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quality_manual [2025/09/22 11:32]
admin 		quality_manual [2025/09/27 03:43] (current)
admin [8.4 Control of records]
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-== QUALITY MANUAL === +==== Quality Manual ==== 
- +===Laboratory Services Sir T Hospital Bhavnagar=== 
-===== LABORATORY SERVICES SIR T HOSPITAL ===== +==Header==
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-===== BHAVNAGAR ===== +
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-=====Header=====+
 ^Name^Unique ID^Edition^Date of Edition^ ^Name^Unique ID^Edition^Date of Edition^
 |Quality Manual|LSSTH/A/Central/P/8.3/1| 1 | 01-03-2023|    |Quality Manual|LSSTH/A/Central/P/8.3/1| 1 | 01-03-2023|   
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 ====6.7 Service agreements==== ====6.7 Service agreements====
 ===6.7.1 Agreements with laboratory users=== ===6.7.1 Agreements with laboratory users===
-The laboratory will have a procedure to establish and periodically review agreements for providing laboratory activities. {{ https://docs.google.com/document/d/1-LTZGrHUJgiTNmTt4YlQTXgd2LTeXQs5zkwmRs6MivY/edit?usp=drive_link | Procedure to establish and periodically review agreements }}+The laboratory will have a [[procedure to establish and periodically review agreements]] for providing laboratory activities. 
  
 The procedure will ensure: The procedure will ensure:
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 A list of all referral laboratories and consultants will be maintained. A list of all referral laboratories and consultants will be maintained.
 ===6.8.3 Review and approval of externally provided products and services=== ===6.8.3 Review and approval of externally provided products and services===
-The laboratory will have procedures and retain records for: {{ https://docs.google.com/document/d/1keevrIOoLG7bbB6QMnZLL0lqwmKwDtAr3NIsuK9ZsJA/edit?usp=drive link | Documentary procedure 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;{{https://docs.google.com/document/d/1uNzY5U5EmNckaLsotzYZiLFm-OHMtmah/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Vendor Evaluation}}
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 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;
-  -  The procedures for requesting and the collection of samples;[[Test requisition procedure]] +  -  The [[procedures for requesting]] and the collection of samples;
   -  The scope of laboratory activities and time for expected availability of results;   -  The scope of laboratory activities and time for expected availability of results;
   -  The availability of advisory services;   -  The availability of advisory services;
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 ===7.2.3.2 Oral requests=== ===7.2.3.2 Oral requests===
-The laboratory will have a procedure for managing oral requests for examinations, if applicable, that includes the provision of documented confirmation of the examination request to the laboratory, within a given time.  [[DP for Oral request]]+The laboratory will have a [[procedure for managing oral requests for examinations]], if applicable, that includes the provision of documented confirmation of the examination request to the laboratory, within a given time.  
  
 ===7.2.4 Primary sample collection and handling=== ===7.2.4 Primary sample collection and handling===
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 ===7.2.4.1 General=== ===7.2.4.1 General===
  
-The laboratory will have procedures for the collection and handling of primary samples.  [[Sample collection manual]]+The laboratory will have [[https://docs.google.com/document/d/1ZvRrc8Fo4bKoN9ycP0Jrw0g9ogXjTZNyhBwa0R54emA/edit?usp=drive_link|procedures for the collection and handling of primary samples]].  
 Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte. Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte.
  
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 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.
-{{ :4.3.f_format_biochemistry_consent_form.pdf |}}{{ :trf_for_special_request.docx.pdf |}} 
  
 **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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 ===7.2.5 Sample transportation===  ===7.2.5 Sample transportation=== 
-[[https://drive.google.com/drive/folders/13bPzaH0fvY5XRF1KENMMz2zO_xyPZESw?usp=drive_link|Sample Transportation]] 
  
 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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 2. If the integrity of a sample has been compromised and there is a health risk, the organization responsible for the transport of the sample will be notified immediately and action taken to reduce the risk and to prevent recurrence. 2. If the integrity of a sample has been compromised and there is a health risk, the organization responsible for the transport of the sample will be notified immediately and action taken to reduce the risk and to prevent recurrence.
  
-3. The laboratory will establish and periodically evaluate adequacy of sample transportation systems.+3. The laboratory will [[establish and periodically evaluate adequacy of sample transportation systems]].
  
 ===7.2.6 Sample receipt=== ===7.2.6 Sample receipt===
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 ==7.2.6.1 Sample receipt procedure== ==7.2.6.1 Sample receipt procedure==
  
-The laboratory will have a procedure for sample receipt [[Procedure for sample receipt]]that includes:+The laboratory will have a [[procedure for sample receipt]] that includes:
   -  the unequivocal traceability of samples by request and labelling, to a uniquely identified patient and when applicable, the anatomical site;   -  the unequivocal traceability of samples by request and labelling, to a uniquely identified patient and when applicable, the anatomical site;
   -  Criteria for acceptance and rejection of samples;     -  Criteria for acceptance and rejection of samples;  
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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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