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quality_manual [2025/09/22 11:26]
admin [4.1 Impartiality] 		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==
- +
-===== 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|   
    
-^Preparing authority^Approving authority^Review period^Review Date^ +| Preparing authority | Approving authority | Review period | Review Date | 
-|All teaching staff|Quality Manager|2 year|+| All teaching staff | Quality Manager | 2 year | 12/09/2025 |
  
  
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 [[https://drive.google.com/file/d/1hE2vU-XcBhHHTu1afXY7xerqgwNq90jD/view?usp=drive_link|NABL Accreditation Application 2025]] [[https://drive.google.com/file/d/1hE2vU-XcBhHHTu1afXY7xerqgwNq90jD/view?usp=drive_link|NABL Accreditation Application 2025]]
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 [[https://drive.google.com/file/d/1APM00p-oZ0pWj60h-sOr0vlYT9zgQVM_/view?usp=drive_link|NABL Accredited scope 2025]] [[https://drive.google.com/file/d/1APM00p-oZ0pWj60h-sOr0vlYT9zgQVM_/view?usp=drive_link|NABL Accredited scope 2025]]
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 [[https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|DOS]] [[https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|DOS]]
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 ====4.1 Impartiality==== ====4.1 Impartiality====
  
-  - Laboratory activities will be undertaken impartially. The laboratory will be structured and managed to safeguard impartiality. +  - Laboratory activities will be undertaken impartially. The laboratory will be [[structured]] and managed to safeguard impartiality. 
   - The laboratory management will be committed to impartiality.   - The laboratory management will be committed to impartiality.
   - The laboratory will be responsible for the impartiality of its laboratory activities and will not allow commercial, financial or other pressures to compromise impartiality.   - The laboratory will be responsible for the impartiality of its laboratory activities and will not allow commercial, financial or other pressures to compromise impartiality.
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 considered proprietary information and will be regarded as confidential.  considered proprietary information and will be regarded as confidential. 
  
