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quality_manual [2026/02/18 04:55] 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, | The laboratory will have [[procedures and retain records for defining the criteria for qualification, | ||
| - | - Defining, reviewing, and approving the laboratory' | + | - Defining, reviewing, and approving the laboratory' |
| - Defining the criteria for qualification, | - Defining the criteria for qualification, | ||
| - Referral of samples; | - Referral of samples; | ||
| - | - Ensuring that externally provided products and services conform to the laboratory' | + | - Ensuring that [[https:// |
| - 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====== | ||
| Line 802: | Line 802: | ||
| 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); | + | - |
| - 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. | ||
| Line 822: | Line 822: | ||
| 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 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; | ||
| Line 858: | Line 858: | ||
| 1. Insufficient sample volume: | 1. Insufficient sample volume: | ||
| - | * Do not reject the sample; | + | |
| - | * Perform as many examinations as possible as per priority. Priority of testing will be decided by the laboratory incharge or consultant; | + | * Perform as many examinations as possible as per priority. Priority of testing will be decided by the laboratory incharge or consultant; |
| - | * Inform the customer; | + | * Inform the customer; |
| - | * Enter remarks of insufficient volume in the report; | + | * Enter remarks of insufficient volume in the report; |
| - | * All pediatric samples with insufficient volume will be received by the laboratory; | + | * All pediatric samples with insufficient volume will be received by the laboratory. |
| 2. Hemolyzed sample: | 2. Hemolyzed sample: | ||
| - | * Do not analyze SGOT, SGPT, LDH, Potassium, Bilirubin, Ammonia, Hemoglobin, Hematocrit from hemolyzed samples; | + | |
| - | * From a less hemolyzed sample Glucose, Cholesterol, | + | * From a less hemolyzed sample Glucose, Cholesterol, |
| - | * Take the decision of which parameters can be analyzed from this sample; | + | * Take the decision of which parameters can be analyzed from this sample; |
| - | Enter remarks of Hemolyzed samples in the report; | + | |
| - | * If blood is collected in EDTA Vacutainer Bilirubin, Cholesterol, | + | * If blood is collected in EDTA Vacutainer Bilirubin, Cholesterol, |