A PILOT OF THE UNITED STATES DONOR HEMOVIGILANCE SYSTEM: MANUAL USE IN A

SMALL BLOOD CENTER

INH Amsterdam February, 2011

Medical Director

Coffee Memorial Blood Center

Amarillo, TX

Regional Medical Director

Blood Systems

Scottsdale, AZ

Mary Townsend, MD

Coffee Memorial Blood Center

What is a Small Blood Center:

WB: 30,000

Apheresis Plt: 3,000

Facilities: 31

Counties: 30

Area: 45,000 sq mile

Blood Systems, Inc

What is a Large Blood Center?

WB: 1,100,000

Apheresis Plt: 150,000

Facilities served: 500+

States: 24

Acknowledgements

Thanks to generous sharing of slides from the following:

• Peter Tomasulo, MD• Mike Strong, PhD • Louis Katz, MD• Barbee Whitaker, PhD• Kevin Land, MD

Donor Biovigilance:one segment of the overall

U.S. Hemovigilance Program

AABB Interorganizational Task Force on Biovigilance(Adverse Reactions/Incidents Working Group)

in partnership with theUS Centers for Disease Control National Healthcare Safety Network (NHSN)

Recipient Hemovigilance

AABB Interorganizational Task Force on BiovigilanceDonor Biovigilance Working Group including American Red Cross,

America’s Blood Centers, and other collectors of blood in USIn partnership with the

US Department of Health and Human Services

Donor Hemovigilance

Unique Model: Public Private Partnerships in Biovigilance

Tissues and Organs

CDC and the United Network for Organ Sharing in partnership withMultiple Tissue and Organ Associations developing TTSN

International Correspondents

Peter Tomasulo, MD, Past Chair Kevin Land, MD, Chair Mary Townsend, MD, ABC

Anne Eder, MD, PhD, ARCMindy Goldman, MD, CBC Hany Kamel, MD

David Lincoln, DOD Mary Gustafson, PPTARoger Dodd, PhDBruce Newman, MDPriya RamanujamMichael Strong, PhDJames Stubbs, MD Barbee Whitaker, PhD Madhav Erraguntla, PhD

The US Biovigilance NetworkDonor Biovigilance Working Group

Jan Jorgensen, MDJo C. Wiersum-Osselton

Charges1. Determine goals and objectives of the Donor

Biovigilance system. 2. Adopt standardized terminology and definitions.3. Develop a system that will be an electronic, voluntary,

confidential, non-punitive reporting service, focused on improving donor safety. It should be managed by experts with ability to analyze data and understand implications for donors and those caring for them, providing immediate data access for participants, periodic access for external analysis, while avoiding duplication of existing systems.

4. Establish the data elements that will be collected from voluntary participants in the Donor Biovigilance system based on objectives and available resources.

Bottom line---improve donor care and experience

Donor HemovigilanceCurrent State versus Ideal State

•Common definitions•Aggregation of data•Standardized Logic

Current State“Facility/Industry Centric”

ARC, ABC, Hospital-based, & PPTAValuable, but limit information

Ideal State“Donor Centric”

Tracks donor safety regardless donation siteUnified voice to FDA, legislation, & vendors

From Kevin Land, MD

We need to all speak the same language

• American Red Cross (ARC)o 15 Complication codes with or without outside medical care

• America’s Blood Centers (ABC)o 8 Categories (24 subcategories)

• International Society of Blood Transfusion(ISBT)o 25 Categories plus grades

• Hospital collection facilities • Canadian Blood Services• NIH• PPTA• Dept of Defense• Others?

Definitions of Donor Events

Categories of Donor Adverse Events: Main

CAT

EGO

RIE

S Nerve Involvement

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma

Vasovagal

Major Cardio/Cerebrovascular Outcomes

Vasovagal

Nerve Irritation

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma

Vasovagal

Major Cardio/ Cerebro-vascular Outcomes

Prefaint: No LOC: lightheaded, feeling of warmth, dizzy, bradycardia, low blood pressure, chills,