-The staff are aware of the need to ensure that Impartiality & confidentiality of information is maintained at all times in accordance with the Lab policy and the staff have signed the Declaration of Impartiality & Confidentiality.{{https://docs.google.com/document/d/1VSnLOVajE0zSD2gHYI_iRLLNlQMMeFQm/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | DECLARATION FOR CONFIDENTIALITY & IMPARTIALITY}} +The staff are aware of the need to ensure that Impartiality & confidentiality of information is maintained at all times in accordance with the Lab policy and the staff have [[signed the Declaration of Impartiality & Confidentiality]]. 
-. +
 ===4.2.2 Release of information=== ===4.2.2 Release of information===
 When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the patient concerned will be notified of the information released, unless prohibited by law. When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the patient concerned will be notified of the information released, unless prohibited by law.
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 The laboratory will establish and implement the following processes: The laboratory will establish and implement the following processes:
   - Opportunities for patients and laboratory users to provide helpful information to aid the laboratory in the selection of the examination methods, and the interpretation of the examination results.   - Opportunities for patients and laboratory users to provide helpful information to aid the laboratory in the selection of the examination methods, and the interpretation of the examination results.
-  - Provision of patients and users with publicly available information about the examination process, including costs when applicable, and when to expect results. For these purposes 1 & 2 Laboratory has established a Document named as a Directory of Services. That is available as a soft copy as well as hard copy is also available at the sample collection area. {{https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Directory of services}}+  - Provision of patients and users with publicly available information about the examination process, including costs when applicable, and when to expect results. For these purposes 1 & 2 Laboratory has established a Document named as a [[https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Directory of Services]]. That is available as a soft copy as well as hard copy is also available at the sample collection area. 
   - Periodic review of the examinations offered by the laboratory to ensure they are clinically appropriate and necessary.   - Periodic review of the examinations offered by the laboratory to ensure they are clinically appropriate and necessary.
   - Where appropriate, disclosure to patients, users and any other relevant persons, of incidents that resulted or could have resulted in patient harm, and records of actions taken to mitigate those harms.   - Where appropriate, disclosure to patients, users and any other relevant persons, of incidents that resulted or could have resulted in patient harm, and records of actions taken to mitigate those harms.
   - Treatment of patients, samples, or remains, with due care and respect. {{https://drive.google.com/file/d/1Sydry2Y6giyNSaikStoh_cajemi_g6Wq/view?usp=drive_link| Biomedical waste Management guideline}} {{https://docs.google.com/presentation/d/1AJSBjZ43-xA--x4EkQDu0TNBLd9oAiBI/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|BMW Training material}}   - Treatment of patients, samples, or remains, with due care and respect. {{https://drive.google.com/file/d/1Sydry2Y6giyNSaikStoh_cajemi_g6Wq/view?usp=drive_link| Biomedical waste Management guideline}} {{https://docs.google.com/presentation/d/1AJSBjZ43-xA--x4EkQDu0TNBLd9oAiBI/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|BMW Training material}}
-  - Obtaining informed consent when required. {{https://drive.google.com/drive/folders/1Tp3glUxNxmL8AAv6WkfJT8YhkkZjc8Rt?usp=drive_link|Format for Biochemistry Consent form}} {{https://docs.google.com/document/d/1Qc8b_0z2dKqbvP_LbL6u8MXZfy8z0eJu/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Format for Pathology Consent form}} +  - Obtaining informed [[consent]] when required. 
   - Ensuring the ongoing availability and integrity of retained patient samples and records in the event of the closure, acquisition or merger of the laboratory.   - Ensuring the ongoing availability and integrity of retained patient samples and records in the event of the closure, acquisition or merger of the laboratory.
   - Making relevant information available to a patient and any other health service provider at the request of the patient or the request of a healthcare provider acting on their behalf.    - Making relevant information available to a patient and any other health service provider at the request of the patient or the request of a healthcare provider acting on their behalf. 
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 ====5.2 Laboratory director==== ====5.2 Laboratory director====
 ===5.2.1 Laboratory director competence=== ===5.2.1 Laboratory director competence===
-The laboratory is directed by a Dr. Hariom Sharma with the specified qualifications, competence, delegated authority, responsibility, and resources to fulfill the requirements of this document.{{|Appointment order of Laboratory Director PENDING}}+The laboratory is directed by a Dr. Hariom Sharma with the specified qualifications, competence, delegated authority, responsibility, and resources to fulfill the requirements of this document.{{https://drive.google.com/file/d/16yMTuR_CJlZPgKLR6qTcasXZniCdugt2/view?usp=drive_link|Appointment order of Laboratory Director}}
 ===5.2.2 Laboratory director responsibilities=== ===5.2.2 Laboratory director responsibilities===
 The laboratory director is responsible for the implementation of the management system, including the  The laboratory director is responsible for the implementation of the management system, including the 
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 ====5.3 Laboratory activities==== ====5.3 Laboratory activities====
 ===5.3.1 General=== ===5.3.1 General===
-The laboratory will specify and document the range of laboratory activities{{https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Laboratory Scope}}, including laboratory activities performed at sites other than the main location (e.g. POCT, sample collection) for which it conforms with this document. +The laboratory will [[https://docs.google.com/spreadsheets/d/1tbIriQpbpiOOWkwDhIkAFy06Qy2V7bDq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|specify and document the range of laboratory activities]], including laboratory activities performed at sites other than the main location (e.g. POCT, sample collection) for which it conforms with this document. 
 The laboratory will only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis. The laboratory will only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.
 ===5.3.2 Conformance with requirements=== ===5.3.2 Conformance with requirements===
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 Laboratory management will ensure that appropriate laboratory advice and interpretation are available and meet the needs of patients and users. Laboratory management will ensure that appropriate laboratory advice and interpretation are available and meet the needs of patients and users.
 The laboratory will The laboratory will communicate via phone calls to treating physician on the following when applicable: The laboratory will The laboratory will communicate via phone calls to treating physician on the following when applicable:
-  - Advising on choice and use of examinations, including required type of sample, clinical indications and limitations of examination methods, and the frequency of requesting the examination. {{|Record of Meeting with Clinicians PENDING}} +  - Advising on choice and use of examinations, including required type of sample, clinical indications and limitations of examination methods, and the frequency of requesting the examination. [[Record of Meeting with Clinicians]] 
-  - Providing professional judgments on the interpretation of the results of examinations. +  - Providing professional judgments on the [[interpretation of the results of examinations]]. 
-  - Promoting the effective utilization of laboratory examinations. {{https://docs.google.com/spreadsheets/d/1ydvHq1Mb9trhnsXM1AYrCZ2mC124QTOa/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |Advice for lab Investigations}}+  - Promoting the [[effective utilization of laboratory examinations]]. 
   - Advising on scientific and logistical matters such as instances of failure of sample(s) to meet acceptability criteria.{{https://docs.google.com/presentation/d/1yG0C_8bppH6gMXLg2Vhu-0q2RWbozsTl/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |ABG training ppt}} {{https://drive.google.com/file/d/1JjgVcBUwbjNL3x5mXh2365Q0HhXvhiOq/view?usp=drive_link| Record of improvement after Training(ABG Paper)}}   - Advising on scientific and logistical matters such as instances of failure of sample(s) to meet acceptability criteria.{{https://docs.google.com/presentation/d/1yG0C_8bppH6gMXLg2Vhu-0q2RWbozsTl/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |ABG training ppt}} {{https://drive.google.com/file/d/1JjgVcBUwbjNL3x5mXh2365Q0HhXvhiOq/view?usp=drive_link| Record of improvement after Training(ABG Paper)}}
  
