Quality System EssentialsDr. Adel A. ElazabAssociate Professor of Clinical PathologyFaculty of MedicineAin Shams University, Cairo, Egypt

1. Commitment to quality and good professional practice: Complying with international, national, local, and organizational requirements

2. Design of organizational structure to ensure quality: Creating and maintaining the laboratory’s organizational chart

3. Effective implementation: Writing QSE policies, processes, and procedures; Periodically reviewing and revising the quality manual

4. Planning for quality: Developing quality goals and objectives; Periodically reviewing and revising the quality goals and objectives

5. Management review: Creating the quality report, Conducting management reviews, Establishing criteria for defining and prioritizing risks

6. Communication: Creating and maintaining a laboratory communication plan, Communicating staff concerns confidentially to laboratory management and others

1. Identifying customer and user expectations: Conducting a customer expectations survey

2. Laboratory’s capability to meet customer expectations: Assessing laboratory capability

3. Measuring customer and user satisfaction: Soliciting patient, customer, staff feedbacks

4. Recording and managing complaints: Reporting patient, customer, and staff complaints; Responding to patient, customer, and staff complaints

1. Facility design and modification: Determining space requirements and needs; Evaluating design and renovation plans for efficiency, comfort, accommodations for people with disabilities, emergency systems, and unidirectional workflow; Planning for adequate energy sources, lighting, ventilation, water and waste disposal, utilities

2. Access: Using access-control devices, as needed

3. Facilities use and maintenance: Maintaining clean work areas and good housekeeping; Monitoring, controlling, and recording any environmental conditions that influence the quality of test results

4. Communications System: Physical means in the daily routine (eg, telephone, pagers, e-mails); Contacting staff in emergencies.

5. Biosafety: Using personal protective equipment (PPE) properly; Collecting blood samples from special precautions (eg, TB) patients; Cleaning up biological spills; Monitoring health and immunizations; Preparing potentially biohazardous materials for shipping; Completing biohazardous materials shipping records

6. Chemical hygiene: Evaluating each chemical in use for hazards and defining handling requirements; Managing Material Safety Data Sheets (MSDS); Cleaning up chemical spills

7. Occupational health, accidents, and illness: Reporting laboratory accidents; Reporting laboratory-acquired illnesses; Establishing and recording decibel levels in the laboratory

8. Hazardous waste management: Identifying waste stream disposing of various types of the laboratory’s hazardous waste

9. Fire prevention: Reporting a fire; Taking follow-up action; Recording staff participation

10. Emergency management: Preparedness, response, and recovery: Assigning roles and responsibilities to laboratory staff in a declared disaster; Evacuating the laboratory in specific situations; Conducting and recording regular evacuation drills; Posting evacuation routes; Executing the business recovery plan

11. Radiation safety, as applicable

1. Job qualifications: Creating and maintaining job descriptions that specify duties and responsibilities for all personnel; Verifying eligibility, applicant education, and credentials

2. Orientation of new personnel

3. Management of personnel training: Creating training plan for each staff member

4. Assessment of competence: Direct observation checklists; Written assessments; Record review assessments; Establishing rating scales and scores for assessment tools

5. Continuing education and professional development: Recording continuing education participation

6. Performance evaluation: Developing performance criteria and expectations; Completing performance evaluation form

7. End of employment: Returning all facility-owned property allocated to transferred or terminated staff

8. Personnel files: Creating personnel files; Maintaining personnel files

1. Selection and qualification, based on expectations: Identifying expectations for product or service; Recording comparison of supplier’s capabilities with laboratory’s expectations

2. Purchase of materials or services: Periodically reviewing purchasing agreements for any necessary revisions; Requesting supplies or services; Generating and maintaining approved supplier list

3. Supplier, contractor, consultant evaluation: Reporting instances of unsatisfactory services or products

4. Inspection and verification of received materials: Recording lot number, date received, results of initial inspection; Performing verifications, as necessary

5. Storage and handling of materials: Storing and handling all types of laboratory materials per manufacturer’s instructions

6. Inventory management: Communicating inventory levels and when reorder is necessary; Tracking expiration dates; Verifying materials before using/reporting results

1. Selection qualification (SQ) and acquisition: Setting criteria based on needs; Identifying potential hazards of the equipment to reduce risk of harm to the operator or facility; Making purchase requests

2. Equipment qualifications: Initiating an equipment master file; Verifying the contents of the equipment master file; Installation qualification; Operational qualification; Validation; Reverifying after moving equipment

3. Calibration program: Selecting calibration materials; Performing calibrations; Applying acceptance and rejection criteria; Comparing actual frequency to intended frequency

4. Maintenance program: Performing maintenance activities; Performing function checks; Recording results of maintenance activities; Contacting manufacturer’s technical support; Recording service and repairs performed.

