LABORATORY QUALITY MANUAL


LABORATORY QUALITY MANUAL




Chato District Hospital Laboratory (CDHL)

Title: Laboratory Quality Manual

Manual number:
CDH-LAB-REC 02-vers 01
Effective date:
01/11/2013
Revision date:
01/11/2015
Pages: 32
Prepared and signed by:


Laboratory manager
Authorized and signed by:


Medical Officer Incharge


 

Revision history

Reviewed date
Revision date
Version
Approved by
Effective date
NA
NA
1.0
Medical Officer Incharge

01/11/2013

























 TABLE OF CONTENTS




ACKNOWLEDGEMENTS

The Chato District Hospital Laboratory CDH wishes to extend sincere gratitude to Ministry of Health (MOH) for initiating the process of Accreditation in the Country.


Special thanks should go to the ICAP laboratory Mentors for moral support and for their dedicated efforts in organizing, communicating, coaching and pushing staff in the process of preparation of this Quality Manual document.


Finally, we would like to acknowledge and congratulate the members Document Development Team who have devoted their time, energy and acknowledge to the development of this manual.



TO THEM WE ARE GRATEFUL

Laboratory Manager
Kassulu District Hospital
ABBREVIATIONS
EQA-External Quality Assessment
MOH- Ministry of Health
CDC-Centres for Disease Control
CLSI-Clinical Laboratory Standards Institute
QMS-Quality Management system
QM-Quality Manual
MSD-Medical Stores Department
IPC-Infection Prevention Control
MSDS-Material safety data Sheets
CDHL-Chato District Hospital Laboratory
IQC- Internal Quality Control
QO- Quality Officer
SOP- Standard Operating Procedure
TAT- Turnaround Time
ICAP- International Center AIDS Care and treatment Programs



DEFINITIONS
All quality definitions are as per ISO 9000:2000 and ISO 15189:2007

Calibration
The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system or values represented by a material measure, and the corresponding known values of a reference standard.

Corrective action
Action taken to eliminate the cause of an identified nonconformity or other undesirable situation.

Documentation
All the written or electronic instructions and records, quality procedures and recorded test results involved in the manufacture of a product.

Non-Conformity
The non fulfillment of a specified requirement.

Quality
The totality of features and characteristics of a product, service or test method that bear on its ability to satisfy stated or implied needs.

Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a product, service, test method will satisfy given requirements for quality.

Quality audit
A systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are appropriate to achieve objectives.

Quality control
The operational techniques and activities that are used to fulfill requirements for quality.

Quality management
Aspect of the overall management function that determines and implements the quality policy.

Quality policy
Overall quality intentions and direction of an organization as regards quality as formally expressed and authorized by top management.

Quality system
The organizational structure, responsibilities, procedures and resources for implementing quality management.

Specification
Document that states the requirements to which the product, service, or test method has to conform.

Traceability
Ability to trace the history, application or location of an item, activity or result by means of documented records.

Validation
The act of confirming a product, service, or test method that it meets the requirements for which it was intended.

Laboratory
Clinical laboratory for the biological, microbiological, immunological, chemical, immune-haematological, haematological, biophysical, cytological, pathological or other examination of materials derived from human body for the purposes of providing information for the diagnosis, prevention, prognosis, surveillance and treatment of disease in assessment of the health of human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation.

Laboratory staff
All members of staff who work at Chato District Hospital Laboratory

Technical staff
Laboratory members of staff who performs laboratory testing and other related activities

Laboratory Management
Comprises of Laboratory Manager, Quality Officers, Safety Officers and Heads of Sections




SCOPE
The quality manual has been written to provide a guide to the strategies required for establishing and maintaining a quality laboratory service in Chato District Hospital. The quality manual provides a basis of delivering quality, clinical and laboratory diagnostic service that are effective, efficient and safe.
This manual defines the policies for the quality management system for the Chato District Hospital. The manual is the ultimate document in terms of the quality system hierarchy. It describes how all the competency requirements for both management and technical requirements are to be met. The quality manual applies to all the sections of the laboratory. All members of staff are to be trained in the use of this manual and are required to apply these requirements whenever they perform their work.   
Chato District Hospital Laboratory provides routine medical laboratory services in the following areas:
·         Microbiology:
·         Clinical Chemistry
·         Haematology
·         Parasitology
·         Serology
·         Blood Transfusion



1. QUALITY POLICY STATEMENT

Chato District Hospital (CDH) Laboratory management is committed to the provision of diagnostic medical laboratory testing services that are of high international standards in line with the principles of good professional laboratory practice.

Management is also committed to the provision of accurate, reliable, credible, relevant and timely laboratory results obtained from tests that are always carried out in accordance with client requirements and Quality Management System based on ISO 15189 requirements. The management of Chato District Hospital Laboratory (CDH) is also committed to providing an un-interrupted, efficient and cost effective service that will stand as a hall mark in the overall management of patients in tits catchment area

Management ensures that all laboratory personnel are competent and qualified for the tasks they perform, and that all personnel familiarize themselves with Quality Management System documentation in order to implement the policies and procedures in their work. Management undertakes to periodically review the performance of the Quality Management System and quality objectives to ensure their effectiveness, continuing relevance and suitability in ensuring production of reliable laboratory results.

2. QUALITY OBJECTIVES

·         To achieve 5 stars of SLIPTA checklist by August 2015.
·         To ensure all personnel are trained and are competent to perform all the procedures in line with their work at any given time.
·         To provide continued education classes every week with attendance of more than 80% of laboratory workers.
·         To participate in accredited EQA schemes and to achieve 85% or more in performance all the time.
·         To ensure that 90% of all patient results are released within the established laboratory turnaround time at any given time.
·         To maintain safe and healthy working conditions to all employees and ensuring zero working accidents per month.

