Improving Blood Specimen Quality and Patient Care · Improving Blood Specimen Quality and Patient Care ... with tubes that are unaffected by altitude ... Variables in Coagulation

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


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.


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


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.


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.


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



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.


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)

Talk with Sarstedt

Documents

Improving Blood Specimen Quality and Patient Care · Improving Blood Specimen Quality and Patient Care ... with tubes that are unaffected by altitude ... Variables in Coagulation