IMPLEMENTATION OF QUALITY CONTROL PERFORMANCE CRITERIA AND APPROVED GUIDELINES FOR UPGRADING OF CLINICAL CHEMISTRY LABORATORY PROCEDURES IN ALEXANDRIA UNIVERSITY HOSPITALS

2. IMPLEMENTATION OF QUALITYIMPLEMENTATION OF QUALITY
CONTROL PERFORMANCE CRITERIACONTROL PERFORMANCE CRITERIA
AND APPROVED GUIDELINES FORAND APPROVED GUIDELINES FOR
UPGRADING OF CLINICALUPGRADING OF CLINICAL
CHEMISTRY LABORATORYCHEMISTRY LABORATORY
PROCEDURES IN ALEXANDRIAPROCEDURES IN ALEXANDRIA
UNIVERSITY HOSPITALSUNIVERSITY HOSPITALSBY
Prof. MOUSTAFA RIZK
CLINICAL PATHOLOGY DEPAR.
ALEX UNIVERSITY

3. INTRODUCTIONINTRODUCTION

4. Decisions about diagnosis,Decisions about diagnosis,
prognosis and treatment areprognosis and treatment are
based on the results andbased on the results and
interpretations of lab tests, andinterpretations of lab tests, and
irreversible harm may be causedirreversible harm may be caused
by erroneous resultsby erroneous results..

5. QualityQuality
Achieving excellent performanceAchieving excellent performance..

6. Laboratory QualityLaboratory Quality
Management PlanManagement Plan
Pre-analytical.Pre-analytical.
Analytical.Analytical.
Post-Analytical.Post-Analytical.

7. Pre-analytical PhasePre-analytical Phase

8. 1.1. Test selection and ordering. Test selection and ordering.
2.2. Patient preparation.Patient preparation.
3.3. Patient identification and specimenPatient identification and specimen
collection procedures.collection procedures.
4.4. Specimen transport, handling, andSpecimen transport, handling, and
storage.storage.

9. Pre-analytical Quality Manual-Pre-analytical Quality Manual-
Based on CLSI GuidelinesBased on CLSI Guidelines
1.1. Patient preparation instructions.Patient preparation instructions.
2.2. Minimum sample volume needed for aMinimum sample volume needed for a
laboratory test.laboratory test.
3.3. Equations to calculate sample volumeEquations to calculate sample volume
for a number of tests.for a number of tests.

10. 4.4. Instructions for patient identification, blood sampleInstructions for patient identification, blood sample
collection & sample identification.collection & sample identification.

11. 5.5. Sample transportation, processing, andSample transportation, processing, and
storage guidelines.storage guidelines.

12. 6.6. Regulations for unacceptable specimensRegulations for unacceptable specimens
& how to avoid causes of rejection.& how to avoid causes of rejection.

13. 7.7. Guidelines for the collection of all types ofGuidelines for the collection of all types of
body fluids.body fluids.
8.8. Listing of analytes and the effect ofListing of analytes and the effect of
commonly encountered interferingcommonly encountered interfering
factors, and drug interferences.factors, and drug interferences.

14.  Knowledge disseminationKnowledge dissemination
between the medical staff.between the medical staff.
 Training and education ofTraining and education of
phlebotomists.phlebotomists.

15. Laboratory QualityLaboratory Quality
Management PlanManagement Plan
Pre-analytical.Pre-analytical.
Analytical.Analytical.
Post-Analytical.Post-Analytical.

16. Analytical PhaseAnalytical Phase

17. CLIA basic requirements forCLIA basic requirements for
analytical qualityanalytical quality
1.1. The lab should have a controlThe lab should have a control
procedure that evaluates the qualityprocedure that evaluates the quality
of the analytical system, correctsof the analytical system, corrects
identified problems, and documentsidentified problems, and documents
remedial actions.remedial actions.
2. It should have Standard Operating2. It should have Standard Operating
Procedures (SOPs) manual.Procedures (SOPs) manual.

18. 3.3. The lab should have a methodThe lab should have a method
selection and evaluation protocol.selection and evaluation protocol.
4.4. It should perform maintenance andIt should perform maintenance and
function-checks for all workingfunction-checks for all working
instruments.instruments.
5. The lab should determine control5. The lab should determine control
procedures to guarantee accurate labprocedures to guarantee accurate lab
results (Internal and External Qualityresults (Internal and External Quality
Control).Control).

19. Six SigmaSix Sigma
Sigma-metricSigma-metric
is a universal measure of quality.is a universal measure of quality.
The higher the value of the Sigma metric, theThe higher the value of the Sigma metric, the
better the process.better the process.

21. WESTGARD QCWESTGARD QC
PROTOCOLPROTOCOL

22. External Quality Control (EQC)External Quality Control (EQC)
OrOr Proficiency Testing (PT)Proficiency Testing (PT)
 Cembrowski multi-rule:Cembrowski multi-rule:
SDI = (laboratory value- peer group mean)/ peer group SDSDI = (laboratory value- peer group mean)/ peer group SD..

23. Screening rule: 2/5Screening rule: 2/511sdisdi rule.rule.
+3SDI
+2SDI
+1SDI
Mean
-1SDI
-2SDI
-3SDI
1 2 3 4 5 6 7 8 9 10
2/51sdi
Rule
violation
SDI = (laboratory value- peer group mean)/ peer group SDSDI = (laboratory value- peer group mean)/ peer group SD..

24. Rule for detection of SE:Rule for detection of SE:
mean rule (Xmean rule (X1.5sdi1.5sdi ))
+3SDI
+2SDI
+1SDI
Mean
-1SDI
-2SDI
-3SDI
1 2 3 4 5 6 7 8 9 10
X1.5sdi
Rule
violation
SDI = (laboratory value- peer group mean)/ peer group SDSDI = (laboratory value- peer group mean)/ peer group SD..

25. Two rules for detection ofTwo rules for detection of
RE:RE:
+3SDI
+2SDI
+1SDI
Mean
-1SDI
-2SDI
-3SDI
1 2 3 4 5 6 7 8 9 10
13sdi
Rule
violation
113sdi3sdi rulerule
SDI = (laboratory value- peer group mean)/ peer group SDSDI = (laboratory value- peer group mean)/ peer group SD..

26. RR4sdi4sdi rulerule..
+3SDI
+2SDI
+1SDI
Mean
-1SDI
-2SDI
-3SDI
1 2 3 4 5 6 7 8 9 10
R4sdi
Rule
violation
SDI = (laboratory value- peer group mean)/ peer group SDSDI = (laboratory value- peer group mean)/ peer group SD..

27. Laboratory QualityLaboratory Quality
Management PlanManagement Plan
Pre-analytical.Pre-analytical.
Analytical.Analytical.
Post-Analytical.Post-Analytical.

28. Post-analyticalPost-analytical
PhasePhase

29. 1.1. Reportable Range:Reportable Range:
 Analytical measurement rangeAnalytical measurement range
(AMR).(AMR).
 Clinically reportable range (CRR).Clinically reportable range (CRR).
2.2. Result Auto-validation:Result Auto-validation:
 Technical check.Technical check.
 Delta check.Delta check.
 Limit check.Limit check.

30. 3.3. Critical Result Notification:Critical Result Notification:
JCAHO; if a test is ordered stat, it isJCAHO; if a test is ordered stat, it is
CRITICAL
CRITICAL

31. ACCREDITATIONACCREDITATION

32. DefinitionDefinition
A voluntary process by whichA voluntary process by which
organizations are certified byorganizations are certified by
an independent companyan independent company
that they comply withthat they comply with..

33. PhilosophyPhilosophy
 Evaluate their performance,Evaluate their performance,
 Compliance with the requirementsCompliance with the requirements
of the accrediting association,of the accrediting association,
 Ability to improve the accuracy ofAbility to improve the accuracy of
the patients' results.the patients' results.

34. AGENCIESAGENCIES
 CAPCAP
 JCAHOJCAHO
 COLACOLA
 NCCLS [CLSI]NCCLS [CLSI]
 NAACLSNAACLS

35. College of AmericanCollege of American
Pathologists (CAPPathologists (CAP((
19461946
1959; Laboratory Standards.1959; Laboratory Standards.
They designed a series ofThey designed a series of
closed- type questions thatclosed- type questions that
could be used forcould be used for
implementation of CAP labimplementation of CAP lab
accreditation standards.accreditation standards.

36. AssessmentAssessment
CriteriaCriteria

37. 1.1. Organization andOrganization and
Administration.Administration.
Alexandria Clinical
Pathology Department

38. 2.2. Layout and design of the lab.Layout and design of the lab.

39. 3.3. Staff qualifications.Staff qualifications.

40. 4.4. MethodMethod
validation.validation.
55..IQCIQC
66..EQCEQC

41. 7.7. Internal audit.Internal audit.

42. 8.8. Continuous improvement.Continuous improvement.
9.9. Quality policy.Quality policy.

43. How to beHow to be
AccreditedAccredited
?

44. ISO Implementation StepsISO Implementation Steps
 Identification of the ISO standard that will beIdentification of the ISO standard that will be
adopted, and the scope of application.adopted, and the scope of application.
 Identification of the resources.Identification of the resources.
 Identification of the processes to which ISOIdentification of the processes to which ISO
will be applied.will be applied.
 Training the staff in ISO standards.Training the staff in ISO standards.
 Defining the quality indicators that will beDefining the quality indicators that will be
used for follow up.used for follow up.

45. ISO Implementation StepsISO Implementation Steps
 Training internal auditor staff who willTraining internal auditor staff who will
inspect and evaluate processes.inspect and evaluate processes.
 Conducting the internal audit.Conducting the internal audit.
 Having an initial ISO inspection visit.Having an initial ISO inspection visit.
 Having the final ISO certification visit.Having the final ISO certification visit.

46. Quality IndicatorsQuality Indicators
 Are measurable lab performanceAre measurable lab performance
characteristics reflecting desirablecharacteristics reflecting desirable
attributes, to determine the level ofattributes, to determine the level of
quality achieved.quality achieved.

47.  Specimen rejected.Specimen rejected.
 Test order accuracy.Test order accuracy.
 STAT tests turn around time (TAT).STAT tests turn around time (TAT).
 Critical values reporting.Critical values reporting.
 Users' satisfaction.Users' satisfaction.
 EQA (PT) participation.EQA (PT) participation.

48. AIM OF THEAIM OF THE
WORKWORK

49. 1.1. To assess the quality of work inTo assess the quality of work in
the Clinical Chemistry Unit;the Clinical Chemistry Unit;
Clinical Pathology Department,Clinical Pathology Department,
Alexandria Main UniversityAlexandria Main University
Hospital, in EgyptHospital, in Egypt
2.2. pre-analytical and analyticalpre-analytical and analytical
activitiesactivities
3.3. In order to outline a path forIn order to outline a path for
successful accreditationsuccessful accreditation

50. MATERIAL ANDMATERIAL AND
METHODSMETHODS

51. CHECKLISTSCHECKLISTS
Inspection sheets wereInspection sheets were
formulated according toformulated according to
checklists of College ofchecklists of College of
American Pathologists" (CAP)American Pathologists" (CAP)
(2006).(2006).

52. EVALUATEDEVALUATED
FIELDSFIELDS
Checklist I:Checklist I:
Requisition forms and specimen receipt.Requisition forms and specimen receipt.
Checklist II:Checklist II:
Specimen collection and handling.Specimen collection and handling.

53. Checklist III:Checklist III:
Reagents used in testing.Reagents used in testing.
Checklist IV:Checklist IV:
Calibration.Calibration.
Checklist V:Checklist V:
Quality control materials.Quality control materials.
Checklist VI:Checklist VI:
Procedure manual of methods and their performance.Procedure manual of methods and their performance.
Checklist VII:Checklist VII:
Proficiency testing.Proficiency testing.
Checklist VIII:Checklist VIII:
Instrument maintenance.Instrument maintenance.

54. Checklist IX:Checklist IX:
Quality management and qualityQuality management and quality
control.control.
Checklist X: Physical facilities.Checklist X: Physical facilities.

55. RESULTSRESULTS

56.  Category A:Category A: requirements that wererequirements that were
fulfilled before the study.fulfilled before the study.
 Category B:Category B: requirements that wererequirements that were
fulfilled during the study.fulfilled during the study.
 Category C:Category C: requirements whoserequirements whose
fulfillment started during the study butfulfillment started during the study but
still under process.still under process.
 Category D:Category D: recommendations to berecommendations to be
achieved in the future.achieved in the future.