 




3. INTRODUCTION

Brief overview
The Department of Laboratory of CDH firmly believes that Quality is the hallmark of our healthcare excellence and is the platform of all functional elements of structure, process and outcome. With this belief the department has prepared a quality manual that describes the quality management system and refers reader(s) to the appropriate processes and procedures for the services offered. The system ensures that the laboratory services are efficient, effective and meet professional and regulatory requirements in accordance with the health policy by the Ministry of Health, Tanzania. The laboratory, in keeping with the hospital goals & objectives, continually strives for excellence while meeting and exceeding the needs of our patients and healthcare personnel.
About Chato District Hospital (KDH)
CDH is a public health institution. The hospital has _____beds capacity.  It receives patients from District Hospital, Surrounding Government and private health facilities. The hospital provides a range of services including general surgical, obstetric and gynecology, medical, pediatric, eye, dental, and other support services.
Department Of Laboratory
The Laboratory is a department within CDH and functions as a part of the larger health system. It provides specific diagnostic laboratory services that are vital to the overall mission of providing patient care.
The department with about 11 technical staff has a reputation for service quality, safety and continuous improvement.  The department is service oriented with special emphasis on accuracy, reliability and timely reporting of laboratory test results. The department plays an important role from its laboratory bench to patient bedside in supporting the hospital’s goal of quality and compassionate patient care for all of its clinical programs.



4. 0 MANAGEMENT REQUIREMENTS 

4.1. Organization and Management

KDH was established through the Ministry of Health Tanzania, which authorizes it to provide public health services to the population of the area. Chato District Hospital laboratory follows the MOHSW reporting structures.

4.1.1 Management Responsibilities


CDHL management is responsible for design, implementation, maintenance and improvement of the quality management system as described below in this Quality Manual:

Authority

All members of staff are given authority by the Laboratory Manager to conduct activities, examinations and use of equipment on behalf of BRRDH Laboratory in areas which they will have been deemed competent. Authorizations are generally documented in their individual job descriptions and followed by Staff Training and Competence Assessment Forms.

Resources

CDH provides aadequate human and financial resources to the laboratory department to ensure they carry out their duties without disruptions and importantly meeting the customer required turnaround times.

Confidentiality

Confidential information shall not be disclosed to any third party without written authorization from the Medical Officer In charge or his/her designee. On orientation all members of staff are trained and required to sign a confidentiality to prevent them from disclosing confidential information to outsiders.

Conflict of Interest

Responsibilities of all laboratory personnel of CDH Laboratory are defined in order to identify conflict of interest. CDHL is committed to identify and investigate any commercial, financial or any other pressure provided by any person or a particular organization which could influence its technical judgment or affect its competencies and trust. All employees are to abide with Ethical Code of Conduct. All employees will complete the Business Commercial Interest Disclosure form upon hire and update the statement when need arises.

Internal and External Pressure

CDH Laboratory encourages all members of staff to disclose any internal and external commercial, financial or other pressures and influences that may affect the quality of their work. Members of staff are free to approach any managerial staff in confidence and share their personnel pressures. It is the responsibility of both the laboratory management and staff to generate and report data objectively and therefore no staff has authority to take any action or to require any action to be taken which interferes with the laboratory in discharging this responsibility, irrespective of the normal line of management.

Fraudulent Results
CDH Laboratory management is responsible for the detection and prevention of fraudulent results misappropriations and other irregularities. Each member of the management team will be familiar with the type of improprieties that might occur within his or her area of responsibility, and be alert for any indication or irregularity.
Any irregularity that is detected or suspected must be reported immediately to the Laboratory Manager who coordinates all investigations within the laboratory and other affected areas both internal and external. All cases relating to fraud will be treated as having serious reputational consequences. Anyone who will be found guilty after investigations, the Medical Officer In charge/Laboratory Manager will take disciplinary actions accordingly.

Activities that Diminish the Integrity of CDH Laboratory

Management ensures that there is confidence in the laboratory operation by making sure all personnel follow Ethical Code of Conduct as well as the procedure of activities that diminish CDH Laboratory operational integrity and all other applicable policies and procedures. 

Supporting Documents
·         Protection of confidential information Procedure
·         Activities That Diminish NHL-QATC’s Operational Integrity
·         Ethical Code of Conduct
·         Confidentiality and Conduct Undertaking Form
·         Business Commercial Interests Disclosure form
·         Disclosure of Internal & External Pressures

4.1.2 Communication 

Communication is vital for the effective performance as well as continual improvement of a Quality Management System. It is in this regard that CDH Laboratory management has put in place communication mechanisms that will ensure that customer requirements (both internal and external) are met. All communications (outgoing and incoming) are logged or filed whichever is appropriate.

Internal Communication
To achieve collective ownership of the system by both Management and staff, Laboratory management involves all staff in every aspect of the development and implementation of the QMS. For effective communication within the laboratory, management has put in place channels of communication, which include but not limited to the following:
·         Memos, letters, notices
·         Meetings
§  Weekly Staff Meetings
§  Quarterly Quality Committee Meetings
·         Telephonic
·         Oral communication
·         Verbal or written instructions (e.g. through Quality Manual, Lectures).

