Rania Mohamed El-Sharkawy
rania.elsharkawy@alex-mri.edu.eg
Lecturer of clinical chemistry, MRI-Alexandria University ,CPHQ...
Case presentation
How can we achieve good laboratory
practice?
1.

A 64 year-old female went to the laboratory to perform the
investigations...
History taking
(1) Full name of the patient
(2) Age
(3) Telephone and Address of the patient

(4) Referring doctor name an...
How can we achieve good laboratory practice?

What information did she
forget to take from the
patient?
How can we achieve good laboratory practice?
The patient is suffering from chronic renal failure
(dialysis) and the doctor...
How can we achieve good laboratory practice?
Sampling unit

(1)The phlebotomist took the sample
following accurate samplin...
The patient returned back to the laboratory
complaining from discrepancy between both laboratory
results?

How Can the lab...
Laboratory results
Total calcium level
10.3 mg/dL (reference interval 8.4-10.5 mg/dL) Total calcium level

10.3 mg/dL (ref...
Immediately after withdrawing the sample the
patient went to another laboratory to repeat
the investigations
All the resul...
How can we achieve good laboratory
practice?

What might occur in this process that may
affect the next process?
This is a problem that may face any
laboratory
Why is the best approach to this problem?
Where is the problem?
How can the...
What is the best practice to this problem?

Ensure your customer satisfaction
by settling a firm, well
communicated patien...
What is the best practice to this problem?

Contact his doctor to gather full clinical
information about the patient`s
con...
What is the clinical interpretation of this case?
•

PTH functions to maintain serum calcium concentrations within a tight...
What is the clinical interpretation of this case?
•The combination of secondary hyperparathyroidism and mineralization def...
The laboratory findings
Are consistent with
Renal osteodestrophy as regards:

 Borderline Calcium level
 Increased alkal...
The laboratory findings which
Are consistent with
Adynamic bone disease as regards:
 Borderline Calcium level (towards hy...
This is a problem that may face any
laboratory
Why is the best approach to this problem?
Where is the problem?
How can the...
Where is the problem?
The problem has to be investigated systematically
(1) Pre-analytical
(2) Analytical

(3) Postanalyti...
Incidence of pre-analytical variables 46-68.7%
97

Exclude the following:
•Patient related variables (drug history
2% of e...
How can we achieve good laboratory
practice?
What information did she forget to take
from the patients?
How can we achieve good laboratory practice?
History taking
(1) Full name of the patient

(2) Age
(3) Telephone and Addres...
The drug history………..
•

The patient is receiving 10 mg /day biotin

•

Biotin has been reported to improve symptoms of
en...
How can we achieve good laboratory practice?
Sampling & transportation processes
(4) sample can be stored at 2-8C for 8h
a...
What are the possible causes of
error in the sampling and
transportation processes?
Incidence of pre-analytical variables 46-68.7%
97

Exclude the following:f
•Patient related variables (drug history
2% of ...
How can we achieve good laboratory practice?
Sampling & transportation processes

(1) Morning sample was taken(nocturnal r...
How can we achieve good laboratory practice?
Analytical process
1.
2.
3.

Revise the reference interval & validation of th...
How can we achieve good laboratory
practice?
Analytical process
(5) Verify the result
(6) Release the report
The principle of the method in our laboratory
A biotinylated anti-PTH monoclonal antibody and a ruthenium-labeled antiPTH...
The principle of the method in our
laboratory
Biotin is recognized as a potential interferent in PTH and
other assays tha...
HOW CAN THE LAB verify the error ?
•Using another method (importance of backup plans)
• To confirm the interfering role of...
Figure 1. Effect of biotin on serum intact PTH concentrations determined using our method.
Percent recovery was calculated...
This is a problem that may face any laboratory
Why is the best approach to this problem?
Where is the problem?
How can the...
Incidence of analytical errors 7-13%
Confirm the following
 Validation of method
IQC results
EQAS results
Uncertainty ...
Incidence of Post-analytical variables
18-47%
Confirm the following:
 Error in recording
Errors in reporting
Errors in ...
Conclusion……….
pre-analytical errors:
Improper identification of the patient
Drug history

 analytical errors
Interferenc...
Data collection period

I year

1 year

1 year

No. of tests

997 000

600 000

40 490

No. of patients

249 000

160 714
...
Finally……….
Define the processes
 The lab should standardize its operating procedures according to national or
internati...
Finally……….
Define ways to decrease laboratory errors and to possibly avoid
completely those with a real or potentially si...
Case presentation (lab analytical quality assurance problem )
Case presentation (lab analytical quality assurance problem )
Case presentation (lab analytical quality assurance problem )
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  • Case presentation (lab analytical quality assurance problem )

