Specimens Collections, Specimen Processing & Culturing Blood.
Improving Blood Specimen Quality and Patient Care · Improving Blood Specimen Quality and Patient...
Transcript of Improving Blood Specimen Quality and Patient Care · Improving Blood Specimen Quality and Patient...
Improving Blood Specimen Quality and Patient Care
Gary Parish, MS
Clinical Sales Manager
Pre-analytic Error
• 70% of errors originate during pre-analytic phase.1,2,3
• Poor specimen quality accounts for 60% of PAEs.3
1. Toybert ME, et al. Why is the laboratory an afterthought for managed care organizations? Clin Chem 1996;42:813–6.
2. Da Rin G. Pre-analytical workstations: A tool for reducing laboratory errors. Clinica Chimica Acta 404 (2009) 68–74.
3. Lippi G, et al. Preanalytical variability: the dark side of the moon in laboratory testing. Clin Chem Lab Med 2006;44(4):358–365.
Pre-analytic Error
Hemolysis
43.6%
Clotting
7.6%
4. Bonini et al. Errors in Laboratory Medicine. Clin Chem 2002;48(5):691-698.
Most prevalent sources of error4:
Clotting QNS
Specimen Errors
16.9%
Specimen Errors: QNS
QNS accounts for 16-22% of all rejected specimens. 5,6
Citrate samples may produce the highest rejection rate of all
tube types received. 7
Under-filled citrate: prolonged PT, APTT and TT;
low fibrinogen and D-dimer results 8
Under-filled EDTA: decreased MCV, HCT, RBC, WBC, PLT
changes in leukocyte morphology 9
Under-filled heparin: increase CK and GGT test results 9
5. Dale, et al. Outpatient phlebotomy success and reasons for specimen rejection. Arch Pathol Lab Med. 2002 Apr;126(4): 416-419.
6. Jacobsz, et al. Chemistry and hematology sample rejection and clinical impact in a tertiary laboratory in Cape Town. Clin Chem Lab Med. 2011 Oct
14;49(12):2047-2050.
7. Atay, et al. Clinical biochemistry laboratory rejection rates due to various types of preanalytical errors. Biochemica Medica 2014;24(3):376-382
8. Bostic and Sykes. How to collect a quality sample, preventing QNS collections. Beaumont Laboratory, Laboratory Bulletin. May 23, 2011
9. Lippi, et al. Incomplete filling of lithium heparin tubes affects the activity of creatine kinase and gamma-glutamyltransferase.
British Journal of Biomedical Science 2012, 69(2), 1-4.
CLSI clearly addresses this quality imperative:
“Venous blood collection tubes must be capable of retaining
a vacuum for the stated shelf life if the tube’s method of
collection is by means of evacuation only.” 10
“When a collection device is tested for draw and fill
accuracy at the time of manufacture, the draw shall be
within 10% of the stated draw. At the expiration date, the
draw volume shall be no more than 10% below the stated
draw volume of the manufacturer.” 10
10. Tubes and additives for venous and capillary blood specimen collection, approved standard. CLSI Document H01-A6, Vol. 30, No. 26
Specimen Errors: QNS
Causes
• Insufficient volume from syringe
• Collection at high altitudes
• Loss of vacuum in tube (within 4 months of expiration) 11,12
• Collapse of fragile veins
Precautions
• Eliminate syringe collection if a transfer step is required
• Collect with tubes that are unaffected by altitude changes
• Test vacuum tubes monthly to verify complete filling
• Prevent collapse of delicate veins by using a
gentle syringe-style blood draw technique
11. Natasa Gros. Evacuated blood-collection tubes for haematological tests- a quality evaluation prior to their intended use for specimen collection.
Clin Chem Lab Med 2013;51(5):1043-1051.
12. Haubner. Elimination of Under-filling and Draw Volume Variability Associated with Traditional Evacuated Blood Tubes.
Sarstedt Technical Bulletin.
Specimen Errors: QNS
Clotting accounts for 14% of total specimen rejections 13
and 65% of hematology specimen rejections. 14
EDTA microtube samples for CBC testing have the highest
rejection rate of all tube types received by the laboratory. 14
Clotted citrate: Prolonged PT, APTT and TT
Loss of fibrinogen, FII, FV and FVIII
Loss of HMW vWF
Obstructed flow in PFA 100 15
Clotted EDTA: Inhibits sample aspiration by instrument
Interferes with cell counting and morphology
13. Alsina, et al. Preanalytical quality control program – an overview of results (2001–2005 summary) Clin Chem Lab Med 2008;46(6):849–854
14. Jones, et al. Complete blood count specimen acceptability. A CAP Q-Probes study of 703 laboratories. Arch Pathol Lab Med V119, March 1995.
