A Sentri7 /Quantifi Case Study in Growing Clinical Programs both in the Pharmacy and Beyond

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1 A Sentri7 /Quantifi Case Study in Growing Clinical Programs both in the Pharmacy and Beyond EXECUTIVE SUMMARY Problem: Chris Virgilio, Clinical Coordinator at Meritus Medical Center, was looking to redesign the pharmacy s kinetics clinical service for monitoring appropriate medication levels in target patients. It was taking too long to identify the patients at need and documentation was cumbersome. Solution: The hospital implemented a clinical data surveillance application and documentation tool (Sentri7 and Quantifi ). Results: The hospital was not only able to expand and improve the clinical kinetics program along with other pharmacy initiatives such as antimicrobial streamlining and anticoagulation management, but also add new programs for multiple hospital departments, including infection control, nutrition and laboratory services. We have prevented significant patient harm and saved lives because of the ability of Sentri7 to easily construct rules, filter out unnecessary work, prospectively identify potential medication errors and present the data in an intuitive format. Christopher Virgilio, PharmD, Clinical Coordinator, Meritus Medical Center Conclusion: The integration of a tool set like Sentri7 and Quantifi can vastly improve the detection, action and documentation of critical patient safety issues. This enables a staff currently working at capacity to increase the amount of clinical work they can perform. BACKGROUND: Meritus Medical Center, located in Hagerstown, Maryland (about 1 hour from Washington DC/Baltimore) is a 300-bed tertiary care facility that has seen steady growth over the last few years. Initially developed as a primary care hospital sending most of its sicker patients to the city, it has recently expanded its offerings to include a Level-2 Neonatal Intensive Care Unit, Level 2 trauma center, cardiac Pharmacy OneSource

2 Meritus Medical Center PHARMACY IMPLEMENTATION catheterization, along with specialties in orthopedics, general medical surgical and maternity. It has an Emergency Room that has been growing very fast 70,000 visits per year of which 50% end up being admitted for care in the hospital. It is a community hospital with very little teaching. Medical staff is comprised mainly of attending physicians. The hospital recently introduced a hospitalist service. These busy physicians look after an attending physician s patients during off hours and when in critical condition. The hospital has an associated for-profit facility, Robinwood, which has its own cancer care pharmacy satellite. This facility deals with mostly long-term care and oncology patients. They also support the Williamsport Home Care Pharmacy and Hagerstown Medical Lab, both undergoing expansion in Meritus Medical Center uses Meditech as the primary hospital information system. Almost all of the clinical systems are run on Meditech. One notable exception is the surgery information system. It is a standalone system that has been interfaced to Meditech. Nursing staff members document care and vital signs in Meditech. Daily patient progress notes are entered into Meditech by prescribers. They do not have CPOE per se, but have workarounds. The doctors notes and orders are entered into Meditech by nursing and can be compared to written orders generated by the physicians. Meritus Medical Center uses Pyxis medication cabinets interfaced to Meditech s pharmacy order systems. The pharmacy is comprised of roughly 16 pharmacists and 20 technicians along with administrative personnel. The pharmacists work 3 on days and 3 on evenings with staggered off times. It is a 24/7/365 operation. There are 3-4 clinical shifts per day. Technicians are primarily distributional and do not participate in clinical roles. The pharmacist shifts are rotated with all pharmacists performing both distributional and clinical shifts. Most of the clinical work has traditionally been performed on days, although there is a desire by the evening shift to start taking on more clinical roles. There has been discussion of migrating to a floorbased model (where the pharmacist participates in both distributional and clinical roles, essentially responsible for order entry and clinical work). The pharmacy has a central fill robot, sterile processing room and has been recently remodeled. Clinical pharmacists participate on rounds in critical care, medical-surgical areas and NICU. Most clinical work is done from the main pharmacy due to computer access issues on the nursing units.

