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Telemedicine in Apheresis

Dr. Mehraboon S. Irani, Senior Medical Director, Clinical and Therapeutic Services, Blood Center of Wisconsin Telemedicine • What is telemedicine? • The diagnosis and treatment of in remote areas using medical information, as X-rays or pictures, transmitted over long distances especially by means of a computer or link (Dictionary.com) • Telemedicine is the use of information to diagnose and treat a without the or caregiver being physically present, i.e. providing from a distance Forms of Telemedicine

 Diagnostic methods supported by distributed server applications, e.g. radiologic imaging

 Devices to support in home care, e.g. remote of cardiac rhythm, blood sugar etc.

: “picture-phone” through a secure computer link (applicable to apheresis) AMA Guidelines for Telemedicine

• The AMA has published guidelines for telemedicine under the Code of • Eleven points in the guidelines • Not all relevant to this presentation AMA Guidelines for Telemedicine

• Relevant points: • d) Be proficient in the use of the relevant and comfortable interacting with patients and/or surrogates electronically. • e) Recognize the limitations of the relevant technologies and take appropriate steps to overcome those limitations. AMA Guidelines for Telemedicine

• Relevant points: • f)…4. Documenting the clinical evaluation and prescription • i) Support ongoing refinement of /telemedicine technologies, and the development and implementation of clinical and technical standards to ensure the safety and quality of care. AMA Guidelines for Telemedicine

• k) Routinely monitor the telehealth/ telemedicine landscape to : • 1. identify and address adverse consequences as technologies and activities evolve • 2. Identify and encourage dissemination of both positive and negative outcomes Therapeutic Apheresis and BCW

• BCW provides therapeutic apheresis across the whole of SE Wisconsin, including Milwaukee, Waukesha, Kenosha, Racine and Ozaukee counties • Largest customer for TPE: Aurora Health Care (AHC), part of Advocate Aurora Health • AHC covers most of eastern Wisconsin • BCW was approached by AHC to provide apheresis at Aurora Baycare Medical Center (ABMC) in Green Bay, Wisconsin Bay Area Medical Center an Aurora Health Care Affiliate

ACL Laboratories Core Service Area: Advocate Aurora Health

Sherman Therapeutic Apheresis and BCW

• Local nurses hired for Green Bay • Physician coverage a problem because of distance (~2 h drive from Milwaukee to Green Bay) • Physician of record for referral: local physician at ABMC; oncologist with limited apheresis experience; frequent off-site • Gap identified for real-time physician consultation with the nurse performing the procedure as well as with the patient during the procedure Telemedicine: the solution

• Videotelephony: “virtual visit” • Camera and monitor at patient end: owned by AHC, located at ABMC • Computer at physician end: • BCW configured to access AHC device • AHC desktop located at Aurora St. Luke’s Medical Center in Milwaukee Telemedicine: Responsibilities • BCW nurse performs the procedure

• Paper orders on BCW order sheet followed by BCW nurse Telemedicine: Responsibilities • Consent, fluid replacement and catheter orders (electronic) responsibility of the local physician, either oncologist (outpatient) or hospitalist (inpatient) after consultation with BCW physician • Consent occasionally performed by BCW Telemedicine: Billing

• Contractual agreement between BCW and AHC • Hourly billing for patient consultation from BCW physician to AHC • BCW does not bill the patient/ directly • Local physician bills for apheresis procedure supervision Telemedicine: Progress

• Model has been up and running for about 2 years • As of 9/30/18 there were 116 “virtual visits” for 399 apheresis procedures (29%) • Positive feedback from patients • Have been able to diagnose a wound and a rash via telemedicine

Telemedicine: Progress

• Virtual examination • Apheresis physician helps monitor progress of the patient and plan future treatments with involvement by the local physician • Precedent in clinical specialties e.g. “eICU”, primary care Telemedicine: Conclusions

• A new modality that works well in the apheresis setting using remote physician expertise • Enables patients to get apheresis treatments near their place of residence Acknowledgements

• Thomas Abshire, MD • Waseem Anani, MD • Sorelle Jefcik, RN • Susan Knight, MBA • Laurie Vokes, IT dept BCW

• Aurora Health Care IT staff • Laura Bebee, RN • Ubaid Nawaz, MD Thank you Is Transfusion Ready to Deliver Telemed?

