The Hong Kong Council for Testing and Certification (HKCTC) and Hong Kong Accreditation Service (HKAS) co-organized a seminar entitled “Accreditation for Medical Laboratory – The Road Towards Quality and Competence” on 12 Oct 2016. Medical laboratories provide essential support to the medical sector. Accurate and reliable laboratory services are crucial for proper clinical diagnosis and treatment. It is important for medical laboratories in Hong Kong to obtain formal recognition of their testing competence and standard through laboratory accreditation. The seminar aims to introduce the medical testing accreditation and share the experience of obtaining accreditation and its benefits.
The first speaker was Ms. Bella Ho (Senior Accreditation Officer, HKAS) and her topic entitled “Accreditation Service for Medical Laboratories”. She said the first launch of HOKLAS based on ISO 15189 was on 16 Feb 2004. Before that accreditation was employed ISO 17025 included NATA. The ISO 15198 Particular requirement for quality and competence of medical laboratories was published in Dec 2003.
There were six disciplines of accreditation scope included Anatomical Pathology, Chemical Pathology, Immunology, Haematology, Microbiology and Medical Genetics. Bella found that no regulatory requirement on the operation of a medical laboratory. Categories of accredited laboratory was separated into “P” and “S” according to the whether the Laboratory Director is a “Pathologist” or a “Scientist”. For approved Signatories, only qualified pathologists in the relevant pathology discipline can be signatories of these tests.
It has only regulated the personnel working in a medical laboratory under the Supplementary Medical Professions Ordinance (SMPO) (CAP 359) which started from early 1990s. The brief of SMPO is showed in the following diagram.
Then Bella mentioned some statistics to us such as total number of medical laboratories accredited since 2004.
And the table of the progress of the medical programme which included HOKLAS, NATA, and CAP.
Finally, Bella summarized the changes in the medical testing field after introduction of medical accreditation programme as follows:
- More educational opportunities,
- More reference resources,
- More platforms for information exchanges.
The second speaker was Dr. QUE Tak-Lun (Chief of Service, Department of Clinical Pathology, Tuen Mun Hospital) and his topic named “Benefits of Accreditation to the Community”. Firstly, he shared with us different types of food he cooked. He said a good cook depends on cooker, manual, raw material, equipment, etc.
Then he shared the common factors between Cooker and Pathologist in the following table. Both career should ensure the quality and had risk management.
At the end, he said accreditation was not from western. It could be traced to the first emperor in China.
Before tea break, all guest speakers took a group photo.
Mr. Stanley Leung (Director of Clinical Laboratories, Hong Kong Adventist Hospital (HKAH)) was the third speaker and his topic was “Value of Laboratory Accreditation on Top of Hospital Accreditation”. Their group had two hospitals in Hong Kong and they located in Tsuen Wan and Stubbs Road. HKAH-SR specialized in cancer & heart treatment, and HKAH-TW as a community hospital in Territory West which provided sub-acute care.
Then Mr. Leung briefed their history of accreditation included UK, JCI, ACHS, WHO and HOKLAS, etc.
After that Mr. Leung told us the three criteria, which was focus on Hospital Accreditations, were “Hospital Safety”, “Staff Competency” and “Overall Quality of Patient Care”. Moreover, criterial of functions included 1) Clinical, 2) Support and 3) Corporate.
Mr. Stanley Leung mentioned that most Hospital Accreditation was focused on Blood Bank. Therefore, good blood transfusion practice was very important. HKAH had accredited Clinical Chemistry, Haematology and Blood Banking, Microbiology, Histopathology and Cytology by HOKLAS, CAP and NATA.
Finally, he showed the sample analysis cycle from test ordered to result reported. They got accreditation because of their values that were Excellence, Service & Care Integrity. He said Laboratory Accreditation (HOKLAS) is equal to Commitment to Quality.
The fourth speaker was Ms. Cordelia Leong (Pathology Department Manager, Alice Ho Miu Ling Nethersole Hospital and North District Hospital) and her topic named “Culture in Laboratory: A Change After Accreditation”. Firstly, she said they had many different requirement and systems before laboratory accreditation. At the time, it was not bad, but greatly depended on a highly competent leader to put all the things together.
However, accreditation based on ISO 15189 brought a structured quality management system into the hospital. It included Management, Man, Machine, Material and Method requirements as following diagrams.
After accreditation, staff changed their culture that QMS elements as part of their daily work. The benefits would be systematic approach, better documentation, traceability, result accuracy and staff competence, continual improvement and learning opportunities.
Finally, Ms. Cordelia Leong use the diagram to explain the Accreditation role from Pull (increase the management level) before got accreditation and then to be Push (maintenance the existing level) after accreditation. The future Pull role is come from “Benefits to the Lab & Staff”.
The last speaker was Mrs. Marianne Leung (Laboratory Director, Pathlab Medical Laboratories Ltd.) and her presentation topic entitled “How Accreditation Helps in Business, from a Commercial Laboratory’s View”. Firstly, Mrs. Leung introduced her laboratory which established since 1975. Now, PathLab has about 140 employees which 50% technical and 50% auxiliary.
She explained why her laboratory did accreditation. Because HOKLAS allowed non-pathologist scientists able to be Lab Directors (S Lab) and staff morals which was not good / bad but stagnant. But she quoted “Do something today that your future self will thank you for.” Mrs. Leung analyzed areas of business in a commercial laboratory included Internal Problems, Staff Moral & Hiring, New Areas of Business, Reputation and Legal Protection, as well as Business Growth.
Then she explained some internal problems they had overcome.
- Phlebotomy side effects and Client’s errors on sample collection & handling (not labeling tubes, no date or time, name mismatch, no individual bags, etc.)
- Multidiscipline MLT Training
- Signatory duties
D. Management & Business
- Financial matters
Finally, Mrs. Leung concluded some benefits about accreditation included “Staff Morale and Hiring Ability Improvement”, “Chance to Bid for New Business – Clinical Trials”, “Better Reputation & Legal Protection”. At the end, she showed their lab business growth after accreditation.
Q&A:During the Q&A, Bella answered some question about accreditation period and preparation time. She said it was about 10 month after initial assessment to get the accreditation. For preparation time, it should be at least from 1 year to 1.5 year to prepare all documentation.
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