evolving aspects of quality assurance in laboratory
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EVOLVING ASPECTS OF QUALITY ASSURANCE IN LABORATORY TESTING Patrick St.Louis, PhD, Dip Clin Chem Sainte-Justine Hospital Montreal, Canada Congress SCPC, 2004. - PowerPoint PPT PresentationTRANSCRIPT
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EVOLVING ASPECTS OF QUALITY
ASSURANCE IN LABORATORY
TESTING
Patrick St.Louis, PhD, Dip Clin Chem
Sainte-Justine Hospital
Montreal, Canada
Congress SCPC, 2004
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Quality the total characteristics of a process or procedure that affect its ability to satisfy its intended application
To appreciate the need for quality we must understand the impact of poor quality
automobile: safety/accidents, repairs - time and cost
cigar: taste, low satisfaction, poor reputation - sales
laboratory test result: inappropriate treatment
delays in treatment
direct harm - repeat punctures
social and economic harm
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Quality Assurance (QA) the systematic activities needed to ensure that the requirements of quality will be met.
An efective laboratory QA program will provide reliable test results with a minimum of delay and the efficient use of resources, taking care to address patient safety and to minimise laboratory errors.
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Select processes and identify steps for improvement
Need objectives with measurable quality indicators; objectives should have clinical, patient care relevance.
For example: “To reduce the number of unlabelled specimens received”
measurable
patient care relevance: number of repeat sticks
time delay to results and treatment
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The laboratory QA program must consider all phases of the laboratory testing process and the steps that can benefit from quality improvement
pre-analytical, analytical and post-analytical
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Pre-analytical phase
patient identification specimen:collection, identification
laboratory: reception and verification pre-test handling: separation
decanting
aliquotting (labelling)
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Patient identification: (CRITICAL)Armbands
“No specimen shall be drawn from a patient who is not wearing an armband”
Double identification: name (ask), numberSpecial situations: newborns, patients in the ER
Sample identification: care should be taken to correctly identify the specimen at this time.
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Specimen collection: proper procedure; repeat
punctures; correct samples - no omissions; needlestick injuries
identification: label must be affixed transport: delays (time-stamping, tube systems) inappropriate and un-protected samples Sample volume issues
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Pre-analytical phase patient identification specimen:collection, identification
laboratory: reception and verification data/order entry pre-test handling: separation
decanting
aliquotting (labelling) delay or loss in laboratory (this occurs more
often than we would like)
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Studies on laboratory errors pre-analytical errors 30%-75% of total errors patient/specimen ID errors 34 - 58% of pre-
analalytical errorsBonini et al. Clin Chem 2002; 48:691-698
Astion et al. Am J Clin Pathol 2003; 120:18-26
CAP-Q Probes study
Order entry errors can be as high as 5% of tests entered; most frequent test request not entered
Valenstein & Meier, Arch Pathol Lab Med 1999; 123:1145-1150
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Analytical phase
need well-written protocols (methods; format)
ensure reliability of test (NCCLS, ISO):
establish or verify linearity
verify limits of detection and analytical range
evaluate precision and accuracy
establish institution-specific reference ranges
reagent handling: storage, expiry dates; fridge temperatures
instrument breakdown and repair logs: down time causes loss of effective working time and delays in results
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Quality control (QC) operational techniques and activities that are used to fulfill requirements for quality
QC for the analytical phase :
traditional
automatic
electronic
Continuous system monitoring: total system; remote sensing and monitoring
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use of split samples and other means of internal assessment and monitoring
concordance between analysers
External QC programs (proficiency testing)
External QC results and proficiency testing material as tests of trueness
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Post-analytical phase Result validation: automatic, absurd results
(contamination by IV fluids, saline, glucose,)
Reflex testing eg TSH and T3, T4 Reports and interpretations (HbS, tumor markers) Managing critical and unusual results:
protocols defining critical values and actions calls and read backs
Problems inherent in manual entry of results Sample storage and retrieval for supplementary
testing; a good system saves time
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The total QA process can benefit from the laboratory information system (LIS):
time stamps
identity tags
traceability from specimen collection to test result
previous results and delta checks
format of laboratory reports; reference values and comments
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Approach to QA program
Develop protocols and policies Identify intervention points Use Risk Reports: laboratory and/or
hospital; government mandated reporting Prepare regular QA reports; ensure
distribution and follow up.
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Preparation of QA reports and follow up
statistical analysis: by period, by clinical unit
explain/understand the consequences of particular problems and the reason for actions: eg improper sample identification leading to sample rejection or certification; real or potential harm to the patient
avoid blame and seek support interdisciplinary problems
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Some policies at HSJ
patient identification
specimen identification and certification
specimens delayed in transport (use of pneumatic tube system)
adequate filling of specimen tubes (anti-coagulation)
instrument maintenance, breakdown and repair log sheets
temperature logs for refrigerators and freezers
critical values protocols: values and actions
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Specimen ID errors: HSJ protocol rejection Specimen not identified/labelled no requisition identification errors: wrong patient, wrong
label on specimen, wrong requisition, sample and requisition do not match
Are all mis-labelled samples rejected?
Some samples are hard to replace Certification by someone responsible on the
clinical side
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HSJ 2003/2004: from “Certification Forms” 132 sample-related incidents
64 - no identification
36 - wrong identification
number of rejections = 90
number of certifications and acceptances = 8
We have noted a marked decrease in the number of events; under-reporting of problem cases ?
What about when the test is already done and the report sent; removing results from the patient chart; do not transfer results
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Responsibility for QA:
Everyone
An institutional issue, having administrative support
Uses analytical and statistical tools
Two aspects
identify and resolve any current problems
long range anticipation to improve processes
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Publications: NCCLS documents
ISO 15189: Standards for Medical Laboratories Relating to Quality and Competence