External Communication
Communication with external stakeholders is in the form of but not limited to electronic mail, fax, telephonic and meetings. Laboratory management is authorized to offer telephonic consultations on technical matters within the scope of their responsibilities to external clients. Records of all communications shall be kept thereof.
Supporting Documents
·         Records of Minutes
·         Memoranda
·       

4.1.3 KDH Laboratory Organisational Chart

 





4.1.4 Personnel Responsibilities
Laboratory Manager

Responsible for:
  • Coordinates the establishment of the quality management system based on SLIPTA checklist and ISO standards 15189, supports its implementation and coordinates activities pertaining to quality.
  • Supervises and directs the work at sectional level.
  • Coordinates and supervises staff induction, training and competence assessment.
  • Monitoring quality management system (QMS) implementation.
  • Ensure the safety requirements of the laboratory are being followed.
  • Ensure that personnel have sound knowledge and recognize the importance of participatory approach in policies and goals of the quality management system as well as needs of customers, laws and regulations.
  • Ensure the completeness of the quality management system (QMS) and its continued maintenance and review.
  • Providing and ensuring availability of resources.
  • To perform any other duties as assigned by the Medical Officer In charge from time to time


Deputy Laboratory Manager
Responsible for:

  • Assist the Lab Manager in Providing advice to those requesting information about the choice of tests, the use of the laboratory service and the interpretation of laboratory data
  • Assist the Lab Manager in supervising and oversee the technical functions of the CDH Laboratory
  • Assist the Lab Manager in advising the head of diagnostic services in technical matters pertaining to the CDH Laboratory
  • Serve as an active member of the medical staff for those facilities served.
  • Assist the Lab Manager in monitoring all works performed in the laboratory to determine that reliable data are being generated in the laboratory.
  • Assist the Lab Manager in providing effective and efficient administration of the medical laboratory service, including budget planning and control with responsible financial management, in accordance with institutional assignment of such responsibilities.
  • Assist the Lab Manager in providing educational programs for the medical and laboratory staff and participate in the educational programs of the institution
  • Assist the Lab Manager in selecting and monitoring all referral laboratories for the quality of service in conjunction with the quality officers.
  • Assist the Lab Manager in identification and addressing of complaints, non-conformances and corrective actions.
  • Assist the Lab Manager in  advising on various developments and review of policies and programs of the CDH Laboratory
  • Assist the Lab Manager in planning, issue orders or instructions, provide leadership, enforce discipline, handling grievances, controlling outputs, and maintain work conditions and preserving records.
  • Assist the Lab Manager in implementing a safe laboratory environment in compliance with good practice and applicable regulations.
  • Assist the Lab Manager in accountability for the implementation of the quality management system.
  • Assist the Lab Manager in coordinating the planning and implementation of training workshops and seminars.
  • Assist the Lab Manager in scheduling of organizing of management review meetings in consultation with the quality officer.
  • Assist the Lab Manager in compilation and distribution of performance reports for Management review
  • To perform any other duties as assigned by the Medical Officer In charge/Laboratory Manager from time to time.

Quality Officer

Responsible for:
  • Development, implementation and revision of the Quality Management System to ensure it is up to date at any given time.
  • Organizing and facilitating internal staff QMS training.
  • Planning and carrying out internal audits of the Quality Management system
  • Identification and addressing of complaints, non-conformances and corrective actions
  • To interact with the accreditation bodies on behalf of the organization.
  • Planning, conducting and facilitating quality assurance training workshops and seminars.
  • Scheduling of organizing management review meetings.
  • Compilation and distribution performance reports for management review
  • To perform any other duties as assigned by the Medical Officer Incharge/Laboratory Manager services from time to time

Deputy Quality Officer
Responsible for:

·         Assist the Quality officer in training staff in medical laboratory QMS.
·         Implements and maintains a safe work environment for laboratory staff
·         Monitor Quality Assessment events and reports to management
·         Ensure quality procedures are maintained with individual sections CDH Laboratory assists in the compilation of Quality System reports for individual sections at CDH Laboratory

Safety Officer
Responsible for:

  • Trains staff in safety.
  • Implements and maintains a safe work environment for laboratory staff.
  • Monitor safety events and report to management
  • Ensures safe and appropriate disposal of laboratory waste on a daily basis.
  • Compile a list of all hazardous materials, chemicals and reagents used in CDH Laboratory followed by Material Safety and Data Sheets (MSDS) for each hazardous substance.
Deputy Safety Officer
Responsible for:

·         Assist the Safety officer in training staff in medical laboratory safety.
·         Implements and maintains a safe work environment for laboratory staff
·         Monitor safety events and reports to management
·         Ensures safe and appropriate disposal of laboratory waste on a daily basis.
·         Assists in the compilation of a list of all hazardous materials, chemicals and reagents used in CDH Laboratory, followed by Material Safety and Data Sheets (MSDS) for each hazardous substance.
Section Heads

Responsible for:

  • Supervision of medical laboratory technologist/scientists within their respective sections
  • Identification and addressing of complaints, non-conformances and corrective actions relating to their sections
  • Perform routine and specialized laboratory tests.
  • Review  and approve all  laboratory results before release
  • Implementation of the quality management system.
  • Training of junior members and orientation of  new members of staff within their sections
  • To conduct competency assessments of the medical technologists.
·         Comply with established quality management system and safety procedures.

Medical laboratory Technologists and others
  • The roles and responsibilities for all other members of staff are defined in their respective Job descriptions available in their personnel files.

NB: The job descriptions listed above only summarize the functions of each role, for further details, check the respective job descriptions.