    1. 1. Rania Mohamed El-Sharkawy rania.elsharkawy@alex-mri.edu.eg Lecturer of clinical chemistry, MRI-Alexandria University ,CPHQ,LSSGB Health governance –MRI-Alex university unit coordinator IHI Egypt & NAHQ member
    2. 2. Case presentation
    3. 3. How can we achieve good laboratory practice? 1. A 64 year-old female went to the laboratory to perform the investigations requested from a referring doctor. 2. She went in to the registration unit 3. The receptionist asked the patient to fill the registration form , the patient was illiterate so the receptionist tried to help the patient and she asked for the following data:
    4. 4. History taking (1) Full name of the patient (2) Age (3) Telephone and Address of the patient (4) Referring doctor name and address (contact) (5) History of chronic illness (6) History of surgeries (7) Requested analytical tests ( fasting hours)
    5. 5. How can we achieve good laboratory practice? What information did she forget to take from the patient?
    6. 6. How can we achieve good laboratory practice? The patient is suffering from chronic renal failure (dialysis) and the doctor requested the following investigations: 1. Total calcium level 2. Alkaline phosphatase 3. Intact parathyroid hormone
    7. 7. How can we achieve good laboratory practice? Sampling unit (1)The phlebotomist took the sample following accurate sampling procedure (2)The sample was transported to the central laboratory for processing
    8. 8. The patient returned back to the laboratory complaining from discrepancy between both laboratory results? How Can the lab ASSURES THE PATIENT SATISFACTION together with Identifying the source of error
    9. 9. Laboratory results Total calcium level 10.3 mg/dL (reference interval 8.4-10.5 mg/dL) Total calcium level 10.3 mg/dL (reference interval 8.4-10.5 mg/dL) Alkaline phosphatase 160 U/L (reference range 30-120 U/l . Mild increase in activity) Intact Parathyroid hormone level were low 40pg/ml (16-87 pg/ml)
    10. 10. Immediately after withdrawing the sample the patient went to another laboratory to repeat the investigations All the results were comparable except for the PTH it was significantly higher 500 pg/ml
    11. 11. How can we achieve good laboratory practice? What might occur in this process that may affect the next process?
    12. 12. This is a problem that may face any laboratory Why is the best approach to this problem? Where is the problem? How can the laboratory be confident about his results?
    13. 13. What is the best practice to this problem? Ensure your customer satisfaction by settling a firm, well communicated patient complaint handling policy?
    14. 14. What is the best practice to this problem? Contact his doctor to gather full clinical information about the patient`s condition Here comes the importance of the doctor name and contact
    15. 15. What is the clinical interpretation of this case? • PTH functions to maintain serum calcium concentrations within a tight physiologic range • Patients with chronic renal failure develop secondary hyperparathyroidism owing to decreased renal production of 1,25-dihydroxyvitamin D, decreased Ca and hyperphosphatemia. •These derangements in mineral metabolism stimulate PTH production to raise serum calcium and promote phosphorus excretion. • Increased serum PTH leads to excessive bone resorption through stimulation of osteoblasts and osteoclasts
    16. 16. What is the clinical interpretation of this case? •The combination of secondary hyperparathyroidism and mineralization defects (osteomalacia) represents the most common form of renal osteodystrophy (ROD). •Subtype of ROD known as adynamic bone disease can be observed in the setting of prolonged peritoneal or hemodialysis, over suppression of PTH with calcitriol or calcium-based phosphate binders, or the use of bisphosphonates for osteoporosis treatment • Common biochemical hallmarks of ABD include hypercalcemia, low or inappropriately normal PTH concentrations, and reduced markers of bone turnover (e.g., alkaline phosphatase)
    17. 17. The laboratory findings Are consistent with Renal osteodestrophy as regards:  Borderline Calcium level  Increased alkaline phosphatase Decreased iPTH What is not with ROD?
    18. 18. The laboratory findings which Are consistent with Adynamic bone disease as regards:  Borderline Calcium level (towards hypercalcemia)  Decreased iPTH Increased alkaline phosphatase ( it should be low due to decreased bone turnover) What is not with ABD
    19. 19. This is a problem that may face any laboratory Why is the best approach to this problem? Where is the problem? How can the laboratory be confident about his
    20. 20. Where is the problem? The problem has to be investigated systematically (1) Pre-analytical (2) Analytical (3) Postanalytical
    21. 21. Incidence of pre-analytical variables 46-68.7% 97 Exclude the following: •Patient related variables (drug history 2% of errors) •Specimen related variables www.westgard.com/guest20.htm
    22. 22. How can we achieve good laboratory practice? What information did she forget to take from the patients?
