quality_manual

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quality_manual [2026/02/18 05:25]
qm_lssth
quality_manual [2026/02/21 06:14] (current)
qm_lssth [7.2 Pre-examination processes]
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 The laboratory will have [[procedures and retain records for defining the criteria for qualification, selection, evaluation of performance and re-evaluation of external providers]]  The laboratory will have [[procedures and retain records for defining the criteria for qualification, selection, evaluation of performance and re-evaluation of external providers]] 
  
-  -  Defining, reviewing, and approving the laboratory's requirements for all externally provided products and services;{{https://docs.google.com/document/d/1uNzY5U5EmNckaLsotzYZiLFm-OHMtmah/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Vendor Evaluation}}+  -  Defining, reviewing, and approving the laboratory's requirements for all externally provided products and services;
   -  Defining the criteria for qualification, selection, evaluation of performance and re-evaluation of external providers;   -  Defining the criteria for qualification, selection, evaluation of performance and re-evaluation of external providers;
   -  Referral of samples;   -  Referral of samples;
-  -  Ensuring that externally provided products and services conform to the laboratory's established requirements, or where applicable to the relevant requirements of this document, before they are used or directly provided to the user;+  -  Ensuring that [[https://docs.google.com/spreadsheets/d/14FU_P1Ri6-8CGyG0VDw5uH5suQr4cDboWfcuLFMQusc/edit?usp=drive_link|externally provided products and services conform to the laboratory's established requirements]], or where applicable to the relevant requirements of this document, before they are used or directly provided to the user;
   -  Taking any actions arising from evaluations of the performance of external providers   -  Taking any actions arising from evaluations of the performance of external providers
 =====7 Process requirements====== =====7 Process requirements======
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 The laboratory will provide information and instructions for pre-collection activities with sufficient detail to ensure that the integrity of the sample is not compromised. The laboratory will provide information and instructions for pre-collection activities with sufficient detail to ensure that the integrity of the sample is not compromised.
 This will include: This will include:
-  -  Preparation of the patient (e.g. instructions to caregivers, sample collectors and patients);+  -  [[Preparation of the patient (e.g. instructions to caregivers, sample collectors and patients)]];
   -  Type and amount of the primary sample to be collected with descriptions of the containers and any necessary additives, and when relevant the order of collecting samples;   -  Type and amount of the primary sample to be collected with descriptions of the containers and any necessary additives, and when relevant the order of collecting samples;
   -  Special timing of collection, where relevant;   -  Special timing of collection, where relevant;
-  -  Provision of clinical information relevant to, or affecting sample collection, examination performance or result interpretation (e.g. history of administration of drugs);+  -  Provision of clinical information relevant to, or affecting sample collection, examination performance or result interpretation (e.g. [[history of administration of drugs]]);
   -  Sample labelling for unequivocal identification of the patient, as well as source and site of sample, and labelling, when several samples from the same patient are to be collected, including multiple pieces of tissue or slides;   -  Sample labelling for unequivocal identification of the patient, as well as source and site of sample, and labelling, when several samples from the same patient are to be collected, including multiple pieces of tissue or slides;
   -  The laboratory’s criteria for acceptance and rejection of samples specific to the examinations requested.   -  The laboratory’s criteria for acceptance and rejection of samples specific to the examinations requested.
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 To ensure safe, accurate and clinically appropriate sample collection and pre-examination storage, the laboratory will provide instructions for: To ensure safe, accurate and clinically appropriate sample collection and pre-examination storage, the laboratory will provide instructions for:
-  -  verification of the identity of the patient from whom a primary sample is collected;+  -  [[verification of the identity of the patient from whom a primary sample is collected]];
   -  verification and when relevant, recording that the patient meets pre-examination requirements [e.g. fasting status, medication status (time of last dose, cessation), sample collection at predetermined time or time intervals];   -  verification and when relevant, recording that the patient meets pre-examination requirements [e.g. fasting status, medication status (time of last dose, cessation), sample collection at predetermined time or time intervals];
   -  collection of primary samples, with descriptions of the primary sample containers and any necessary additives, as well as the order of sample collection, where relevant;   -  collection of primary samples, with descriptions of the primary sample containers and any necessary additives, as well as the order of sample collection, where relevant;
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