Christopher W. Kennedy, MSM BREAKING DOWN THE QUESTIONS WITHIN THE QUESTION

“Is READY to DELIVER Telemed?”

o Is the industry looking for a rapid on-demand way to connect experts? o Can face-to-face virtual interactions advance industry initiatives / outcomes? o Is there a well established and reliable technology to deliver these interactions? o Can expectations be met using virtual engagements versus traditional methods? o Does our industry want to be innovative?

2 HARNESSING THE POWER OF VIRTUAL

o RESEARCH PROGRAM MANAGEMENT CONFERENCING o PHYSICIAN PEER-TO-TO PEER REFERRAL PROGRAMS o PHYSICIAN-TO-PATIENT TELEMEDICINE (CONSUMER) o PHYSICIAN-TO-PAYER (INSURANCE) PROGRAMS o / VIRTUAL PROGRAMS o DATA / RECORDING FEATURES o TELEMED ADVANCEMENTS o INTERCONNECTED PLATFORMS o REAL-TIME INFO SHARING o ONDEMAND SOLUTIONS

3 ACCESS TO EXPERT CARE

4 2018 ATA PRESIDENT’S INNOVATION AWARD

5 INNOVATION BORN FROM A CRITICAL NEED

The story is relatively simple. A tremendous gap exists in the US healthcare system for hemophilia patients. HemoMD is a virtual telehealth program that connects expert hemophilia physicians with patients who have an urgent healthcare need. Immediate access to qualified hemophilia expert consultations changes the unfortunate standard of care that many patients find themselves in today.

Hemophilia patients report being left to navigate access to quality medical care on their own. This frantic search for medical attention often results in a visit to the ER. HemoMD offers an innovative solution to this significant problem in the form of collaborative virtual care.

6 THE PROBLEM

Hemophilia patients do not have reliable access to qualified expert care.

(This results in a multitude of financial and health consequences for the patient and the greater healthcare community.)

7 R E A L L I F E

“The ER doctor told me I was too much of a liability for the to admit me. He simply sent me home with an active GI bleed and some pain pills. Yes, I have a hard time trusting the healthcare system.”

- Patient Mike

8 MARKET DYNAMICS

 Limited Adult Hemophilia Care Access  Patients Left to Self-Treat / Medicate  1 Annual HTC Visit (avg.)  Lacking 24/7 Access to Experts  Emergency Room Not Ready to Treat  Limited Nursing Access  Limited Access to Hemophilia Expert MDs  Missing Care Coordination (Continuity of Care)  Lack of Medical Training in Community  Urgent Care Centers Not Qualified to Treat

HEMOPHILIA PATIENTS ARE LEFT TO NAVIGATE A SUBOPTIMAL CLINICAL ENVIRONMENT THAT IS UNQUALIFIED TO HANDLE THEIR NEEDS

9 MARKET DEMAND

IN A 2016 STUDY OF 5,000 PATIENTS* 77% 19% of patients would use of patients already have a virtual visit used a virtual visit

*SOURCE: https://www.advisory.com/-/media/Advisory-com/Research/MPLC/Resources/Posters/Specialty-Virtual-Visits/33338_MIC_Virtual_Visit_infographic_web.pdf

10 THE COST OF POOR ACCESS

11 THE SOLUTION

• URGENT CARE / ER • HOSPITALIST • • PRIMARY CARE

PATIENT VIRTUAL EXPERTS DATA

12 PLATFORM MODEL

POSITIVE PATIENT IN EXPERT HEALTH NEED OUTCOME

13 THE BIGGER PICTURE

14 SIMPLE PROCESS

THE VIRTUAL VISIT PATIENT USES SMART NOTES ARE DEVICE OR CAPTURED AND COMPUTER TO SHARED WITH ACCESS HEMOMD APPROPRIATE STAKEHOLDERS

PATIENT HAS AN PATIENT IS IMMEDIATE CONNECTED WITH HEALTHCARE NEED HIGHLY TRAINED AND REQUIRES HEMOPHILIA HEMOPHILIA CARE PHYSICIAN

(1) (2) (3) (4)

15 EXPERT CLINICAL LEADERSHIP

DR. LOUIS M. ALEDORT DR. DANIELLE NANCE ICAHN SCHOOL OF MEDICINE ARIZONA BLEEDING DISORDERS MOUNT SINAI HEALTH AND WELLNESS CENTER

16 THE OUTCOMES

17 SUMMARY

YES, CHANGE IS HERE.