    23. 23. How can we achieve good laboratory practice? History taking (1) Full name of the patient (2) Age (3) Telephone and Address of the patient (4) Referring doctor name and address (contact) (5) History of chronic illness (6) History of surgeries (7) Requested analytical tests (preparation)
    24. 24. The drug history……….. • The patient is receiving 10 mg /day biotin • Biotin has been reported to improve symptoms of encephalopathy and peripheral neuropathy in patients with RF and undergoing hemodialysis • Also she is taking Ca based phosphate binders • Vitamin D
    25. 25. How can we achieve good laboratory practice? Sampling & transportation processes (4) sample can be stored at 2-8C for 8h after collection or longer stored up to 2 month in – 20C.
    26. 26. What are the possible causes of error in the sampling and transportation processes?
    27. 27. Incidence of pre-analytical variables 46-68.7% 97 Exclude the following:f •Patient related variables (drug history 2% of errors) •Specimen related variables www.westgard.com/guest20.htm
    28. 28. How can we achieve good laboratory practice? Sampling & transportation processes (1) Morning sample was taken(nocturnal rise) (2) EDTA (filled to the desired mark on the tube as excess EDTA will interfere with the assay causing false decrease )or serum sample could be taken . (3) Rapid collection and separation of the sample using refrigerated centrifuge to keep the sample at 2-8C.
    29. 29. How can we achieve good laboratory practice? Analytical process 1. 2. 3. Revise the reference interval & validation of the method Apply acceptance , rejection criteria Reconstitute the control or adjustor vial with accurate amount of distilled water using calibrated pipette and should be put in ice in between swirling. 4. Introduce the control, judge on the control 5. Introduce sample
    30. 30. How can we achieve good laboratory practice? Analytical process (5) Verify the result (6) Release the report
    31. 31. The principle of the method in our laboratory A biotinylated anti-PTH monoclonal antibody and a ruthenium-labeled antiPTH monoclonal antibody form a sandwich complex with PTH After which streptavidin-coated microparticles are added to magnetically separate out the sandwich complex via biotin and streptavidin interaction Specimens with high concentrations of biotin may prevent the binding of the sandwich complex to the streptavidin-coated micro particles, thus giving falsely low signals
    32. 32. The principle of the method in our laboratory Biotin is recognized as a potential interferent in PTH and other assays that uses the same method, and it is recommended in the product insert that samples from patients receiving high biotin doses of >5 mg/day be collected at least 8 h after biotin administration
    33. 33. HOW CAN THE LAB verify the error ? •Using another method (importance of backup plans) • To confirm the interfering role of biotin , iPTH concentration were measured in two labs after the patient stopped taking the drug for 2 weeks (both results were the same) •Recovery experiment using both normal and increased i PTH levels .
    34. 34. Figure 1. Effect of biotin on serum intact PTH concentrations determined using our method. Percent recovery was calculated as the ratio of PTH concentration after the addition of biotin at various concentrations (sigma –Aldrich) (5, 10, 20, 40, 80, 160 µg/L) to the samples.( solid diamond indicates normal level& solid square indicates increased level)
    35. 35. This is a problem that may face any laboratory Why is the best approach to this problem? Where is the problem? How can the laboratory be confident about his results?
    36. 36. Incidence of analytical errors 7-13% Confirm the following  Validation of method IQC results EQAS results Uncertainty of measurements Total allowable error •Revise your reference interval or establish… www.westgard.com/guest20.htm
    37. 37. Incidence of Post-analytical variables 18-47% Confirm the following:  Error in recording Errors in reporting Errors in interpretations???(role of lab doctors) www.westgard.com/guest20.htm
    38. 38. Conclusion………. pre-analytical errors: Improper identification of the patient Drug history  analytical errors Interference and no backup plans Postanalytical : No analytical validation of the test result and halting the report should be done
    39. 39. Data collection period I year 1 year 1 year No. of tests 997 000 600 000 40 490 No. of patients 249 000 160 714 10 000 120 180 189 0.05% of patients 0.11% of patients 0.47% of test results Preanalytical phase 31.6% 55.6% 68.2% Analytical phase 31.6% 13.3% overall (4.4% if referral laboratory 13.3% Postanalytical phase 30.8% 30% 18.5% No. of errors Frequency Mulitiple phases 6%
    40. 40. Finally………. Define the processes  The lab should standardize its operating procedures according to national or international standards.. Put a control measures to each process.  Standardize the laboratory error detection program. Using (process analysis, audit , questionnaires , and collection of complaints)  Accurate analysis of the errors
    41. 41. Finally………. Define ways to decrease laboratory errors and to possibly avoid completely those with a real or potentially significant negative effect on a patient’s health. And here starts the improvement that should never ends………………

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