15. Favaloro, et al. Pre-analytical Variables in Coagulation Testing Associated With Diagnostic Errors in Hemostasis
February 2012, Volume 43, Number 2, LabMedicine.
Specimen Errors: Clotting
CLSI clearly addresses this quality imperative:
“The following are not suitable for testing and are causes for
specimen rejection:
• specimens that are clotted.” 16
“ [plasma and whole blood] Specimens that are clotted, …
are not suitable for testing and should be rejected. 16
16. Sections 5.2.1.3 and 5.3.1.6. Causes for specimen rejection. CLSI Document H21-A5
Specimen Errors: Clotting
Causes
• Collection into untreated syringe 17
• Inadequate mixing 18
• Collection into microtubes 18
• Difficult draws (dwell time in catheter or butterfly tubing)
Precautions
• Eliminate collection with untreated syringe
• Ensure proper mixing
• Minimize use of microtubes for venous draws
• Use equipment and techniques that prevent vein collapse
and minimize difficult draws
• Never “rim” clots! Always recollect clotted samples.
17. Causes for specimen rejection. CLSI Document H21-A5
18. Jones, et al. Complete blood count specimen acceptability. A CAP Q-Probes study of 703 laboratories. Arch Pathol Lab Med V119, March 1995.
Specimen Errors: Clotting
The release of RBC components during hemolysis changes chemistry values.
LDH
ALT
AST K
Mg
Specimen Errors: Hemolysis
• Overall ~3% 19
• ED / ICU 8-12% 19
Hemolysis is No. 1 source
of ED specimen rejection
(52-85%).20,21
19. Lippi, et al. Critical review and meta-analysis of spurious hemolysis in blood samples collected from intravenous catheters. Biochemica Medica
2013;23(2):193-200.
20. Tamimi, et al. Evaluation of biological specimen acceptability in a complex clinical laboratory before and after implementing automated grading serum
indices. Br J Biomed Sci. 2012;69(3): 103-7.
21. Harrison, et al. A comparison of the quality of blood specimens drawn in the field by EMS versus specimens obtained in the emergency department. J
Emerg Nurs, 2010;36(1): 16-20.
Specimen Rejection
EDs & CCUs:
• 2-5 times higher rates of
specimen rejection
• Produce > 50% of
rejections facility-wide.22
Major Implication:
We accept the worst specimen quality and
reliability for our most critical patients!
22. Stark, et al. Clinical laboratory specimen rejection- association with the site of patient care and patient’s characteristics: findings from a single
healthcare organization. Arch Patho Lab Med 2007;131(4):588-92.
ED & CCU Specimens
AST ++ Creatinine +
Cl + Bilirubin ++
CK ++ Glucose +
LDH ++ Triglycerides +
K ++ D-dimer +
Na ++ FVIIa ++
Lipase + PT ++
Mg + aPTT +
Amylase ++ CEPI ++
ALP + CADP ++
23. Koseaglu, et al. Effects of hemolysis interference on routine biochemistry parameters. Biochemica Medica 2011;21(2):79-85.
24. Laga, et al. The effects of specimen hemolysis on coagulation test results. Am J Clin Pathol 2006;126:748-755.
25. Lippi, et al. Influence of hemolysis on routine clinical chemistry testing. Clin Chem Lab Med 2006;44(3):311-316.
26. Lippi, et al. Interference of blood cell lysis on routine coagulation testing. Arch Pathol Lab Med 2006;130:181-184.
Hemolysis Alters Lab Values
Low hemolysis
(≥ 30-60 mg/dl):
K, LDH , AST, ALT
Strong hemolysis
(≥ 200 mg/dl):
all parameters
Troponin, ß-HCG,
glucose, CK, PT,
aPTT, D-Dimer
Moderate hemolysis
(≥ 60-200 mg/dl):
Discredited / Unsupported Causes of Hemolysis:
27. G. Lima-Oliveira, et al. Effects of Vigorous Mixing of Blood Vacuum Tubes on Laboratory Test Results. Clin Biochem 2013 Feb;46(3):250-254.