3 PRE-SENTRI7 AND QUANTIFI CLINICAL PROGRAMS Prior to the implementation of Sentri7 and Quantifi, the pharmacy clinical program was primarily focused on pharmacokinetic dosing of target drugs such as aminoglycoside and vancomycin antibiotics. Each of these drugs was worked up on a paper form that identified patient demographic information and current serum creatinine values. The computer system would calculate an estimated creatinine clearance. Based on the patient parameters and renal function, suggestions for appropriate dosing of these medications would take place. Around 2006, IV to PO target drugs and renal dosing programs were added to the clinical workload. Chris Virgilio, Pharm.D., Pharmacy Clinical Director, notes: We ran individual searches in Meditech for each particular drug or class which involved choosing the report, running the report (2-8 minutes) then going back and printing the report. It wasn t an efficient process, but it was all we had. The reports themselves also weren t clean [it included] Pre-op doses [and] patients who were discharged (the list was run once a day, so they are here in the morning but gone by the time you get to them). Documentation of these events was also cumbersome. [Interventions] were documented separately in Meditech and all of the information had to be entered; only the name would pre-populate the form. The previous day s renal dosing and IV to PO lists were written on with notes and other information. You should save them for the next day so the next person is not starting out from zero, but this didn t always happen. In addition, management reporting out of Meditech was not as robust as needed. Basic information such as number and type of intervention done could be gleaned from the system, but had to be manually paired with cost and user data to get any kind of realistic, actionable information. This was also a very time intensive management process. A number of desired clinical programs just could not be implemented due to the impact on the staff. We never could do an Avelox or Zithromax IV to PO conversion program because of the increased burden on staff, Virgilio said. Adverse Drug Reaction documentation on paper occurred as needed. Christopher Virgilio, PharmD, Clinical Coordinator, Meritus Medical Center

4 SENTRI7 AND QUANTIFI INTEGRATION AND INSTALLATION Sentri7 and Quantifi were implemented in late 2007 and early The process went pretty smoothly with Lab, Microbiology, Medication Order and Admit-Discharge-Transfer data feeds set up to an existing Rhapsody Interface Engine ( that consolidated the necessary data from their Meditech systems and staged it for real-time HL7 message delivery via secure VPN(virtual private network) to the Pharmacy OneSource data facilities. The clinical rollout of Sentri7 was involved, but promoted a general feeling of trust throughout the clinical staff. For my own personal style, I needed to work with the system myself with real patient data at my institution. This helped answer questions which were raised with the implementation Why doesn t this patient appear if they qualify? How do certain patients appear? This is why we did a month of testing and compared the existing process with the new method to validate the data, gain a comfort level and trust the system does accurately capture everyone. Eventually, the learning curve flattened out and you actually begin to think like the system, said Dr. Virgilio. He was able to access Sentri7 prior to official training, set up and play with many of the rules prior to official roll out. This hands-on approach to building the lists in Sentri7 gave him the confidence that the system was actually flagging the patients he expected. He could use this time to fine tune the logic around some of the rules to better represent the patients he wanted his staff to follow up with. A critical part of the setup process was building out a set of matching interventions in Quantifi that linked to Sentri7 list issues being identified. In this way, he was able to use Sentri7 to identify a clinical issue, then link that clinical issue to a specific intervention type being documented in Quantifi. Because Sentri7 can pre-populate a documentation form in Quantifi, he could streamline the documentation step his pharmacy staff would be asked to perform and still gather rich data about the event without adding to their already busy workload. Once this initial setup and testing phase was complete, he began a phased roll out to clinical staff. Two individuals became super-users and decided on the overall workflow before rolling it out to the staff. You only get one chance at a first impression and we didn t want anyone to instantly hate the system and not use it, said Virgilio. Some people are more paper oriented and it is difficult to look at the same data which is presented in a different format because we all become creatures of habit. The Pharmacokinetics service was the first set of patients to be identified, then IV:PO, then safety rules (Hgb > 12 and on Aranesp, SrCr > 1.4 in females and on Metformin) then the Renal Dosing protocol. We are now doing some next generation items like Antibiotic Stewardship and Anticoagulation monitoring for JCAHO mandates. This phased roll out allowed staff participation in the process and gained early staff buyin for using the tool. My existing IV to PO program ratios actually got better, which I really hadn t expected. It makes sense now because Sentri7 is always looking and presenting the results in a common area, Virgilio said.