Supporting Documents
·         Job Descriptions

4.2 Quality Management System

The CDH Laboratory has a documented Quality Management System which comprises of policies, procedures, forms, job descriptions, external reference and regulatory documents and records. CDH Laboratory management ensures that all members of staff have been trained on QMS and understood it upon employment and as when necessary. Records of the training and understanding of the QMS are documented in the reading and understanding form which is found at the end of all Quality Manual and procedures. All relevant QMS documents are made available at each work station for easy implementation.
 Management has instituted Internal Quality Controls (IQC) for all tests performed and ensures that the laboratory participates in Proficiency Testing in each discipline of the laboratory. CDH Laboratory management ensures that all instruments and equipment are working properly and produced accurate results, through its quality control and quality assurance policy, which also includes preventive maintenance and calibration to ensure proper function of instruments, reagents and analytical systems.
 The following diagram outlines the Quality Management System documentation structure
 Quality System Documentation

Quality Manual
Policies and statements of intent for meeting applicable ISO 15189 Standard requirements

 



The Quality Manual is the governing document that defines the quality system policies and statements of intent by KDH Laboratory and is based on ISO 15189 requirements
Management and Technical Procedures describe who, what, when, where and how quality management system and testing processes are performed.
Forms, Logs, Registers: either related to management or technical procedures or not, are used for data collection.
Quality Records are retained as objective evidence of compliance to the requirements of ISO 15189 and KDH Laboratory management and technical procedures per Quality and Technical Record Control Procedure.

Supporting Documents
·         Quality and Technical Records Control Procedure

4.3 Document Control
CDH laboratory uses document control procedure to control all documents whether internally or externally generated. A copy of each document in the QMS is archived for later reference.  All quality documents are retained for a minimum period as defined in the Documents and Sample retention guideline. One master copy of the quality documents is maintained as a soft copy under the authority of the Quality Officer, and for daily use, a hard copy of the Quality Manual and relevant procedures are available at each workstation.
All documents issued to personnel are reviewed by the Quality Officer and Laboratory Manager and then approved by the Head of Laboratory Unit prior to issue.  The Quality Officer maintains the Master Index which shows the current revision status of all documents and their distribution. It is the responsibility of the Quality Officer and Deputy Quality officer to ensure that only current authorized versions of appropriate documents are available for use at each work station.  All documents in the system are reviewed every two years, revised when necessary, and approved by authorized personnel. All obsolete documents are removed from the workstations by the Quality Officer and Deputy Quality officer to prevent inadvertent use.  All archived documents are written with the words “OBSOLETE” with a red ink on all pages.  The laboratory management does not allow document corrections and changes to be done by hand.  
All documents are uniquely identified with the following identifiers: Title; Edition, Effective Date/Revision and Version Number; Number of Pages; Authority for issue and Source identification
Supporting Documents
·         Documents control procedure
·         Documents and Sample retention guideline
·         Master Index



4.4 Review of Contracts (Requests)

The CDHL main function is to provide medical laboratory services to the KDH wards, out patients departments and referred samples from nearby health facilities. Review of Contracts Procedure is used for review of all contracts which can either be individual or large sample sizes.  Review of individual contracts is done upon receipt of samples and request form, from the wards or request form in case of out- patients department. It is a requirement that all samples and request forms meet the acceptance criteria for them to be accepted by the laboratory otherwise they will be rejected. Acceptance/Rejection criteria are defined in the Sample collection Manual. Reviews are also done to check that clients have not requested a test not done by the laboratory.  For large sample sizes, the hospital management shall notify the laboratory manager in writing who in turn shall review whether the laboratory has the capacity to conduct the tests according to the client’s requirements. The laboratory manager shall either accept the contract if he/she deems that the laboratory has the necessary capacity to conduct the work or deny the contract if the laboratory does not have the required capacity. The laboratory manager can in some cases suggest having the testing process staggered on different days depending on the availability of human resources and reagents.  In all cases consideration is given to specimen collection, transportation, human resources, equipment, reagents, time frame for testing and collecting results for the laboratory to either accept or reject the contracts.

Supporting Documents
·         Review of Contracts Procedure

4.5 Examination by Referral Laboratories

The CDH Laboratory uses Evaluation and Selection of Referral laboratories for evaluating and selecting the services of referral laboratories for laboratory tests not performed at CDH Laboratory or in cases where back-up services are required. All referral laboratories are evaluated and selected on basis of the following requirements, in their order of priority:
  1. Accreditation to relevant ISO standard and equivalent standards
  2. Audit conducted by CDH Laboratory or a recognized body
  3. Satisfactory performance in relevant proficiency testing.
  4. Acceptable results for known samples.

The CDH Laboratory maintains a list of all selected referral laboratories with their contact details. Arrangements with the referral laboratories shall be reviewed once in two years. All referred tests will be recorded in Sample Referral Log which will be kept in the referring sections.
The CDH Laboratory will be responsible for ensuring that referral laboratories examination results and findings are provided to the person making the request. The results from accredited referral laboratories shall be sent to the requested clinicians as they are.

