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Accreditation and Certification

Quality Management System

The Department of Pathology and Laboratory Medicine (DPLM) has established 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.

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All laboratory sections in DPLM subscribe to various external quality assurance (EQA) proficiency testing, and have established quality control programs that monitor ongoing test performance as well as the section’s performance in EQA surveys. 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 taken as valuable inputs that enables the department to constantly improve its performance in order to meet the needs of customers.

Together, these systems and quality-centered activities enable DPLM to achieve clinical excellence by providing accurate reports, reliable and timely services.

 

Accreditations & Certifications

DPLM is licensed by Ministry of Health, Singapore under the Private Hospitals and Medical Clinics (PHMC) Act (Chapter 248). The specialized tests or services approved under Regulation 52(4) of the PHMC Regulations are as listed:

  1. Blood Group ABO and Rhesus (D) Type Tests
  2. Acid-Fast Bacilli (Smear) Test
  3. Human Immunodeficiency Virus (HIV) Test
  4. Malaria Parasite Test

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 ProgrammeEffective SinceLaboratory Section Accredited or Certified
SAC-SINGLAS ISO 15189:2012 Medical Laboratory2003All laboratory sections in DPLM
Business Continuity Management (BCM)Prior to 2013Hospital 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 2021All 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.

EQA programmes provide the laboratory several beneficial learning and improvement opportunities. This includes helping the laboratory identify possible areas of deficiency and opportunities for process improvement, providing trigger points for review of procedures and education of laboratory staff, and also actionable feedback obtained from inter-laboratory comparison of methods/instruments and reporting practices. DPLM have been obtaining good results for national proficiency programmes and proficiency testing programmes which cover the full spectrum of tests that are offered by the different laboratory sections. Alternative performance assessment are performed on tests where external proficiency testing is not available to determine the reliability of analytic testing. The external quality programmes that are used for proficiency testing are listed in Table 2 below.


Laboratory SectionEQA Programme
Biochemical Genetics & National Expanded Newborn Screening
  • CAP Surveys
  • CDC Quality Assurance Programme (Newborn)
  • ERNDIM External Quality Assessment
Blood Bank
  • National Proficiency Testing Scheme for ABO Group/Rh Type
  • HSA External QAP for Immunohaematology
  • CAP Surveys
Clinical Chemistry
  • CAP Surveys
  • National Proficiency Testing for HIV
  • HSA HbA1C and Chemical Metrology External Quality Assessment
  • RCPA Quality Assurance Programs
  • RIQAS EQA Programme (NEFA)
  • UK NEQAS EQA (Down's Syndrome Screening)
Cytology
  • CAP Surveys
Cytogenetics
  • CAP Surveys
Haematology
  • CAP Surveys
  • National Proficiency Testing Scheme for Malaria Parasite
  • RCPA Quality Assurance Programs
Histopathology
  • CAP Surveys
  • NordiQC Immunohistochemistry Proficiency Testing
  • RCPA Quality Assurance Programs
  • UK National Gynaecological Pathology Scheme
  • UK NEQAS External Quality Assessment
Molecular Histopathology
  • CAP Surveys
Microbiology
  • CAP Surveys
  • National Proficiency Testing for AFB (Smear)
  • RCPA Quality Assurance Programs
Molecular Microbiology
  • CAP Surveys
  • RCPA Quality Assurance Programs
  • QCMD External Quality Assessment
Non-Invasive Prenatal Testing
  • CAP Surveys

Table 2: List of Proficiency Testing Specific to Different Laboratory Sections within DPLM.