28. R. Sulaiman, et al. Effect of Order of Draw of Blood Samples During Phlebotomy on Routine Biochemistry Results. J Clin Pathol 2011;64:1019-1020.
29. Salvagno, et al. Avoidance to wipe alcohol before venipuncture in sot a source of spurious hemolysis. Biochemica Medica 2013;23(2):201-205.
30. Kocak, et al. The effects of transport by pneumatic tube system on blood cell count, erythrocyte sedimentation rate and coagulation tests. Biochem
Med 2013;23(2):206-210.
31. Fernandes, et al. Pneumatic tube delivery system for blood samples reduces turnaround times without affecting sample quality. J Emerg Nurs
2006;32(2):139-143.
Hemolysis Misconceptions
• Vigorous mixing 27
• Order of draw 28
• Alcohol from wipe 29
• Prolonged tourniquet
• Pneumatic tubes 30,31
The Blame Game
Remember, EDs & CCUs have 2-5 times higher rates of
rejection and generate >50% of rejections facility-wide. 32
“The ED nursing staff believed that the determination of
hemolysis was highly dependent on who was working in
the ED laboratory on a particular shift. The laboratory staff
thought hemolysis was related to who was working on the
nursing staff.” 33
32. Stark, et al. Clinical laboratory specimen rejection- association with the site of patient care and patient’s characteristics: findings from a single
healthcare organization. Arch Patho Lab Med 2007;131(4):588-92.
33. Grant, Marian Sue RN. The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood samples. J Emerg Nurs 2003.
• Prevention of hemolysis in blood samples collected from intravenous catheters
Lippi et al. Clin Biochem 46: 561-564, 2013
• Effectiveness of practices to reduce blood sample hemolysis in EDs: A laboratory medicine best
practices systematic review and meta-analysis
Heyer et al. Clin Biochem 45: 1012-1032, 2012
• Obtaining blood samples from peripheral intravenous catheters: Best practice?
Halm et al. Am J Crit Care 18: 474-478, 2009
• Reducing blood sample hemolysis at a tertiary hospital emergency department
Ong et al. Am J Med 122(11):1054.e1-e6, 2009
• The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood
samples
Grant MS. J Emerg Nurs 29:116-121, 2003
• Use of separate venipunctures for IV access and laboratory studies decreases hemolysis rates
Straszewski et al. J Intern Emerg Med 6(4):357-359, 2011
• Factors affecting hemolysis rates in blood samples drawn from newly placed IV sites
in the emergency department
Dugan et al. J Emerg Nurs 31(4): 338-345, 2005
Extract of International Studies
Ong, et al. 36% (29/81) 11% (16/146)
Wollowitz, et al. 15% (544/3727) ---
Grant, et al. 77% (151/195) 28% (17/60)
Dugan, et al. 13% (35/278) 14% (14/104)
Kennedy, et al. --- 14% (12/87)
Straszewski, et al. 23% (72/315) ---
Schmotzer, et al. 20% (130/660) 18% (131/715)
IV catheter & IV catheter &
Study vacuum tube syringe/transfer
ED Hemolysis Rates
34. Ong, et al. Reducing blood sample hemolysis at a tertiary hospital emergency department. Am J Medicine 2009;122:1054e1-e6.
35. Halm, et al. Obtaining blood samples from peripheral intravenous catheters: best practice? Am J Crit Care 2009;18:474-8.
36. Wollowitz, et al. Use of butterfly needles to draw blood is independently associated with marked reduction in hemolysis compared to intravenous
catheter. Ac Emerg. Med 2013;20:1151-1155.
37. ENA’s Translation Into Practice. Reducing Hemolysis of Peripherally Drawn Blood Samples. December, 2012 (Emergency Nursing Association).
38. Grant, et al. The effect of blood drawing techniques and equipment on the hemolysis of ED laboratory blood samples. J Emerg Nurs 2003;29:116-121.
39. Dugan, et al. Factors affecting hemolysis rates in blood samples drawn from newly placed IV sites in the emergency department. J Emerg Nurs
2005;31:338-345.
40. Kennedy, et al. A comparison of hemolysis rates using intravenous catheters versus venipuncture tubes for obtaining blood samples. J Emerg Nurs
1996;22(6):566-569.
