MedStar Investigators Examine Patient Safety Issues from the EHR Surveillance Program

Researchers from MedStar Health National Center for Human Factors in Healthcare and Georgetown University School of Medicine analyzed electronic health records (EHR) surveillance data collected by The Office of the National Coordinator (ONC) for safety issues that could lead to patient harm.  The ONC collects data to determine whether EHR systems, which were certified as meeting specific design, functionality, and security standards set forth by the ONC, still meet those standards when implemented and used. 

The research team included Raj Ratwani, PhD and Aaron Z. Hettinger, MD from MedStar Health National Center for Human Factors in Healthcare; and Thomas B. Pacheco, BS from Georgetown University School of Medicine, Washington, DC.  

The ONC may perform surveillance on EHR vendor products in response to a reported issue (reactive) or by randomly selecting products for investigation (randomized). The researchers examined the surveillance data from January 2016 through June 2019 to determine whether identified issues had the potential for patient harm, and the frequency of these issues. The research focused on nonconformity issues that may have patient safety implications.

The analysis surveilled 697 EHR systems and 358 of all vendor products examined had a certified capability nonconformity issue. The study found that close to 4% (275 EHR systems), had an issue with the potential for patient harm. Most surveillance was reactive, with 352 product IDs having a certified capability nonconformity issue and 273 were coded as being associated with possible patient harm. With most issues being identified through reactive surveillance, 41.8% of product IDs were classified as having a possible patient harm issue.

The study concluded the need for an EHR safety reporting program.  To date, the health information technology industry does not have a method for clinicians or patients to openly report safety issues with EHR software. “This research highlights the need for proactive safety surveillance. We need to develop algorithms to identify safety issues before the issues reach patients, “ said Raj Ratwani, Ph.D.

Dr. Ratwani is supported by AHRQ grants R01HS023701 and R01HS025136. Dr. Hettinger is supported by Agency for Healthcare Research and Quality (AHRQ) grant R01HS025136. Mr. Pacheco is supported by the Frank S. Pellegrini, MD Medical Student Research Scholarship Endowment.

JAMA, 2019. DOI: 10.1001/jama.2019.17242  






December Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in December 2019. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on PubMed.gov here.

Selected research:

  1. Combined Vascular Brachytherapy and Stenting for the Treatment of In-Stent Restenosis.
    The American Journal of Cariology, DOI: 10.1016/j.amjcard.2019.11.035
    Chen Y, Buchanan KD, Chan RC, Zhang C, Torguson R, Satler LF, Waksman R.

  2. Frequency of Advanced Cardiac Life Support Medication Use and Association with Survival During In-Hospital Cardiac Arrest.
    Clinical Therapeutics, 2019. DOI: 1016/j.clinthera.2019.11.001
    Benz P, Chong S, Woo S, Brenner N, Wilson M, Dubin J, Heinrichs D, Titus S, Ahn J, Goyal M.

  3. Adherence among post-partum women living with HIV.
    The Lancet HIV, DOI: 10.1016/S2352-3018(19)30403-5
    Scott RK.

  4. Microbiologic Failure Despite Clinical Cure in Pneumonia: Cum Hoc and Post Hoc Ergo Propter Hoc.
    Clinical Infectious Diseases, DOI:10.1093/cid/ciz1191
    Shorr AF, Spellberg B, Zilberberg MD, Kollef MH.

  5. Creating a Care for the Caregiver Program in a Ten-Hospital Health System.
    Critical Care Nursing Clinics of North America, 2019. DOI:10.1177/1078390319878781
    Morales CL, Brown MM.






MHRI…Step Right Up!

In December, MHRI associates took some time out of their busy schedules to celebrate the successes of 2019 with their fellow associates. These events are also our opportunity to recognize associates with milestone years of service with MedStar Health.

