The first speaker was Dr. Alex Chan (Accreditation Officer, HKAS) and his topic entitled "Implementation Schedule for HOKLAS 015 (5th Edition)".
The ISO 15189:2012 requirement list was showed and the red colour topics were minor change or different wordings and the blue colour topics were new requirements.
Some change of requirements were summarized as follows.
Management requirements
Section 3 - Terms and definitions (New definitions added)
3.2 Alert / Critical Interval - indicating an immediate risk to the patient of injury or death (equal to Panic Value)
3.8 Interlaboratory Comparison - organization, performance an evaluation of measurements or tests on the same or similar items by two or more laboratories (Included the own laboratory).
3.19 Quality indicator - measure of the degree (e.g. DPMO, CPk)
3.25 turnaround time - two specified points are defined by the laboratory
Section 4.1 - Organization and management responsibility
Additional responsibilities for lab director
4.1.1.4 (h) - select and monitor laboratory suppliers
4.1.1.4 (n) - design and implement a contingency plan & periodically tested
4.1.2.6 - Communication -appropriate communication processes are established between the laboratory and its stakeholders
Section 4.3 - Document control
4.3 (e) - amendments are clearly marked, initiated and dated, and a revised documents is issued within a specified time period
Section 3 - Terms and definitions (New definitions added)
3.2 Alert / Critical Interval - indicating an immediate risk to the patient of injury or death (equal to Panic Value)
3.8 Interlaboratory Comparison - organization, performance an evaluation of measurements or tests on the same or similar items by two or more laboratories (Included the own laboratory).
3.19 Quality indicator - measure of the degree (e.g. DPMO, CPk)
3.25 turnaround time - two specified points are defined by the laboratory
Section 4.1 - Organization and management responsibility
Additional responsibilities for lab director
4.1.1.4 (h) - select and monitor laboratory suppliers
4.1.1.4 (n) - design and implement a contingency plan & periodically tested
4.1.2.6 - Communication -appropriate communication processes are established between the laboratory and its stakeholders
Section 4.3 - Document control
4.3 (e) - amendments are clearly marked, initiated and dated, and a revised documents is issued within a specified time period
Section 4.4 - Service agreements
4.4.1 - Reference shall be made to any work referred by the laboratory to a referral laboratory or consultant.
Note 3 under 4.4.1 is related to ethics.
Section 4.12 - Continual Improvement
Minor changes in the requirements
- risk assessments to be conducted and improvement plans to be communicated to staff.
Section 4.13 - Control of records
Note 3 - For some records, especially those stored electronically, the safest storage may be on secure media and an offsite location (Backup copy)
Section 4.14 - Evaluation and audits
New requirement
4.14.3 - Assessment of user feedback (already in ISO 17025)
4.14.4 - Staff suggestions
4.14.6 - Risk management
4.14.7 - Quality indicators
Technical requirements
Section 5.2 - Accommodation and environmental conditions
Elaborate requirement on accommodation
- examinations at sites other than the main laboratory premises (e.g. Point-of-care testing (POCT))
- Access control
- Safety facilities and devices (regularly verified)
- Staff facilities (e.g. Washrooms, supply of drinking water, facilities for storage of personal protective equipment and clothing)
- Quiet and uninterrupted work environment
Section 5.3 - Laboratory equipment, reagents and consumables
- Laboratory equipment adverse incident reporting (investigated and reported to the manufacturer and appropriate authorities, as requirement - e.g. CE IVD)
Section 5.4 - Pre-examination process
5.4.4 - Primary sample collection and handling (elaborated requirements on patient consent)
5.4.6 - Sample reception - specify time limit for requesting additional or futher test on the same primary sample
Section 5.5 - Example process
5.5.1.2 - Verification of examination procedures
- validate examination procedures used without modification included FDA approved or CE IVD assays.
Section 5.6 - Ensuring quality of examination results
5.6.3 - Interlaboratory comparisons - Documented procedure for interlaboratory comparison participation
Section 5.9 - Release of results
New requirement
5.9.2 - Automated selection and reporting of results
Section 5.10 - Laboratory Information Management
New requirement
5.10.2 - Authorities and Responsibilities
- Access patient data and information
- Enter and change patient data and result
- Authorize release of results
The third speaker was Dr. Lillian Chow (Accreditation Officer, HKAS) and her presentation was "Changes in HOKLAS Policies in relation to the revised requirements stated in ISO 15189:2012".
Dr. Chow said the changes in HOKLAS policies aimed to clarify and elaborate the new requirements in ISO 15189:2012 in follows.
In 4.1.H, it stated to ensure staff do not work under undue pressure that may affect integrity and quality of work.
In 4.3.H, a revised document shall normally be issued upon its annual review and be paid to controlled documents distributed for use at the branch and mobile facilities.
In 4.5.H, Examination by referral laboratories should be reputable with demonstrated evidence of competency for the referred test.
In 4.7.H, documented communication between the laboratory and the users, and shall be advised on limitations of the tests.
In 5.1.H, Competency assessment included EQAP performance, records of continuing medical education (CME) or continuing professional development (CPD)
In 5.4.H, at least two identifiers of the submitted specimen (One should be name or ID number of the patient) and define a list of time critical tests
In 5.7.H, When samples are disposal of, care shall be taken to protect patient's confidential information.
Dr. Chow said a new clause of 5.10 was come from Annex B (Informative) of ISO 15189:2007. Storage of pa patient database with confidential information on standalone computers with accessibility to internet is not recommended.
Reference:
HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm
4.4.1 - Reference shall be made to any work referred by the laboratory to a referral laboratory or consultant.
Note 3 under 4.4.1 is related to ethics.
Section 4.12 - Continual Improvement
Minor changes in the requirements
- risk assessments to be conducted and improvement plans to be communicated to staff.
Section 4.13 - Control of records
Note 3 - For some records, especially those stored electronically, the safest storage may be on secure media and an offsite location (Backup copy)
Section 4.14 - Evaluation and audits
New requirement
4.14.3 - Assessment of user feedback (already in ISO 17025)
4.14.4 - Staff suggestions
4.14.6 - Risk management
4.14.7 - Quality indicators
Technical requirements
Section 5.2 - Accommodation and environmental conditions
Elaborate requirement on accommodation
- examinations at sites other than the main laboratory premises (e.g. Point-of-care testing (POCT))
- Access control
- Safety facilities and devices (regularly verified)
- Staff facilities (e.g. Washrooms, supply of drinking water, facilities for storage of personal protective equipment and clothing)
- Quiet and uninterrupted work environment
Section 5.3 - Laboratory equipment, reagents and consumables
- Laboratory equipment adverse incident reporting (investigated and reported to the manufacturer and appropriate authorities, as requirement - e.g. CE IVD)
Section 5.4 - Pre-examination process
5.4.4 - Primary sample collection and handling (elaborated requirements on patient consent)
5.4.6 - Sample reception - specify time limit for requesting additional or futher test on the same primary sample
Section 5.5 - Example process
5.5.1.2 - Verification of examination procedures
- validate examination procedures used without modification included FDA approved or CE IVD assays.
Section 5.6 - Ensuring quality of examination results
5.6.3 - Interlaboratory comparisons - Documented procedure for interlaboratory comparison participation
Section 5.9 - Release of results
New requirement
5.9.2 - Automated selection and reporting of results
Section 5.10 - Laboratory Information Management
New requirement
5.10.2 - Authorities and Responsibilities
- Access patient data and information
- Enter and change patient data and result
- Authorize release of results
The third speaker was Dr. Lillian Chow (Accreditation Officer, HKAS) and her presentation was "Changes in HOKLAS Policies in relation to the revised requirements stated in ISO 15189:2012".
Dr. Chow said the changes in HOKLAS policies aimed to clarify and elaborate the new requirements in ISO 15189:2012 in follows.
In 4.1.H, it stated to ensure staff do not work under undue pressure that may affect integrity and quality of work.
In 4.3.H, a revised document shall normally be issued upon its annual review and be paid to controlled documents distributed for use at the branch and mobile facilities.
In 4.5.H, Examination by referral laboratories should be reputable with demonstrated evidence of competency for the referred test.
In 4.7.H, documented communication between the laboratory and the users, and shall be advised on limitations of the tests.
In 5.1.H, Competency assessment included EQAP performance, records of continuing medical education (CME) or continuing professional development (CPD)
In 5.4.H, at least two identifiers of the submitted specimen (One should be name or ID number of the patient) and define a list of time critical tests
In 5.7.H, When samples are disposal of, care shall be taken to protect patient's confidential information.
Dr. Chow said a new clause of 5.10 was come from Annex B (Informative) of ISO 15189:2007. Storage of pa patient database with confidential information on standalone computers with accessibility to internet is not recommended.
Reference:
HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm
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