• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Case presentation (lab analytical quality assurance problem )
 

Case presentation (lab analytical quality assurance problem )

on

  • 260 views

 

Statistics

Views

Total Views
260
Views on SlideShare
260
Embed Views
0

Actions

Likes
0
Downloads
9
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • Currently innovative techniques and equipment ARE AVAILABLE AND BEING PRODUCED have changed a lot of the conventional implant procedures like:
  • CAD/CAM technology has changed a lot of our conventional prosthetic and restorative procedures
  • CAD/CAM technology has currently changed conventional dental implant procedures
  • What also made a great difference in the prosthetic part of the dental implant procedure is the great advancement in the all ceramic CAD/CAM technology.

Case presentation (lab analytical quality assurance problem ) Case presentation (lab analytical quality assurance problem ) Presentation Transcript

  • 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
  • Case presentation
  • 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:
  • 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)
  • 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 requested the following investigations: 1. Total calcium level 2. Alkaline phosphatase 3. Intact parathyroid hormone
  • 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
  • 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
  • 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)
  • 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
  • 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 laboratory be confident about his results?
  • What is the best practice to this problem? Ensure your customer satisfaction by settling a firm, well communicated patient complaint handling policy?
  • 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
  • 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
  • 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)
  • The laboratory findings Are consistent with Renal osteodestrophy as regards:  Borderline Calcium level  Increased alkaline phosphatase Decreased iPTH What is not with ROD?
  • 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
  • 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
  • Where is the problem? The problem has to be investigated systematically (1) Pre-analytical (2) Analytical (3) Postanalytical
  • 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
  • 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 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)
  • 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
  • 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.
  • 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 errors) •Specimen related variables www.westgard.com/guest20.htm
  • 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.
  • 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
  • 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 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
  • 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
  • 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 .
  • 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)
  • 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?
  • 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
  • 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
  • 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
  • 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%
  • 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
  • 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………………