Through feedback and collaboration with our Associate Engagement Committee, we moved to two parties for this year. Both celebrations brought together leadership and associates to embrace our circus/carnival theme, “Step Right Up!”. This year we recognized excellence as we acknowledged our High Recruitment Studies that have reached their goals.  We also recognized our 2019 SPIRIT Award Recipients: the Ryan White Team, Allison Selman-Lovell and Surafel Zenebe.  Our associate recognition program, KUDOS was highlighted as we congratulated individuals for sending and receiving Kudos from one another.  We played a competitive game of trivia that challenged our knowledge of carnivals, state fairs and the circus. The events also featured our service award presentations and our wonderful raffle and associate gifts!  

Thank you to all of our MHRI performers and ringleaders, who achieve great things through the year on a daily basis and help make a difference in the lives of our patients and the organization they represent.

Many thanks to all the associates who assisted with planning, set-up, and clean up at each location. Your efforts made the events a success! Thank you to all the associates who brought a donation for Dr. Bear’s Closest at Children’s National Hospital in Washington, DC. We’d also like to thank Amy Avergas and Karen Vaughan for organizing donations from the Greater Baltimore Oncology Nurse Society. More than 60 toys were donated to help children and their siblings celebrate this season.

Congratulations to our service award recipients for your years of dedicated service to MedStar. Your work and support allow us to continue our commitment to advancing health in our community.

25 Years of Service
Barbara Rector

20 Years of Service
Grace Nasrallah
Petros Okubagzi
Mary Park
Jianhui Zhu

15 Years of Service
Lin Han
Suman Singh

10 Years of Service
Rachel Campbell
Brandon Clark
Teshome Deksissa
Stephen Fernandez
Xia Liu
Theresa Moriarty
Patricia Tanjutco

5 Years of Service
Abdul Naser Alkhalil
Susan Cranford
Abera Dengezo
Preethy Feit
David Gaviria-Munoz
Daniel Hoffman
Matthew Hoffman
Audrey Jenkins
Ji Jin
Chad League
Florence Mwicigi
Sarah Null
Shreejana Pokharel
Kevin Reeves
Timothy Rodriguez
Jose Rodriguez-Weisson
Christina Stanger
Sharon Taho
Surafel Zenebe
Amir Ali Zohdi­­­­­

You may view and download photos here, along with the slide presentations: https://medstar.box.com/s/bxxjifzfjx9534514to36rjxjjajqrfn

Sorting out Single IRB Review: What Investigators Need to Know at MHRI

As of January 2018, most non-exempt multi-site human subjects research (HSR) projects funded through NIH agencies require single IRB review. Additionally, in recent years, there has been an increasing trend toward the use of a single IRB (sIRB) review for multi-site HSR projects funded through other sources.  Specifically, many commercial sponsors prefer single IRB review for their multi-site projects.

Finally, the revised common rule includes a requirement for single IRB review of most federally funded multi-site non-exempt human subjects research projects. Initially, the Office of Human Research Protections (OHRP) indicated only that compliance with this common rule requirement was required starting on January 20, 2020. In a recent communication OHRP clarified that although sIRB review is required for all federally funded multi-site non-exempt HSR projects, the agency has granted an exemption for all projects approved prior to January 20, 2020. This eliminates the need to transition currently approve projects from review by multiple IRBs to sIRB review.

For all future federally-funded projects, it is strongly suggested that investigators include IRB review fees in the budget for their grant proposals. In most cases it is assumed that sIRB review will be conducted by a commercial IRB (such as WIRB or Advarra) or a larger academic/medical institution IRB. In some limited cases, the MHRI IRB may agree to serve as the IRB of record for a multi-site HSR project but this will not be the norm.

In all cases (regardless of funding) for which a MedStar investigator intends to request the MHRI IRB serve as the IRB of record, they must submit a request to the ORI office. The request must be submitted before the investigator commits the MHRI IRB to the responsibility of serving as IRB of record for other sites and before discussing reliance with any outside institution. The request should include a copy of the research protocol, an indication of the source of funding (if any), a list of all sites that may be engaged in the project, and the scope of involvement for each site. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request will  be approved or should be declined.