Supporting Documents
·         Evaluation and Selection of Referral laboratories
·         Sample Referral Log
·         Evaluation Check List For Referral Laboratory

4.6 External Services and Supplies

The CDH Laboratory follows government procurement regulations in purchasing equipment and supplies for the laboratory. All required items are purchased by CDH Laboratory through the CDH Procurement Department. CDH Laboratory collaborates with hospital procurement and supply department to make sure that equipment and other supplies purchase are of acceptable quality.
The CDH Laboratory performs inspection on all received items before they can be put into inventory. Inventory control procedure is used to monitor all the items placed into inventory. All items shall be subject to quality control before they can be used for testing patient samples. The reagents which pass quality control shall be accepted and put into use, and those which fail the quality control tests shall be rejected and returned to the supplier.
All items are stored according to the manufacturer’s recommendations and all storage facilities shall be monitored for temperature to ensure that temperature will not affect the stored items.
Supporting Documents
·         External Services and Supplies Procedure
·         Inventory Control Procedure
·         Receiving and Inspection checklist
·         Inventory Control form

4.7 Advisory Services

Any qualified technical laboratory personnel can provide advice on the choice of examination and the use of services including repeat frequencies and the required type of sample.  The laboratory has Sample Collection Manual that is also used to provide information to clinicians for sample collections.  The laboratory also provides advice to clinicians in situations where laboratory results reveal that further analysis is required.
The laboratory conducts quarterly meetings with clinicians regarding the use of the laboratory services and for the purpose of consultation on scientific matters. The minutes of these meetings are maintained by the laboratory manager. 

Supporting Documents
·         Sample Collection Manual
·         Quality Management Plan
·         Minutes of Meeting with Clinicians

4.8 Resolution of complaints
CDH Laboratory uses Resolution of Complaints Procedure to receive record, investigate and resolve complaints from the users of the laboratory. Complaints are received through the suggestion box, phone calls from clinicians and other parties, consultative meetings as well as verbal complaints and are recorded on the Client Complaint Form. CDH Laboratory investigates the genuineness of all complaints and takes the appropriate corrective action, using the Corrective Action Procedure. CDH Laboratory also conducts surveys once in 12 months using Customer Satisfaction Survey Form. Data from customer satisfaction surveys is collected and analyzed and a report is generated. All complaints and suggestions from customer satisfaction surveys are forwarded for management reviews and are resolved following Corrective action Procedure.

Supporting documents
  • Resolution of Complaints Procedure
  • Corrective Action Procedure
  • Client Complaint Form
  • Customer Satisfaction Survey Form.

4.9 Identification and control of nonconformities

The CDH Laboratory members of staff identify nonconformities in their examinations or management systems when they are not in compliance with their procedures or policies as stated in the Quality Management System. All non-conformances shall be addressed according to Identification and Control of Nonconformities procedure. It is the responsibility of sectional heads or designee to clear non-conformities in their respective sections.

Medical significance is considered for each nonconformity identified and the nonconformity is then classified as either a major or a minor. If the nonconformity is classified as major, the operations are halted by laboratory manager and in such instances the requesting clinician is also informed. Corrective action is taken immediately and the results of nonconforming examination released are identified and recalled. It is the responsibility of the laboratory manager to authorize the resumption of examinations after satisfactory implementation of the corrective action.  
Each episode of nonconformity is documented and recorded on the Non conformance log, and Non-Conformance - Corrective Action Form. The Quality assurance committee reviews all corrective actions quarterly to detect trends and initiated corrective action. For all nonconformities, a root cause analysis is conducted by the use of tools like the ‘5 whys analysis”, cause analysis diagram and brain storming sessions.

Supporting Documents
  • Identification and control of nonconformities procedure
  •  Non conformance log
  • Non-Conformance - Corrective Action Form

4.10 Corrective Action
The laboratory uses corrective action procedure to make corrective actions for all identified non-conformities.  Before a corrective action is taken, root-cause analysis is done by using appropriate tools such as Cause analysis diagram, 5 Whys Analysis and Brainstorming sessions. For all non conformities, corrective action is taken and preventive measures are put in place and monitored to prevent recurrence. Corrective actions are recorded and documented on the non conformance corrective action form. The sectional heads or personnel designated implement any changes resulting from corrective action investigations. Changes in the quality management system arising from the corrective actions are put in place by the quality officer following the document control procedure.

Supporting Documents
·         Document Control Procedure
·         Corrective Action Procedure
·         Non-conformance Corrective Action Form


4.11 Preventive Action

CDH Laboratory uses the preventive action procedure to identify potential sources of non-conformities in technical and/or quality management system and prevent its occurrence.  When a potential non-conformance is identified, a preventive action plan is developed, implemented and monitored by the Quality Assurance committee to reduce the likelihood of it turning into a non-conformance and to take advantage of the opportunities for improvement. The Quality Assurance committee reviews the results of preventive actions on a quarterly basis and minutes of reviews are maintained.    

Supporting Documents
  • Preventive action Procedure
  • Preventive action Plan

4.12 Continual Improvement

CDH Laboratory continuously improves the quality management system by the review of all its operational policies and procedures once in two years by laboratory management. During these reviews, potential sources of non-conformance or other opportunities for improvement in the quality management system or technical practices are identified and action plans for improvement are developed, documented, implemented and monitored. Continual Improvement procedure is used to conduct continual improvement activities.

Once the action has been taken, the quality assurance committee reviews and evaluates the effectiveness of the actions through auditing of the concerned area. The outcome of such actions shall be submitted to the laboratory management for review and implementation of any changes to the quality management system.

The laboratory implements quality indicators in every section of the laboratory for systematic monitoring and evaluation of the laboratory’s contribution to patient care, and if an opportunity for improvement is identified the laboratory management shall address them accordingly. The quality indicators are displayed monthly on notice boards for all members to see their performance in each section.

The laboratory management provides access to suitable educational and training opportunities for laboratory personnel and relevant users of laboratory services like clinicians so as to improve in areas with high incidences of non-conformities.

