The Quality Management System model in the Department of Pathology and Laboratory Medicine at the King Abdulaziz Medical City (KAMC) –Riyadh has been designed as recommended by the Clinical Laboratory Standards Institute (CLSI) that aims on the outcome of Patient Care. Important are the identification and understanding of the customer needs and/or requirements. Our goals are not only to meet these requirements but even to exceed these requirements.

Our Quality Management System describes – documents – implements – measures- and monitors the implementation, compliance and effectiveness of the path of workflow (work operations) related to the pre-analytical, analytical and post analytical processes of our laboratory.

The frame work of the Quality system to which all laboratory processes in all laboratory divisions (managerial and operational) are aligned to, consists of 12 Quality System Essentials (QSE).

1. Documents and Records:

The Department of Pathology and Laboratory Medicine has a system to ensure that documents and records are properly created, identified, controlled, reviewed, approved and retained. The Department’s document structure enables the user of linking policies, processes, procedures and forms.

2. Organization:

The Department of Pathology and Laboratory Medicine updates its organizational structure on regular basis as well as makes sure that the laboratory’s quality system and quality improvement plan cover all aspects of the laboratory services, and that both are implemented as designed and properly coordinated within the facility. Q quality Improvement Committee governs and directs most of our QM related issues.

3. Personnel:

The Department of Pathology and Laboratory Medicine has a system to ensure that the quality of laboratory services to its customers AND the job satisfaction of laboratory personnel are adequately maintained through proper recruitment requirements, on-going training and competency assessments, adequate staffing, levels, etc.

4. Equipment:

The Department of Pathology and Laboratory Medicine has procedures in place to ensure that all laboratory equipment, that is needed to the provision of good laboratory services-, is properly selected, installed, calibrated, maintained according to manufacturer’s recommendations, regulatory requirements, accreditation requirements and internal hospital requirements.

5. Purchasing and Inventory:

The Department of Pathology and Laboratory Medicine has processes and procedures in place to ensure initial as well as on-going evaluation and review of contracts, vendor qualification and selection to provide its laboratory service. The review must also ensure that specific pre-set requirements are met for reagents, equipment and services. Maintaining adequate supplies as well as identifying critical materials are also part of the inventory management. The Laboratory also maintains a policy, -as part of its quality assurance program-, not to use any expired reagents in its laboratory operation processes.

The laboratory also ensures high laboratory standards for evaluating and selecting referral laboratories with reference to the quality and competence of the referral laboratory. Reference laboratories are also monitored on their performance with reference to reliability and accuracy of patient test results.

6. Process Control:

The Department of Pathology and Laboratory Medicine ensures that all work policies & processes are supported by controlled/uncontrolled documented procedures and related forms. All new or changed processes in the path of workflow are verified and validated for performance prior to implementation for patient testing. All methodologies, including in-house established methods, are validated and documented according to established validation processes. Reportable reference ranges and biological reference ranges claimed by manufactures on new instruments, reagent kits and/or systems are checked for comparability through population studies. The laboratory also ensures comparability of patient examinations throughout the clinically appropriate ranges for examinations when using different methodologies or instruments or when performed at different examination sites.

7. Information Management:

The Department of Pathology and Laboratory Medicine has defined processes for receiving and handling patient information. The LIS system in use ensures accessibility, security, confidentiality and privacy of patient information, both on paper-based and electronic information system. The LIS also meets the necessary requirements for data retrieval and storage, system maintenance, interfaces and networks and is in full compliance with accreditation requirements.

8. Occurrence Management:

The Department of Pathology and Laboratory Medicine maintains a system, through the OVA (Occurrence – Variance – Accident report)reporting-, to investigate and document events that may have a negative impact or may interfere with the quality of products and services to deliver  . The OVA system also gives the opportunity to anyone of the staff to document and report problems in the laboratory operations that may jeopardize the quality of services. Investigation is performed (root cause analysis) and corrective (preventive) action is put in place where necessary eventually to prevent recurrence. OVA’s are submitted through the Department’s chain of command and is submitted to the management for review, corrective actions, approval and close-out.  The Department’s Operation analysts in cooperation with the Quality Management perform trends analysis which is incorporated into the QM reports.

9. Assessment:

The Department of Pathology and Laboratory Medicine participates, both voluntary and mandatory, in different external assessments schemes to determine if regulations, standards and requirements are being met (CAP, AABB, JCIA, etc). The Department of Pathology and Laboratory Medicine has developed and implemented, through various policies and procedures categorizing the various regulations and requirements,  a quality management system and Continuous Quality Improvement Program (see point B- CQIP) that is fully compliant to these accreditation requirements. An important aspect of the external assessment is the participation of our laboratory in the External Quality Assessment/Proficiency Testing Programs that provides external means of verifying examination methods performance. The program provides the means to determine the accuracy and reliability of examination results on patient testing.

The laboratory management also identifies and monitors on regular basis Quality Key Indicators that measure process performance in the pre-analytical, analytical and post-analytical operations of the laboratory’s path of workflow. Regularly Internal Audits are conducted to monitor the effectiveness of the Laboratory’s Quality System and the Continuous Quality Improvement Plan.

10. Process Improvement:

The Department of Pathology and Laboratory Medicine uses the following activities as a source of ideas for process improvements:

• yearly patient/customer satisfaction surveys
• yearly medical questionnaires
• findings from Quality Indicators ( QI) of operating systems
• Internal Quality audits
• Recommendations from hospital committees
• OVA analysis

B. Continuous Quality Improvement Plan (CQIP):

Our Continuous Quality Improvement Program focuses on identifying opportunities for preventing problems through improvement processes rather than on immediate problem finding which is/was more the older style of quality assurance.

The policy of “find a problem– fix the problem” has been abandoned and replaced with a more integrated continuous Quality Improvement (CQI) approach, hence our CQI Plan that interrelates 5 of the above mentioned QSE’s to anticipate – prevent – and control  the risks instead of managing them: