Occupational Safety Health Ordinance and Regulations

Labour Department, Fire service department..etc

Provide safety system of work, make arrangements to ensure safety in use, handling and storage of
plants/substance, provide info/instruction, training, supervision to ensure safety of employee, maintain
workplace condition & means of access to and egress workplace safe, provide safe working environment
OSHA Hazard Communication Program: workers understand hazards they may be exposed & understand
how to adequately protect themselves
OSHA Chemical Hygiene Plan: Develop SOP for using lab chemicals that describe the hazards & what
measures to protect them
Engineering control for Laboratory Safety
Methods:
Elimination of hazardous techniques, process, material
Substitution of less hazard technique for more hazard one
Segregation of ppl from hazard
Enclose hazard
Ventilate workplace & source of contaminants
Repair/replace faulty equipment/machinery
Administrative control: Plan ahead, dont underestimate risks, minimize exposure, be prepared for
accidents
Dangerous Goods classification:
Class 4: Flammable solid; 5: Oxidizer; 6: toxic substance; 7: radioactive
8: corrosive; 9: miscellaneous
Elements: Chemical Inventory + MSDS + container Labels + Training + SOP
Assessment + Self inspection
Physical Hazard: flammability, reactivity, explosivity, corrosivity
Waste Chemicals: lab director plan waste disposal before starting any project; label waste promptly &
properly, must specified identified for disposal purpose; dont mix chemical waste; limit excess chemical by
reduce, reuse, recycle, reclaim, treat, destroy, dispose
Storage of chemical waste: properly labeled, in a suitable area before collection, close to generation site,
away from incompatible waste, in area w/ proper warning panel/notice
Decontamination:
Surface decontamination, Inner parts (Gas) decontamination
Steam sterilization, Dry heat sterilization
Chemical emergency: get away, alert others, get help, seal area off, dont clean if not trained

BSC Level I: agents not known to cause disease

Level II: agents associated w/ human disease
Level III: exotic agents associated w/ human disease & potential for aerosol
transmission
Level IV: dangerous agent of life threating nature
Biological Spill
Hold breath & leave lab immediately no enter lab for at least 30 mins
Wear PPE to protect eyes & mucous membranes decontaminate spills (BSL2/BSL3)
Risk assessment
Identify all hazardous materials, consult MSDS, evaluate BSL & type of toxicity
Consider possible route of exposure Evaluate quantitative info on toxicity, select appropriate procedures
to minimize exposure, prepare contingencies
Modes of transmission: Airborne, Droplets, Contact, Blood borne
Prevention:
Percutaneous Injuries: Sharp box
Cutaneous Injuries: Gloves when handle blood & body fluids, wash hands
Mucosal exposures: Goggles
Droplets: Wear N95
Airborne: Wear mask (N95), negative pressure room with doors closed
PPE: respiratory equipment, garments, barrier materials protecting rescuers & medical personnel from
exposure to biological, chemical & radioactive hazard which is poisonous, irritating, corrosive, carcinogenic
or protect from hearing loss from excessive noise levels
Other protective clothing: safety shoes, boots, apron, coveralls, full body suitx
Common route of exposure: inhalation, skin contact, ingestion
Ergonmics: science of designing a job, equipment & workplace to suit workers needs, with ultimate goals
of making them safe, comfortable and efficient and avoiding adverse health effects.
DSE: Display screen equipment prolong use pain and discomfort in upper limbs, tired eyes, muscle
fatigue, mental stress
DSE user: work at computer for total average of 6 hours />1/3 daily
MHO: Mind your back
Compressed Gas-Cat 2 hazard:
Chemical properties of gas, Physical hazards
Gas cylinders: heavy, high pressure, left standing alone unsupported, damage valve, jet away like missiles

Safety: follow guidelines, secured at all times at fixed location, secured individually, cylinder cart
Centrifuge: safety cups, disinfect weekly & after all spills/breakage, lubricate O rings & rotor threads, dont
use rotor that have been dropped, contact centrifuge rep for specific information
Fire: evacuate, alert others, close doors to confine fire & smoke, evacuate through nearest safe exit, no
elevators, move away from building, dont return until all clear announced
Electrical conductors: water, metal, human body
Personal injury: fire, radiological spill
Risk management:
Top management set policy, allocate resource; supervisor implement policy, training workers strict &
rigorous attention to details of procedures and practices & report incidents & exposures