5. Decommission of equipment no longer in use: decommission checklist

6. Equipment files and records: Maintain and manage all required equipment information

1. Analysis, design, and documentation of the laboratory’s path of workflow and QSE activities: Identifying activities in the laboratory’s path of workflow and QSEs; Flow-charting work activities; Retaining samples

2. Process validation and/or verification: Defining acceptance criteria; Performing validations, verifications; Assessing impact of measurement uncertainty on examination processes and procedures

3. Process control: Developing, reviewing, and evaluating a QC plan; Selecting appropriate control materials; For quantitative examinations, applying QC rules with a high probability of error detection and low probability of false rejection; Establishing acceptance and rejection criteria; Periodically reviewing and evaluating control records

4. Change management: Identifying and assessing the need for change; Initiating a change; Evaluating effects of changes on other processes, sections, or services; Recording changes made; Communicating changes; Documenting evaluations and changes

1. Document management system: Creating, identifying, revising, reviewing, and approving new documents; Controlling both internal and external documents; Changing approved documents; Archiving documents; Storing archived documents; Retaining archived documents

2. Record management system: Scheduling and documenting review of records; Changing paper records; Hanging electronic records; Storing records; Moving records; Retaining records; Accessing records; Destroying records

1. Planning for overall information needs: Defining the flow of information

2. Confidentiality of information: Completing the confidentiality agreement form; Managing clinical trials information; Releasing patient information

3. Security for data access: Establishing security access levels or groups; Changing access levels; Defining authority to change results; Electronic only: Establishing password definition and frequency of change, Changing a computer password, Changing or modifying software data files

4. Integrity of data transfers or transmissions: Verifying data integrity at initial installation; Verifying data transfer after equipment maintenance or downtime; Verifying data integrity after changes in equipment or software upgrades; Verifying formula calculations; Changing reference intervals; Electronic only: Verifying data integrity after restoration of data files, Verifying integrity of system interface transmissions

5. Provision for information availability during downtime: Archiving and data retrieval; Communicating significant software malfunctions; Establishing system backup and data storage protocols; Maintaining daily operations during a software malfunction; Incorporating downtime processes into the facility’s disaster preparedness plan

1. NCE program: Identifying and reporting deviations, nonconformances, unusual occurrences, and unexpected or adverse outcomes; Recording results of NCE processes

2. Investigation of NCEs: Process to investigate NCEs; Processes for remedial action of: Non-QMS–related NCEs, Path of workflow–related NCEs, Complaints

3. NCEs related to manufacturers’ products: Response to manufacturer’s recalls of materials, equipment, or software; recall of nonconforming products or services; Report defective medical devices

4. Classification, analysis, and trending of the data and information collected: Classifying NCEs; Analyzing NCE data using statistical tools; Tracking and trending NCE data and information

5. Identification of need for root cause analysis and process improvement: Capturing results of root cause analysis; Preparing action plan and follow-up; Reporting analysis findings to laboratory management

6. Management review of NCE: Preparing NCE information for the management report; Reviewing NCE information

1. External Assessments:◦ Planning for the external accreditation assessment

◦ Following up on the external accreditation assessment report

◦ Enrolling in the appropriate PT/EQA programs

◦ Reporting results to the PT/EQA provider

◦ Following up on the PT/EQA results report

◦ Designing an alternative examination method assessment

2. Internal assessments:• Planning, scheduling, and conducting an internal audit

• Preparing a report of audit findings

• Following up on audit findings

• Defining a quality indicator

• Collecting data for a given quality indicator

• Monitoring quality indicators

• Comparing laboratory performance data with those from other laboratories

• Preparing blood utilization data

1. Participation in quality improvement activities at the organizational level

2. Use of a defined strategy for continual improvement: Identifying opportunities for improvement, Selecting an opportunity [form], Generating solution(s), Implementing solution(s) [tools], Evaluating effect of solution(s) [report], Integrating and sustaining improvement(s)

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