This process is similar to  that for investigators requesting reliance on an external IRB. When an investigator would like to rely on an external IRB for review of their non-exempt HSR project, a request to cede review must be submitted to ORI in advance. In the case of the commercial IRBs for which there is a master reliance agreement (currently WIRB and Advarra), the investigator may simply submit an external IRB application through the Huron system. For other IRBs, a reliance agreement must be executed for each individual project. In the event that MedStar has not previously had an agreement with the intended external IRB, a request should be submitted to the ORI by email. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request may be approved or should be declined. If approved the organization will be added to the Huron system and the investigator may submit the external IRB application for the project.

Please note that in most cases request for reliance involving exempt HSR projects will not be approved. Generally speaking, it is more efficient for these projects to be reviewed individually by each institution and most institutions have not been willing to enter into a reliance agreement for these projects.

In all cases, requests for reliance (either for the MHRI IRB to serve as the IRB of record or for MedStar to rely on an external IRB) will be considered with regard to the need for reliance, the feasibility of the arraignment and nature of the project. Ultimately the determination of reliance is left to the discretion of the ORI Director and the Institutional Official.

If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at [email protected].

Research Grand Rounds: Hypothyroidism Treatment: The Basics and Beyond – January 17, 2020

Research Grand Rounds are sponsored by MedStar Health Research Institute and Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) and bring together the MedStar Health community for a learning experience focusing on a different topic each month.

On behalf of the Georgetown-Howard Universities Center for Clinical and Translational Science, and MedStar Health Research Institute, you are invited to Clinical and Translational Research Grand Rounds on Friday, January 17, 2020 from 12:00 Noon pm to 1:00pm. The speaker will be Jacqueline Jonklaas, MD, PhD. The Talk is titled, “Hypothyroidism Treatment: The Basics and Beyond”. Grand Rounds will be held at the MedStar Washington Hospital Center True Auditorium (East Building, 1st Floor) rather than in the CTEC Auditorium. Lunch will be served at 1pm.

Dr. Jonklaas is Professor of Medicine at Georgetown University, Co-Director of the Participant and Clinical Interactions component of the GHUCCTS, and Director of the Clinical Research Unit at Georgetown. Dr. Jonklaas obtained her MD, residency, and fellowship training at Georgetown University. Her NIH-supported clinical and translational research and patient care both focus on management of thyroid cancer and on the assessment and treatment of hypothyroidism.

Her research spans from early molecular work through biomarker studies, novel therapies, clinical trials, and patient reported outcomes and then to translation into clinical practice via her leadership of the guidelines committee of the American Thyroid Association.

Hypothyroidism Treatment: The Basics and Beyond
Jacqueline Jonklaas, MD, PhD
Professor of Medicine at Georgetown University, Co-Director of the Participant and Clinical Interactions component of the GHUCCTS, and Director of the Clinical Research Unit at Georgetown

January 17, 2020

12 Noon to 1 PM – Presentation
1 PM to 1:30 PM – Lunch
MedStar Washington Hospital Center, True Auditorium (East Building, 1st Floor)

For those located at remote sites and unable to attend in-person, log on to:  https://georgetown.zoom.us/s/482085870 on January 17, 2020 at 12:00 Noon to hear Dr. Jonklaas’ presentation.

If you have any questions regarding the Research Grand Rounds program, please contact [email protected]





Introduction to the Principles and Practice of Clinical Research (IPPCR)

MedStar Health is proud to be participating in The Introduction to the Principles and Practice of Clinical Research (IPPCR) course established by the National Institutes of Health (NIH). The program provides training in designing a successful clinical trial by focusing on biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much more. Other areas covered include data management and ethical issues, including protection of human subjects. This course will be of interest to resident and fellow physicians, as well as junior level faculty, wishing to enhance their understanding and expertise in clinical research.