41. Sharp and Mohammad. Scaling of Hemolysis in Needles and Catheters. Ann Biomed Eng 1998;26:788-797.
Root Cause of Hemolysis
• IV catheter & vacuum tube 34,35,36,37
Strong Vacuum force
• IV catheter & syringe and transfer 38,39,40
- Clotting & QNS
- Double Transfer
Strong Vacuum force 41
Source of ED Hemolysis
Flow simulation in an IV catheter
Local variation of shear stress
Axial position in a catheter system [m]
Sh
ea
r str
ess [P
a]
Catheter Kinetics - Simulation
Vpiston = 3.5mm/s
Blood collection
Vacuum method
Vacuum tube collection results in 3-10 times higher velocity (IV)
Blood collection
Aspiration method
Flow simulation in an IV catheter
Catheter Kinetics - Simulation
Collection Equipment
Collection equipment
Syringe + transfer to vacuum tubes
Controlled collection force, but requires transfer
Access device + vacuum tubes
Enables direct collection into blood tubes
Pros
- Quick, easy, needleless (safe), inexpensive
- Improved patient comfort & patient safety
- Excellent quality specimen if hemolysis is prevented 42,43
Cons
Vacuum tube collection technology → Hemolysis
Recommendations: - Eliminate IV collections with dedicated phlebotomy.
- For IV line draws, use gentle syringe collection without sample transfer
to practically eliminate specimen rejection due to hemolysis. 44,45,46
42. Hambleton et al. Venipuncture versus peripheral catheter: do infusions alter laboratory results? J Emerg Nurs 2014;40:20-6.
43. Ortells-Abuye, et al. A cross-sectional study to compare two blood collection methods: direct venous puncture and peripheral venous catheter.
BMJ Open 2014;4:e004250.
44. Lippi, et al. Critical review and meta-analysis of spurious hemolysis in blood samples collected from intravenous catheters. Biochemica Medica
2013;23(2):193-200.
45. Lippi, et al. Prevention of hemolysis in blood samples collected from intravenous catheters. Clin Biochem 2013;46(7-8):561-4.
46. Goegebuer, Debrabandere. Clinical Laboratory, H-Hartziekenhuis Roeselare-Menen vzw. Influence of the Serum Collection System on Hemolysis.
Focus Diagnostica 2008;16(2):22-25.
IV Catheters
Allows for gentle, syringe-style blood collection
Directly into pre-treated tubes
Without a sample transfer step
Gentle, Cost-Effective Solution
Consider blood collection technology that…
Direct, dual-
collection system
31% <2%
Vacuum tube A 29%
Blood Tube Vacuum Syringe-style
>15-fold reduction in
hemolysis versus
vacuum tube
Results?
n/a
Results?
Strongly
Blood Tube Hemolyzed
Vacuum Tube A 11.7 %
Direct, dual system 0.6 %
Vacuum Tube A 14.1 %
Vacuum Tube B 11.3 %
>20-fold reduction
in strong hemolysis
versus vacuum
tubes
Specimen Rejection & Costs
47. Carraro, et al. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007;53:7 1338-42.
• 25% of rejections result in
negative real patient outcomes. 47
• Including: hematoma, pain, cellulitis,
anemia and fainting with injury
• Repeat phlebotomy is bad enough…
Patient Care
• 21% of rejected specimens are abandoned. 48
• Median processing delay of 65 minutes! 48
• “Lack of timely reporting may cause delays in treatment. In some cases, patients may leave against medical advice or be transferred before another specimen can be obtained.” 49
Case Study:
48. CAP Q-Probes 2011. QP114 Clinical consequences of specimen rejection.
49. Pennsylvania PSRS. In-vitro Hemolysis: Delays may pose safety issues. Patient Safety Advisory, Vol.4(2), June 2007.
Consequences of Rejection
• “90% said a second stick was required.
Almost 90% of these patients suffered
bruising and 84% felt more pain.” 50
• 8 out of 10 patients report that their
blood collection experience influenced
their satisfaction level. 50
• Blood collection is an extremely intimate
point of patient contact.
Low cost investment…huge impact!