Quality Control in Haematology

Standards: known constitution for calibration/reference purpose
Controls: identical w/ sample being tested; monitor precision/ assess variance from true value in inter-lab
trials <unstated value>
Accuracy: degree of agreement of individual/average value with standard/ref
Precision: degree of agreement among individual on same sample; Precision characterized as SD of errors
of measurement
Random error: inconsistent & unpredictable error; from lack of control in measurement e.g. wrong sample,
transcription errors, clots, sample carry-over, lipaemic, agglutination, hemolysis
Prevented by retest every sample after re-identification
1. Further examination samples (undetected clots/lipid/hemolysis)
2. Duplicate testing of random samples (taking several measures w/ control samples @ fixed intervals of
<30 samples; compare immediately to ensure no random error developed>
3. Confirm by related investigations (from expertise)
4. Comparison w/ previous results (delta check from computer storage within 72h)
check against previous patient result test CV & physiological variation
Systemic error: consistent, predictable, results with trend (error of method/operation/instrument)
Quality control procedures
1. Using control samples (twice)
2. Determine confidence limits (20 determinations on same sample)
see distribution is normal and calculate SD
25-donor pool <secondary standards> include in every assay
act as proficiency test of individuals assess accuracy & precision
5-donor pool <screening test only> not secondary assay standard
3. Presentation & Assessment of control data (LJ chart w/ +-2SD CI) under control
4. Cusum technique; mean subtracted from control result plot (w/ + or - sign)
5. Two-sampled/Youden plot
6. Daily/Batch means
7. Use of modal values (instead of mean); more stable and not affected by abnormal results
8. Use of samples from previous day / previous batch <retest>
From method error/operation error/instrument related error
Coefficient of variation (CV)= SD/mean * 100
Weighted mean=trim data recalculated mean
Deviation index=Test result-mean/SD
IQC=laboratory in-house QC procedure using ref & control preparation of statistical data from patients test
result
EQA=objective evaluation by external agency; under direction of professional colleagues of performance by

a # of lab on material supplied for specific tests

local/regional/national/international; disadv: delay results
Aims of QC: ensure all procedures carried out w/ highest level of accuracy & reliability
General approach to QC
Control charts includes
-Test in duplicate check precision & detect random errors
<not detect incorrect calibration & insensitive to gradual drift>
-Work batch include control in normal & abnormal range
-Control chart include mean, upper & lower confidence limit (+/- 2 SD)
-Batch # of control sample
-Date of each analysis, time taken for test & results
Results includes:
-Values for normal & abnormal controls
-Test values
-Ref range for lab
-Comment on significance of results
-Date & time of receipt of sample & date of analysis
-Signature by scientist/medical technologist
EQAP (Proficiency Trials); International quality control & standardization
-relate & compare results from lab w/ others
-improve reliability & test accuracy
-identify unsatisfactory performance
-achieve high standard of performance over extended period
Hong Kong Accreditation Service (HKAS)
Scope of Accreditation: Formal & precise statement of the activities which the laboratory is accredited for
HKAS medical programme
P lab = directed by Pathologist
S Lab = directed by Biomedical Scientist
Lab director must be full-time staff
HKAS 002: Regulations for Lab Accreditation
HOKLAS 015: Technical Criteria for Lab Accreditation
`
Reference Range
1. Select analyte, methodology, instrumentation use for testing. Study what already known about the

analyte that might cause inter individual variation.

2. Define reference population; consider whether separate reference range should be established e.g.
Adult VS children
3. Choose a sampling method that yields a random sample of individual representing the reference
population
4. Collect, process, test the specimen
5. Analyze results: Organize data, Eliminate outliers (Largest/Smallest Neighbor/Largest-Smallest >1/3),
Descriptive statistics (mean/median/mode/skewness/kurtosis), Select method for calculation e.g.
parametric (minimum 30 result; mean +- 2 SD) or non-parametric (%)
6. Verification of Established Reference Range (20 individuals)
If 2 or fewer result fall outside claimed ref range verified
Sensitivity: proportion of diseased correctly classified by test; detect TP
Specificity: proportion of healthy subject correctly classified; e.g. detect TN
Sensitivity: TP/TP+FN %
Specificity: TN/TN+FP%
+ve Predictive Value: Fraction of correct +ve test results: TP/TP+FP%
-ve Predictive Value: Proportion of correct ve test result: TN/TN+FN%
Prevalence: fraction of population having disease: TP+FN/TP+FN+TN+FP