Supporting Documents
·         Continual Improvement Procedure
·         List of Quality Indicators
4.13 Quality and Technical records
CDH Laboratory uses Quality and Technical Records Control Procedure for identification, collection, indexing, access, storage, maintenance and safe disposal of quality and technical records. Management ensures that all records are clear and understandable before they are stored and that they are readily retrievable whenever they are required. CDH Laboratory stores its records as hardcopy. All records are stored in wooden and lockable metal cabinets, to prevent damage from fire and flooding, deterioration, losses and unauthorized access. CDH Laboratory uses Document and Records Retention Schedule to define the length of time for keeping all documents and records.

Supporting Documents   
·         Quality and Technical Records control Procedure.
·         Document and Records Retention Guideline

4. 14 Internal Audits
In order to verify that operations continue to comply with the requirements of the quality management system, internal audits of all elements of the quality management system, both managerial and technical, are conducted twice in 12 months as defined in the Internal Audit Schedule. Audits shall be formally planned and organized by quality officer. Internal audits shall be conducted by personnel qualified to conduct internal audits. Personnel shall not audit their own activities. The procedure for internal audit defines types of audit, frequencies, methodologies and required documentation. Three types of internal audits conducted which are horizontal, vertical as well as witnessing.  When deficiencies or opportunities for improvement are noted, CDH undertakes corrective or preventive action according to the respective procedures. The results of internal audits shall be submitted to laboratory management for review.  

Supporting Documents
·         Internal Auditing Procedure
·         Internal Audit Schedule

4.15 Management Review

In accordance with a Management Review procedure, CDH Laboratory management conducts a review of the Quality Management System and all the testing activities twice in 12 months, on dates advised by the Laboratory Quality plan. The frequency of the reviews shall be increased depending on recommendations by the management review committee.  The management review committee includes and not limited to;
  • The laboratory manager
  • The Deputy Laboratory manager
  • Hospital Management (One representative)
  • Quality officers
  • Sectional heads
  • Safety Officers.
It is up to the chair person discretion to invite relevant stakeholders for the management review meetings.  The agenda for the management review is detailed in the management review procedure.

The ability of the QMS to meet the laboratory’s objectives is evaluated and any changes or improvements that may be essential are implemented. The quality and appropriateness of the laboratory’s contribution to public and patient care shall, to the extent possible, be monitored and evaluated objectively. The results of the review shall be captured and incorporated into a plan that includes goals, objectives and action plans. Action plans shall be executed within an appropriate and agreed upon timeframe. Results of the management review are communicated to all members of staff at least 2 weeks after the management review meeting.

Supporting Documents
·         Management Review Procedure
·         Minutes of Management Review Template
·         Laboratory Quality Plan

5.0 TECHNICAL MANAGEMENT

5.1. Personnel 
CDH Laboratory has approved job descriptions that define the qualification and duties of all personnel in place. All new staff members undergo a period of laboratory orientation for them to be fully conversant with laboratory practices and personnel policies upon engagement with CDH Laboratory. The laboratory uses the Ministry of health personnel policies (Ethical Code of Conduct). New members of staff are issued with the above mentioned documents for reading and understanding the requirements of the Ministry of Health. This is done in accordance with Staff Orientation Procedure.

The laboratory management maintains records of relevant education and professional qualifications, training and experience, and competence, records of immunisation, certificate of registration, practicing license, and incident and accident s of all personnel in personnel files.

 The laboratory is directed by the head laboratory services whose responsibilities are described in the job description. The laboratory management in conjunction with the Hospital administration ensure that staff resources are adequate to undertake the work and carrying out other functions of the quality management system.

All laboratory technical members are trained in internal quality control to ensure that they understand the basics of the quality management system and can implement it effectively.

The laboratory management ensures that all personnel are competent through training and thereafter authorized to perform particular tasks. The competence tests are done after an interval of 2 years.  Personnel are authorized to perform particular tasks after they have been deemed competent in those particular tasks. The laboratory also provides continuing education and training for all members of staff each week. The laboratory ensures that all members of staff are trained to prevent or contain the effects of adverse incidents such as fire and accidents.  The laboratory also conducts internal continual education once every week.

Supporting Documents
·         Ethical Code of Conduct
·         Staff Orientation Procedure
·         Staff Training and Competence Procedure


5.2. Accommodation and environmental conditions

The CDH Laboratory management ensures that there is adequate space to perform its work efficiently to ensure quality of patient results, proper quality control procedures, and safety of personnel. The hospital management provides resources to support the activities of the laboratory and that the laboratory is maintained in a functional and reliable state. In situations where the laboratory uses other facilities outside the permanent laboratory facility, laboratory management ensures that the environmental conditions will not affect the quality of the examinations.

The laboratory uses the Safety Manual as a guide to protect patients, employees and visitors from recognized hazards. All laboratory analysers are connected to Uninterruptable power supply (UPS) and the hospital uses a generator as a backup source of electrical power.

The laboratory cleans and monitors environmental conditions using the Monitoring of Environmental Condition Procedure. Fridge, freezer, incubator and water bath temperatures are monitored twice on a daily basis. Records of monitoring the environmental conditions are kept by the section heads and it is the responsibility of the section head to review all the records on a monthly basis. Access to the laboratory facilities is limited to laboratory staff only or any other person authorised by the Laboratory Management

The laboratory management ensures that relevant storage space and conditions are provided for continuing integrity of samples, slides, documents, files, manuals, equipment, reagents, laboratory supplies, records and results. Reagents and samples are not stored in the same fridges/freezers to avoid contamination of reagents.