18 Is Transfusion Medicine Ready to Deliver Telemed?

Christopher W. Kennedy, MSM BREAKING DOWN THE QUESTIONS WITHIN THE QUESTION

“Is Transfusion Medicine READY to DELIVER Telemed?”

o Is the industry looking for a rapid on-demand way to connect experts? o Can face-to-face virtual interactions advance industry initiatives / outcomes? o Is there a well established and reliable technology to deliver these interactions? o Can expectations be met using virtual engagements versus traditional methods? o Does our industry want to be innovative?

2 HARNESSING THE POWER OF VIRTUAL

o RESEARCH PROGRAM MANAGEMENT CONFERENCING o PHYSICIAN PEER-TO-TO PEER REFERRAL PROGRAMS o PHYSICIAN-TO-PATIENT TELEMEDICINE (CONSUMER) o PHYSICIAN-TO-PAYER (INSURANCE) PROGRAMS o PHARMACY / NURSING VIRTUAL PROGRAMS o DATA / RECORDING FEATURES o TELEMED ROBOTICS ADVANCEMENTS o INTERCONNECTED PLATFORMS o REAL-TIME INFO SHARING o ONDEMAND SOLUTIONS

3 ACCESS TO EXPERT CARE

4 2018 ATA PRESIDENT’S INNOVATION AWARD

5 INNOVATION BORN FROM A CRITICAL NEED

The story is relatively simple. A tremendous gap exists in the US healthcare system for hemophilia patients. HemoMD is a virtual telehealth program that connects expert hemophilia physicians with patients who have an urgent healthcare need. Immediate access to qualified hemophilia expert consultations changes the unfortunate standard of care that many patients find themselves in today.

Hemophilia patients report being left to navigate access to quality medical care on their own. This frantic search for medical attention often results in a visit to the ER. HemoMD offers an innovative solution to this significant problem in the form of collaborative virtual care.

6 THE PROBLEM

Hemophilia patients do not have reliable access to qualified expert care.

(This results in a multitude of financial and health consequences for the patient and the greater healthcare community.)

7 R E A L L I F E

“The ER doctor told me I was too much of a liability for the hospital to admit me. He simply sent me home with an active GI bleed and some pain pills. Yes, I have a hard time trusting the healthcare system.”

- Patient Mike

8 MARKET DYNAMICS

❖ Limited Adult Hemophilia Care Access ❖ Patients Left to Self-Treat / Medicate ❖ 1 Annual HTC Visit (avg.) ❖ Lacking 24/7 Access to Experts ❖ Emergency Room Not Ready to Treat ❖ Limited Nursing Access ❖ Limited Access to Hemophilia Expert MDs ❖ Missing Care Coordination (Continuity of Care) ❖ Lack of Medical Training in Community ❖ Urgent Care Centers Not Qualified to Treat

HEMOPHILIA PATIENTS ARE LEFT TO NAVIGATE A SUBOPTIMAL CLINICAL ENVIRONMENT THAT IS UNQUALIFIED TO HANDLE THEIR NEEDS

9 MARKET DEMAND

IN A 2016 STUDY OF 5,000 PATIENTS* 77% 19% of patients would use of patients already have a virtual visit used a virtual visit

*SOURCE: https://www.advisory.com/-/media/Advisory-com/Research/MPLC/Resources/Posters/Specialty-Virtual-Visits/33338_MIC_Virtual_Visit_infographic_web.pdf

10 THE COST OF POOR ACCESS

11 THE SOLUTION

• HEMATOLOGY • URGENT CARE / ER • HOSPITALIST • PAIN MANAGEMENT • PRIMARY CARE

PATIENT VIRTUAL EXPERTS DATA

12 PLATFORM MODEL

POSITIVE PATIENT IN EXPERT HEALTH NEED CLINICIAN OUTCOME

13 THE BIGGER PICTURE

14 SIMPLE PROCESS

THE VIRTUAL VISIT PATIENT USES NOTES ARE SMART DEVICE OR CAPTURED AND COMPUTER TO SHARED WITH ACCESS HEMOMD APPROPRIATE STAKEHOLDERS