The course will be conducted entirely online in a self-paced format. However, it is recommended that participants view 1 to 2 lectures per week to give themselves ample time to understand the theoretical and practical aspects of the content and to prepare for the final examination. The course is comprised of approximately 40 lectures, and participants should plan approximately 50 hours to watch the video-archived lectures, and additional time for course readings, discussion board participation, and the on-line multiple choice final examination.

This course is being offered as a certificate program. Registration is required in order for you to be eligible to take the examination and receive certification. You must receive a grade of 75% to receive a certificate of completion. The final exam will be available on the course website starting January 2nd and closing on June 30th.

Textbook:  The course textbook, Principles and Practice of Clinical Research, Fourth Edition, is available online through the Georgetown School of Medicine Dahlgren Library. You will need your GU Net ID to access this.

Course Objectives:

  • Provide an overview of basic biostatistical and epidemiologic methods involved in conducting clinical research
  • Describe the principles involved in the ethical, legal, and regulatory issues in clinical human subjects research, including the role of Institutional Review Boards (IRBs)
  • Describe principles and issues involved in monitoring patient-oriented research
  • Describe the infrastructure required in performing clinical research and the steps involved in developing and funding research studies

The 2019-2020 Course Schedule, Syllabus and additional registration information is available online: https://ocr.od.nih.gov/courses/ippcr.html






MedStar Investigator Orientation—January 23, 2020

The MedStar Health Research Institute (MHRI) is offering a one-day orientation session on Thursday, January 23, focused on conducting research at MedStar Health. This orientation session is for both early-career investigators as well as experienced investigators who recently moved to MedStar who wish to learn more about the services and resources available for every stage of the research lifecycle.

This 1-day orientation helps both experienced and early-career investigators learn to successfully conduct research within the MedStar system and access the research support services available from MedStar Health Research Institute (MHRI). Topics include:

  • An overview of the core business and research support services available to you
  • Tips and tools for finding funding and research collaborators
  • Research informatics and statistical support
  • The IRB process
  • An overview of study contracting mechanisms and financial management procedures
  • Answers to the most frequently asked compliance questions
  • Best practices for effective proposal preparation and submission

Thursday, January 23
8:00am – 4:00pm
MHRI Administrative Offices at University Town Center
6525 Belcrest Road, Suite 700
Hyattsville, MD 20782

Please email [email protected] to RSVP.
Note: breakfast and lunch will be provided.





November Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in November 2019. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on PubMed.gov here.

Selected research:

  1. Silent Myocardial Infarction and Sudden Cardiac Death—Finding the Culprit
    Jama Cardiology, 2019. DOI: https://doi.org/10.1001/jamacardio.2019.4377
    Kuku KO, Olatunji-Bello T, Garcia-Garcia HM.
  1. Neurogenic Stunned Myocardium in Severe Neurological Injury
    Current Neurology and Neuroscience Reports, DOI:10.1007/s11910-019-0999-7
    Kenigsberg BB, Barnett CF, Mai JC, Chang JJ.
  1. Evaluation of Risk-Assessment Tools for Severe Postpartum Hemorrhage in Women Undergoing Cesarean Delivery.
    Obstetrics & Gynecology, 2019. DOI: 10.1097/AOG.0000000000003574
    Kawakita T, Mokhtari N, Huang JC, Landy HJ.
  1. Bariatric Surgery Among Vulnerable Populations: The Effect of the Affordable Care Act's Medicaid Expansion
    Surgery: Official Journal of the Society of University Surgeons, Central Surgical Association, and the American Association of Endocrine Surgeons, 2019. DOI: 10.1016/j.surg.2019.05.005
    Gould KM, Zeymo A, Chan KS, DeLeire T, Shara N, Shope TR, Al-Refaie WB.
  1. Does a Care Bundle Reduce Racial Disparities in Postcesarean Surgical Site Infections?
    American Journal of Perinatology, 2019. DOI: 10.1055/s-0039-1688822
    Kawakita T, Umans JG.






