Total Quality Management for Medical Laboratories

Introduction

There is a broader and more international interest in quality systems. Quality concepts in
analytical laboratories are changing very quickly. In many fields of laboratory tests,
accreditation has become a must. This standard not only requires technical competence and
analytical quality management, but also the management of other quality aspects such as
human resources, structure of the organization, management of documents, etc. Sri Lankan
laboratories are driven primarily by the Ministry of Health regulatory guidelines and
laboratories are developing quality systems that more closely follow international standards
particularly the ISO standards. This should cover either the pre-analytical phase (sampling,
patient preparation, sample transport, etc.) and the post-analytical phase (biological and clinical
validation of results) and include also national requirements that are not always relevant for a
quality system. This document provides a guidelines in implementing TQM system in a
laboratory set up.

Scope of medical laboratory analyses

Medical laboratories are involved in medical trials and in patient care. It must follow good
laboratory practice (GLP) standards. The general philosophy of GLP is based on concern about
potential fraud and underscores the need for transparency of results and raw data. Tests for
patient care are mainly performed for the follow-up of a therapy or a health status of a patient
and diagnostic purpose as confirmation or as an aid for clinical diagnosis.
Internal and external quality control

Almost all medical laboratories get involved in quality Control process and have a long
tradition of internal and external quality control. In clinical chemistry laboratories, Levey and
Jennings introduced control charts are used in medical especially with the Westgard multi-rule
chart for internal quality control in clinical laboratories. External quality Control is now
replaced by External quality assessment. Most of the programs are essentially educational and
not limited to participant analytical performance evaluation. The objective of EQA is
improvement of health care through improvement of laboratory performance. It is also
supposed that EQA results reflect routine performance of the laboratories.

The regulation of medical laboratories by the Health Authorities was intended for regulating
public expenditure on health care, preventing poor performing laboratories from practicing and
to provide education, training and help toward enhancement of laboratory competency.

National Quality System

Elements of TQM System should include following requirements and it should be checked
with critical analytic path. It includes Plan, Do, Check and Action. In order to maintain a high
analytical quality level, periodic review of the quality system will be essential. This review
must be done within the laboratory (internal audit and management review) and by an external
party (external audit). Accreditation is the final outcome of TQM system which can be achieved
after implementing a QTM to the laboratory.

PLAN
Management system
a) The quality manual and underlying documents are kept up-to-date
b) The quality manual and underlying documents are known and understood by the staff
c) The quality policy is known and understood by the staff
Quality Manager/Quality officer:
It is appointed by Ministry of Health. They should follow the Duty description issued by
Ministry of Health.
Quality manual:
Laboratory should follow the guide lines of Quality Manual which is issued by Ministry of
Health
Review of enquiries, tenders, contracts, purchase of services and goods:
Procedures should follow the administrative and financial regulation of the ministry of Health
and public service. There should be an enquiry reviewing procedure and reviews should be
documented.
There should be purchase documents for goods that affect the quality of the
laboratory/inspection body and that the quality requirements should be met. There should be
checking process when products are received that can affect the quality of activities.
Complaint management:
Procedures for handling complaints should be there. Documentation of complaints should be
easily accessible, contains all important information and should be kept up-to-date. Complaints
and other non-conformities should be handled during the management review.

DO
Standard Operating Procedures (SOP's)
It is recommended to prepare SOP referring existing SOP in Teaching hospitals which are
approved by respective professional colleges
Documents management
Document management system should be introduced. There should be a written process for
authority, maintaining and discarding documents. Only applicable documents should be used
at the laboratory/inspection body and should be available to all staff. Applicable documents
should be approved by an authorized person. Any changes in the documents should be traceable
Infrastructural requirements
Guidelines of Ministry of Health should be followed. Laboratory manual contains
infrastructural requirements for each type of laboratory.
Human resources requirements
Ministry of Health guidelines should be followed.
The very rapidly changing techniques and the introduction of new tests will require a
continuous training of laboratory professionals and workers.
Equipment requirements
Recommendations of Laboratory Manual should be followed.
Reagents & standards requirements
Recommendations of Laboratory Manual should be followed.
CHECK
Internal audit:
Audit report should be established with required information. The quality manager should give
reassurance that the audit report, and where appropriate, any non-conformities are
communicated to the management. Action must be taken on non-conformities and this action
should be followed up to ensure that it has been suitable. Non-conformities can then be
‘removed’. Reports and records from internal audits must be archived for the specified time
period.
Team with an In-charge should be nominated. It should include both clinical and technical
experts in each discipline. The person who is in charge of the audit program can be responsible
for making the final decision about the aims, scope and type of audits that must be carried out.
Appointment of internal auditors should be authorized by Head of the institution/Ministry of
Health.
Once a year internal audit should be carried out.
Process of internal audit should include following steps
a) Producing a program for the current audit
b) Reviewing documents (including method descriptions and records)
c) Preparing the audit of practical activities
d) Carrying out the audit of practical activities
e) Producing and distributing the audit report
f) Reviewing corrective action
g) Carrying out any audit follow-ups.
Horizontal audit: A detailed inspection to ensure that an element in the management system
has been implemented. Elements include staff training, the handling of standards, the
maintenance and calibration of equipment, calibration/test/inspection methods and
instructions.
Vertical audit: A detailed inspection to ensure that all elements in the management system has
been introduced when carrying out a specific test/calibration/inspection.
a) Sample handling
b) Competence and authorization of the people involved
c) Calibration and maintenance of equipment
d) Use of test/calibration/inspection methods and instructions
e) Quality controls
f) Environmental conditions (premises, etc.) when work is carried out
g) Test/calibration reports, inspection reports and reports of the results
h) Archiving of data and calculations that have been carried out.
Management Review:
The management review should be carried out with the schedule that has been drawn up in
advance to ensure the management system and activities are suitable and effective. It will
introduce any necessary changes and improvements. The need for changes to the management
system are required due to comment of internal or external audit, environmental changes,
complaints and surveillance or re-assessment that has been carried out by the Ministry of
health. The management is responsible for ensuring that all action that needs to be taken as a
result of the review is carried out within a time frame.
Management review should be carried out once a year with involving Quality manager, clinical
consultants and Superintendent and chief medical laboratory technologists. The review should
be carried out in a systematic way by using a formal agenda. The management review must be
documented. This documentation may consist of minutes from meetings with the management
along with clear indications of what action should be taken, by whom and within what time
limit. The documentation shall also include a statement about the suitability and effectiveness
of the management system. The documentation must be easily available and archived for the
stipulated amount of time.

External audit:
Team should be nominated by Ministry of Health. Once in two years external audit should be
carried out.
ADJUST
Remedial Action
Remedial actions should be taken with stake holder meetings and auditor recommendations
while without altering ministry of health regulations and guidelines.
New implementations
Identification the requirement and feasibility study should be carried out
Stake holder meetings are required prior to any new implementation

National
Require
ment

Medical
Competence

Technical Competence

Quality Management System

Accreditation and Certification