All hazardous/biomedical waste is discarded into appropriate biohazard waste containers that are handled and disposed off in accordance with the Safety Practices Procedure, KDH Laboratory Safety Manual and also comply with guidelines of Infection Prevention control followed by all other hospital sections. All work surfaces are maintained in clean condition and records of daily cleaning and swabbing shall be recorded on Daily Cleaning Checklist.

Supporting Documents
·         Monitoring and Cleaning of Environmental Condition Procedure.
·         Safety Practices Procedure.
·         Daily Cleaning Checklist

5.3. Laboratory Equipment 

The CDH Laboratory management ensures that the laboratory has adequate equipment to provide uninterrupted referral laboratory services to the nation. All equipments are validated to confirm its suitability for the intended use before it is put into service. Management has established an equipment management procedure which is used to ensure that all equipment is functioning well at all times. Among several things the following shall be done:
  • Only trained and authorised personnel shall use the CDH Laboratory equipments.
  • All equipments shall be regularly calibrated and serviced following an established program. Members of staff are instructed not to use equipment which is not calibrated or which the calibration period is expired. 
  • All temperature sensitive equipment is monitored twice daily to ensure that it is operating correctly.
  • An equipment inventory is maintained to monitor the location and status of each piece of equipment.
  • All equipment is maintained on a daily, weekly and monthly basis following the manufacturer’s instructions.
  • All laboratory equipment shall be regularly serviced, calibrated and tested for safety and efficiency.
  • All non-functioning equipment is appropriately identified to prevent its usage.
  • In preventing contamination or deterioration, the equipment shall be handled, transported, stored and used by using the Equipment Management Procedure
  • All equipment is prevented from unauthorised access and tampering with the manufacturers’ settings.

Supporting Documents
·         Equipment Management Procedure
·         Equipment Calibration/Service Schedule
·         Equipment Inventory Form
·         Equipment Decontamination Form

5.4. Pre-examination procedures

Samples shall be accompanied by a detailed Laboratory Request-Report Form. The request form consist of the following at a minimum; patient identification details, date and time of sample collection, date and time of sample reception in the laboratory, date and time examination completed, sample type and examination requested, clinical data and requesting clinician name. A Sample Collection Manual provides information to clinicians regarding sample collection and laboratory services, and is distributed to all sample collection sites.

Samples are traceable to a laboratory request form to identify a particular individual by means of a laboratory allocated number. Samples and request forms lacking proper identification are not accepted or processed by the laboratory. However, where there is uncertainty in the identification of the sample or instability of the analytes in the sample and the sample is an irreplaceable or critical (cerebrospinal fluid, biopsy and bone marrow aspirate) the laboratory may process the sample but do not release the results until the requesting physician or person responsible for the sample collection takes responsibility for identifying and accepting the sample, or for providing proper information, or all these.

The quality assurance committee monitors and reviews the transportation of samples to ensure that they are; within time frame appropriate of the requested examination, within temperature specified intervals and with designated preservative and transported in a manner that is safe for carriers, the general public and the receiving laboratory. All samples from within the hospital are transported in cool boxes, and all samples from external facilities should be securely packaged to ensure safety of carriers as well as the environment.

All samples upon receipt are recorded in the laboratory register in which the date and time of sample reception and the name of the receiving officer is indicated.

CDH Laboratory reviews the sample volume requirements for phlebotomy (and other samples such as cerebrospinal fluid) every after two years to ensure that neither insufficient nor excessive amounts of sample are collected. CDH Laboratory has a documented Sample Management Procedure that defines receipt, labelling, processing, storage and disposal of samples. CDH Laboratory ensures that samples are allocated laboratory and section numbers and the sample portions maintain the same section numbers for traceability. 

CDH Laboratory does not allow any verbal request for any examination. All samples are stored according to Document and Sample Retention Guidelines.

Supporting Documents
·         Sample Management Procedure
·         Document and Sample Retention Guidelines
·         Sample Collection Manual
·         Sample Reception Form

5.5. Examination procedures

CDH Laboratory uses examination procedures found in authoritative text books and journals or procedures which meet the needs of the users of the laboratory services.

In cases where the laboratory develops an in-house procedure, it shall be fully documented and validated before being put to use.  Laboratory management ensures that all procedures are validated according to Method Validation Procedure.  Validations are conducted under the following circumstances;
i.                    New method being put to use.
ii.                  When there is a significant change to the testing system, equipment or software.

Validation files are kept under the responsibility of the quality officer. The procedures are reviewed once in two years during the document review period by sectional heads. All changes made to the examination procedure follow Document Control Procedure.

CDH Laboratory has documented all examination procedures and has made them available to relevant personnel at their respective workstations. The Laboratory Manager is responsible for ensuring that the contents of the examination procedures are complete, current and have been thoroughly reviewed before being authorized by the Head of Laboratory Services.

The laboratory has a documented list of current examination procedures available in the Sample Collection Manual In cases where the laboratory intends to change an examination procedure such that results or their interpretations could be significantly different, the implications are explained to users of the laboratory services through memoranda prior to the introduction of the change.`        

Supporting Documents
·         Document Control Procedure.
·         Method Validation Procedure
·         Sample Collection Manual

5.6 Assuring Quality of Examination Procedures

Internal Quality Control
CDH Laboratory conducts internal quality controls on all tests carried out in the laboratory, as outlined in the test examination procedures. For qualitative tests, positive and negative controls are used and for quantitative tests, three levels of controls are used (low, normal and high). All quantitative results are plotted on Levy-Jennings Chart and interpreted based on the Westgard Rules.  Quality Control Results Review Procedure is used for reviewing the QC results.

