Quality Management System
The Department of Pathology and Laboratory Medicine (DPLM) has a Quality Management System (QMS) to ensure that testing, operations and services provided by the laboratories meet and comply with applicable/relevant regulations and customers' expectations. The QMS safeguards the high standards of care KKH aims to provide patients by offering quality laboratory service that is accurate, reliable and holistic for women and children.
All laboratory sections in DPLM participate in external quality assurance (EQA) proficiency testing, and have established quality control programmes that monitor ongoing test performance. Laboratory sections also participate in regular quality and safety communication sessions, periodical review of section-specific policies and standard operating procedures, ongoing personnel training and competency assessments, and monthly operation meetings that include review of feedback given by customers. Feedback by customers are valuable inputs that enable the department to constantly improve.
Accreditations & Certifications
DPLM is licensed by Ministry of Health, Singapore under the Section 11(1)(a) of the Healthcare Services Act 2020 (HCSA). The authorised Specified Services as part of its Clinical Laboratory Service license are as listed:
Laboratories in DPLM are accredited or certified by the following locally and internationally recognized accreditation or certification programmes to meet the quality standards and competency requirements for medical laboratories.
Accreditation/Certification Programme | Effective Since | Laboratory Section Accredited or Certified |
SAC-SINGLAS ISO 15189:2022 Medical Testing | 2003 | All laboratory sections in DPLM |
ISO 23301 Business Continuity Management (BCM) | Prior to 2013 | Hospital wide, all laboratory sections in DPLM |
ISO 45001 standards (*Previously ISO 9001, ISO 14001, OHSAS) |
2018 (*2007) |
Hospital wide, all laboratory sections in DPLM |
College of American Pathologists (CAP) | October 2021 | All laboratory sections in DPLM |
Table 1: List of Accreditation and Certification Programmes in KKH
DPLM is committed to providing quality clinical laboratory service for women and children by engaging in locally and internationally recognized EQA programmes. EQA testings are conducted all year round with specified frequencies depending on the different laboratory sections. Results are monitored at specified frequencies.
The external quality programmes that are used for proficiency testing are listed in Table 2 below.
Laboratory Section | EQA Programme |
Biochemical Genetics & National Expanded Newborn Screening |
|
Blood Bank |
|
Clinical Chemistry |
|
Cytology |
|
Cytogenetics |
|
Haematology |
|
Histopathology |
|
Molecular Pathology |
|
Microbiology |
|
Molecular Microbiology |
|
Non-Invasive Prenatal Testing |
|
Table 2: List of Proficiency Testing Specific to Different Laboratory Sections within DPLM.
Abbreviations
CAP |
College of American Pathologists |
CDC |
Centre for Disease Control and Prevention |
ERNDIM |
European Research Network for the evaluation and improvement of screening, Diagnosis and treatment of Inherited disorders of Metabolism |
HSA |
Health Sciences Authority |
NordicQC |
Nordic Immunohistochemical Quality Control |
QCMD |
Quality Control for Molecular Diagnostics |
RCPA |
Royal College of Pathologists of Australia |
RIQAS |
Randox International Quality Assessment Scheme |
UK National Gynaecological Pathology Scheme |
United Kingdom National Gynaecological Pathology Scheme |
UK NEQAS |
United Kingdom National External Quality Assessment Services |
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