5 EXPANSION OF CLINICAL SERVICES PHARMACY IV:PO Renal Dosing Pharmacokinetics As noted above, Dr. Virgilio s initial step was to transition his existing clinical programs to Sentri7 and Quantifi. A major part of this process was developing more robust surveillance and documentation processes around these current clinical initiatives. Because there was limited documentation of clinical events prior to the implementation of Sentri7 and Quantifi, a direct comparison of before and after for many interventions does not make sense. Some numbers never existed before, like we never could do an Avelox or Zithromax IV to PO conversion program because of the increased burden on staff. So, we have a 100% increase in those numbers because we could expand services with Sentri7, said Virgilio. Where previous interventions were being done, the use of Sentri7 and Quantifi showed a dramatic increase in the numbers of identified, acted upon and documented issues. My existing IV to PO program ratios actually got better, which I really hadn t expected. It makes sense now because Sentri7 is always looking and presenting the results in a common area. With the old method, you may not have had time to get to all of the IV to PO reports or you skipped a day. For example in the 3 months I have been working with the system, my Zyvox IV to PO ratio went from 1:1 to 1:4 (it was 3:1 before the formal program was started) and I expect it to become even better, said Virgilio. The expanded IV:PO program at Meritus Medical Center now includes: Pantoprazole Ciprofloxicin Folic Acid, MVI and Thiamine Famotidine Renal Dosing protocol expansion now covers: Ciprofloxacin Cefotetan Ampicillin/Sulbactam Cefepime Enoxaparin Pharmacokinetic programs still primarily revolve around monitoring drug levels for traditional agents: Vancomycin, Gentamicin and Tobramycin. All of these pre-existing clinical activities have migrated from paper-based surveillance and documentation to Sentri7 and Quantifi s electronic systems, allowing for easier identification of issue and more robust documentation and reporting. Antimicrobial Streamlining Maxifloxacin Linezolid Azithromycin Fluconazole Levothyroxine Ertapenem Cefazolin Daptomycin Pipericillin/ Tazobactam Infectious diseases have been placed in the spotlight recently with the surge in multidrug resistant strains such as MRSA and C. difficile. Dr. Virgilio was able to expand upon his existing clinical efforts to introduce a number of new issues related to more effective management of antimicrobial agents. Current lists include: Antibiotics - C.Diff positive, Eraxis or Ampho B Antibiotics - Expiring within 1 day Antibiotics - Zithromax and Avelox Duplication Antibiotics - Cipro and Flagyl Antibiotics - Pseudomonas Patients Antibiotics - Vanco/Zyvox with no MRSA Pneumonia Antibiotics - CC2/CC3 receiving antibiotics Antibiotics - Positive blood cultures Antibiotics - > 3 days, WBC < 12, neg blood/urine Antibiotics - MRSA screen and on systemic therapy Antibiotics - C.Diff and Antidiarrheals Antibiotics - C.Diff - Possible Patients Antibiotics - IV Antibiotics Sentri7 has allowed my institution to restart a robust antimicrobial stewardship program without any additional staffing. Using Sentri7 helped to reduce ventilatorassociated pneumonia (VAP) cases from four to zero at an average cost of $22,000 per case, saving $88,000, said Virgilio.

6 Compliance and Safety The focus today on patient safety and quality in hospitals and healthcare organizations is acute. The Centers for Medicare and Medicaid Services (CMS) have set forth numerous drug related core measures to ensure that patients with known medical conditions that have a standard literature-supported treatment regimen be treated appropriately. For example, all patients with a diagnosis of acute myocardial infarction (heart attack) should be on aspirin, beta blockers and statin agents (amongst others). CMS has instituted policies to not pay for certain diagnoses that are hospital acquired for example certain hospitalacquired infections. The Joint Commission also has its Medication Management Standards and National Patient Safety Goals designed to improve healthcare quality and patient safety. Many of these quality initiatives are managed today in a retrospective fashion. Patients are identified after discharge and extensive chart review is done to identify whether these quality initiatives have been met - often too late. The quality indicators lend themselves to automated surveillance in real time. This would allow a patient to be identified as a potential candidate for meeting a particular quality initiative and having caregivers step in, assess the patient and treat them in advance of discharge. Dr. Virgilio has set up Sentri7 and Quantifi to proactively identify patients that meet the pharmacy related CMS quality initiatives. These initiatives include: Core Measure - MI and No Beta Blocker Core Measure - MI and No Aspirin Core Measure - MI and No Statins Core Measure - MI and No ACE/ARB Core Measure - Flu Vaccine The Joint Commission announced in 2007 a new National Patient Safety Goal focused on anticoagulation management. More and better management of drugs such as warfarin and heparin would be expected to meet the new guidelines. Dr. Virgilio was able to quickly respond to this new mandate by setting up lists related to these drugs. Anticoagulation - Thrombocytopenia Anticoagulation - > 7 days Anticoagulation - Lovenox and Heparin Duplication Anticoagulation - Warfarin and INR The rule looking for Heparin-induced thrombocytopenia is particularly interesting and a good example of how a proactive surveillance system can assist in the identification of possible patient safety issues. Thrombocytopenia, defined as a relative and rapid reduction in platelet counts, is difficult to monitor on a daily basis. Relying on manual surveillance of platelet counts would be very difficult and prone to error. Dr. Virgilio was able to set up a list in Sentri7 looking for all patients on the drug heparin who also had low platelet counts or had seen a reduction in platelet counts by 20% over the last three days. We identified about 4 patients last year with heparin-induced thrombocytopenia. With Sentri7, we are finding about 4 per month! he said. Compliance and Safety Screen shot: Sentri7 personalized dashboard for infection control.