External Quality Assessment
CDH Laboratory participates in External Quality Assessment (EQA) schemes like NICD and NHL-QATC. The laboratory management monitors the results of the external quality assessment and implements the corrective action when EQA criteria are not fulfilled. The frequency of participation is dependent on the EQA provider. Results of performance in EQA are communicated to all members of the laboratory section concerned. EQA results are reviewed using review of EQA results procedure.

Uncertainty of Measurements
Each section shall determine uncertainty of measurement of results where possible by using measurement of Uncertainty procedure. CDH Laboratory does not report uncertainty of measurement on patients unless requested for by the clinician or the laboratory service users. The uncertainty of measurement is reviewed after every 2 years. Uncertainty of measurement results are kept on Uncertainty of Measurement Records.

Calibration of Measuring Systems
The laboratory conducts calibration of measuring systems using manufacturers’ recommended calibration material. The calibration period varies according to manufacturer’s recommendation.

For those examination performed using different procedure or equipment or at different sites or all these, the laboratory shall compare the results for verifying the comparability of results after every 12 months or as needed.  The sectional head is responsible for conducting the comparability studies.

Supporting Documents
·         Quality Control Results Review Procedure
·         Measurement of Uncertainty Procedure
·         Review of EQA Results Procedure
·         Uncertainty of Measurement Records.

5.7 Post-Examination Procedures
Examination procedures are done by competent personnel, and review and authorization of results is done by other technical personnel competent in that test examination procedure as well. Technically competent personnel will systematically review and evaluate the results of examination in conformity with the clinical information available regarding the patient.

The storage and safe disposal of samples after examination is done according to the Sample Management procedure and hospital guidelines. Samples are stored for a period of time as defined in Document and Sample Retention Period Schedule.

Supporting Documents
·         Sample Management Procedure.
·         Document and Sample Retention Period Schedule.

5.8. Reporting of Results

CDH Laboratory has formatted result reports in form of softcopy and Paper for communicating results to the laboratory service users. Format of laboratory are reviewed after two years with the laboratory service users. The laboratory management and the laboratory service users share the responsibility of delivering within the established turnaround time and to the appropriate individuals. The laboratory uses Management of Results Procedure for generating and reporting results and the procedure also defines the action steps for reporting of results within the critical/alert intervals. Critical/alert value intervals have been established in consultation with the clinicians.         

Patient’s results are released to clinicians however for outpatient; results may be given to the patient bind with staple pins. No results are issued on the phone except for urgent sample and results falling within critical value intervals are only issued to the authorized receivers. The hard copy laboratory shall also be issued later to the requesting clinician. In such situation a record of Communication of urgent or Critical Value is maintained by the laboratory. 

Alteration of reports is permissible however it has to be done in accordance with Results Management procedure.

The sectional heads are responsible for ensuring that all results whether internally generated or from referral laboratories are legible and are without transcription errors. Records of patient results are retained in patient registers for a period of time defined in Document and Record Retention Schedule. All reports shall be issued and interpreted in full and are copyright of CDH Laboratory. Reports shall not be used for any other purpose other than for treatment or disease prevention.

Supporting Documents
·         Results Management Procedure.
·         Document and Record Retention Schedule.
·         Communication of urgent or Critical Value Results.

6.0 LABORATORY SAFETY

CDH Laboratory is committed to promote the upholding of highest safety standards for its employees and users of its services. To achieve this, the laboratory has developed a Safety Manual to ensure safe work practices and has a Safety officer who is responsible for enforcing safe working practices within CDH Laboratory. In addition to the above mentioned strategies, the following have also been implemented.

  • Management ensures that all employees are well trained in laboratory safety which covers all issues regarding bio-safety and bio-security in their work environment as well as corrective actions in cases of unexpected events.
  • The CDH Laboratory management shall provide a safe work environment by compliance with the universal safety precautions and provision of appropriate personal protective equipment to all members of staff.
  • Safety is the responsibility of everyone, therefore every employee while working in the laboratory, shall take reasonable care of his/her own safety and that of persons who may be affected by his/her actions.
  • All personnel who work in the laboratory shall be offered immunization to prevent infections such as Hepatitis B and Yellow fever associated with organisms to which the personnel are likely to be exposed. Personnel working in tuberculosis laboratory have to be immunized also against TB infection and also undergo medical check-up once annually for TB.
  • All occupational illness, injuries, adverse incidents, accidents and consequential actions shall be reported to the Head of Laboratory Services or Laboratory Manager and documented in Work Related Injury Form. The records shall be kept in the personnel files. Employees who have had an occupational exposure to blood or other potentially infectious material shall follow the Post Exposure Prophylaxis Procedure and work practices outlined in the safety manual to mitigate the effects.
  • All chemicals are stored according to the Material Safety Data Sheets instructions. Access to laboratories is only to the authorized personnel. Management does not allow the use of mobile phones when working in the laboratory. 
  • Safety Officer is responsible for ensuring that the members of staff adhere to safety guidelines in all operations of the laboratory.

Supporting documents:
·         Safety manual
·         Post Exposure Prophylaxis Procedure
·         Work Related Injury Form.






















Signing page
We, staff members of …………………………………………..do hereby certify that we have read, discussed (where applicable) and understood the content of this manual. We commit ourselves to abide by its spirit and shall strive to comply and make it complied with.

Staff Names
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Date
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I, …………………………being the head of unit / section indicated above, do hereby certify that all the staff, as listed above, have read, discussed and understood the manual as indicated herein.
Name and signature of the Laboratory Manager:                         Date:




Amendment Page

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