57. The relation between category "A" andThe relation between category "A" and
all the other categories (B/C/D) in eachall the other categories (B/C/D) in each
checklist, at the start of the studychecklist, at the start of the study..
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10
A B,C,D100%100%
78.9%78.9%
85.7%85.7%
91.7%91.7%

58. Average percentage of rejected samplesAverage percentage of rejected samples
per month, from the Internal Medicineper month, from the Internal Medicine
Department before starting the studyDepartment before starting the study
15.8
1.81
0.7 0.51
0
2
4
6
8
10
12
14
16
18
H
aem
olysis
C
lotted
Q
N
S
Lost
15.815.8
0.51.81 0.7

59. The degree of requirements fulfillmentThe degree of requirements fulfillment
in each checklist, at the end of thein each checklist, at the end of the
studystudy
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10
A B,C D
85.7%85.7%
42.1%42.1%
85.7%85.7%

60. Average percentage of rejected samplesAverage percentage of rejected samples
per month, from the Internal Medicineper month, from the Internal Medicine
Department before and after completingDepartment before and after completing
the studythe study
15.8
7
1.81
0.77 0.7 0.08 0.51 0.05
0
2
4
6
8
10
12
14
16
18
Haem
olysis
Clotted
QNS
Lost
Before
After

61. The relation between categoriesThe relation between categories
"A/B/C" and category (D) in each"A/B/C" and category (D) in each
checklist, at the end of the studychecklist, at the end of the study..
0
10
20
30
40
50
60
70
80
90
100
1 2 3 4 5 6 7 8 9 10
A,B,C D
63.2%63.2%
85.7%85.7% 83.3%83.3%
80%80%

62. CAP requirements that wereCAP requirements that were
formulated as recommendationsformulated as recommendations
(Category D(Category D((
 Distribution of the pre-analytical manual to all samplingDistribution of the pre-analytical manual to all sampling
stations.stations.
 "Criteria for rejection of unacceptable specimens""Criteria for rejection of unacceptable specimens"
 The SOPs will be revised annually by the lab director.The SOPs will be revised annually by the lab director.
 Calibration verification.Calibration verification.
 Method validation.Method validation.
 QM/QC program that covers all areas of the lab.QM/QC program that covers all areas of the lab.
 An easy way for communication between different lab unitsAn easy way for communication between different lab units
and between the main lab and other subsidiary labs shouldand between the main lab and other subsidiary labs should
be considered.be considered.

63. CONCLUSIONSCONCLUSIONS

64.  Documentation is the first stepDocumentation is the first step
to achieve lab quality.to achieve lab quality.

65.  All details of the pre-analyticalAll details of the pre-analytical
phase should be written in thephase should be written in the
“Pre-analytical Quality Manual”.“Pre-analytical Quality Manual”.

66.  Management of the analyticalManagement of the analytical
phase was the mostphase was the most
standardized and regulated.standardized and regulated.

67. The pre-analytical phase wasThe pre-analytical phase was
the most defective phase.the most defective phase.

68.  Proficiency testing is one ofProficiency testing is one of
the main QC measures tothe main QC measures to
control analytical quality.control analytical quality.

69. AccreditationAccreditation
Alexandria Clinical Pathology
Department
Is an important key to improve lab performance.

70. RECOMMENDATIONSRECOMMENDATIONS

71. 1.1. Routine checking of the total testingRoutine checking of the total testing
process through internationalprocess through international
checklists should be performedchecklists should be performed
annually, by the lab director.annually, by the lab director.

72. 2.2. Assessment of the post-analyticalAssessment of the post-analytical
activities, and laboratory safetyactivities, and laboratory safety
procedures should be considered,procedures should be considered,
to have an overall assessmentto have an overall assessment
picture for the clinical chemistrypicture for the clinical chemistry
unit.unit.

73. 3.3. Assessment of the pre-analytical,Assessment of the pre-analytical,
analytical, and post-analyticalanalytical, and post-analytical
errors should be performed inerrors should be performed in
relation to the total laboratoryrelation to the total laboratory
errors.errors.

74. 4.4. A system for inter- laboratory checkA system for inter- laboratory check
could be organized, by the Clinicalcould be organized, by the Clinical
Pathology Department, AlexandriaPathology Department, Alexandria
University Hospital, to allow otherUniversity Hospital, to allow other
labs and institutions in Alexandria tolabs and institutions in Alexandria to
check their performance, at leastcheck their performance, at least
semi-annually, as an alternative waysemi-annually, as an alternative way
for proficiency testing.for proficiency testing.

75. Nashwa A El BadawiNashwa A El Badawi22
, Pacint E Moez, Pacint E Moez11
, Azza A Khattab, Azza A Khattab33
1-1-
Departement of clinical pathology, Alexandria university,Departement of clinical pathology, Alexandria university,
Egypt.Egypt.
2-2-
Departement of clinical pathology, Ain Shams university,Departement of clinical pathology, Ain Shams university,
Egypt.Egypt.
3-3-
Lab department, Naval hospital, Military services, Egypt.Lab department, Naval hospital, Military services, Egypt.