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quality_manual [2025/09/23 11:22]
admin [7.2 Pre-examination processes] 		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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 ===7.2.2 Laboratory information for patients and users=== ===7.2.2 Laboratory information for patients and users===
-The laboratory will have appropriate information available for its users and patients. The information will be sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements.+The laboratory will have appropriate information available for its users and patients {{ |DOS}}. The information will be sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements.
 The information will include as appropriate: The information will include as appropriate:
   - The location(s) of the laboratory, operating hours and contact information;   - The location(s) of the laboratory, operating hours and contact information;
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 ===7.2.3.1 General=== ===7.2.3.1 General===
  
-1. Each request accepted by the laboratory for examination(s) will be considered an agreement.+1. Each request accepted by the laboratory for examination(s) will be considered an agreement{{ ::4.3.f_format_biochemistry_consent_form.pdf |TRF 1}}{{ ::trf_for_special_request.docx.pdf |TRF 2}}.
  
  2. The examination request will provide sufficient information to ensure:  2. The examination request will provide sufficient information to ensure:
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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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 ===7.2.4.3 Patient consent=== ===7.2.4.3 Patient consent===
  
-1. The laboratory will obtain the informed consent of the patient for all procedures carried out on the patient.+1. The laboratory will obtain the informed consent of the patient for all procedures carried out on the patient.[[https://drive.google.com/drive/folders/1UiZEv93GU1TgValjx6h7I_2u8AVVZDc_?usp=drive_link]]
  
 **NOTE:** For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture. **NOTE:** For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture.
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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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   -  safe disposal of materials used in the collection process.   -  safe disposal of materials used in the collection process.
  
-===7.2.5 Sample transportation=== +===7.2.5 Sample transportation=== [[https://docs.google.com/spreadsheets/d/1neiu-rsC5tIdsDzbIS_8w3vV-dfEgFoN/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true]]
  
 1. To ensure the timely and safe transportation of samples, the laboratory will provide instructions for: 1. To ensure the timely and safe transportation of samples, the laboratory will provide instructions for:
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 ==7.2.6.2 Sample acceptance exceptions== ==7.2.6.2 Sample acceptance exceptions==
  
-1. The laboratory will have a process that considers the best interests of the patient in receiving care, when a sample has been compromised due to +1. Insufficient sample volume: 
-  * Incorrect patient or sample identification, +  *  Do not reject the sample; 
-  * Sample instability due to, for example, delay in transport, +  *  Perform as many examinations as possible as per priority. Priority of testing will be decided by the laboratory incharge or consultant; 
-  * Incorrect storage or handling temperature, +  *  Inform the customer;  
-  * Inappropriate container(s),  +  *  Enter remarks of insufficient volume in the report; 
-  * Insufficient sample volume.+  *  All pediatric samples with insufficient volume will be received by the laboratory. 
 +2.  Hemolyzed sample: 
 +  *  Do not analyze SGOT, SGPT, LDH, Potassium, Bilirubin, Ammonia, Hemoglobin, Hematocrit from hemolyzed samples;  
 +  *  From a less hemolyzed sample Glucose, Cholesterol, Uric acid, Urea, Creatinine, Albumin, Alkaline phosphatase, Total protein, UIBC, Sodium, Calcium can be performed; 
 +  *  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, Triglyceride, ALT, AST, Creatinine, Urea can be performed. However it is unsuitable for Coagulation study,Enzyme assay, Hormonal assay & electrolyte analysis or methods that require electrolyte or metallic cofactors.
  
-2. When a compromised clinically critical or irreplaceable sample is accepted, after consideration of the risk to patient safety, the final report will indicate the nature of the problem and where applicable, advising caution when interpreting results that can be affected. 
  
 ===7.2.7 Pre-examination handling, preparation, and storage=== ===7.2.7 Pre-examination handling, preparation, and storage===
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 The laboratory will have procedures and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage. [[Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage]] The laboratory will have procedures and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage. [[Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage]]
 ==7.2.7.2 Criteria for additional examination requests== ==7.2.7.2 Criteria for additional examination requests==
-Laboratory procedures will include time limits for requesting additional examinations on the same sample.+Laboratory procedures will include time limits for requesting [[dp_for_oral_request|additional examinations]] on the same sample.
  
 ==7.2.7.3 Sample stability== ==7.2.7.3 Sample stability==
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 ===8.2.1 General=== ===8.2.1 General===
  
-Laboratory management will establish, document, and maintain objectives and policies for the fulfilment of the purposes of this document and will ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization. +Laboratory management will establish document, and maintain objectives and policies for the fulfilment of the purposes of this document and will ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization.
-{{|--------QM pdf}}+
  
 **NOTE:** The management system documents can, but are not required to, be contained in a quality manual. **NOTE:** The management system documents can, but are not required to, be contained in a quality manual.
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 ===8.3.1 General=== ===8.3.1 General===
  
-The laboratory will control the documents (internal and external) that relate to the fulfilment of this  +The laboratory will control the documents (internal and external) that relate to the fulfilment of this document.
-document.+
  
 **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital. **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital.
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 ===8.3.2 Control of documents=== ===8.3.2 Control of documents===
 The laboratory will ensure that: The laboratory will ensure that:
-{{ https://docs.google.com/spreadsheets/d/1FgPYEGFZ7v3LObAUIYsLXDp8zg1cFdjT/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Master list of documents }} 
- {{ https://docs.google.com/document/d/10j2wNoTWdooTE-QhwIaZTn3Jg5YG5uv_/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Documents }} 
   - Documents are uniquely identified;   - Documents are uniquely identified;
   - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy;   - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy;
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 ====8.4 Control of records====  ====8.4 Control of records==== 
- 
-{{ https://docs.google.com/document/d/172kNPn_W_NldSaDGKfGr9sT5TAv3LOqw/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Records 
-}} 
  
 ===8.4.1 Creation of records=== ===8.4.1 Creation of records===
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