Lab Quality Improvement Plan

KINGDOM OF SAUDI ARABIA
Ministry of Health
‫مستشفى األمير سلطان‬
‫بعريعرة‬
LABORATORY DEPARTMENT
QUALITY IMPROVEMENT PLAN-2021
PRINCE SULTAN HOSPITAL – URAIRAH
SCOPE
The Laboratory QI program is structured to systemically monitor and evaluate the quality and
appropriateness of the laboratories contribution to improving patient care. Quality Management
activities also include evaluation and/or monitoring of compliance with patient safety goals
identified by accrediting agencies. Policies and procedures are reviewed annually to ensure
continued compliance with applicable laws and regulations. All departmental personnel are
responsible for the application and outcomes of the quality improvement plans.
GOALS
The goals of the Laboratory QI program are as follows:
To ensure high standards of laboratory and diagnostic medicine are practiced and achieved
from all staff.
Provide laboratory services of the highest quality to all patients in a timely and cost effective
manner.
Identify the important aspects of care and continually identify opportunities for improvement.
Assure accurate laboratory testing.
QUALITY SYSTEM ESSENTIALS
Organization – Laboratory updates its organizational structure on regular basis as well as make
sure that the laboratory quality system and quality improvement plan covers all aspect of
laboratory services, and that both are implemented and coordinated with Quality Improvement
Department.
Personnel – Laboratory ensure that the quality of services are maintained. There is clear
defined job qualifications and job descriptions, documented processes for employee orientation,
training, competency assessment, continuing education and performance appraisal.
Equipment – Laboratory ensure that equipment needed for the provision of good laboratory
services is properly selected, installed, calibrated, maintained according to manufacturer’s
recommendations, regulatory requirements, accreditation requirement and internal hospital
requirement. Maintenance, troubleshooting, service and repair of equipment are documented.
Purchasing and Inventory – Laboratory has process and procedures for Identification of critical
supplies and services, desire quality, vendor evaluation, purchasing processes and inventory
management. Laboratory also maintains a policy as part of quality assurance program not to
use any expired reagents in its laboratory operation processes
Process Control – Laboratory ensures that all work policies and processes are supported by
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 are
validated and documented according to established validation processes. Reportable reference
ranges claimed by the manufacturers on new instruments, reagent kits and/or systems are
checked.
Ministry of Health
Documents and Records – laboratory has defined formats and guidelines for document
development, revision, distribution and management and records are reviewed, controlled,
approved and retained.
Occurrence Management – Laboratory maintains a system through OVR (Occurrence Variance

Report) to investigate and document events that may have negative impact or may interfere in
the quality of services. The OVR 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. OVR’s are submitted in
laboratory supervisor/Head of laboratory and to QMPS department for review, corrective
actions, approval and close-out.
Assessment – Laboratory has develop and implemented a quality management system and
continuous Quality Improvement Program that is fully compliant to the accreditation
requirements .An important aspect of the external assessment is the participation of our
laboratory in the External Quality Assessment/Proficiency Testing Program 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.
Laboratory 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 workflow.Regular internal audit are conducted to monitor the effectiveness of the
Laboratory Quality System and Continuous Quality Improvement Plan..
Process Improvement – Laboratory uses the following as source of ideasUse of PDCA
methodology for problem resolution.
Service and Satisfaction – Assess internal and external customer satisfaction with service and
provide feedback.
QUALITY INDICATORS
Selection of Indicators – Selected indicators must be measurable and should have one or more
of the following characteristics:
High Volume – the aspect of care occurs frequently or involves a large number of patients.
Problem Prone – the aspect of care has produced problems in the past for patients and staff.
Key indicators for 2021 are:
reporting critical values,
2 patient identifiers
TAT for routine and Urgent samples
Blood Usage and discards
Each indicator will be reviewed quarterly for evaluation of effectiveness and opportunities for
improvement.
Ministry of Health
Evaluation Criteria – Criteria should reflect the best of current knowledge and current standards
of service and practice. Each indicator has clinically valid criteria applied to it. Benchmarks for
establishing criteria may be obtained from the laboratories databases and daily logbooks.
Methodology and Analysis – Methodology for data collection and analysis must be established
prior to implementing a QI indicator.
Data Sources – inpatient and outpatient.
Sample Size – random sampling versus total data pool.
Frequency – data collection and reporting. The frequency should be based upon the number of
patients by the aspect of care being monitored, the risk involved to the patient, the volumes of
data generated over a set interval and the intent to which the aspect of care consistently meets
the criteria for acceptance.
CORRECTIVE ACTIONS
If the evaluation process identifies opportunities for improvement, corrective action will be
implemented. The corrective action plan should include:
Who or what is expected to change.
Responsible party for implementation.
Target dates for initiation and completion of action.
Outcome analysis is necessary to monitor effectiveness of corrective actions and overall

performance. Effectiveness is determined by comparing performance outcomes. If outcome
demonstrates improvement and is sustainable, the indicator may be discontinued. If
performance does not improve, corrective actions need to be re-evaluated and monitoring
continued.
The Head of laboratory will review quarterly key indicators for appropriateness and
effectiveness. He/she will also review the Quality Improvement Plan annually for effectiveness,
necessary corrective actions, and whether indicators need to continue being evaluated or new
indicators chosen.

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KINGDOM OF SAUDI ARABIA

QUALITY SYSTEM ESSENTIALS

Occurrence Management – Laboratory maintains a system through OVR (Occurrence Variance

Outcome analysis is necessary to monitor effectiveness of corrective actions and overall

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