 ====5.4 Structure and authority==== ====5.4 Structure and authority====
 ===5.4.1 General=== ===5.4.1 General===
-Laboratory Services Sir T Hospital(LSSTH), Bhavnagar is operated under three departments. 
-Department of Biochemistry 
-Department of Microbiology 
-Department of Pathology 
-All three departments have following staff in descending authority of control 
-  - Head of department 
-  - Associate Professor 
-  - Assistant Professor 
-  - Tutor 
-  - Senior Residents 
-  - Junior Residents 
-  - Technicians 
-  - Class 4 servants 
-In addition, departments may have other personnel (for example, research assistants) who may be working under any other person assigned by Head of the Department. 
-Responsibilities and authorities are defined by Head of the Department in accordance with various instructions provided by Government of Gujarat. 
  
 The laboratory will: The laboratory will:
-  - Define its  Organization chart and management structure, its place in any parent organization, and the relationships between management, technical operations and support services.{{https://docs.google.com/presentation/d/1uGYuUTY2E4d8lGzvZMaVGNtlrpAZ0mCn/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Organization Chart}}+  - Define its  [[https://drive.google.com/file/d/1yzEeVm0r329cRyEazJ-ycOtbACPnbBqk/view?usp=drive_link|Organization chart]] and management structure, its place in any parent organization, and the relationships between management, technical operations and support services.
   - Specify the responsibility, authority, lines of communication and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities.   - Specify the responsibility, authority, lines of communication and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities.
   - Specify its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.   - Specify its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.
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 **NOTE:** These responsibilities can be assigned to one or more persons. **NOTE:** These responsibilities can be assigned to one or more persons.
 ====5.5 Objectives and policies==== ====5.5 Objectives and policies====
- 1) Laboratory management will establish and maintain objectives and policies to:{{https://docs.google.com/document/d/14DAC9pi9uau2wEfbNEzk5PdVk93P7ezu/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Quality policy, Objectives & Indicators}}+ 1) Laboratory management will establish and maintain [[objectives and policies]] to:
   * Meet the needs and requirements of its patients and users;   * Meet the needs and requirements of its patients and users;
   * Commit to good professional practice;   * Commit to good professional practice;
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 **NOTE:** Types of quality indicators include the number of unacceptable samples relative to the number received, the number of errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified turnaround times. **NOTE:** Types of quality indicators include the number of unacceptable samples relative to the number received, the number of errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified turnaround times.
 ====5.6 Risk management==== ====5.6 Risk management====
-  -  Laboratory management will establish, implement, and maintain processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions to address both risks and opportunities for improvement.{{https://docs.google.com/document/d/1ZuZwb7QZ5fEjFInpkhp7t3e_Uzq2Y5wE/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Risk Management Plan}}+  -  Laboratory management will establish, implement, and maintain [[processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions]] to address both risks and opportunities for improvement.
   -  The laboratory director will ensure that these processes are evaluated for effectiveness and modified, when identified as being ineffective.   -  The laboratory director will ensure that these processes are evaluated for effectiveness and modified, when identified as being ineffective.
 **NOTE 1:** ISO 22367 provides details for managing risk in medical laboratories. **NOTE 1:** ISO 22367 provides details for managing risk in medical laboratories.
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 ===6.2.1 General=== ===6.2.1 General===
  