7 EXPANSION OF SERVICES OTHER CLINICAL DEPARTMENT One of the most exciting developments since Sentri7 and Quantifi have gone live at Washington County is the expansion of their use to other clinical departments. Dr. Virgilio was approached by other departments to set up lists to help them identify patients that require their attention. Nutrition Services The nutrition services department is tasked with performing patient consults prior to discharge about food-drug interactions. It was difficult for them to identify patients on certain target medications that they needed to know so they could arrange a predischarge consultation. Dr. Virgilio was able to set up a specific dashboard of lists just for Nutrition Services to assist them in identification of these patients. Now patients on warfarin and phenytoin were identified so the nutritionists could perform their teaching without doing lengthy chart reviews. In addition, when a teaching event was performed, Sentri7 would remove them from the list. The dashboard also identifies all patients on hyperalimentation or TPN. Another list identifies patients who have had a recent prealbumin lab done. These lists assist the nutritionists in their daily workflow of managing patients on hyperalimentation. Laboratory The lab was required to run chemistry panels first for patients on TPN and had a difficult time knowing who these patients were. A specific dashboard identifying all current patients receiving TPN has streamlined their work flows as well. Infection Control As mentioned above, infectious disease management has become a very big issue in the public mind recently. Infection control professionals are tasked with identifying outbreaks and developing policies and reporting related to infectious processes in the organization. Dr. Virgilio has set up a dashboard of lists specifically designed for the infection control professionals at Washington County. These lists identify all patients with documented MRSA or VRE microbiology labs where resistant organisms have been identified, all patients positive for influenza and all patients currently in isolation. This allows for the infection control personnel to reduce the amount of time they spend doing manual chart review to identify the patients they need to follow up on. Wolters Kluwer Health Pharmacy OneSource 3535 Factoria Boulevard SE Suite 440 Bellevue, WA pharmacyonesource.com Pharmacy OneSource

8 CONCLUSION Meritus Medical Center is a rapidly growing and evolving medical center. The clinical programs in the pharmacy prior to the implementation of Sentri7 and Quantifi are exemplary of many midsized healthcare organizations around the country. Pressure from governmental and non-governmental safety and quality organizations is driving the need for the pharmacy to step up these clinical programs to include quality and patient safety issues previously not performed. Many of these new demands would be impossible given current staffing and the clinical load being placed on them at present. The integration of a tool set like Sentri7 and Quantifi can vastly improve the detection, action and documentation of critical patient safety issues. This enables a staff currently working at capacity to increase the amount of clinical work they can perform. Dr. Virgilio said it best: We have prevented significant patient harm and saved lives because of the ability of Sentri7 to easily construct rules, filter out unnecessary work, prospectively identify potential medication errors and present the data in an intuitive format. In addition to expanding the capabilities of the pharmacy, other clinical departments are realizing streamlined workflow due to the ability of Sentri7 to proactively identify patients who meet critical quality, safety and efficiency criteria all in real time. We identified about 4 patients last year with heparin-induced thrombocytopenia. With Sentri7, we are finding about 4 per month! Virgilio said. Wolters Kluwer Health Pharmacy OneSource 3535 Factoria Boulevard SE Suite 440 Bellevue, WA pharmacyonesource.com Pharmacy OneSource