PATIENT HAS AN PATIENT IS IMMEDIATE CONNECTED WITH HEALTHCARE NEED HIGHLY TRAINED AND REQUIRES HEMOPHILIA HEMOPHILIA CARE PHYSICIAN

(1) (2) (3) (4)

15 EXPERT CLINICAL LEADERSHIP

DR. LOUIS M. ALEDORT DR. DANIELLE NANCE ICAHN SCHOOL OF MEDICINE ARIZONA BLEEDING DISORDERS MOUNT SINAI HEALTH AND WELLNESS CENTER

16 THE OUTCOMES

17 SUMMARY

YES, CHANGE IS HERE.

18 Telemedicine and Transfusion Medicine Diagnostic Testing Pampee P. Young, MD, PhD Chief Medical Officer Biomedical Services Americal Red Cross Objectives

• Brief words on Vanderbilt Telemedicine • Example of successful model of telemedicine utilized by immunohematology reference laboratory/blood • Future of Transfusion Medicine and telemedicine

www.aabb.org 2 Telemedicine is being legislated

• "Telehealth" or "telemedicine" means the use of real-time audio, , or other electronic media and technologies that enable interaction between the healthcare services provider and the patient, or also store-and-forward telemedicine services, for the purpose of diagnosis, consultation, or treatment of a patient in another location where there may be no in- person exchange, within the scope of practice of the healthcare services provider. • Source: TN Code Annotated, Title 56, Ch. 7, Part 10.

• Telemedicine is the practice of medicine using electronic communication, or other means, between a licensee in one location and a patient in another location. Telemedicine is not an audio only conversation, / conversation or . It typically involves the application or secure video conferencing or store-and-forward to provide or support healthcare delivery by replicating the interaction of a traditional encounter between a provider and a patient.

• Source: TN Rule Annotated, Rule 0880-02.-16. Telemedicine in Tennessee • Tennessee has enacted legislation requiring commercial insurance payors to cover telehealth services. On April 14, 2014, Governor Bill Haslam signed into law HB 1895/SB 2050.

• Is prohibited from excluding from coverage a healthcare service solely because it is provided through telehealth and is not provided through an in-person encounter between a healthcare services provider and a patient; and

– Must reimburse healthcare services providers who are out-of- network for telehealth care services under the same reimbursement policies applicable to other out-of-network healthcare services providers.

• The law in effect October 1, 2015, • – Stroke diagnosis – decreased transfers • Genetic Counseling

• Meds to Beds- pharm counseling • Teleaudiology – reducing loss to follow-up • Setting up tele-ICU

• Why? – Patient convenience – Overall driver of lower costs – receiving care closer to home

www.aabb.org 5 • Remote validation of immunohematological and serological analysis – AKA: authorization for clinical use of laboratory results performed by someone far from the site where the tests were performed Published report of telemedicine survey

• 2011 – Survey to determine the degree of spread of telemedicine techniques among Italian Blood Services – Carried out by Italian Society of Transfusion Medicine and Immunohematology (SIMTI) • Presented in Pisa May 2011 • National Conference of Blood Centers The Questionairre

• First six topics discussed: what does telemedicine look like in Italy • Last topic: opinions and issues resolved prior to the adoption of telemedicine techniques • Expected to take an hour to complete Results • 280 Blood Services contacted: – 196 filled out at least one of the questions of the online questionnaire

– 132 Centers reported using some form of Telemedicine • More frequent use in the North West and Central Italy Results

• 74 used telemedicine for more than 1 activity – Supervision of analysis was more frequently observed in concurrence with biological validation of blood components, with remote assignment or with both (12, 7, and 10 cases respectively) The unmet need for telemedicine in immunohematology testing • This study takes place in Slovenia • Current serological/immunohematology testing process – Patient’s blood is sent to local lab – Local staff performs gel-card based testing; additional test is performed and interpretations done locally • However, 1-5% of blood bank tests have serological difficulties and ambiguities – The staff then sends the samples to the centralized reference lab. – This causes transfusion delay due to delay in obtaining expert opinion or mistakes due to lost specimens and traceability issues

• This method leads to poor safety and quality What did this study do?

