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 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

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 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 2012 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

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 2012 Abbott issues a product recall MedStar ceases testing all PT/INR on I-Stat

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

Data Compared for Safety Before Software Upgrade --- GSH only data Acceptability rate (POC result) n Medstar New Criteria 1.0-2.0 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% < 25% acceptability for all patients After Software Upgrade --- All MedStar Sites combined Acceptability rate (POC result) n Medstar New Criteria 1.0-2.0 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% < 95% acceptability for all patients

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

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

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.

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

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