weakness, twitching, sweating, pallor, cold extremities

LOC uncomplicated: Any of above symptoms plus LOC< 60sec

LOC complicated—any of above, plusLOC> 60 sec, loss bowel/bladder, convulsion

LOC w injury

Hematoma

Nerve Irritation

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma/Bruise

Vasovagal

Major Cardio/ Cerebro-vascular Outcomes

Only hematomas with symptomsare reported

• Pain • Pressure, swelling, tenderness

• Redness, warmth

Nerve Irritation

Nerve Irritation

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma/Bruise

Vasovagal

Major Cardio/ Cerebro-vascular Outcomes

• Immediate intense pain at site• Parasthesias, numbness, or tingling of arm,

hand or fingers• Shooting pain down arm• Weakness of arm

Allergic

Nerve Irritation

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma/Bruise

Vasovagal

Major Cardio/ Cerebro-vascular Outcomes

Allergic-local• Itching at insertion or bandage site

• Rash/hives at insertion or bandage site• Redness at insertion or bandage site

Allergic-systemic• Anxiousness, restlessness

• Arrhythmias• Cyanosis

• Generalized hives, itching or rash• Blood pressure changes (elevated, low)

• Laryngeal edema with stridor• Pulmonary edema

• Shortness of breath• Sneezing and nasal congestion

• Wheezing

Allergic-anaphylaxis—see systemic plus• Mental Confusion

• Low blood pressure with weakness, pallor• Loss of consciousness

• Gasping for breath, using neck muscles to breath• Swollen tongue, throat, eyes and face

Apheresis

Nerve Irritation

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma/Bruise

Vasovagal

Major Cardio/Cerebro-vascular Outcomes

Apheresis citrate• Cyanosis

• Carpopedal spasm• Chills/shivering

• Circumoral parasthesis• Mental confusion

• Muscle tightening, cramping, tetany• Nausea/vomiting

• Pallor• Pulse variable

• Sharp chest pain• Shock—low blood pressure

• Shortness of breath• Tachycardia/irregular heart beat

• Twitching, tremors (sensation of vibration)

Apheresis-hemolysis• Back/flank pain

• Cyanosis• Hematuria• Confusion

• Red plasma• Shock

• Shortness of breath

Apheresis, embolism• Back/flank pain

• Cyanosis• Mental confusion• Nausea/vomiting• Sharp chest pain

• Shortness of breath

Sequelae

Nerve Involvement

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma

Vasovagal

Major Cardio/Cerebrovascular Outcomes

S: thrombophlebitis

S: Pseudoaneurism

S: AV fistula

S: compartment syn.

S: axillary thrombosis

S: DVT

S: angina <24h

S: MI <24h

S:-TIA<24h

S: CVA<24h

S: cardiac arrest

Sequ

elae

to v

asov

agal

, ci

trat

e or

nee

dle

stic

k in

jury

Arterial Puncture

Nerve Involvement

Major Outcomes due to Needle Insertion

Arterial Puncture

Allergic

Apheresis Related

Hematoma

Vasovagal

Major Cardio/Cerebrovascular OutcomesArterial Puncture

bright red blood, <4 min collection,

Charges1. Determine goals and objectives of the Donor

Biovigilance system. 2. Adopt standardized terminology and definitions.3. Develop a system that will be an electronic, voluntary,

confidential, non-punitive reporting service, focused on improving donor safety. It should be managed by experts with ability to analyze data and understand implications for donors and those caring for them, providing immediate data access for participants, periodic access for external analysis, while avoiding duplication of existing systems.

4. Establish the data elements that will be collected from voluntary participants in the Donor Biovigilance system based on objectives and available resources.

Bottom line---improve donor care and experience

Numerator

Data

DONOR INFORMATION

• Donor Identifier• Facility Identifier• Donor Birth date• Race Ethnicity• Donor History• Number Donations in last year• Gender• Donor Height• Donor Weight

DONATION INFORMATION

• Donation Number• Donation Date• Collection Site• Sponsoring Group• Time needle inserted• Time needle removed• Intended donation type• Intended procedure type• Manufacturer of device• Predonation VS• Hct/Hgb• Plt Count/T Protein

• Bag type/collection container

• Number/type units produced

• Volume removed• Volume infused • Successful donation

REACTION INFORMATION

• Date Reaction Began

• Time Reaction Began

• Time Reaction Ended

• Location of Reaction

• Reaction Type

• Symptoms

• Resolution of Acute Reaction

• Outside Medical Care

• Outcome

• Resolution Date (Prolonged Reaction)

• Sequelae

• Date/time of Sequelae

Denominator

Data

DenominatorsAttribute/Dimension Denominator items

Total # Total Donations (donations = collections = needle in arm)

Donation Type # allogeneic collections# autologous collections# directed collections# therapeutic donations# other donations

Procedure Type # whole blood donations# sample only donations# apheresis plts donations# apheresis 2 rbc donations# apheresis plasma donations