-1. The laboratory will have access to a sufficient number of competent persons to perform its activities. +1. The laboratory will have access to a [[sufficient number of competent persons to perform]] its activities. 
- {{https://docs.google.com/document/d/19RqDJZSnX5NN2KnBMmlZSm1VXGzqYNl2/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Biochemistry Staff list}} [[https://drive.google.com/drive/folders/1LUqN4zYAkkwejGXT0ST_vJ60aQ76rI6H?usp=drive_link| Appointment Order of all staff]] [[https://drive.google.com/drive/folders/1NMeHHPZ_hoh_Ufl99VxCz2c__p4ciNJ9?usp=drive_link| Educational Qualifications of all staff]] [[https://drive.google.com/drive/folders/19KrjAjLfq32MWHLxy8_ptycV8xxpy9WY?usp=drive_link| Employee's Personal Details]] +[[https://drive.google.com/drive/folders/19KrjAjLfq32MWHLxy8_ptycV8xxpy9WY?usp=drive_link| Employee's Personal Details]] 
-{{https://docs.google.com/document/d/1tdi0BwK_f_YeoccT_o4KMlPy5_YxOqgI/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Format for Employee's Personal Profile}}+{{https://drive.google.com/file/d/1W_FCQwodQYiiSguh18G1f2B2o2AiFVvd/view?usp=drive_link| Format for Employee's Personal Profile}}
  
  
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 3. The laboratory will communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document. 3. The laboratory will communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document.
  
-4. The laboratory has a programme to introduce personnel to the organization, the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services.{{https://docs.google.com/document/d/1SivFfxPNa-fc1jBkSZmfgn2yCtXRs7pH/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |Format for Induction training}} [[https://drive.google.com/drive/folders/1Cj2VwQX9fDecSeGOdPZXD8C8QmvOJhUP?usp=drive_link|Record of induction training of new staff]]+4. The laboratory has a [[https://drive.google.com/file/d/1MuRx8vTBC310uuJCob7DI0gKz7anFXoy/view?usp=drive_link|programmed to introduce personnel to the organization]], the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services.[[https://drive.google.com/drive/folders/1Cj2VwQX9fDecSeGOdPZXD8C8QmvOJhUP?usp=drive_link|Record of induction training of new staff]]
  
 ===6.2.2 Competence requirements=== ===6.2.2 Competence requirements===
-  - The laboratory will specify the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, re-training, technical knowledge, skills and experience. {{https://docs.google.com/document/d/1P77PVOT59Ralg8IWWad4BFHl8_ZZfEZHYWJU-NM6kEs/edit?usp=drive_link | Documentary procedure for personnel management }} +  - The laboratory will [[specify the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, re-training, technical knowledge, skills and experience]].
   - The laboratory will ensure all personnel have the competence to perform laboratory activities for which they are responsible.   - The laboratory will ensure all personnel have the competence to perform laboratory activities for which they are responsible.
   - The laboratory has a process for managing competence of its personnel, that includes requirements for frequency of competence assessment.   - The laboratory has a process for managing competence of its personnel, that includes requirements for frequency of competence assessment.
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   - assessment of problem-solving skills,   - assessment of problem-solving skills,
   - examination of specially provided samples, e.g. previously examined samples, interlaboratory comparison materials, or split samples.   - examination of specially provided samples, e.g. previously examined samples, interlaboratory comparison materials, or split samples.
-  - Objective Structured Practical Exaination {{https://docs.google.com/spreadsheets/d/1vUhYixTjQ_HWxuwwJWG7HPvZuvaR62dq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| OSPE method}}+  - [[Objective Structured Practical Examination]] 
  
