.<br><br> REPERTOIRE OF ALL AVAILABLE TESTS TestRequired specimen and specimen volume Special precautionsTurn- around time Reference ranges Laboratory pH BLOOD GASESblood gas syringe filled with arterial blood, transported in iced water to be tested immediatelyGeneral Chemistry Laboratory PNF1 tube of whole blood send no. 01, completed form PORPHYRINurine collected over a 24-hour period store in a cool, dark place, deliver before noon. To be tested immediately Special Test Laboratory PRECIPITINES1 tube of whole blood, seal Protein Chemistry Laboratory PREGNANETRIOLurine collected over a 24-hour period measure volume and prepare 100-ml specimen Urine Laboratory CODE) DOCUMENT: QMM07 (INSTITUTION): EC4 UNIVERSITY HOSPITAL (CODE) SECTION: QMM07-S03 (CHAPTER TITLE): PRE-ANALYTICAL PHASE (DATE): 21/10/01 PAGE 6 OF 8 (SECTION TITLE): REPERTOIRE EC4 CLINICAL CHEMISTRY DEPARTMENT AUTHORVERSIONAPPROVED BYDATE PROCAINAMIDE LEVEL 2 tubes of whole blood, seal send no.<br><br> 29, obtain specimen before intake of food/drink PROLACTINWITH NEEDLE THAT YOU LEAVE IN 3x1 tube of whole blood timing: 0, 30 and 60 minutes Isotope Laboratory by arrangement PROSTATE-SPECI FIC ANTIGEN 1 tube of whole blood, immediately seal and freeze Isotope Laboratory PROTEIN C (ACTIVITY) 1 tube citrated blood, immediately seal (15 min) and freeze Special Test Laboratory PROTOPOR- PHYRIN 1 tube heparinized blood, store in a cool, dark place Special Test Laboratory PYRUVATEspecial tube, see appropriate test procedure General Chemistry Laboratory, by arrangement &&&&&& (INSTITUTION): EC4 UNIVERSITY HOSPITAL (CODE) DOCUMENT: QMM07 (CHAPTER TITLE): PRE-ANALYTICAL PHASE (CODE) SECTION: QMM07-S03 (DATE): 21/10/01 EC4 CLINICAL CHEMISTRY DEPARTMENT (SECTION TITLE): REPERTOIRE PAGE 7 OF 8 AUTHORVERSIONAPPROVED BYDATE 5. ROLE FOR THE LABORATORY IN THE VALIDATION, ASSESSMENT AND QUALITY CONTROL OF NEAR PATIENT AND POINT OF CARE TESTING Professional staffs from the Clinical Chemistry Department participate in all the Hospital Committees dealing with point of care testing. The Clinical Chemistry Department participation in the point of care testing is executive and includes: " selection of point of care devices " validation of analytical procedures " training of personnel " quality control The Clinical Chemistry Department prepares an annual report on the use and quality of point of care testing.<br><br> 6. REFERENCE VALUES According the document QM 09-04 Reference values and the procedure MPD 0202-0-0911 Biological reference values the list of reference values is presented as a supplement of the Laboratory newsletter (updated annually) and in the handbook MPD 0202-0-0715 Laboratory users 9 handbook. 7.<br><br> SPECIFICATIONS According the documents MPD 0202-0-0761 Procedure for specimen collection, MPD 0202-0-0765 Procedure for specimen preparation, the specifications include: (a) kind of specimen; (b) kind of container; (c) anticoagulant or preservative; (d) minimum quantity of specimen The information is compiled in the MPD 0202-0-0702 Handbook of specimen collection . 8. RESPONSABILITIES ON cREPERTOIRE d The Director of the Clinical Chemistry Department is responsible of the analytical services offered by the Clinical Chemistry Department, according the proposals of the Heads of each area.<br><br> The writing, revision and maintenance of documents concerning the repertoire is responsibility of the Quality Officer. 9. DOCUMENT MANAGEMENT Updated documents concerning the analytical services procedures and list are available in the document volume of the LIS.<br><br> One copy of these procedures is kept in the Quality System Files. Staff members of the Clinical Chemistry Department receive an update copy as soon as it is available. 10.<br><br> REVIEW OF DOCUMENTS Documents concerning the repertoire of analytical services are revised at least once a year. CODE) DOCUMENT: QMM07 (INSTITUTION): EC4 UNIVERSITY HOSPITAL (CODE) SECTION: QMM07-S03 (CHAPTER TITLE): PRE-ANALYTICAL PHASE (DATE): 21/10/01 PAGE 8 OF 8 (SECTION TITLE): REPERTOIRE EC4 CLINICAL CHEMISTRY DEPARTMENT AUTHORVERSIONAPPROVED BYDATE Blank page

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