ISO15189
4. Management requirements
4.1. Organization & Management
(authority, resources, no pressure) O chart
Quality Manager: ensure consistency, quality & technical validity of lab results;
Maintain quality manual & operation documentation, monitor lab practice to verify continuing
compliance w/ documented policies, ensure equipment calibration & maintenance done per schedule,
selection, training & evaluation of internal auditors, schedule & coordination of internal audits &
management review
4.2. Quality Management System: document polices & procedures communicated, available,
understood & implemented + QC, QC, EQAP, PT; depends on size of lab, staff #, range, vol of tests
Quality Manual: quality manual describe labs quality system; shall be developed as a working
document for use by lab staff, not check list for presentation to lab assessors
Include quality policy & objectives, documentation structure, policies, procedures & roles, scope of test
4.3. Document Control <review annually>
must have title, date of issue, page #, total # of page, issue authorities, source identification
4.4. Review of request & contracts
4.5. Examination by referral laboratories
4.6. External services and supplies (verify & validated before use)
4.7. Advisory Services (advice client on choice of examination & interpret results)
4.8. Resolution of complaints
4.9 Identification & control of Nonconformities
e.g. Out QC, complains, calibration, consumable defect, audits
4.10 Corrective action (investigate to determine root cause P.A)
Process of preventing recurrence of prob/mistake
4.11. Preventive Action (Pro-active)
Process of preventing occurrence of prob/improvement
4.12. Continual improvement (Quality indicator e.g. TAT, education, training)
4.13. Quality & technical records (Legible, Authentic, Reliable, Integral)
4.14. Internal audits (at least once annually/ every 12m)
4.15. Management review (once every 12 m)
5. Technical Requirements
5.1. Personnel; Approved Signatories
5.2. Accommodation & environment; Health, Safety, Manual Handling Operations
5.3. Laboratory equipment; Instruments, Ref materials, Consumables, Reagents, Analytical Systems;
test Bias, Reproducibility (diff lab comparison), Repeatability (same person), Stability, Linearity, Drift

Function well, accurate, calibrated, checked before using, environmentally friendly

5.4. Pre-examination Procedure; consistent, reproducible, traceable, efficacious
Sample collection, sample labeling, sample storage and packaging ,sample transport
Sample receipt, Sample logged, Secondary samples for multiple test, Sample storage
5.5 Examination procedures; SOP w/ purpose of test, sample specifications, principle, performance
specifications, reagents and equipment, interferences, calibration, safety, interpretation, variability
5.6. Assuring quality of examination procedures (QC, Uncertainty, Calibration)
QC: testing system that focus on detecting quality problems by monitoring outcomes of process
Provide info on uncertainty & assess staff competence
Process control: system for controlling processes and outcomes so variability/uncertainty is reduced as
much as possible e.g. Westgard
Uncertainty attributes: Material suppliers, Equipment, Process/Techniques, Environment, Personnel,
Information, Patient/Client, Physical Damage/Contamination, Microbial Contamination, Result
(Accuracy, Precision, Efficiency, Confidentiality)
Evaluate uncertainty in Preanalytical, analytical, postanalytical, intra-individual effect from biological
variation
5.7. Post-examination process (review results periodically, storage & disposal of samples)
5.8. Reporting of results; Clear, unambiguous, Objective, Include info required by clinician/patients,
ISO15189, Method
Annexes B: LIS
Annexes C: Ethics
Major changes in 2007 & 2012 version
More user-friendly, subheadings, deleted/amended & added new definitions, Ethics under
Management requirements 4.1.1.3; Lab director 4.1.1.4; Service agreements 4.4.1
Section 5; Procedures Process
New section 5.9 Release of results; 5.10 LIS

Quality System: Organizational management, Training, Documentation, Assessment, Standards

Good Laboratory Practice: Man, Machine, Materials, Methods, Environment, Information, Monitoring &
Measuring
Good Quality Cycle: Plan, Implmenet+/- Change, Control, Assess, Improve
Quality Standard Compliance Triangle: Documentation, Training, Audit QMS
Certification body: assess quality system conform to standard certificate
Accreditation body: official organization appointed by national gov check certification bodies
competent to award certificates
Standard: document established by consensus & approved by recognized body common & repeated
use

Plan Do Check Act

Plan: Identification of processes criteria & methods
Do: Implementation of the planning
Check: Measurement & Analysis
Act: Implementation of improvement
Scope of Accreditation: Anatomical Pathology, Chemical Pathology, Clinical microbiology & infection,
hematology, immunology
QMS: Quality Manual, Staff Manual, Purchasing Manual, Safety Manual, Operation procedure manual,
Equipment maintenance & Calibration record, Sample collection manual, test procedure manual,
internal audits schedule & reports, proficiency testing results
Balance (recal every 3 yrs)
Incubators (cal every 6m)

Westgard Multirules
Control rules for interpreting control data; Objective is to obtain high probability of error detection and
low frequency of false rejection of runs.
High detection error from selecting rules sensitive to random & systemic errors
Daily QC: 1 3s, 2 2s, 10x
1 2s Detect systemic error <warning>;
1 3s detect random error <reject>
2 2s Detect systemic error <reject>
R 4s detect random error <reject>
4 1s Detect systemic error <reject>
10 x Detect systemic error <reject>
Hold back patient results check instrument settings, reagents, standards, device repeat run w/
fresh QC & reagents if out again check methodology & instrumentation refer to i/c
call service & take contingency measures keep log