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

Bobbie.Eichensehr@medstar.net

Marcelino Gabriel

POC Supervisor

MedStar Point of Care Team Member

MedStar Good Samaritan Hospital

Marcelino.Gabriel@medstar.net