 ===6.2.3 Authorization=== ===6.2.3 Authorization===
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 The laboratory has procedures and retain records for: The laboratory has procedures and retain records for:
   - Determining the competence requirements    - Determining the competence requirements 
-  - Position descriptions{{https://docs.google.com/document/d/1J4cCLRbHk81jJ82NMGMjwwQDyde7AEmk/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Job discription of Staff}}+  - [[Position descriptions]]
   - Training and re-training; {{https://drive.google.com/drive/folders/1NlkUzYusXsLhvfIhvdk77RNONV05F-L1?usp=drive_link| Training mateials}}    - Training and re-training; {{https://drive.google.com/drive/folders/1NlkUzYusXsLhvfIhvdk77RNONV05F-L1?usp=drive_link| Training mateials}} 
-  - Authorization of personnel;{{https://docs.google.com/document/d/1ztS2agW7tZPkJuQ-5YHxs4aWpDT19yVl/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |Authorized personnel list}}+  - [[https://docs.google.com/document/d/1ztS2agW7tZPkJuQ-5YHxs4aWpDT19yVl/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |Authorization of personnel]];
   - Monitoring competence of personnel.   - Monitoring competence of personnel.
 ====6.3 Facilities and environmental conditions==== ====6.3 Facilities and environmental conditions====
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 The facilities and environmental conditions will be suitable for the laboratory activities and will not adversely affect the validity of results, or the safety of patients, visitors, laboratory users, and personnel. This will include pre-examination related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT. The facilities and environmental conditions will be suitable for the laboratory activities and will not adversely affect the validity of results, or the safety of patients, visitors, laboratory users, and personnel. This will include pre-examination related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT.
  
-The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities will be specified, monitored, and recorded. [[https://drive.google.com/drive/folders/1dYkknSDRIgd4AvK2W9kcYOcGseJzfDZe?usp=drive_link|Facility and environment control record]]+The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities will be specified, monitored, and [[recorded]]. 
  
 **NOTE 1:** ISO 15190 provides details for facility and environmental conditions. **NOTE 1:** ISO 15190 provides details for facility and environmental conditions.
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 ====6.4 Equipment==== ====6.4 Equipment====
 ===6.4.1 General=== ===6.4.1 General===
-The laboratory has processes for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration.{{https://docs.google.com/document/d/1SwIUndhySsoMHdSY7CJboPwpdkIdrsnv/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Process for selection, procurement, installation, acceptance testing, handling, transport, storage, use, maintenance, and decommissioning of equipment}}+The laboratory has [[processes]] for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration.
  
 **NOTE:** Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems, or any equipment that influences the results of laboratory activities, including sample transportation systems. **NOTE:** Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems, or any equipment that influences the results of laboratory activities, including sample transportation systems.
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   - The laboratory has appropriate safeguards to prevent unintended adjustments of equipment that can invalidate examination results.   - The laboratory has appropriate safeguards to prevent unintended adjustments of equipment that can invalidate examination results.
   - Equipment will be operated by trained, authorized, and competent personnel.   - Equipment will be operated by trained, authorized, and competent personnel.
-  - Instructions for the use of equipment, including those provided by the manufacturer, will be readily available.+  - [[Instructions for the use of equipment]], including those provided by the manufacturer, will be readily available.
   - The equipment will be used as specified by the manufacturer, unless validated by the laboratory.   - The equipment will be used as specified by the manufacturer, unless validated by the laboratory.
  
