Point of Care Testing Quality Confab 2012. MedStar Health A not-for-profit healthcare system serving...
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Transcript of Point of Care Testing Quality Confab 2012. MedStar Health A not-for-profit healthcare system serving...
Point of Care Testing
Quality Confab 2012
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
Laboratory Teams
• Chemistry• Hematology• Coagulation• Microbiology• Blood Bank• Point of Care Testing
• Cytology• Anatomic Pathology• Shared Testing• Safety• Quality Assurance• Compliance
• Laboratory Advisory Council
Challenges for the POC TeamVariability 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
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
I-STAT PT/INR
Gabby Gets the CallDecember 2011 Pharmacists from Coumadin Clinic
Expressed concerns about iSTAT INR results >4.0 # of incidents and poor correlation to the main lab
January 2012 Pharmacists still concerned2011 – Jan 2012 Correlation reviewed
91.8% correlated
All QC, liquid and electronic reviewedall acceptable
Instrument Performance Reviewed1 instrument had a higher % of results >4.0
Notified Abbott Point of CareReplaced the instrument, conducted own investigation
Notified Medical Director & POC Chair about the issue
Bobbie Gets the CallNotifications made 4 sites using I-stat were informed
One other facility reported similar issuesData and details were collected to look for common factors
Sites work together Correlation data was collectedAll North site Coumadin clinics express concern
Data was not correlating and could not be used for dosing
Abbott begins assisting in data collectionData causes Abbott to escalate concerns
March 2012 Abbott issues a product recall MedStar ceases testing all PT/INR on I-Stat
Team meets to discuss plan Patient Safety primary goalIncluded Technical Experts and Coagulation team
Look back of prior reported patientsValidation of Abbott recommended software upgradeComparison to MedStar dosing schedules Impact analysis of any biases before patient testing resumesIs POC safe for our patients and coumadin dosing?
Data is gathered and reviewedAll sites actively participated in reviews & decisions
2 weeks of 100% correlations yielded hundreds of data points100’s of patient records were reviewed with pharmacyCoagulation experts were consultedTechnical standards were evaluated and compared
POC Team Works Together
Data Compared for SafetyBefore Software Upgrade --- GSH only data
Acceptability rate (POC result) nMedstar
New Criteria1.0-2.0 11 91%2.1-2.5 18 44%2.6-3.0 20 20%3.1-3.5 13 8%3.6-4.5 6 0%
overall w/in therapeutic range 57 23%
After Software Upgrade --- All MedStar Sites combined
Acceptability rate (POC result) nMedstar New
Criteria1.0-2.0 91 100%2.1-2.5 75 99%2.6-3.0 59 95%3.1-3.5 12 58%3.6-4.5 6 33%
overall w/in therapeutic range 152 91%
< 25% acceptability for all patients
< 95% acceptability for all patients
Decisions are madeTeam evaluates data to determine SAFE limits
Standards from CLSI, Vendor and Medstar appliedCLSI +/- 0.4 difference up to 3.0 INRAbbott +/- 20% difference Pharmacy dosing patterns are in 0.5 INR increments
MedStar Reinstates Testing
Conservative but safe limits are definedPharmacy, Lab and Medical Staff agree
+/- 0.4 INR difference for INR ≤ 2.5Within 15% agreement for INR >2.5 to 3.5Reporting limit of 3.5
More proactive monitoring practices adopted by all POC INR sites. Some sites opted to cease POC INR
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.
Going ForwardMedStar 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
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