# apheresis plts and plasma donations# apheresis plts and rbc donations# apheresis leukocytes donations

DenominatorsAttribute/Dimension Denominator items

Pre-Donation Pulse # donations with pulse < 70

# donations with pulse 70 – 100# donations with pulse > 100

Pre- Donation Blood Pressure # donations with diastolic bp < 60

# donations with diastolic bp 60 – 90

# donations with diastolic bp > 90Height # donations with height < 60

# donations with height 60-63# donations with height 64-67

# donations with height 68 to 72# donations with height > 72

Weight # donations with weight < 110

DenominatorsAttribute/Dimension Denominator items

Sponsor Group Type # donations at high schools# donations at colleges

# donations at military drives

# donations at work place drives# donations at other drives

Device # collections with TRIMA

# collections with SPECTRA# collections with CYMBAL

Container # collections with Terumo# collections with Baxter# collections with Caridian

Gender # collections from male donors

# collections from female donors

DenominatorsAttribute/Dimension Denominator items

Ethnicity # donations from Hispanics

# donations from Non-HispanicsAge # donations from 16-18 yo

# donations from 19-22 yo# donations from 23-29 yo# donations from 30-39 yo# donations from 40-49 yo# donations from 50-59 yo# donations > 60 yo

Donation History # donations from first time donors

# donations from repeat donors

Collection Site # donations at inside set up mobile# d i fi d i

aaBB Donor Biovigilance Pilot• Date of Implementation: July 1, 2009

• Demographic data: Donor IDDemographic data: SafeTrace

• Donor Incident Report form--manual

• Data entry limited to 2 employees, Medical Reviewers

• All incident reports reviewed by Medical Director

aaBB Donor Biovigilance Pilot• Donor ID—at physical exam

– Data captured electronically– Data entered (DHV) manually– Pulse– Blood Pressure– Temperature– Weight (<115, >115)– General appearance– Arm check– Has donor eaten in last 6 hr

aaBB Donor Biovigilance Pilot• Donor ID—at phlebotomy

– Data captured using handheld scanner

– Lot number (drop down menu)– Tubes barcode scanned– Arm selection (L, R)– Start time– Stop time– Reaction (Y,N)

• Healthcare ID has new module for entry of donor reaction data

AABB Donor Biovigilance Pilot

• Donor has a reaction or incident Documented manually for now on form Form redesigned to expedite data recording at time of

incident Form redesigned to expedite data entry into aaBB

Donor BV database

• Form designed with multiple check boxes to minimize written recording

Charges1. Determine goals and objectives of the Donor

Biovigilance system. 2. Adopt standardized terminology and definitions.3. Develop a system that will be an electronic, voluntary,

confidential, non-punitive reporting service, focused on improving donor safety. It should be managed by experts with ability to analyze data and understand implications for donors and those caring for them, providing immediate data access for participants, periodic access for external analysis, while avoiding duplication of existing systems.

4. Establish the data elements that will be collected from voluntary participants in the Donor Biovigilance system based on objectives and available resources.

Bottom line---improve donor care and experience

•Based in College Station, TX

•BASIS website, created for the Office of Public Health and Science•

•BASIS allows DHHS to gather and analyze blood collection and usage data, helping them improve blood resource management policies & procedures•.

•Same technology for donor system

KBSI-Knowledge Based Systems, Inc

Reports

18 mo data: July 2009- Dec 2010 Reports-Key Metrics

18 mo data: July 2009- Dec 2010

Reports-Key Metrics

18 mo data: July 2009- Dec 2010

Reports-Key Metrics

Reports-Drill Down

Confidence Interval Reports:

Rx Type: Needlestick

Injuries

Category: Nerve Irritation

Reports-Confidence

Interval

Rx Type: Needlestick Injuries

Category: Nerve Irritation

Confidence Interval Reports:

Rx Type: Needlestick

Injuries

Category: Nerve Irritation

Custom Analysis Reports

18 months data: July 2009 through December 2010

Vasovagal Rates by Gender

All Reactions by Gender

Needle Stick Related Incidents

Reaction Rate by Donation History

All Reactions

Vasovagal ReactionsNeedle Stick Related

VV Reaction rate by Donation Type

VV Reactions by Donation Site

What Does All this Data tell us?

Next Steps

• Short term– Device and kit vigilance

• Medium term– National level reports

• Long term– Multivariate analysis

Summary• To compile data nationwide we have to

use the same language: identical or mappable definitions of reactions

• To really know what is going on in your center you have to start looking systematically

• When you start looking you never know what you will find…..

• It’s all about the donor……