Implementation Science: Time and Motion Research to Improve Inpatient Diabetes Education at MedStar

Recently published research evaluated nurse and patient care technician workflow to identify opportunities for providing education to patients during care. The study sought to examine the feasibility of implementing a diabetes education program on a tablet computer in the hospital setting within existing nursing workflow with existing staff.

“Understanding Nursing Workflow for Inpatient Education Delivery: Time and Motion Study” was published in the Journal of Nursing Care Quality. The collaborative research team included Kelley M. Baker, MA and Kelly M. Smith, MSc, PhD from the MedStar Institute for Quality and Safety and MedStar Health Research Institute; and Michelle Magee, MD from the MedStar Diabetes Institute, MedStar Health Research Institute and the School of Medicine and Healthcare Sciences at Georgetown University.

The researchers conducted a time and motion study of nurses and patient care technicians on three medical-surgical units within a 912-bed tertiary care medical center. Two units were standard medical-surgical units and the third unit was a cardiac care unit. Five trained observers conducted observations in 2-hour blocks. During the observation block, one observer shadowed a nurse and one observer shadowed a patient care technician and recorded tasks, locations, and their durations using a web-based time and motion data collection tool.

The results of this observation study show that nurses spent approximately one-third of their time in direct patient care and 60% on the unit but not in a patient room. Patient care technicians spent 42% of their time in direct patient care, compared with nurses. Patient care technicians averaged 18.2 tasks per hour, while nurses averaged 16.2. On average, the amount of time spent for a direct patient care session was 3:42 minutes for nurses and 3:02 minutes for patient care technicians. For nurses, 56% of task durations were 2 minutes or less and 38% were 1 minute or less. For patient care technicians, 62% of task durations were 2 minutes or less and 44% were 1 minutes or less. Nurses visited 5.3 patient rooms per hour, while patient care technicians visited 9.4 patient rooms per hour.

The research team concluded that within the existing workflow of nurses and patient care technicians, constantly in and out of patient rooms, it is possible to deliver a tablet to the patient to provide diabetes education. However, the short duration of direct patient care sessions could potentially limit the ability of the nurses and patient care technicians to spend much time with each patient on instruction for use of the technology platform or in answering questions about the content. Diabetes self-management education and support is beneficial for persons living with diabetes. Future research should identify ways to implement technology to support education delivery in the hospital within the existing workflow for nurses and patient care technicians.

This research was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases (R34DK109503). Dr. Smith also received funding from the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR001409.

JMIR Nursing, 2019. DOI: 10.2196/15658






KL2 Junior Faculty Scholars Program: Now Accepting Applications

Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) is now accepting applications for its KL2 Junior Faculty Scholars Program. Projects that are novel, inter- or multi-disciplinary and collaborative will be favored. The KL2 scholars will be awarded up to $90, 000 salary support and $40,000 project support per year (for up to three years).

Who is eligible: Junior Faculty with a full-time or equivalent appointment at a GHUCCTS institution (Georgetown University, Howard University, or MedStar Health) at the time of award activation. Scholars must devote 75% effort to the program for three yearsscholars must be US Citizens, Non-citizen Nationals, or Permanent Residents. Individuals who were, or currently are Principal Investigator of NIH R01, P01 or P50 subprojects, or individual K (e.g., K01, K08, K22, K23) grant ARE NOT eligible; current/former PIs of non-NIH peer reviewed research grants >$100k annual direct costs are ineligible.

Learn more about the program and applicatation requirements on the GHUCCTS website.

When:
Pre-Applications are due DECEMBER 13, 2019
Final Applications are due FEBRUARY 19, 2020

Online Informational Sessions:
November 22nd - 2:00PM
November 25th - 5:30PM
December 2nd – 3:00PM
December 4th- 2:00PM

To register for the sessions, e-mail [email protected]

ZOOM LINK: https://georgetown.zoom.us/j/784424793
Learn more on the GHUCCTS website

QUESTIONS? Contact the Executive Committee:
Jason G. Umans, MD, PhD [email protected]
Dexter L. Lee, PhD [email protected]
Kathryn Sandberg, PhD [email protected]