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 ===6.4.6 Equipment adverse incident reporting=== ===6.4.6 Equipment adverse incident reporting===
 Adverse incidents and accidents that can be attributed directly to specific equipment will be investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required. Adverse incidents and accidents that can be attributed directly to specific equipment will be investigated and reported to either the manufacturer or supplier, or both, and appropriate authorities, as required.
-The laboratory will have procedures for responding to any manufacturer's recall or other notice, and taking actions recommended by the manufacturer.                                                                                  {{ https://docs.google.com/document/d/1FzCS5FkT9wOoJFlp9lrVn6X3o6wAJrxxQUfa83MhqqM/edit?usp=drive_link | Documentary procedures for responding to any manufacturer's recall or other notice }} +The laboratory will have [[https://docs.google.com/document/d/1FzCS5FkT9wOoJFlp9lrVn6X3o6wAJrxxQUfa83MhqqM/edit?usp=drive_link|procedures for responding to any manufacturer's recall]] or other notice, and taking actions recommended by the manufacturer.                                                                                 
  
 ===6.4.7 Equipment records=== ===6.4.7 Equipment records===
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 activities. activities.
 These records will include the following, where relevant: These records will include the following, where relevant:
-  - Manufacturer and supplier details, and sufficient information to uniquely identify each item of equipment, including software and firmware; {{https://docs.google.com/spreadsheets/d/1oB5mclXPP51h9UBgn5UF62Vlgf-lnpHm/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Equipment stock register}} +  - [[Manufacturer and supplier details, and sufficient information to uniquely identify each item of equipment]], including software and firmware; 
   - Dates of receipt, acceptance testing and entering into service;   - Dates of receipt, acceptance testing and entering into service;
-  - Evidence that equipment conforms with specified acceptability criteria;+  - [[Evidence that equipment conforms with specified acceptability criteria]];
   - The current location;   - The current location;
   - Condition when received (e.g. new, used or reconditioned);   - Condition when received (e.g. new, used or reconditioned);
-  - Manufacturer's instructions;{{https://drive.google.com/drive/folders/1Kli-zUH8Q1U9tx12SvjK9Q_K-BJGzlkw?usp=drive_link| Equipment Instructions for Use}} +  - [[Manufacturer's instructions]]; 
-  - The programme for preventive maintenance;  +  - [[The programme for preventive maintenance]];  
-  - Any maintenance activities performed by the laboratory or approved external service provider; +  - [[Any maintenance activities performed by the laboratory or approved external service provider]]; 
-  - Damage to, malfunction, modification, or repair of the equipment; +  - [[Damage to, malfunction, modification, or repair of the equipment]] 
-  - Equipment performance records such as reports or certificates of calibrations or verifications, or both, including dates, times and results; {{https://drive.google.com/drive/folders/1vVDKrKE2kPw435ryPcaAwZuCg78CjyZ5?usp=drive_link| Equipment Calibration Certificate & raw data}} +  - Equipment performance records such as reports or [[certificates of calibrations or verifications]], or both, including dates, times and results; 
   - status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.   - status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.
  
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 **NOTE:** Examples of qualitative methods and quantitative methods that may not allow metrological traceability include red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry marker staining, and tumor HER2 immunohistochemical staining. **NOTE:** Examples of qualitative methods and quantitative methods that may not allow metrological traceability include red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry marker staining, and tumor HER2 immunohistochemical staining.
 ===6.5.2 Equipment calibration=== ===6.5.2 Equipment calibration===
-The laboratory will have procedures for the calibration of equipment that directly or indirectly affects  +The laboratory will have [[procedures for the calibration of equipment]] that directly or indirectly affects  
-examination results. {{ https://docs.google.com/document/d/1UX0PwfoxIp0lnRjXoVOil-hp_KWRO5gUWOOBzs6IW8s/edit?usp=drive_link | Documentary Procedures for the calibration of equipment }} +examination results. 
 The procedures will specify: The procedures will specify:
   -  Conditions of use and manufacturer's instructions for calibration;   -  Conditions of use and manufacturer's instructions for calibration;
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 ====6.6 Reagents and consumables==== ====6.6 Reagents and consumables====
 ===6.6.1 General=== ===6.6.1 General===
-The laboratory will have processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables.{{https://docs.google.com/document/d/1C_Arq2sbMklhV_NiBq7V_OI308_Nr7zGYiK2_472BuY/edit?usp=drive_link|Process for the Selection, Procurement, Reception, Storage, Acceptance testing and Inventory management of reagents and consumables}}+The laboratory will have [[processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables]].
  
 **NOTE:** Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc. **NOTE:** Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc.
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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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