Table 1. Questionnaire Respondents


 TotalSite TypeLaboratory ClassificationLocation
POL*HospitalIL**Waived/PPMPModerate/High***AccreditedUrbanRural
Targeted (N) 591 333 198 60 119 247 225 324 267
Respondent (N) 297 152 117 28 45 140 112 159 138
Response rate (%) 50 46 59 47 38 57 50 49 52

*POL includes the following types of sites: physician office laboratories, clinics, community health clinics, home health agencies, health maintenance organizations, and ambulatory surgical centers.

**IL, independent laboratory.

***Moderate/High, moderate or high complexity testing, but not accredited.


Table 2. PT Test Methods


Site TypeTraditional MethodsPOC Devices
NumberPercentNumberPercent
Hospital 108 61 5 7
Independent laboratory 22 13 1 1
POL 46 26 69 92


Table 3. Testing Personnel


Testing Personnel BackgroundSites Employing Testing Personnel With the Background
Traditional MethodsPOC Devices
NumberPercentNumberPercent
Medical technologist 171 98 34 46
Medical laboratory technician 99 57 27 36
Medical assistant 2 1 33 45
Registered nurse 3 2 23 31
On the job trained 9 5 13 18
Licensed practical nurse 0 0 12 16
Pharmacist 3 2 4 5
Phlebotomist 3 2 4 5
Laboratory assistant 3 2 2 3
Physician assistant 0 0 3 4
Advanced registered nurse practitioner 1 1 1 1
Non-registered technologist 2 1 0 0
Emergency medical technician 0 0 1 1


Table 4. PT Reagents - Traditional Methods (N=176 sites)


Reagent ManufacturerNumber of RespondentsExamples of Brand NamesRange of ISI Values
Dade Behring 58 Innovin 0.90 to 1.13
Thromborel S
Thromboplastin C+ 1.77 to 2.21
Beckman Coulter/Instrumentation Laboratory 50 IL PT-Fibrinogen Recombinant 0.85 to 1.13
IL PT-Fibrinogen HS+
IL PT-Fibrinogen HS 1.35 to 1.44
IL PT-Fibrinogen >2.00
IL Thromboplastin
BioMerieux 24 HTF 1.15 to 1.26
Simplastin Excel 1.81 to 1.91
Diagnostica Stago 13 Neoplastin 1.26 to 1.35
Neoplastin C1+
Hemoliance 11 Recombiplastin  
RTF 0.94 to 1.03
Brain thromboplastin 2.00 to 2.33
Sigma Diagnostics/Sigma Trinity Biotech 10 Thrombomax HS 1.15 to 1.31
Thromborel HS
Thrombomax 1.69 to 1.71
Pacific Hemostasis 6 None given 1.16 to 2.04
Ortho 3 None given 0.85 to 1.00
Other 1 MLA Recombiplastin 1.03
Total 176 -- 0.85 to 2.33


Table 5. Distribution of Traditional PT Reagents by ISI Values (N=172 sites)


ISI ValuesNumber of SitesPercent of Sites
<1.20 91 53
>1.20 and <1.50 36 21
>1.50 and <1.70 3 2
>1.70 and ≤2.00 20 12
2.01 to 2.40 22 13


Table 6. PT Reagents - POC Devices (N=75 sites)


ManufacturerExamples of Brand NamesNumber of RespondentsISI Values
Roche Diagnostics CoaguChek 61 29 sites = 2.00
CoaguChek S 2 sites = 1.00
30 sites did not give a value
International Technidyne Corporation Hemochron Jr 8 1.00
Protime
Protime 3
Bayer Diagnostics PT-NC 5 1.00 to 1.20
RapidPoint
Thrombocard
Hemosense INRatio 1 1.00


Table 7. Specimen Acceptance and Rejection Policies


Specimen Acceptance/Rejection IssuePercent of Sites That Included the Issue in Their Written PoliciesNumber
Properly anticoagulated specimen 98 194
Correct volume of blood 98 194
Appropriate storage temperature 97 189
Adequate labeling of specimen 96 190
Time delays prior to testing 96 187
Adequate centrifugation (speed and time) 92 178
Information on requisition and specimen label match 90 174
Adequate information on requisition 90 173
Hemolysis 90 170
Appropriate transport times 89 168
Order of multiple tubes 86 166
Lipemia 79 146
Drawing specimens from patient lines 73 136
Icterus 71 131
Collection of samples in a syringe 67 129
Difficult draws 67 127
Abnormal hematocrits 65 123
Heparinized specimens 60 113


Table 8. Evaluation of New Lots of Reagents


Quality PracticeSites That Perform
Traditional MethodsPOC Devices
PercentNumberPercentNumber
Establish patient mean of normal 95 158 35 19
Conduct parallel testing between lots 93 156 35 19
Verify reference (normal) range 92 153 62 36
Confirm calculations of INR 89 148 34 19
Verify that the ISI is correct for instrument/reagent combination 89 147 60 35
Alert clinicians when a new reagent or reagent with a different ISI is placed into use 66 107 33 19
Perform correlation studies with another method or site 42 67 40 22
Establish ISI with calibrators 20 32 30 17


Table 9. Patient Test Reports


 Percent of Sites That ReportNumber
Test values*
PT as INR 99.6 232
PT in seconds 89 204
PT ratio 7 14
Interpretation or comments**
Reference (normal) ranges 84 211
Specimen comments 79 195
Therapeutic ranges 74 182
Interpretation 30 66

*Other responses were: patient mean of normal value (N=4), normal control value/quality control value (N=3), therapeutic range (N=1), and last dose of medication (N=1).

**Other responses were: dose of medication (N=5), clinician sees patient and knows what ranges are (N=2), extenuating circumstances (N=1), and normal patient mean (N=1).