50. Tips from the Clinical Experts. Putting patients first during blood collection. MLO, August 2013.
Patient Satisfaction & Reimbursement
• 40% of the average hospital payer mix is Medicare. 51
• Because CMS Value Based Purchasing (VBP) “thresholds for
earning incentive points are set at the 50th percentile, it would
be reasonable to expect that about half of all participating
hospitals will experience reduced Medicare payment. 52
• Patient Experience of Care is an applicable domain based on
HCAHPS scores, with a weighted value of 30% through at
least 2015. 53
• VBP Diagnosis-Related Group (DRG) payment percentages
increase from 1% in 2013 to 2% in 2017. 53
51. http://www.chanet.org/NR/rdonlyres/AD4CABB2-0A6E-4015-A701-769900EC3881/350/hospitalfinance101_online.pdf
52. Shoemaker, P. What value-based purchasing means to your hospital. Healthcare Fin Mgmt , August 2011:61-68.
53. Department of Health and Human Services. Hospital Value-Based Purchasing Program. ICN 907664 March 2013.
Patient Satisfaction: HCAHPS & Reimbursements
Source $ / Year Facility Size
Ŧ Total, all-in cost of specimen rejection
# Total, direct cost of ED specimen rejection due to hemolysis
^ Direct material and/or labor cost of ED specimen rejection due to hemolysis.
54. Carlson, et al. A primer on the cost of quality for improvement of laboratory and pathology specimen processes. Am J Clin Pathol 2012;138:347-354. 33.
55. Ong, et al. Reducing blood sample hemolysis at a tertiary hospital emergency department. Am J Medicine 2009;122:1054e1-e6.
56. Rob Latino. System analyzed: blood drawing process opportunity analysis. Specimen Integrity OA, Reliability Center, Inc. 2011.
57. Jacobs, et al. Cost of Haemolysis. Ann Clin Biochem. 2012;49: 412.
Total Cost of Specimen Rejection
Carson, et al 54 $222,000Ŧ Average - Medium
Ong, et al 55 $203,000# Large metro
Latino, R 56 $311,000Ŧ Large
Jacobs, et al 57 $87,000 ^ Medium - Large
Technical Staff Costs to process a routine
hemolyzed specimen is $25.91 each. 58
Calculation:
3 rejections / day = $28,400.00 per year
5 rejections / day = $47,300.00 per year
10 rejections / day = $94,600.00 per year
Specimen recollection costs per hospital
due to hemolysis:
58. Pretlow, et al. A novel approach to managing hemolyzed specimens. Clinical Lab Sci. Vol 26(3), Summer 2013.
Cost Scenarios
Sheppard, et al 59 8.4 $561,000
Latino 60 25.0 $697,000
Calculated 61,62 9.0 $404,000
Source FTE $ / Year
59. Sheppard, et al. Improving quality of patient care in an emergency department. Am J Clin Pathol 2008;130:573-577.
60. Rob Latino. LEAP Analysis, System analyzed: blood drawing process opportunity analysis. Specimen Integrity OA, Reliability Center, Inc. 2011.
61. BLS, Occupational employment and wages, May 2013 (phlebotomy). www.bls-gov/oes319097.htm
62. BLS, Employer costs for employee compensation, March 2014. www.bls-gov/news.release/ecec.nr0.htm
Cost-Benefit Analysis
• Costs of $400-700K / year
• To capture $200-300K / year in savings
• Increased delays, patient discomfort
Dedicated Phlebotomy
Phlebotomy Solution is Difficult to Implement and Maintain
63
65
63. Grant, et al. The effect of blood drawing techniques and equipment on hemolysis of ED laboratory blood samples. J. Emerg Nursing 2003;29:116-121.
64. Lowe, et al. Nursing blood specimen collection techniques and hemolysis rates in emergency department: analysis of venipuncture versus
intravenous catheter collection techniques. J. Emerg Nurs. 2008;34:26-32.
65. Lippi, et al. Critical review and meta-analysis of spurious hemolysis in blood samples collected from intravenous catheters. Biochemica Medica
2013;23(2):193-200.
Dedicated Phlebotomy
64
Recommendations:
Adopt evidence-based best practices to reduce specimen rejection rates, improve TAT, reduce costs and positively affect patient satisfaction.
• Avoid syringe draws that require subsequent transfer (QNS)
• Use blood tubes that are unaffected by altitude changes (QNS)
• Avoid collection with untreated syringe (Clot)
• Avoid transfers into microtubes for peds draws (Clot)
• Do not use vacuum tubes for I.V. line draws (Hemolysis)
• Do not use syringe and transfer style collection (Hemolysis)
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