1. Point of Care Testing
Quality Confab 2012

2. MedStar Health
‘A not-for-profit healthcare system serving Maryland and the Washington DC region’
Maryland Hospitals:
MedStar Franklin Square Med. Center
MedStar Good Samaritan Hospital
MedStar Harbor Hospital
MedStar Montgomery Med Center
MedStar St. Mary’s Hospital
MedStar Union Memorial Hospital
Washington DC Hospitals:
MedStar Georgetown University Hospital
MedStar Washington Hospital Center
MedStar National Rehabilitation Hospital

3. Laboratory Teams Chemistry Hematology Coagulation Microbiology
Blood Bank
Point of Care Testing
Cytology
Anatomic Pathology
Shared Testing
Safety
Quality Assurance
Compliance
Laboratory Advisory Council

4. Challenges for the POC Team
Variability Hospital to Hospital
Scope of POC Services / Test Menus
Disparate equipment
Varying clinician needs
Some have fulltime POC staff and some cover POC in addition to other responsibilities
Aside from a common Glucometer vendor, the team seemed to have little else to focus on as a group
Team did not function as a team
Meetings held via conference call were poorly attended
Members didn’t see the benefits of the team
Members resisted bringing their issues to the group

5. Team Refocus 2011 Began meeting face-to-face Developed a Team Charter
Discovered that some members had 20+ years of POC experience while the newest POC coordinator (Gabby) had been on the job for only 4 months.
All shared the same LIS and had similar needs for interfaces and group purchasing advantages
Despite their differences all were challenged with:
Meeting regulatory requirements
Controlling “rogue’ testing
Enforcing general policies in POC testing areas

6. I-STAT PT/INR

7. Gabby Gets the Call December 2011 Pharmacists from Coumadin Clinic
Expressed concerns about iSTAT INR results >4.0
# of incidents and poor correlation to the main lab
January Pharmacists still concerned
2011 – Jan 2012 Correlation reviewed
91.8% correlated
All QC, liquid and electronic reviewed
all acceptable
Instrument Performance Reviewed
1 instrument had a higher % of results >4.0
Notified Abbott Point of Care
Replaced the instrument, conducted own investigation
Notified Medical Director & POC Chair about the issue

9. Bobbie Gets the Call
Notifications made 4 sites using I-stat were informed
One other facility reported similar issues
Data and details were collected to look for common factors
Sites work together Correlation data was collected
All North site Coumadin clinics express concern
Data was not correlating and could not be used for dosing
Abbott begins assisting in data collection
Data causes Abbott to escalate concerns
March Abbott issues a product recall
MedStar ceases testing all PT/INR on I-Stat

10. POC Team Works Together
Team meets to discuss plan Patient Safety primary goal
Included Technical Experts and Coagulation team
Look back of prior reported patients
Validation of Abbott recommended software upgrade
Comparison to MedStar dosing schedules
Impact analysis of any biases before patient testing resumes
Is POC safe for our patients and coumadin dosing?
Data is gathered and reviewed
All sites actively participated in reviews & decisions
2 weeks of 100% correlations yielded hundreds of data points
100’s of patient records were reviewed with pharmacy
Coagulation experts were consulted
Technical standards were evaluated and compared

11. Data Compared for Safety
Before Software Upgrade --- GSH only data
Acceptability rate (POC result) n
Medstar New Criteria 11
91% 18
44% 20
20% 13 8% 6 0%
overall w/in therapeutic range 57
23%
< 25% acceptability for all patients
After Software Upgrade --- All MedStar Sites combined
Acceptability rate (POC result) n
Medstar New Criteria 91
100% 75
99% 59
95% 12
58% 6
33%
overall w/in therapeutic range
152
91%
< 95% acceptability for all patients

12. Decisions are made Team evaluates data to determine SAFE limits
Standards from CLSI, Vendor and Medstar applied
CLSI +/- 0.4 difference up to 3.0 INR
Abbott +/- 20% difference
Pharmacy dosing patterns are in 0.5 INR increments

13. MedStar Reinstates Testing
Conservative but safe limits are defined
Pharmacy, Lab and Medical Staff agree
+/- 0.4 INR difference for INR ≤ 2.5
Within 15% agreement for INR >2.5 to 3.5
Reporting limit of 3.5
More proactive monitoring practices adopted by all POC INR sites. Some sites opted to cease POC INR

14. Lessons Learned Team work led to improved patient safety
Coagulation experts were instrumental in truly understanding how data was used.
Actual comparison biases were essential to maintaining a safe correlation standard.
A strict correlation factor or R value will not show the potential dangers in dosing anti-coagulation medications.

15. Ensuring Patient Safety
Going Forward
MedStar Point of Care Workgroup members have committed themselves to understanding the clinical use of Point of Care testing within our institutions and to ensure that clinicians using these methods fully understand their limitations, accuracy expectations, and correlation to main lab methods before allowing their use.
The MedStar POC team finally realized they have one very important goal in common ---
Ensuring Patient Safety

16. Presenters
Bobbie Eichensehr, QA and POC Supervisor MedStar Point of Care Team Leader MedStar Union Memorial Hospital
Marcelino Gabriel POC Supervisor MedStar Point of Care Team Member MedStar Good Samaritan Hospital