• Development of a system to help the local areas by introducing telemedicine if experts were not available – Provides automated image capture of the ID-Cards, teleconsultation and exchange of immunohematological expertise – IMPROVED DECISION MAKING! • The setting in Slovenia – 2 large blood transfusion establishments – 9 hospital associated blood • Supply blood products and provide serological testing (pre- transfusion) – Continuous availability of experts present at 1 of the 11 institutions 24/7 Infrastructure

• 2 locations associated with a reference laboratory • Synchronous, real-time videoconference – Java programing environment – Attention to simple user interface • Terminal- Server setup – Terminals at the with PCs, AV communication as well as bar-code reading and ID card image capture – Images can be magnified up to 20x without visible degradation of the image • “makes it easier to read than the standard visual method” – DATATEC  patient information How are the consultants notified they are needed? • Via a text! • Techs get notified on phone when consultant is ready to begin • Often requires a video conference if complex but may be performed solely by audio Process, continued

• Tech preps according to SOP • Result the gel cards • Then begin the consult – First…. Blood sample entered into interface by sample number bar code – Data (images of the card and local interpretations) are then pulled up automatically – is initiated…. • Teleconference or just audioconference • Up to ten gel cards • Specific question must be selected to initiated consultation Example

Validation

• 99 cases • Serologically questionable samples used – Weak ABO subgroups – Low titer isohemagglutinins – D positive and negative samples – Weak D – Cold and warm antibodies, etc Results

• No errors in agglutination strength in 98 readouts using the telemedicine method • Same tubes were read visually – correct in 97/99 • All final interpretations were correct • This is reliable! • Time to consultation decreased and no need to transfer samples by courier Process Points • capture of high-resolution images of CAT (gel cards) that could be transmitted and archived; • magnification of the ID-card images for detailed observation of agglutinates; • real-time interaction/audiovisual communication between the technician in the local hospital laboratory and the expert in the reference lab • a store-and-forward telemedicine model for non-urgent transfusion cases; • permanent connection to the national databases of blood donors and patients for the provision of information about transfusions and case histories • complete traceability of all procedures • reliable, safe, secure and encrypted data transmissions; Economic assessment of telemedicine in Slovenian Blood Transfusion Service • From 2005-2012 – 35,650 cases used teleconsultation Usage dynamics

• Steady increase in consults • For the year 2009: – 609,000 Euros were saved! How might it be used in US

• Consideration for centers with multiple IRL • Cost and time reduction opportunity – Nashville Red Cross IRL experience with phone/fax consults and aid in completing work ups and aid in interpretation – With challenges in maintaining immunohematology trained staff, this type of requests are actually decreasing Pitfalls

• Infrastructure costs • Reimbursement challenges • Regulatory barriers • Inability to get money • Technology challenges (i.e. stability of reactions in tube testing) Acknowledgements

Melissa Straub, MD--PGY3 Resident at Vanderbilt Medical Center

Christy Hall, MT (ASCP) IRL Manager, Red Cross, Tn Valley Region

www.aabb.org 26 References • https://vanderbilthealth.com/telemedicine/45444 • www.cchpca.org/tn-state-law-telemedicinetelehealth-definition • Berti, P., Verlicchi, F., Fiorin, F., Guaschino, R., & Cangemi, A. (2014). The use of telemedicine in Italian Blood Banks: a nationwide survey. Blood Transfusion, 12(Suppl 1), s131. • Meža, M., Breskvar, M., Košir, A., Bricl, I., Tasič, J., & Rožman, P. (2007). Telemedicine in the blood transfusion laboratory–remote interpretation of pre-transfusion tests. Journal of telemedicine and telecare, 13(7), 357-362. • Vavpotič, T. V., Breskvar, M., & Velušček, I. (2014). Economic assessment of telemedicine in Slovenian Blood Transfusion Service. • Meža, M., Tasič, J., & Burnik, U. (2013). Telemedical System in the Blood Transfusion Service: Usage Analysis. In ICT Innovations 2012 (pp. 173-182). Springer Berlin Heidelberg. • Wong, K. F. (2011). Virtual blood bank. Journal of pathology informatics, 2(1), 6